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#Darbepoetin Alfa injection
omkarmeds · 16 days
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What is the importance of a Phlegm suction machine?
If you have been wondering how to clear phlegm this is the right time to give Tynor Mucus Suction Machine a try.
If someone is experiencing it or a family member is a patient of the same condition, then it becomes a tiresome process to help the throat expel the phlegm and mucus. Sometimes, you may struggle to cough it up when it is excessive, and this ends up tiring you. This is where Tynor’s phlegm suction machine can be of great assistance in the process. Being one of the leading orthopedic appliance manufacturers in India, Tynor has an efficient mucus suction machine to avail.
The Phlegm Suction Machine is an apparatus that helps to suck out thick phlegm that accumulates in the throat and airway passages of patients suffering from throat ailments such as sore throat, flu, and throat cancer.
It employs a vacuum pump and the suction tubes to administer negative pressure whereby the mucus is pulled up gently, not by a forceful cough.
The Tynor Products in Bangalore such as suction machine has standard accessories like a 0.5 HP oil-free diaphragm vacuum pump for suction purposes. It has a two-chamber design – one chamber to place the sucked mucus and another, empty chamber which catches any spillage. This high-quality device came with pressure control knobs to allow comfortable suction as desired. This makes the disposable silicone suction tubes provide hygienic mucus removal.
What People With CF Need to Know About a Mucus Suction Machine?
Excessive phlegm and mucus can be caused by conditions like:
Chronic bronchitis
Pneumonia
Asthma
Chronic bronchitis and emphysema or also known as chronic obstructive pulmonary disease (COPD).
Cystic fibrosis
Lung infections
Irrespective of the fact that people with the flu often try to eliminate all that mucus by coughing, the exercise can be exhausting and unappreciated. Just through coughing, one can be forced to develop chest complications, not mentioning when done on a long-term basis. This is where the Tynor phlegm suction machine can really come in handy for people like me. Husk well that it removes mucus without straining or tiring which helps to keep the airways open.
The technique is particularly valuable for geriatric patients, newborns, and patients with critical health conditions who cannot produce a forceful cough on their own. The mucus suction machine is another device that conveniently sucks phlegm from the patient without any much demand.
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Tynor Mucus Suction Machine Product Features Below are the following features of the mucus suction machine;
For patients requiring assistance in removing phlegm, Tynor presents one of the best mucus suction machines. Salient features include:
Vacuum pump capacity: Ac 0.5 HP, oil-free diaphragm type
Twin jar setup – one mucus collection jar of 800 ml and one jar for overflow protection with 800 ml capacity
It also features adjustable pressure knobs ranging from 0 to 0.8 bar to allow proper suction pressure to be attained.
Low noise operation: Another example of a loud noise which may cause hearing damage is 60 decibels.
A total of 5 disposable tubes and connectors were provided
Strong wheels and handle for perfect manoeuvre
Effective, efficient and clean mucolytic agents
One year warranty
This highly developed equipment enables the patient or the carer to remove unwanted and annoying phlegm and secretion conveniently and without contamination. A variety of pressure settings can be adjusted in relation to an individual, allowing for comfortable suction. The disposable tubes reduce potential for cross-contamination incidents.
There you have it folks, dear reader, and your loved ones who suffer from chronic mucus problems, look no further than the Tynor mucus suction machine! Remove bothersome phlegm effectively without taking a toll on the sensitive tissues and without any risk of infection. This will help lead a healthier life without those problematic mucus congestions all because of this handy device.
Author’s Bio Omkarmeds deals in medical products where it sells a variety of products to healthcare professionals and patients. Our product portfolio entails specialty medicines, injectables, critical care, oncology, antibiotics, orthopedics, surgery goods, physiotherapy aids, mobility devices, patient care, and home healthcare.
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gomedsin · 2 years
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Zynesp Injection
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We all know you love to be ahead of the top news. That's why we’re giving you a sneak peek of the newest innovation from #Brandname: ZYNESP 
ZYNESP Injection is a powerful and revolutionary treatment in drug therapy, so stay tuned for more info to come on how this can help you overall. Zynesp works just like a vaccine for children and helps curb outbreaks of this horrible disease that still happens in many places around the globe. It is used to treat chronic kidney disease and anemia in people who are receiving hemodialysis or peritoneal dialysis. 
Got a hard-to-reach spot that needs attention, irritation, or soothing? #Zynesp is the thing you need to get it under control. You can use all the benefits of immediate power and subcutaneous penetration, for all those nagging situations. The patented formulation provides pain relief faster than ever before, making it ideal for addressing a wide. The ZYNESP injection price is $7 per vial. It is given under the prescription of a professional.
ZYNESP is a pre-filled syringe that contains 40mcg darbepoetin alfa injection. Zynesp injection comes in many strengths - The Zynesp 200mcg strength should be used for patients who have a high risk of developing renal impairment, while the Zynesp 40mcg strength should be used for patients who have a low risk of developing renal impairment.
Stay tuned for more information on Zynesp injection and its benefits.
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modi02 · 1 year
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surgicalhouse · 2 years
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Darbepoetin Alfa Cresp 40 Injections are used for the treatment of Anemia which may cause by kidney disease or cancer chemotherapy and it works by stimulating the bone marrow to produce more red blood cells.
For more details, visit- https://www.surgicalhouses.com/products/Anti-cancer-medicines/darbepoetin-alfa-injection-cresp-40
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Darbepoetin Alfa
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Common Brand Names: Aranesp
Therapeutic Class: Colony stimulating factor, growth factor.
Common Injectable Dosage Forms:
Polysorbate Solution: 25 mcg/mL, 40 mcg/mL, 60 mcg/mL, 100 mcg/mL, 200 mcg/mL
Albumin Solution: 25 mcg/mL, 40 mcg/mL, 60 mcg/mL, 100 mcg/mL, 150 mcg/0.75 mL, 200 mcg/mL, 300 mcg/mL, 500 mcg/mL
Dosage Ranges:
For the treatment of anemia associated with chronic renal failure: The recommended starting dose is 0.45 mcg/mL, administered as a single IV or SC injection once a week. Because of individual variability, doses should be titrated to not exceed target hemoglobin concentration of 12 g/dL. Maintenance doses can be less than the starting dose and some patients have been treated successfully with every other week dosing. Dosage increases should not occur more frequently than every 4 weeks. If hemoglobin increases by more than 1.0 g/dL in a 2-week period, decrease the dose by 25%.
For the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy: The recommended starting dose is 2.25 mcg/kg administered as a weekly SC injection. If hemoglobin increases by more than 1.0 g/dL in a 2-week period or if the hemoglobin concentration exceeds 12 g/dL, the dose should be reduced by 25%.
Administration and Stability: Aranesp should be stored under refrigeration at 2°-8°C (36°-46°F). Do not freeze or shake. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use any vials exhibiting particulate matter or discoloration. Do not dilute or administer with any other drug solutions. Discard any unused portion due to the lack of preservatives.
Pharmacology/Pharmacokinetics: Darbepoetin alfa is an erythropoiesis stimulating protein made in Chinese hamster ovary cells by recombinant DNA technology. It differs from recombinant human erythropoietin in that it contains 5 N-linked oligosaccharide chains instead of 3 chains. Erythropoietin is made in the kidneys and is released into the bloodstream in response to hypoxia. It then stimulates red cell production after interacting with progenitor stem cells. Darbepoetin alfa stimulates erythropoiesis by the same mechanism. Anemia in patients with chronic renal failure is usually caused by a decrease in endogenous erythropoietin production. Subcutaneous administration results in a slow absorption and a half-life of 49 hours. Intravenous administration results in mean terminal half-life of 21 hours.
Drug and Lab Interactions: No known drug interactions exist.
Contraindications/Precautions: Contraindicated in patients with uncontrolled hypertension and in patients with known hypersensitivity to the active ingredient or any of the excipients. High hemoglobin and/or high rates of rise of hemoglobin increase the risk of cardiovascular events, including death. The hemoglobin level should be managed carefully to avoid exceeding a target dose of 12 g/dL or rise of more than 1.0 g/dL in a 2-week period. Blood pressure may rise during treatment and special care should be taken to closely monitor and control blood pressure. Use with caution in patients with chronic renal failure. Pregnancy Category C.
Monitoring Parameters: Hemoglobin, iron stores, blood pressure.
Adverse Effects: The most frequent adverse effects include infection, hypertension, hypotension, myalgia, headache, nausea/vomiting, and diarrhea. The most frequent serious adverse effects include thrombotic events, congestive heart failure, sepsis, and cardiac arrhythmias. There is a theoretical risk for transmission of viral diseases with the use of the albumin (human) solution.
Common Clinical Applications: Effective treatment for anemia associated with chronic kidney failure and anemia associated with chemotherapy.
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bigstudentsublime · 4 years
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DESCRIPTION
Darbepoetin alfa is an erythropoiesis stimulating protein and it has the same mechanism of action as Erythropoietin. Darbepoetin alfa is produced in Chinese Hamster Ovary (CHO) cell line by recombinant DNA technology and is made of 165 amino acids with a molecular weight of about 37 kDa. Compared to Erythropoietin, darbepoetin alfa has two additional N-linked glycosylation sites i.e., 5 N-linked glycosylation sites instead of 3 N-linked glycosylation sites in EPO. The additional N-linked glycosylation sites result in longer half-life (about 3 times higher than EPO) in the human body. Darbepoetin alfa is formulated as a sterile, colorless, preservative-free protein solution for subcutaneous or intravenous injection.
DOSAGE
Missed Dose
If you miss a dose of this medicine, contact your doctor immediately for further instructions.
Overdose
Seek emergency medical treatment or contact the doctor in case of an overdose.
TAKE
Your doctor or nurse will give you this medicine. Kindly do not self administer.
SIDE EFFECTS
Cough
Stomach pain
Redness, swelling, bruising, itching, or a lump at the injection site
Skin rash and itching
Difficulty in breathing
Difficulty in swallowing
Swelling of the face, arms, hands, lower legs, or feet
Excessive tiredness and weakness
Dizziness and fainting
Pale skin
Nausea or vomiting
Diarrhea
Irregular heartbeat
Anxiety
Convulsions (seizures)
Burning, numbness, tingling in the arms and feet
INTERACTIONS
Acetaminophen
Albuterol
Alprazolam
Amlodipine
Aspirin
Atorvastatin
Cholecalciferol
Cyanocobalamin
Filgrastim
Furosemide
WHEN NOT TO USE ACTORISE INJECTION
Pure red cell aplasia
Serious allergic reactions to drug
Uncontrolled hypertension
STORAGE
Keep this medicine out of reach of children
Do not use this medicine after the expiry date
Store in a refrigerator (2–8°C)
Do not freeze
Do not use ACTORISE if you think it has been frozen
Keep the pre-filled syringe in the outer carton to protect from light
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cancermedicines1122 · 3 years
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darbepoetin alfa
Our goal is to improve the lives of our patients by meeting their healthcare needs with the highest level of service, quality, and convenience. if you want to buy darbepoetin alfa injection online. visit our website. our website is given below. thanks
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newsinsights · 3 years
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Chemotherapy-Induced Myelosuppression Treatment Market Key Players, End User, Demand and by Forecast 2028
A new study by FMI reveals that the chemotherapy-induced myelosuppression treatment market is expected to grow at a subdued 3% y-o-y in 2019. Valued at nearly US$ 7 billion in 2018, gains are likely to be driven by a combination of multipronged factors, including,
Development of natural product interventions for chemotherapy-induced side effects
Growing implementation of radiation treatment in cancer treatment owing to the associated high success rate of chemotherapy
Growing R&D investments in cancer research
The FMI study finds that ‘growth factor’ drugs continued to garner highest revenues in the chemotherapy-induced myelosuppression treatment market. In 2018, over 73% of the chemotherapy-induced myelosuppression treatment market revenues were consolidated in the growth factors. Gains were especially notable for granulocyte-colony stimulating factor or G-CSF, which accounted for over 60% of the global chemotherapy-induced myelosuppression treatment market revenues in 2018.
The FMI study reveals that erythropoietin-stimulating agents (ESA) also accounted for a significant market share, with revenues likely to grow at 2.8% in 2019. In April 2017, FDA announced the removal of risk evaluation and mitigation strategy (REMS) requirement for the use of ESA drugs in myelosuppression treatment. The ESAs used in the treatment of radiation-induced myelosuppression treatment are epoetin alfa and darbepoetin alfa. This has led healthcare professionals to engage in the practice of discussing benefits as well as risks of treatments that include ESAs before initiating the use.
Hematopoietic growth factors have transformed the practice of cancer treatment by allowing stimulation of production of specific cells. With this, use of thrombopoietin receptor agonists is expected to rise rapidly at the rate of 3.5% in 2019.
Injectable Drugs Present Higher Therapeutic Availability over Orals
The FMI study finds that injectable drugs accounted for over 97% of the chemotherapy-induced myelosuppression treatment market revenues in 2018. The status-quo will continue in the future, however, the oral route of administration is expected to garner increasing annual revenues and expected to grow at 4.8% in 2019 over 2018.
Increasing number of research validations related to the benefits of the oral route of administration can be attributed to the higher growth rate of the segment in the future. However, revenues from the injectable route of the administration continue to grow steadily on the back of their higher therapeutic availability over orally administered drugs.
Get Report Sample @ https://www.futuremarketinsights.com/reports/sample/rep-gb-1364
Market Revenues Consolidated in Neutropenia Treatment
According to the study, chemotherapy-induced myelosuppression treatment market revenues heavily consolidated in the neutropenia treatment. In 2018, neutropenia indication accounted for over 62% of market revenues. As neutropenia is one of the most common side effects of chemotherapy wherein prolongation of the same can lead to life-threatening infections. Owing to the severity of the implications, chemotherapy-induced myelosuppression therapeutics are heavily used in the treatment of neutropenia.
Anemia and thrombocytopenia indications also utilize chemotherapy-induced myelosuppression treatment therapeutics. The study finds that revenues in the thrombocytopenia treatment will grow at 3.7% y-o-y in 2019.
Retail Pharmacies Most Prominent Sales Channel
The study opines that chemotherapy-induced myelosuppression treatment therapeutics sales remain higher through retail pharmacies. Suppliers of these therapeutics have extensive distribution network with international retail pharmacies. Due to this, retail pharmacies accounted for over 48% of the chemotherapy-induced myelosuppression treatment market revenues in 2018.
Owing to heavy integration of pharmacies in the hospitals, distribution of chemotherapy-induced myelosuppression treatment therapeutics through hospital pharmacies also account for a considerable share of the market revenues. The study finds that hospital pharmacies can be called the second largest distributor of chemotherapy-induced myelosuppression treatment therapeutics owing to their 45% of the market revenues.
US – The World’s Largest Chemotherapy-induced Myelosupression Treatment Market
FMI reveals that North America accounted for over 82% of the revenues in chemotherapy-induced myelosuppression treatment market in 2018. Presence of leading cancer therapeutics providers, significant R&D investments and established healthcare sector contribute to the bulk of market revenues. The U.S. remains the largest consumer of the chemotherapy-induced myelosuppression treatment market.
Any Questions, ask us @ https://www.futuremarketinsights.com/ask-question/rep-gb-1364
Market revenues in the APEJ region are likely to grow at higher rate owing to improving healthcare facility and growing penetration of advanced cancer care treatments. China, followed by India, accounts for the highest market revenues in APEJ owing to improving economic scenario and developing healthcare infrastructure.
The FMI report analyses chemotherapy-induced myelosuppression treatment market for the forecast period 2018-2028. As per the report, the chemotherapy-induced myelosuppression treatment market is estimated to grow at 3.2% CAGR through 2028.
More Reports from Healthcare Category:
Radiation-Induced Myelosuppression Treatment Market
Neuroendocrine Carcinoma Treatment Market
Parasomnia Treatment Market
About FMI
Future Market Insights (FMI) is a leading provider of market intelligence and consulting services, serving clients in over 150 countries. FMI is headquartered in Dubai, the global financial capital, and has delivery centers in the U.S. and India. FMI's latest market research reports and industry analysis help businesses navigate challenges and make critical decisions with confidence and clarity amidst breakneck competition. Our customized and syndicated market research reports deliver actionable insights that drive sustainable growth. A team of expert-led analysts at FMI continuously tracks emerging trends and events in a broad range of industries to ensure that our clients prepare for the evolving needs of their consumers.
Contact
Mr. Abhishek Budholiya
Unit No: AU-01-H Gold Tower (AU), Plot No: JLT-PH1-I3A,
Jumeirah Lakes Towers, Dubai,
United Arab Emirates
MARKET ACCESS DMCC Initiative
For Sales Enquiries: [email protected]
For Media Enquiries: [email protected]
Press Release: https://www.futuremarketinsights.com/press-release/chemotherapy-induced-myelosuppression-treatment-market
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omkarmeds · 1 month
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Darbepoetin Alfa injection - Where To Find The Best Store?
For one, in sourcing for injections, medications, vaccines or any other supplies for your medical practice, clinic, or hospital, you need a reliable Wholesaler and distributor. For CKD- and chemotherapy-related anemia, the useful injection type of treatment is darbepoetin alfa. Darbepoetin alfa as an effective erythropoiesis-stimulating agent helps increase red blood cell mass and minimizes requirement of RBC transfusions. Therefore, this article is very useful to help people find a good Darbepoetin Alfa injection wholesaler such as OmkarMedS that has a reasonable price.
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OmkarMedS, is a prominent wholesaler and exporter of pharmaceutical products in India that offers a range of high-quality generic injectable drugs and formulations including darbepoetin alfa. Regardless of your medical injections supply requirements, OmkarMedS‘ goal is to bring affordable medicines to healthcare facilities, medical professions, and distributors worldwide.
OmkarMedS supplies all injections and infusion fluids from reliable manufacturers at reasonable prices for healthcare providers. Whether you require darbepoetin alfa or other critically needed generic injectables such as pegfilgrastim, iron sucrose, or methotrexate, you can get them from OmkarMedS’s extensive list of generic affordable prices. Being a reliable wholesaler, OmkarMedS guarantees that items are packed appropriately to arrive in a timely manner to enhance maximum patient care.
As a trusted injection wholesaler, OmkarMedS also guarantees:
Good quality control and clean and hygienic environment that are in compliance with the current cGMP requirements.
Large network of suppliers with sufficient stock to cater for market requirements
Effective cool chain product delivery mechanism
Doing business ethically and the issue of transparency
When you place your wholesale injections from OmkarMedS, you can be assured that what you receive from us is pure FDA approved injections that go through all the stringent tests as far as safety and potency are concerned. OmkarMedS then aims to meet every order as fast and quickly as possible through fast processing and dispatching.
Being one of the top darbepoetin alfa and pharmaceutical injection suppliers, OmkarMedS is always prepared to meet all your requirements and provide the necessary wholesale medicines. Call OmkarMedS today to find out more about how you can get started with our wholesale injection supplies and the services that help healthcare providers throughout India and beyond. Choose a reliable wholesaler, who will not only complement your efforts to improve the quality of treatment, but also to reduce its cost. If you are looking for Wholesaler of injections, consider visiting us!
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greatestlcve · 4 years
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Aranesp Uses, Dosage, Side Effects, Precautions & Warnings
Drug Online
Therapeutic class: Cancerology and hematology Active ingredients: Darbepoetin alfa
Important to know about Aranesp ?
Darbepoetin alfa injections stimulate the body to produce red blood cells.
In case of severe anemia (as can occur in certain kidney diseases), in cancer chemotherapy and prior to surgery if the doctors expect a lot of blood loss.
It takes 2 to 6 weeks for the number of red blood cells to be up to standard.
You usually receive the injections once every 1, 2 or 3 weeks.
Side effects include: increased blood pressure and swollen ankles and feet. Do you suffer a lot from this? Consult your doctor.
Furthermore: hypersensitivity to this medication. You notice that among other things skin rash, itching, fever or tightness. Then warn a doctor.
A rare side effect is thrombosis (blood clot in a blood vessel). You notice thrombosis of sudden pain or swelling in your leg, or chest tightness or shortness of breath. Then immediately notify a doctor.
What is Aranesp used to treat and indication ?
Treatment of symptomatic anemia related to chronic renal insufficiency (CKD) in adults and children ( see Dosage and Method of Administration ).
Treatment of symptomatic anemia in adult patients with non-myeloid malignancies receiving chemotherapy.
aranesp injection dosage
Treatment of symptomatic anemia in adults and children with chronic renal failure
The symptoms and consequences of anemia may vary depending on age, sex and the overall clinical picture; It is necessary for a doctor to evaluate the disease and its evolution. Aranesp can be administered subcutaneously or intravenously to increase hemoglobin to a maximum of 12 g / dl (7.5 mmol / l). The subcutaneous route is preferred in patients who are not hemodialysis, in order to preserve the peripheral veins.
Patients should be closely monitored to ensure that the minimum adequate dose of Aranesp is used to control the symptoms of anemia while maintaining hemoglobinemia less than or equal to 12 g / dL (7.5 mmol / L) . Caution is required when increasing doses of Aranesp in patients with chronic renal failure. Alternative explanations for poor response to treatment should be sought in patients treated with Aranesp who have an insufficient increase in hemoglobin (see Warnings and Precautions and Pharmacodynamic Properties section ).
Due to intra-individual variability, point concentrations of hemoglobin can be observed below and above the desired values. The variability of hemoglobin level should be controlled by adjusting the dosage, relative to the target hemoglobin level between 10 g / dl (6.2 mmol / l) and 12 g / dl (7.5 mmol / l) . Maintaining a hemoglobin level above 12 g / dl (7.5 mmol / l) should be avoided; recommendations for dosage adjustment when the hemoglobin level exceeds 12 g / dl (7.5 mmol / l) are detailed below. An increase of hemoglobin above 2 g / dl (1.25 mmol / l) over a period of 4 weeks should be avoided. If this occurs, the dosage should be adjusted.
Treatment with Aranesp is divided into two phases, corrective phase and maintenance phase. Treatment modalities are presented separately for adults and children.
Adults with chronic renal failure
Corrective phase :
The initial dose is 0.45 μg / kg body weight administered subcutaneously or intravenously as a single weekly injection. In non-dialysis patients, the following initial doses may also be administered subcutaneously as a single injection: 0.75 μg / kg once every two weeks or 1.5 μg / kg once a month. If the increase in hemoglobin is insufficient (less than 1 g / dl [0.6 mmol / l] in four weeks), the dose may be increased by approximately 25%. The dosage should not be increased more than once every four weeks.
If the increase in hemoglobin is greater than 2 g / dl (1.25 mmol / l) over a four-week period, reduce the dose by approximately 25% from the previous dose, depending on the dose. importance of this increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.
The hemoglobin level should be measured once a week or every two weeks until it has stabilized. Then the hemoglobin level can be measured at longer intervals.
Maintenance phase :
In dialysis patients, Aranesp can continue to be administered as a once weekly injection or once every two weeks. Dialysis patients treated with an Aranesp injection every 2 weeks should receive an initial dose of Aranesp equivalent to twice the weekly dose previously administered.
In non-dialysis patients, Aranesp can continue to be administered as a single injection once a week or once every two weeks or once a month. In patients treated with Aranesp once every two weeks, and after the target hemoglobin level has been reached, Aranesp can then be administered by subcutaneous injection once a month using an initial dose equivalent to twice the dose used every two weeks.
The dose administered should be evaluated to maintain the target hemoglobin level.
If a dose adjustment is necessary to maintain hemoglobin at the desired level, it is recommended to increase or decrease the dose by approximately 25% from the previous dose.
If the hemoglobin level increases by more than 2 g / dl (1.25 mmol / l) over a period of 4 weeks, reduce the dose by approximately 25% depending on the significance of this increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.
After each dose or schedule adjustment, the hemoglobin level should be checked once a week or every two weeks. During the maintenance phase, the dosage should not be changed more than once every two weeks.
When the route of administration is changed, the same dose should be used and the hemoglobin should be monitored once a week or every two weeks to adjust the dose to maintain the desired level.
Clinical trials have shown that adult patients receiving r-HuEPO once, twice or three times a week may receive Aranesp once weekly or once every 2 weeks. The initial weekly dose of Aranesp (μg / week) can be calculated by dividing the total weekly dose of r-HuEPO (IU / week) by 200. The initial dose of Aranesp administered every 2 weeks (μg / 2 weeks) can be calculated by dividing by 200 the total dose of r-HuEPO administered over a 2-week period. Due to individual variability, the search for the optimal therapeutic dose should be done for each patient. When replacing r-HuEPO with Aranesp, the rate of
Children with chronic renal failure
Treatment of children under 1 year of age has not been studied in randomized clinical trials.
Corrective phase :
In children from 1 year of age, the initial dose is 0.45 μg / kg body weight administered subcutaneously or intravenously as a single weekly injection. In non-dialysis patients, an initial dose of 0.75 μg / kg can be administered subcutaneously as a single injection once every two weeks. If the increase in hemoglobin is insufficient (less than 1 g / dl [0.6 mmol / l] in four weeks), the dose may be increased by approximately 25% . The dosage should not be increased more than once every four weeks .
If the increase in hemoglobin is greater than 2 g / dl (1.25 mmol / l) over a four-week period, reduce the dose by approximately 25% from the previous dose, depending on the level. increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.
The hemoglobin level should be measured once a week or every two weeks until it has stabilized. Then the hemoglobin level can be measured at larger intervals.
Correction of anemia in pediatric patients with a monthly administration frequency of Aranesp has not been studied.
Maintenance phase :
In children from 1 year of age, during the maintenance phase, Aranesp can continue to be administered as a single once-weekly injection or once every two weeks.
In patients younger than 6 years of age, higher doses may be needed to maintain target hemoglobin levels compared to patients 6 years of age and older. Dialysis patients treated with an Aranesp injection every 2 weeks should receive an initial dose of Aranesp equivalent to twice the weekly dose previously administered.
In patients 11 years of age and older who are not on dialysis, once the target hemoglobin level is reached by one dose every two weeks, Aranesp can be administered by subcutaneous injection once a month. using an initial dose equivalent to twice the dose used every two weeks.
Clinical data available in children have shown that patients receiving r-HuEPO two or three times a week can receive Aranesp once a week, and those receiving r-HuEPO once per week could benefit from administration of Aranesp once every two weeks. The initial weekly dose of Aranesp (μg / week) in pediatrics can be calculated by dividing the total weekly dose of r-HuEPO (IU / week) by 240. The initial dose of Aranesp (μg / week) to be administered every two weeks in pediatrics can be calculated by dividing the total dose of r-HuEPO (UI / week) over two weeks by 240. Due to individual variability, the search for the optimal therapeutic dose should be performed for each patient.
The dose administered should be periodically evaluated to maintain the target hemoglobin level.
If a dose adjustment is necessary to maintain hemoglobin at the desired level, it is recommended to increase or decrease the dose by approximately 25% from the previous dose.
If the hemoglobin level increases by more than 2 g / dl (1.25 mmol / l) in 4 weeks, reduce the dose by approximately 25% depending on the importance of this increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.
Patients starting dialysis during Aranesp therapy should be closely monitored for adequate control of their hemoglobin levels.
After each adjustment in dose or rate of administration, the hemoglobin level should be checked once a week or every two weeks. During the maintenance phase, the dosage should not be changed more than once every two weeks.
When the route of administration is changed, the same dose should be used and hemoglobin should be monitored once a week or every two weeks to adjust the dose to maintain the desired hemoglobin level.
Treatment of symptomatic anemia induced by chemotherapy in cancer patients
Aranesp should be administered subcutaneously to patients with anemia (eg, hemoglobin ≤ 10 g / dl (6.2 mmol / l)) to achieve a hemoglobin level not exceeding 12 g / dl (7.5 mmol / l). The symptoms and consequences of anemia may vary depending on age, sex and the overall clinical picture; It is necessary for a doctor to evaluate the disease and its evolution.
Due to intra-individual variability, point concentrations of hemoglobin can be observed below and above the desired values. The variability in hemoglobin levels should be controlled by adjusting the dose to the target hemoglobin level between 10 g / dl (6.2 mmol / l) and 12 g / dl (7.5 mmol / l). Maintaining a hemoglobin level greater than 12 g / dl (7.5 mmol / l) should be avoided; recommendations for dosage adjustment when the hemoglobin level exceeds 12 g / dl are detailed below.
The recommended starting dose is 500 pg (6.75 μg / kg body weight), administered once every three weeks, or 2.25 μg / kg body weight given once a week. If the clinical response (fatigue, hemoglobin level) is not satisfactory after nine weeks of treatment, continued treatment may be ineffective.
Aranesp treatment should be discontinued approximately four weeks after the end of chemotherapy.
Once the individual therapeutic goal is reached, the dose should be reduced by 25 to 50% to ensure that the appropriate minimum dose of Aranesp is used to maintain hemoglobin levels to control the symptoms of anemia. . The choice of a dose of 500 μg, 300 μg or 150 μg should be considered.
Patients should be closely monitored. If the hemoglobin level exceeds 12 g / dl (7.5 mmol / l), the dose should be reduced by approximately 25-50%. Aranesp treatment should be temporarily discontinued if the hemoglobin level exceeds 13 g / dl (8.1 mmol / l). Treatment will be resumed at approximately 25% lower than the previous dose when the hemoglobin level has dropped to 12 g / dl (7.5 mmol / l) or less.
If the hemoglobin level increases by more than 2 g / dl (1.25 mmol / l) over a period of four weeks, the dose should be reduced by 25 to 50%.
Administration mode
Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 micrograms solution for injection in pre-filled syringe
Aranesp is administered subcutaneously or intravenously as described under Dosage. Alternate injection sites and inject slowly to avoid discomfort at the injection site.
Aranesp is presented in a pre-filled syringe ready for injection.
Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 micrograms solution for injection in pre-filled pen
Aranesp in pre-filled pen is intended for subcutaneous administration only.
Alternate injection sites to avoid discomfort at the injection site.
Aranesp is presented in pre-filled pen ready for injection.
Aranesp 25, 40, 60, 100, 200, 300 micrograms solution for injection in vial
Aranesp is administered subcutaneously or intravenously as described under Dosage.
Alternate injection sites and inject slowly to avoid discomfort at the injection site.
Aranesp is presented in a ready-to-use bottle.
For instructions on use, handling and disposal, see section Instructions for use, handling and disposal .
what is aranesp contraindications
CONTRA-INDICATED:
– Known hypersensitivity to darbepoetin alfa, to r-HuEPO or to any of the excipients.
– Poorly controlled arterial hypertension.
– Cases of erythroblastopenia due to neutralizing antibodies directed against erythropoietin have been reported with recombinant erythropoietins, including darbepoetin alfa. These neutralizing antibodies cross-react with other erythropoietins and a relay treatment with darbepoetin alfa should not be initiated in a patient for whom the presence of neutralizing antibodies is suspected or confirmed.
– Breast-feeding: as there is no clinical experience in women during breast-feeding, it is recommended not to administer Aranesp to women who are breast-feeding. When treatment with Aranesp is absolutely indicated, breast-feeding should be discontinued.
ADVISED AGAINST:
Pregnancy: No clinical data are available in pregnant women. Animal studies have not shown any deleterious effects on gestation, embryofoetal development, parturition or postnatal development.
Precautionary measures are required when prescribing in pregnant women.
Aranesp Side Effects
In addition to the desired effect, this medicine can cause side effects.
The main side effects are the following.
Sometimes (from 10 to 30 people in 100)
Increased blood pressure . You should only use this medicine if the blood pressure is good. If necessary, you can give blood pressure reducers to your doctor. Very rarely (in fewer than 1 in 100 people) suddenly a strongly increased blood pressure occurs. Warn your doctor with muscle twitches and sudden migraine-like headaches (vigorous throbbing unilateral headache).
Edema . You will notice this especially with swollen ankles and feet. Consult your doctor if you have a lot of problems with this.
Hypersensitivity to darbepoetin alfa. This can be seen, among other things, in unexplained fatigue, tightness in itching or hives, skin rash, skin redness, flu-like symptoms, fever, muscle pain, tightness or fainting. Stop using and consult your doctor. In very rare cases, a serious skin condition can develop with fever and blistering. The blisters mainly develop on the lips and on the mucous membranes of the mouth and genitals. Then immediately notify a doctor or go to the First Aid Service. You can not use this medicine in the future. Therefore tell the pharmacy that you are hypersensitive to darbepoetin alfa. The pharmacy team can then ensure that you do not get this remedy again.
Rarely (from 1 to 10 in 100 people)
Headache.
Pain at the injection site . This will pass after some time.
Formation of blood clots in the vessels (thrombosis), especially at the site of the injection needle. Do not use this medicine if you have an increased risk of thrombosis or if you have ever had a heart attack or stroke due to thrombosis. Your doctor may combine the treatment of darbepoietin with anticoagulants.
Stroke (cerebral infarction). You will notice this mainly by sudden complaints. These may be paralysis in the face (crooked mouth for example), confused speaking and thinking, paralysis of the arm or leg, loss of vision, and tingling. Tell a doctor immediately.
Very rare (affects less than 1 in 100 people)
Epileptic seizures . Then tell your doctor.
Too much potassium in the blood . This can be seen in an irregular heartbeat (often the first symptom), numbness or strange sensations in the arms and legs, lethargy, confusion and weakness. Consult your doctor for these symptoms.
If there are enough red blood cells in your blood and you still use darbepoietin alfa, it can happen that too many blood cells occur. This causes too much blood and increased blood pressure, especially if the number of red blood cells rises very quickly. That is why the doctor checks the blood regularly and keeps an eye on whether the increase does not go too fast. Consult your doctor if you suffer too much from any of the above mentioned side effects or if you experience other side effects that you are worried about.
Aranesp Interactions
The clinical results available to date have not shown any interaction between darbepoetin alfa and other substances.
However, there is a potential risk of drug interaction with substances with a high binding affinity for red blood cells such as ciclosporin and tacrolimus.
If Aranesp is administered concurrently with any of these treatments, their blood levels should be monitored and their dose adjusted according to the increase in hemoglobin.
Aranesp Warnings and Precautions
Overview
In order to improve the traceability of erythropoiesis stimulating agents (ESAs), the commercial name of the ESA administered should be clearly recorded in the patient’s chart.
Blood pressure should be monitored in all patients, especially during the initiation phase of Aranesp therapy. If blood pressure is difficult to control after appropriate measures are taken, hemoglobin levels can be reduced by decreasing the dosage or by spacing Aranesp injections (see Dosage and Method of Administration ). . Cases of severe hypertension, including hypertensive crises, hypertensive encephalopathy, and seizures have been observed in CKD patients treated with Aranesp.
To ensure effective erythropoiesis, martial status should be controlled in all patients, before and during treatment, iron supplementation may be required.
The lack of response to treatment with Aranesp should lead quickly to investigate the causes. A deficiency of iron, folic acid or vitamin B12 decreases the effectiveness of ESAs and must be corrected. Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, severe aluminum intoxication, underlying hematological disease or myelofibrosis may also alter the erythropoietic response. The count of reticulocytes is an element of evaluation of the medullary activity. If usual causes of no response have been excluded, and if the patient has reticulopenia, bone marrow examination should be considered. If the bone marrow biopsy is compatible with PRCA, a search for
Pure red cell aplasia due to neutralizing antibodies to erythropoietin has been reported with ESAs, including Aranesp. This has mainly been reported in patients with chronic renal failure treated subcutaneously. These neutralizing antibodies cross-react with other epoetins and Aranesp relay therapy should not be initiated in a patient for whom the presence of neutralizing antibodies is suspected or confirmed (see section 4.8 ).
A paradoxical decrease in hemoglobin and the development of severe anemia associated with a low number of reticulocytes should prompt rapid discontinuation of epoetin and an anti-erythropoietin antibody test. Cases have been reported in patients with hepatitis C treated with interferon and ribavirin when epoetins are used concomitantly. Epoetins are not indicated for the treatment of anemia associated with hepatitis C.
The existence of a progressive liver pathology was an exclusion criterion for all studies with Aranesp. Therefore, no data are available in patients with hepatic impairment. Since the liver is considered the main route of elimination of darbepoetin alfa and r-HuEPO, Aranesp should be used with caution in patients with liver disease.
Aranesp should also be used with caution in patients with sickle cell anemia.
Misuse of Aranesp in healthy subjects may result in an excessive increase in hematocrit. This can be associated with life-threatening cardiovascular complications.
The protective cap of the pre-filled syringe or pre-filled pen contains natural rubber (a derivative of the latex) that can cause allergic reactions.
Aranesp should be used with caution in patients with epilepsy. Seizures have been reported in patients treated with Aranesp.
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie it is considered essentially “sodium-free”.
Chronic renal failure patients
In patients with chronic renal impairment, the hemoglobin level during the maintenance phase should not exceed the upper limit of the target hemoglobin level recommended under Dosage and Method of Administration . In clinical studies, an increase in the number of deaths, serious cardiovascular or cerebrovascular events, including stroke, and vascular thrombosis at the access point was observed when ESAs were administered in order to achieve Hemoglobin targets greater than 12g / dl (7.5 mmol / l).
Caution should be exercised with dose escalation of Aranesp in patients with chronic renal failure, as high cumulative doses of epoetin may be associated with an increased risk of mortality and serious cardiovascular and cerebrovascular events. In patients aynt a poor response to epoetins, other factors behind the poor response should be considered (see Dosage and Administration and Pharmacodynamic properties ).
Controlled clinical trials did not demonstrate any significant benefits attributable to epoetin administration when hemoglobin levels were increased beyond values ​​to control the symptoms of anemia and to avoid the use of transfusions. blood.
Iron supplementation is recommended for all patients with serum ferritin levels below 100 pg / l or transferrin saturation <20%.
Serum potassium should be monitored regularly during treatment with Aranesp. Potassium elevation has been reported in a few patients treated with Aranesp, although the causal link has not been established. If there is a high level or an increase in serum potassium, discontinuation of Aranesp should be considered until serum potassium is normalized.
Cancer patients
Effect on tumor growth
Epoetins are growth factors that essentially stimulate the production of red blood cells. Erythropoietin receptors would be expressed on the surface of different types of tumor cells. Like any growth factor, epoetins may stimulate growth of tumors. In several controlled studies in which epoetins have been administered, there has been no improvement in overall survival or decreased risk of tumor progression in patients with cancer-associated anemia.
In controlled clinical studies, the use of Aranesp and other ESAs has shown:
a shortening of time to tumor progression in patients with advanced head and neck cancer receiving radiotherapy when ESAs were administered to achieve target hemoglobin levels greater than 14 g / dl (8.7 mmol / l). ESAs are not indicated for use in this patient population.
a decrease in overall survival and an increase in the number of deaths at 4 months, attributed to disease progression, in patients with metastatic breast cancer receiving chemotherapy, when ESAs were administered for the purpose of target hemoglobin levels of between 12 and 14 g / dl (7.5-8.7 mmol / l).
an increased risk of death when ESAs were administered to achieve a target hemoglobin level of 12 g / dl (7.5 mmol / l) in patients with active malignancy who were not receiving chemotherapy, nor radiotherapy. ESAs are not indicated for use in this patient population.
In view of the above information, in certain clinical situations, blood transfusion should be the preferred treatment for anemia in cancer patients. The decision to administer recombinant epoetins should be based on a benefit-risk assessment taking into account the patient’s opinion in its specific clinical context. Factors to be considered in this assessment should include the type of tumor and its stage, the degree of anemia, life expectancy, the environment in which the patient is treated and the patient’s preference (see section 5.1 ). .
If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l) in patients with solid tumors or lymphoproliferative malignancies, strictly adhere to the dose adjustment described in section Dosage and method of administration , in order to minimize the possible risks of thromboembolic events. Platelet count and hemoglobin should also be monitored at regular intervals.
Drive and use machines
Aranesp has no or negligible influence on the ability to drive and use machines.
Aranesp and PREGNANCY / BREAST FEEDING
aranesp in pregnancy
There are no relevant and well-conducted studies regarding the use of Aranesp in pregnant women.
Animal studies have not shown deleterious effects on pregnancy, embryo-fetal development, parturition or postnatal development. No alteration of fertility was detected.
Caution is required when prescribing Aranesp in pregnant women.
Women whose pregnancies occur during treatment with Aranesp should be encouraged to enroll in the Amgen Pregnancy Surveillance Program. The contact details are in section 6 of the package leaflet.
aranesp in Breastfeeding
It is not known if Aranesp is excreted in breast milk. A risk for infants can not be ruled out.
The decision to discontinue breastfeeding or discontinue / abstain from treatment with Aranesp should be made with regard to the benefit of breastfeeding for the child and the benefit of treatment for the woman.
What should I do if I miss a dose?
If you inject yourself:
have you forgotten a dose and are you discovering it the same day? 
Use the dose as yet.
Do you discover it the next day? 
Consult your doctor.
 Never use a double dose.
What happens if I overdose from Aranesp ?
The maximum amount of Aranesp that can be safely administered at single or multiple doses has not been determined.
Aranesp treatment may result in polycythemia if the hemoglobin level is not closely monitored and the dose adjusted properly.
Cases of severe arterial hypertension have been observed after an overdose with Aranesp ( see Warnings and Precautions ).
In case of polycythemia, treatment with Aranesp should be temporarily interrupted ( see Dosage and Method of Administration ).
A bleeding can be performed in case of clinical need.
What is  Forms and Composition?
SC or IV solution for injection (clear, colorless) at 10 μg (25 μg / ml):   0.4 ml pre-filled syringe * with 27 G needle, unitary box. Injection solution SC or IV (clear, colorless) at 20 μg (40 μg / ml):   Pre-filled syringe * 0.5 ml secure with 27 G needle, unitary box.
SC or IV solution for injection (clear, colorless) at 30 μg (100 μg / ml):   0.3 ml pre-filled syringe * with 27 G needle, unitary box. SC or IV (clear, colorless) solution for injection at 40 μg (100 μg / ml):   0.4 ml secure * pre-filled syringe with 27 G needle, single unit.
Injection solution SC (clear, colorless) at 40 μg (100 μg / ml):   0.4 ml pre-filled pen * (SureClick) containing a 27 G needle syringe, unitary box.
Injection solution SC or IV (clear, colorless) at 50 μg (100 μg / ml):   Pre-filled syringe * 0.5 ml secure with 27 G needle, single box.
SC or IV solution for injection (clear, colorless) at 60 μg (200 μg / ml):   0.3 ml pre-filled syringe * with 27 G needle, unitary box.
Solution for injection SC (clear, colorless) at 60 μg (200 μg / ml):   0.3 ml pre-filled pen * (SureClick) containing a 27 G needle syringe, unitary box.
SC or IV injection solution (clear, colorless) at 80 μg (200 μg / ml):   0.4 ml secure * pre-filled syringe with 27G needle, single unit.
Injection solution SC (clear, colorless) at 80 μg (200 μg / ml):   0.4 ml pre-filled pen * (SureClick) containing a 27 G needle syringe, unitary box.
SC or IV solution for injection (clear, colorless) at 100 μg (200 μg / ml):   Pre-filled syringe * 0.5 ml secure with 27 G needle, single unit.
Solution for injection SC (clear, colorless) at 100 μg (200 μg / ml):   0.5 ml pre-filled * pen (SureClick) containing a 27 G needle syringe, unitary box.
SC or IV (clear, colorless) solution for injection at 130 μg (200 μg / ml):   0.65 ml pre-filled * safety syringe with 27 G needle, single unit.
SC or IV solution for injection (clear, colorless) at 150 μg (500 μg / ml):   0.3 ml pre-filled syringe * with 27 G needle, single box.
Solution for injection SC (clear, colorless) at 150 μg (500 μg / ml):   0.3 ml pre-filled * pen (SureClick) containing a 27 G needle syringe, unitary box.
SC or IV injection solution (clear, colorless) to 300 micrograms (500 micrograms / ml):   Pre-filled syringe * Secure 0.6 ml with 27 G needle, unitary box.
Solution for injection SC (clear, colorless) 300 μg (500 μg / ml):   * Prefilled pen * (SureClick) 0.6 ml containing a syringe with 27 G needle, unitary box.
Solution for injection SC or IV (clear, colorless) at 500 μg (500 μg / ml):   1 ml pre-filled syringe * with 27 G needle, unitary box.
Solution for injection SC (clear, colorless) 500 μg (500 μg / ml):   1 ml pre-filled *pen (SureClick) containing a 27 G needle syringe, unitary box.
*  The protective cap of the pre-filled syringe or pre-filled pen contains natural rubber (a derivative of the latex): see Warnings and Precautions for Use .
NOT’s
Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:
general information:
Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles
Additional information:
General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.
Special warnings:
For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.
Side effects:
It treats possible side effects and drug interactions that require attention and its effect on continuous use.
The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
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Aranesp Uses, Dosage, Side Effects, Precautions & Warnings
Drug Online
Therapeutic class: Cancerology and hematology Active ingredients: Darbepoetin alfa
Important to know about Aranesp ?
Darbepoetin alfa injections stimulate the body to produce red blood cells.
In case of severe anemia (as can occur in certain kidney diseases), in cancer chemotherapy and prior to surgery if the doctors expect a lot of blood loss.
It takes 2 to 6 weeks for the number of red blood cells to be up to standard.
You usually receive the injections once every 1, 2 or 3 weeks.
Side effects include: increased blood pressure and swollen ankles and feet. Do you suffer a lot from this? Consult your doctor.
Furthermore: hypersensitivity to this medication. You notice that among other things skin rash, itching, fever or tightness. Then warn a doctor.
A rare side effect is thrombosis (blood clot in a blood vessel). You notice thrombosis of sudden pain or swelling in your leg, or chest tightness or shortness of breath. Then immediately notify a doctor.
What is Aranesp used to treat and indication ?
Treatment of symptomatic anemia related to chronic renal insufficiency (CKD) in adults and children ( see Dosage and Method of Administration ).
Treatment of symptomatic anemia in adult patients with non-myeloid malignancies receiving chemotherapy.
aranesp injection dosage
Treatment of symptomatic anemia in adults and children with chronic renal failure
The symptoms and consequences of anemia may vary depending on age, sex and the overall clinical picture; It is necessary for a doctor to evaluate the disease and its evolution. Aranesp can be administered subcutaneously or intravenously to increase hemoglobin to a maximum of 12 g / dl (7.5 mmol / l). The subcutaneous route is preferred in patients who are not hemodialysis, in order to preserve the peripheral veins.
Patients should be closely monitored to ensure that the minimum adequate dose of Aranesp is used to control the symptoms of anemia while maintaining hemoglobinemia less than or equal to 12 g / dL (7.5 mmol / L) . Caution is required when increasing doses of Aranesp in patients with chronic renal failure. Alternative explanations for poor response to treatment should be sought in patients treated with Aranesp who have an insufficient increase in hemoglobin (see Warnings and Precautions and Pharmacodynamic Properties section ).
Due to intra-individual variability, point concentrations of hemoglobin can be observed below and above the desired values. The variability of hemoglobin level should be controlled by adjusting the dosage, relative to the target hemoglobin level between 10 g / dl (6.2 mmol / l) and 12 g / dl (7.5 mmol / l) . Maintaining a hemoglobin level above 12 g / dl (7.5 mmol / l) should be avoided; recommendations for dosage adjustment when the hemoglobin level exceeds 12 g / dl (7.5 mmol / l) are detailed below. An increase of hemoglobin above 2 g / dl (1.25 mmol / l) over a period of 4 weeks should be avoided. If this occurs, the dosage should be adjusted.
Treatment with Aranesp is divided into two phases, corrective phase and maintenance phase. Treatment modalities are presented separately for adults and children.
Adults with chronic renal failure
Corrective phase :
The initial dose is 0.45 μg / kg body weight administered subcutaneously or intravenously as a single weekly injection. In non-dialysis patients, the following initial doses may also be administered subcutaneously as a single injection: 0.75 μg / kg once every two weeks or 1.5 μg / kg once a month. If the increase in hemoglobin is insufficient (less than 1 g / dl [0.6 mmol / l] in four weeks), the dose may be increased by approximately 25%. The dosage should not be increased more than once every four weeks.
If the increase in hemoglobin is greater than 2 g / dl (1.25 mmol / l) over a four-week period, reduce the dose by approximately 25% from the previous dose, depending on the dose. importance of this increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.
The hemoglobin level should be measured once a week or every two weeks until it has stabilized. Then the hemoglobin level can be measured at longer intervals.
Maintenance phase :
In dialysis patients, Aranesp can continue to be administered as a once weekly injection or once every two weeks. Dialysis patients treated with an Aranesp injection every 2 weeks should receive an initial dose of Aranesp equivalent to twice the weekly dose previously administered.
In non-dialysis patients, Aranesp can continue to be administered as a single injection once a week or once every two weeks or once a month. In patients treated with Aranesp once every two weeks, and after the target hemoglobin level has been reached, Aranesp can then be administered by subcutaneous injection once a month using an initial dose equivalent to twice the dose used every two weeks.
The dose administered should be evaluated to maintain the target hemoglobin level.
If a dose adjustment is necessary to maintain hemoglobin at the desired level, it is recommended to increase or decrease the dose by approximately 25% from the previous dose.
If the hemoglobin level increases by more than 2 g / dl (1.25 mmol / l) over a period of 4 weeks, reduce the dose by approximately 25% depending on the significance of this increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.
After each dose or schedule adjustment, the hemoglobin level should be checked once a week or every two weeks. During the maintenance phase, the dosage should not be changed more than once every two weeks.
When the route of administration is changed, the same dose should be used and the hemoglobin should be monitored once a week or every two weeks to adjust the dose to maintain the desired level.
Clinical trials have shown that adult patients receiving r-HuEPO once, twice or three times a week may receive Aranesp once weekly or once every 2 weeks. The initial weekly dose of Aranesp (μg / week) can be calculated by dividing the total weekly dose of r-HuEPO (IU / week) by 200. The initial dose of Aranesp administered every 2 weeks (μg / 2 weeks) can be calculated by dividing by 200 the total dose of r-HuEPO administered over a 2-week period. Due to individual variability, the search for the optimal therapeutic dose should be done for each patient. When replacing r-HuEPO with Aranesp, the rate of
Children with chronic renal failure
Treatment of children under 1 year of age has not been studied in randomized clinical trials.
Corrective phase :
In children from 1 year of age, the initial dose is 0.45 μg / kg body weight administered subcutaneously or intravenously as a single weekly injection. In non-dialysis patients, an initial dose of 0.75 μg / kg can be administered subcutaneously as a single injection once every two weeks. If the increase in hemoglobin is insufficient (less than 1 g / dl [0.6 mmol / l] in four weeks), the dose may be increased by approximately 25% . The dosage should not be increased more than once every four weeks .
If the increase in hemoglobin is greater than 2 g / dl (1.25 mmol / l) over a four-week period, reduce the dose by approximately 25% from the previous dose, depending on the level. increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.
The hemoglobin level should be measured once a week or every two weeks until it has stabilized. Then the hemoglobin level can be measured at larger intervals.
Correction of anemia in pediatric patients with a monthly administration frequency of Aranesp has not been studied.
Maintenance phase :
In children from 1 year of age, during the maintenance phase, Aranesp can continue to be administered as a single once-weekly injection or once every two weeks.
In patients younger than 6 years of age, higher doses may be needed to maintain target hemoglobin levels compared to patients 6 years of age and older. Dialysis patients treated with an Aranesp injection every 2 weeks should receive an initial dose of Aranesp equivalent to twice the weekly dose previously administered.
In patients 11 years of age and older who are not on dialysis, once the target hemoglobin level is reached by one dose every two weeks, Aranesp can be administered by subcutaneous injection once a month. using an initial dose equivalent to twice the dose used every two weeks.
Clinical data available in children have shown that patients receiving r-HuEPO two or three times a week can receive Aranesp once a week, and those receiving r-HuEPO once per week could benefit from administration of Aranesp once every two weeks. The initial weekly dose of Aranesp (μg / week) in pediatrics can be calculated by dividing the total weekly dose of r-HuEPO (IU / week) by 240. The initial dose of Aranesp (μg / week) to be administered every two weeks in pediatrics can be calculated by dividing the total dose of r-HuEPO (UI / week) over two weeks by 240. Due to individual variability, the search for the optimal therapeutic dose should be performed for each patient.
The dose administered should be periodically evaluated to maintain the target hemoglobin level.
If a dose adjustment is necessary to maintain hemoglobin at the desired level, it is recommended to increase or decrease the dose by approximately 25% from the previous dose.
If the hemoglobin level increases by more than 2 g / dl (1.25 mmol / l) in 4 weeks, reduce the dose by approximately 25% depending on the importance of this increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.
Patients starting dialysis during Aranesp therapy should be closely monitored for adequate control of their hemoglobin levels.
After each adjustment in dose or rate of administration, the hemoglobin level should be checked once a week or every two weeks. During the maintenance phase, the dosage should not be changed more than once every two weeks.
When the route of administration is changed, the same dose should be used and hemoglobin should be monitored once a week or every two weeks to adjust the dose to maintain the desired hemoglobin level.
Treatment of symptomatic anemia induced by chemotherapy in cancer patients
Aranesp should be administered subcutaneously to patients with anemia (eg, hemoglobin ≤ 10 g / dl (6.2 mmol / l)) to achieve a hemoglobin level not exceeding 12 g / dl (7.5 mmol / l). The symptoms and consequences of anemia may vary depending on age, sex and the overall clinical picture; It is necessary for a doctor to evaluate the disease and its evolution.
Due to intra-individual variability, point concentrations of hemoglobin can be observed below and above the desired values. The variability in hemoglobin levels should be controlled by adjusting the dose to the target hemoglobin level between 10 g / dl (6.2 mmol / l) and 12 g / dl (7.5 mmol / l). Maintaining a hemoglobin level greater than 12 g / dl (7.5 mmol / l) should be avoided; recommendations for dosage adjustment when the hemoglobin level exceeds 12 g / dl are detailed below.
The recommended starting dose is 500 pg (6.75 μg / kg body weight), administered once every three weeks, or 2.25 μg / kg body weight given once a week. If the clinical response (fatigue, hemoglobin level) is not satisfactory after nine weeks of treatment, continued treatment may be ineffective.
Aranesp treatment should be discontinued approximately four weeks after the end of chemotherapy.
Once the individual therapeutic goal is reached, the dose should be reduced by 25 to 50% to ensure that the appropriate minimum dose of Aranesp is used to maintain hemoglobin levels to control the symptoms of anemia. . The choice of a dose of 500 μg, 300 μg or 150 μg should be considered.
Patients should be closely monitored. If the hemoglobin level exceeds 12 g / dl (7.5 mmol / l), the dose should be reduced by approximately 25-50%. Aranesp treatment should be temporarily discontinued if the hemoglobin level exceeds 13 g / dl (8.1 mmol / l). Treatment will be resumed at approximately 25% lower than the previous dose when the hemoglobin level has dropped to 12 g / dl (7.5 mmol / l) or less.
If the hemoglobin level increases by more than 2 g / dl (1.25 mmol / l) over a period of four weeks, the dose should be reduced by 25 to 50%.
Administration mode
Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 micrograms solution for injection in pre-filled syringe
Aranesp is administered subcutaneously or intravenously as described under Dosage. Alternate injection sites and inject slowly to avoid discomfort at the injection site.
Aranesp is presented in a pre-filled syringe ready for injection.
Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 micrograms solution for injection in pre-filled pen
Aranesp in pre-filled pen is intended for subcutaneous administration only.
Alternate injection sites to avoid discomfort at the injection site.
Aranesp is presented in pre-filled pen ready for injection.
Aranesp 25, 40, 60, 100, 200, 300 micrograms solution for injection in vial
Aranesp is administered subcutaneously or intravenously as described under Dosage.
Alternate injection sites and inject slowly to avoid discomfort at the injection site.
Aranesp is presented in a ready-to-use bottle.
For instructions on use, handling and disposal, see section Instructions for use, handling and disposal .
what is aranesp contraindications
CONTRA-INDICATED:
– Known hypersensitivity to darbepoetin alfa, to r-HuEPO or to any of the excipients.
– Poorly controlled arterial hypertension.
– Cases of erythroblastopenia due to neutralizing antibodies directed against erythropoietin have been reported with recombinant erythropoietins, including darbepoetin alfa. These neutralizing antibodies cross-react with other erythropoietins and a relay treatment with darbepoetin alfa should not be initiated in a patient for whom the presence of neutralizing antibodies is suspected or confirmed.
– Breast-feeding: as there is no clinical experience in women during breast-feeding, it is recommended not to administer Aranesp to women who are breast-feeding. When treatment with Aranesp is absolutely indicated, breast-feeding should be discontinued.
ADVISED AGAINST:
Pregnancy: No clinical data are available in pregnant women. Animal studies have not shown any deleterious effects on gestation, embryofoetal development, parturition or postnatal development.
Precautionary measures are required when prescribing in pregnant women.
Aranesp Side Effects
In addition to the desired effect, this medicine can cause side effects.
The main side effects are the following.
Sometimes (from 10 to 30 people in 100)
Increased blood pressure . You should only use this medicine if the blood pressure is good. If necessary, you can give blood pressure reducers to your doctor. Very rarely (in fewer than 1 in 100 people) suddenly a strongly increased blood pressure occurs. Warn your doctor with muscle twitches and sudden migraine-like headaches (vigorous throbbing unilateral headache).
Edema . You will notice this especially with swollen ankles and feet. Consult your doctor if you have a lot of problems with this.
Hypersensitivity to darbepoetin alfa. This can be seen, among other things, in unexplained fatigue, tightness in itching or hives, skin rash, skin redness, flu-like symptoms, fever, muscle pain, tightness or fainting. Stop using and consult your doctor. In very rare cases, a serious skin condition can develop with fever and blistering. The blisters mainly develop on the lips and on the mucous membranes of the mouth and genitals. Then immediately notify a doctor or go to the First Aid Service. You can not use this medicine in the future. Therefore tell the pharmacy that you are hypersensitive to darbepoetin alfa. The pharmacy team can then ensure that you do not get this remedy again.
Rarely (from 1 to 10 in 100 people)
Headache.
Pain at the injection site . This will pass after some time.
Formation of blood clots in the vessels (thrombosis), especially at the site of the injection needle. Do not use this medicine if you have an increased risk of thrombosis or if you have ever had a heart attack or stroke due to thrombosis. Your doctor may combine the treatment of darbepoietin with anticoagulants.
Stroke (cerebral infarction). You will notice this mainly by sudden complaints. These may be paralysis in the face (crooked mouth for example), confused speaking and thinking, paralysis of the arm or leg, loss of vision, and tingling. Tell a doctor immediately.
Very rare (affects less than 1 in 100 people)
Epileptic seizures . Then tell your doctor.
Too much potassium in the blood . This can be seen in an irregular heartbeat (often the first symptom), numbness or strange sensations in the arms and legs, lethargy, confusion and weakness. Consult your doctor for these symptoms.
If there are enough red blood cells in your blood and you still use darbepoietin alfa, it can happen that too many blood cells occur. This causes too much blood and increased blood pressure, especially if the number of red blood cells rises very quickly. That is why the doctor checks the blood regularly and keeps an eye on whether the increase does not go too fast. Consult your doctor if you suffer too much from any of the above mentioned side effects or if you experience other side effects that you are worried about.
Aranesp Interactions
The clinical results available to date have not shown any interaction between darbepoetin alfa and other substances.
However, there is a potential risk of drug interaction with substances with a high binding affinity for red blood cells such as ciclosporin and tacrolimus.
If Aranesp is administered concurrently with any of these treatments, their blood levels should be monitored and their dose adjusted according to the increase in hemoglobin.
Aranesp Warnings and Precautions
Overview
In order to improve the traceability of erythropoiesis stimulating agents (ESAs), the commercial name of the ESA administered should be clearly recorded in the patient’s chart.
Blood pressure should be monitored in all patients, especially during the initiation phase of Aranesp therapy. If blood pressure is difficult to control after appropriate measures are taken, hemoglobin levels can be reduced by decreasing the dosage or by spacing Aranesp injections (see Dosage and Method of Administration ). . Cases of severe hypertension, including hypertensive crises, hypertensive encephalopathy, and seizures have been observed in CKD patients treated with Aranesp.
To ensure effective erythropoiesis, martial status should be controlled in all patients, before and during treatment, iron supplementation may be required.
The lack of response to treatment with Aranesp should lead quickly to investigate the causes. A deficiency of iron, folic acid or vitamin B12 decreases the effectiveness of ESAs and must be corrected. Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, severe aluminum intoxication, underlying hematological disease or myelofibrosis may also alter the erythropoietic response. The count of reticulocytes is an element of evaluation of the medullary activity. If usual causes of no response have been excluded, and if the patient has reticulopenia, bone marrow examination should be considered. If the bone marrow biopsy is compatible with PRCA, a search for
Pure red cell aplasia due to neutralizing antibodies to erythropoietin has been reported with ESAs, including Aranesp. This has mainly been reported in patients with chronic renal failure treated subcutaneously. These neutralizing antibodies cross-react with other epoetins and Aranesp relay therapy should not be initiated in a patient for whom the presence of neutralizing antibodies is suspected or confirmed (see section 4.8 ).
A paradoxical decrease in hemoglobin and the development of severe anemia associated with a low number of reticulocytes should prompt rapid discontinuation of epoetin and an anti-erythropoietin antibody test. Cases have been reported in patients with hepatitis C treated with interferon and ribavirin when epoetins are used concomitantly. Epoetins are not indicated for the treatment of anemia associated with hepatitis C.
The existence of a progressive liver pathology was an exclusion criterion for all studies with Aranesp. Therefore, no data are available in patients with hepatic impairment. Since the liver is considered the main route of elimination of darbepoetin alfa and r-HuEPO, Aranesp should be used with caution in patients with liver disease.
Aranesp should also be used with caution in patients with sickle cell anemia.
Misuse of Aranesp in healthy subjects may result in an excessive increase in hematocrit. This can be associated with life-threatening cardiovascular complications.
The protective cap of the pre-filled syringe or pre-filled pen contains natural rubber (a derivative of the latex) that can cause allergic reactions.
Aranesp should be used with caution in patients with epilepsy. Seizures have been reported in patients treated with Aranesp.
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie it is considered essentially “sodium-free”.
Chronic renal failure patients
In patients with chronic renal impairment, the hemoglobin level during the maintenance phase should not exceed the upper limit of the target hemoglobin level recommended under Dosage and Method of Administration . In clinical studies, an increase in the number of deaths, serious cardiovascular or cerebrovascular events, including stroke, and vascular thrombosis at the access point was observed when ESAs were administered in order to achieve Hemoglobin targets greater than 12g / dl (7.5 mmol / l).
Caution should be exercised with dose escalation of Aranesp in patients with chronic renal failure, as high cumulative doses of epoetin may be associated with an increased risk of mortality and serious cardiovascular and cerebrovascular events. In patients aynt a poor response to epoetins, other factors behind the poor response should be considered (see Dosage and Administration and Pharmacodynamic properties ).
Controlled clinical trials did not demonstrate any significant benefits attributable to epoetin administration when hemoglobin levels were increased beyond values ​​to control the symptoms of anemia and to avoid the use of transfusions. blood.
Iron supplementation is recommended for all patients with serum ferritin levels below 100 pg / l or transferrin saturation <20%.
Serum potassium should be monitored regularly during treatment with Aranesp. Potassium elevation has been reported in a few patients treated with Aranesp, although the causal link has not been established. If there is a high level or an increase in serum potassium, discontinuation of Aranesp should be considered until serum potassium is normalized.
Cancer patients
Effect on tumor growth
Epoetins are growth factors that essentially stimulate the production of red blood cells. Erythropoietin receptors would be expressed on the surface of different types of tumor cells. Like any growth factor, epoetins may stimulate growth of tumors. In several controlled studies in which epoetins have been administered, there has been no improvement in overall survival or decreased risk of tumor progression in patients with cancer-associated anemia.
In controlled clinical studies, the use of Aranesp and other ESAs has shown:
a shortening of time to tumor progression in patients with advanced head and neck cancer receiving radiotherapy when ESAs were administered to achieve target hemoglobin levels greater than 14 g / dl (8.7 mmol / l). ESAs are not indicated for use in this patient population.
a decrease in overall survival and an increase in the number of deaths at 4 months, attributed to disease progression, in patients with metastatic breast cancer receiving chemotherapy, when ESAs were administered for the purpose of target hemoglobin levels of between 12 and 14 g / dl (7.5-8.7 mmol / l).
an increased risk of death when ESAs were administered to achieve a target hemoglobin level of 12 g / dl (7.5 mmol / l) in patients with active malignancy who were not receiving chemotherapy, nor radiotherapy. ESAs are not indicated for use in this patient population.
In view of the above information, in certain clinical situations, blood transfusion should be the preferred treatment for anemia in cancer patients. The decision to administer recombinant epoetins should be based on a benefit-risk assessment taking into account the patient’s opinion in its specific clinical context. Factors to be considered in this assessment should include the type of tumor and its stage, the degree of anemia, life expectancy, the environment in which the patient is treated and the patient’s preference (see section 5.1 ). .
If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l) in patients with solid tumors or lymphoproliferative malignancies, strictly adhere to the dose adjustment described in section Dosage and method of administration , in order to minimize the possible risks of thromboembolic events. Platelet count and hemoglobin should also be monitored at regular intervals.
Drive and use machines
Aranesp has no or negligible influence on the ability to drive and use machines.
Aranesp and PREGNANCY / BREAST FEEDING
aranesp in pregnancy
There are no relevant and well-conducted studies regarding the use of Aranesp in pregnant women.
Animal studies have not shown deleterious effects on pregnancy, embryo-fetal development, parturition or postnatal development. No alteration of fertility was detected.
Caution is required when prescribing Aranesp in pregnant women.
Women whose pregnancies occur during treatment with Aranesp should be encouraged to enroll in the Amgen Pregnancy Surveillance Program. The contact details are in section 6 of the package leaflet.
aranesp in Breastfeeding
It is not known if Aranesp is excreted in breast milk. A risk for infants can not be ruled out.
The decision to discontinue breastfeeding or discontinue / abstain from treatment with Aranesp should be made with regard to the benefit of breastfeeding for the child and the benefit of treatment for the woman.
What should I do if I miss a dose?
If you inject yourself:
have you forgotten a dose and are you discovering it the same day? 
Use the dose as yet.
Do you discover it the next day? 
Consult your doctor.
 Never use a double dose.
What happens if I overdose from Aranesp ?
The maximum amount of Aranesp that can be safely administered at single or multiple doses has not been determined.
Aranesp treatment may result in polycythemia if the hemoglobin level is not closely monitored and the dose adjusted properly.
Cases of severe arterial hypertension have been observed after an overdose with Aranesp ( see Warnings and Precautions ).
In case of polycythemia, treatment with Aranesp should be temporarily interrupted ( see Dosage and Method of Administration ).
A bleeding can be performed in case of clinical need.
What is  Forms and Composition?
SC or IV solution for injection (clear, colorless) at 10 μg (25 μg / ml):   0.4 ml pre-filled syringe * with 27 G needle, unitary box. Injection solution SC or IV (clear, colorless) at 20 μg (40 μg / ml):   Pre-filled syringe * 0.5 ml secure with 27 G needle, unitary box.
SC or IV solution for injection (clear, colorless) at 30 μg (100 μg / ml):   0.3 ml pre-filled syringe * with 27 G needle, unitary box. SC or IV (clear, colorless) solution for injection at 40 μg (100 μg / ml):   0.4 ml secure * pre-filled syringe with 27 G needle, single unit.
Injection solution SC (clear, colorless) at 40 μg (100 μg / ml):   0.4 ml pre-filled pen * (SureClick) containing a 27 G needle syringe, unitary box.
Injection solution SC or IV (clear, colorless) at 50 μg (100 μg / ml):   Pre-filled syringe * 0.5 ml secure with 27 G needle, single box.
SC or IV solution for injection (clear, colorless) at 60 μg (200 μg / ml):   0.3 ml pre-filled syringe * with 27 G needle, unitary box.
Solution for injection SC (clear, colorless) at 60 μg (200 μg / ml):   0.3 ml pre-filled pen * (SureClick) containing a 27 G needle syringe, unitary box.
SC or IV injection solution (clear, colorless) at 80 μg (200 μg / ml):   0.4 ml secure * pre-filled syringe with 27G needle, single unit.
Injection solution SC (clear, colorless) at 80 μg (200 μg / ml):   0.4 ml pre-filled pen * (SureClick) containing a 27 G needle syringe, unitary box.
SC or IV solution for injection (clear, colorless) at 100 μg (200 μg / ml):   Pre-filled syringe * 0.5 ml secure with 27 G needle, single unit.
Solution for injection SC (clear, colorless) at 100 μg (200 μg / ml):   0.5 ml pre-filled * pen (SureClick) containing a 27 G needle syringe, unitary box.
SC or IV (clear, colorless) solution for injection at 130 μg (200 μg / ml):   0.65 ml pre-filled * safety syringe with 27 G needle, single unit.
SC or IV solution for injection (clear, colorless) at 150 μg (500 μg / ml):   0.3 ml pre-filled syringe * with 27 G needle, single box.
Solution for injection SC (clear, colorless) at 150 μg (500 μg / ml):   0.3 ml pre-filled * pen (SureClick) containing a 27 G needle syringe, unitary box.
SC or IV injection solution (clear, colorless) to 300 micrograms (500 micrograms / ml):   Pre-filled syringe * Secure 0.6 ml with 27 G needle, unitary box.
Solution for injection SC (clear, colorless) 300 μg (500 μg / ml):   * Prefilled pen * (SureClick) 0.6 ml containing a syringe with 27 G needle, unitary box.
Solution for injection SC or IV (clear, colorless) at 500 μg (500 μg / ml):   1 ml pre-filled syringe * with 27 G needle, unitary box.
Solution for injection SC (clear, colorless) 500 μg (500 μg / ml):   1 ml pre-filled *pen (SureClick) containing a 27 G needle syringe, unitary box.
*  The protective cap of the pre-filled syringe or pre-filled pen contains natural rubber (a derivative of the latex): see Warnings and Precautions for Use .
NOT’s
Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:
general information:
Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles
Additional information:
General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.
Special warnings:
For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.
Side effects:
It treats possible side effects and drug interactions that require attention and its effect on continuous use.
The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
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Aranesp Uses, Dosage, Side Effects, Precautions & Warnings
Drug Online
Therapeutic class: Cancerology and hematology Active ingredients: Darbepoetin alfa
Important to know about Aranesp ?
Darbepoetin alfa injections stimulate the body to produce red blood cells.
In case of severe anemia (as can occur in certain kidney diseases), in cancer chemotherapy and prior to surgery if the doctors expect a lot of blood loss.
It takes 2 to 6 weeks for the number of red blood cells to be up to standard.
You usually receive the injections once every 1, 2 or 3 weeks.
Side effects include: increased blood pressure and swollen ankles and feet. Do you suffer a lot from this? Consult your doctor.
Furthermore: hypersensitivity to this medication. You notice that among other things skin rash, itching, fever or tightness. Then warn a doctor.
A rare side effect is thrombosis (blood clot in a blood vessel). You notice thrombosis of sudden pain or swelling in your leg, or chest tightness or shortness of breath. Then immediately notify a doctor.
What is Aranesp used to treat and indication ?
Treatment of symptomatic anemia related to chronic renal insufficiency (CKD) in adults and children ( see Dosage and Method of Administration ).
Treatment of symptomatic anemia in adult patients with non-myeloid malignancies receiving chemotherapy.
aranesp injection dosage
Treatment of symptomatic anemia in adults and children with chronic renal failure
The symptoms and consequences of anemia may vary depending on age, sex and the overall clinical picture; It is necessary for a doctor to evaluate the disease and its evolution. Aranesp can be administered subcutaneously or intravenously to increase hemoglobin to a maximum of 12 g / dl (7.5 mmol / l). The subcutaneous route is preferred in patients who are not hemodialysis, in order to preserve the peripheral veins.
Patients should be closely monitored to ensure that the minimum adequate dose of Aranesp is used to control the symptoms of anemia while maintaining hemoglobinemia less than or equal to 12 g / dL (7.5 mmol / L) . Caution is required when increasing doses of Aranesp in patients with chronic renal failure. Alternative explanations for poor response to treatment should be sought in patients treated with Aranesp who have an insufficient increase in hemoglobin (see Warnings and Precautions and Pharmacodynamic Properties section ).
Due to intra-individual variability, point concentrations of hemoglobin can be observed below and above the desired values. The variability of hemoglobin level should be controlled by adjusting the dosage, relative to the target hemoglobin level between 10 g / dl (6.2 mmol / l) and 12 g / dl (7.5 mmol / l) . Maintaining a hemoglobin level above 12 g / dl (7.5 mmol / l) should be avoided; recommendations for dosage adjustment when the hemoglobin level exceeds 12 g / dl (7.5 mmol / l) are detailed below. An increase of hemoglobin above 2 g / dl (1.25 mmol / l) over a period of 4 weeks should be avoided. If this occurs, the dosage should be adjusted.
Treatment with Aranesp is divided into two phases, corrective phase and maintenance phase. Treatment modalities are presented separately for adults and children.
Adults with chronic renal failure
Corrective phase :
The initial dose is 0.45 μg / kg body weight administered subcutaneously or intravenously as a single weekly injection. In non-dialysis patients, the following initial doses may also be administered subcutaneously as a single injection: 0.75 μg / kg once every two weeks or 1.5 μg / kg once a month. If the increase in hemoglobin is insufficient (less than 1 g / dl [0.6 mmol / l] in four weeks), the dose may be increased by approximately 25%. The dosage should not be increased more than once every four weeks.
If the increase in hemoglobin is greater than 2 g / dl (1.25 mmol / l) over a four-week period, reduce the dose by approximately 25% from the previous dose, depending on the dose. importance of this increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.
The hemoglobin level should be measured once a week or every two weeks until it has stabilized. Then the hemoglobin level can be measured at longer intervals.
Maintenance phase :
In dialysis patients, Aranesp can continue to be administered as a once weekly injection or once every two weeks. Dialysis patients treated with an Aranesp injection every 2 weeks should receive an initial dose of Aranesp equivalent to twice the weekly dose previously administered.
In non-dialysis patients, Aranesp can continue to be administered as a single injection once a week or once every two weeks or once a month. In patients treated with Aranesp once every two weeks, and after the target hemoglobin level has been reached, Aranesp can then be administered by subcutaneous injection once a month using an initial dose equivalent to twice the dose used every two weeks.
The dose administered should be evaluated to maintain the target hemoglobin level.
If a dose adjustment is necessary to maintain hemoglobin at the desired level, it is recommended to increase or decrease the dose by approximately 25% from the previous dose.
If the hemoglobin level increases by more than 2 g / dl (1.25 mmol / l) over a period of 4 weeks, reduce the dose by approximately 25% depending on the significance of this increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.
After each dose or schedule adjustment, the hemoglobin level should be checked once a week or every two weeks. During the maintenance phase, the dosage should not be changed more than once every two weeks.
When the route of administration is changed, the same dose should be used and the hemoglobin should be monitored once a week or every two weeks to adjust the dose to maintain the desired level.
Clinical trials have shown that adult patients receiving r-HuEPO once, twice or three times a week may receive Aranesp once weekly or once every 2 weeks. The initial weekly dose of Aranesp (μg / week) can be calculated by dividing the total weekly dose of r-HuEPO (IU / week) by 200. The initial dose of Aranesp administered every 2 weeks (μg / 2 weeks) can be calculated by dividing by 200 the total dose of r-HuEPO administered over a 2-week period. Due to individual variability, the search for the optimal therapeutic dose should be done for each patient. When replacing r-HuEPO with Aranesp, the rate of
Children with chronic renal failure
Treatment of children under 1 year of age has not been studied in randomized clinical trials.
Corrective phase :
In children from 1 year of age, the initial dose is 0.45 μg / kg body weight administered subcutaneously or intravenously as a single weekly injection. In non-dialysis patients, an initial dose of 0.75 μg / kg can be administered subcutaneously as a single injection once every two weeks. If the increase in hemoglobin is insufficient (less than 1 g / dl [0.6 mmol / l] in four weeks), the dose may be increased by approximately 25% . The dosage should not be increased more than once every four weeks .
If the increase in hemoglobin is greater than 2 g / dl (1.25 mmol / l) over a four-week period, reduce the dose by approximately 25% from the previous dose, depending on the level. increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.
The hemoglobin level should be measured once a week or every two weeks until it has stabilized. Then the hemoglobin level can be measured at larger intervals.
Correction of anemia in pediatric patients with a monthly administration frequency of Aranesp has not been studied.
Maintenance phase :
In children from 1 year of age, during the maintenance phase, Aranesp can continue to be administered as a single once-weekly injection or once every two weeks.
In patients younger than 6 years of age, higher doses may be needed to maintain target hemoglobin levels compared to patients 6 years of age and older. Dialysis patients treated with an Aranesp injection every 2 weeks should receive an initial dose of Aranesp equivalent to twice the weekly dose previously administered.
In patients 11 years of age and older who are not on dialysis, once the target hemoglobin level is reached by one dose every two weeks, Aranesp can be administered by subcutaneous injection once a month. using an initial dose equivalent to twice the dose used every two weeks.
Clinical data available in children have shown that patients receiving r-HuEPO two or three times a week can receive Aranesp once a week, and those receiving r-HuEPO once per week could benefit from administration of Aranesp once every two weeks. The initial weekly dose of Aranesp (μg / week) in pediatrics can be calculated by dividing the total weekly dose of r-HuEPO (IU / week) by 240. The initial dose of Aranesp (μg / week) to be administered every two weeks in pediatrics can be calculated by dividing the total dose of r-HuEPO (UI / week) over two weeks by 240. Due to individual variability, the search for the optimal therapeutic dose should be performed for each patient.
The dose administered should be periodically evaluated to maintain the target hemoglobin level.
If a dose adjustment is necessary to maintain hemoglobin at the desired level, it is recommended to increase or decrease the dose by approximately 25% from the previous dose.
If the hemoglobin level increases by more than 2 g / dl (1.25 mmol / l) in 4 weeks, reduce the dose by approximately 25% depending on the importance of this increase. If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l), a dose reduction should be considered. If the hemoglobin level continues to increase, the dose should be reduced by approximately 25%. If, after this dose reduction, the hemoglobin level still increases, the administration should be temporarily suspended until the hemoglobin level begins to decrease. The treatment will then be resumed at a dose of 25% lower than the previous dose.
Patients starting dialysis during Aranesp therapy should be closely monitored for adequate control of their hemoglobin levels.
After each adjustment in dose or rate of administration, the hemoglobin level should be checked once a week or every two weeks. During the maintenance phase, the dosage should not be changed more than once every two weeks.
When the route of administration is changed, the same dose should be used and hemoglobin should be monitored once a week or every two weeks to adjust the dose to maintain the desired hemoglobin level.
Treatment of symptomatic anemia induced by chemotherapy in cancer patients
Aranesp should be administered subcutaneously to patients with anemia (eg, hemoglobin ≤ 10 g / dl (6.2 mmol / l)) to achieve a hemoglobin level not exceeding 12 g / dl (7.5 mmol / l). The symptoms and consequences of anemia may vary depending on age, sex and the overall clinical picture; It is necessary for a doctor to evaluate the disease and its evolution.
Due to intra-individual variability, point concentrations of hemoglobin can be observed below and above the desired values. The variability in hemoglobin levels should be controlled by adjusting the dose to the target hemoglobin level between 10 g / dl (6.2 mmol / l) and 12 g / dl (7.5 mmol / l). Maintaining a hemoglobin level greater than 12 g / dl (7.5 mmol / l) should be avoided; recommendations for dosage adjustment when the hemoglobin level exceeds 12 g / dl are detailed below.
The recommended starting dose is 500 pg (6.75 μg / kg body weight), administered once every three weeks, or 2.25 μg / kg body weight given once a week. If the clinical response (fatigue, hemoglobin level) is not satisfactory after nine weeks of treatment, continued treatment may be ineffective.
Aranesp treatment should be discontinued approximately four weeks after the end of chemotherapy.
Once the individual therapeutic goal is reached, the dose should be reduced by 25 to 50% to ensure that the appropriate minimum dose of Aranesp is used to maintain hemoglobin levels to control the symptoms of anemia. . The choice of a dose of 500 μg, 300 μg or 150 μg should be considered.
Patients should be closely monitored. If the hemoglobin level exceeds 12 g / dl (7.5 mmol / l), the dose should be reduced by approximately 25-50%. Aranesp treatment should be temporarily discontinued if the hemoglobin level exceeds 13 g / dl (8.1 mmol / l). Treatment will be resumed at approximately 25% lower than the previous dose when the hemoglobin level has dropped to 12 g / dl (7.5 mmol / l) or less.
If the hemoglobin level increases by more than 2 g / dl (1.25 mmol / l) over a period of four weeks, the dose should be reduced by 25 to 50%.
Administration mode
Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 micrograms solution for injection in pre-filled syringe
Aranesp is administered subcutaneously or intravenously as described under Dosage. Alternate injection sites and inject slowly to avoid discomfort at the injection site.
Aranesp is presented in a pre-filled syringe ready for injection.
Aranesp 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 300, 500 micrograms solution for injection in pre-filled pen
Aranesp in pre-filled pen is intended for subcutaneous administration only.
Alternate injection sites to avoid discomfort at the injection site.
Aranesp is presented in pre-filled pen ready for injection.
Aranesp 25, 40, 60, 100, 200, 300 micrograms solution for injection in vial
Aranesp is administered subcutaneously or intravenously as described under Dosage.
Alternate injection sites and inject slowly to avoid discomfort at the injection site.
Aranesp is presented in a ready-to-use bottle.
For instructions on use, handling and disposal, see section Instructions for use, handling and disposal .
what is aranesp contraindications
CONTRA-INDICATED:
– Known hypersensitivity to darbepoetin alfa, to r-HuEPO or to any of the excipients.
– Poorly controlled arterial hypertension.
– Cases of erythroblastopenia due to neutralizing antibodies directed against erythropoietin have been reported with recombinant erythropoietins, including darbepoetin alfa. These neutralizing antibodies cross-react with other erythropoietins and a relay treatment with darbepoetin alfa should not be initiated in a patient for whom the presence of neutralizing antibodies is suspected or confirmed.
– Breast-feeding: as there is no clinical experience in women during breast-feeding, it is recommended not to administer Aranesp to women who are breast-feeding. When treatment with Aranesp is absolutely indicated, breast-feeding should be discontinued.
ADVISED AGAINST:
Pregnancy: No clinical data are available in pregnant women. Animal studies have not shown any deleterious effects on gestation, embryofoetal development, parturition or postnatal development.
Precautionary measures are required when prescribing in pregnant women.
Aranesp Side Effects
In addition to the desired effect, this medicine can cause side effects.
The main side effects are the following.
Sometimes (from 10 to 30 people in 100)
Increased blood pressure . You should only use this medicine if the blood pressure is good. If necessary, you can give blood pressure reducers to your doctor. Very rarely (in fewer than 1 in 100 people) suddenly a strongly increased blood pressure occurs. Warn your doctor with muscle twitches and sudden migraine-like headaches (vigorous throbbing unilateral headache).
Edema . You will notice this especially with swollen ankles and feet. Consult your doctor if you have a lot of problems with this.
Hypersensitivity to darbepoetin alfa. This can be seen, among other things, in unexplained fatigue, tightness in itching or hives, skin rash, skin redness, flu-like symptoms, fever, muscle pain, tightness or fainting. Stop using and consult your doctor. In very rare cases, a serious skin condition can develop with fever and blistering. The blisters mainly develop on the lips and on the mucous membranes of the mouth and genitals. Then immediately notify a doctor or go to the First Aid Service. You can not use this medicine in the future. Therefore tell the pharmacy that you are hypersensitive to darbepoetin alfa. The pharmacy team can then ensure that you do not get this remedy again.
Rarely (from 1 to 10 in 100 people)
Headache.
Pain at the injection site . This will pass after some time.
Formation of blood clots in the vessels (thrombosis), especially at the site of the injection needle. Do not use this medicine if you have an increased risk of thrombosis or if you have ever had a heart attack or stroke due to thrombosis. Your doctor may combine the treatment of darbepoietin with anticoagulants.
Stroke (cerebral infarction). You will notice this mainly by sudden complaints. These may be paralysis in the face (crooked mouth for example), confused speaking and thinking, paralysis of the arm or leg, loss of vision, and tingling. Tell a doctor immediately.
Very rare (affects less than 1 in 100 people)
Epileptic seizures . Then tell your doctor.
Too much potassium in the blood . This can be seen in an irregular heartbeat (often the first symptom), numbness or strange sensations in the arms and legs, lethargy, confusion and weakness. Consult your doctor for these symptoms.
If there are enough red blood cells in your blood and you still use darbepoietin alfa, it can happen that too many blood cells occur. This causes too much blood and increased blood pressure, especially if the number of red blood cells rises very quickly. That is why the doctor checks the blood regularly and keeps an eye on whether the increase does not go too fast. Consult your doctor if you suffer too much from any of the above mentioned side effects or if you experience other side effects that you are worried about.
Aranesp Interactions
The clinical results available to date have not shown any interaction between darbepoetin alfa and other substances.
However, there is a potential risk of drug interaction with substances with a high binding affinity for red blood cells such as ciclosporin and tacrolimus.
If Aranesp is administered concurrently with any of these treatments, their blood levels should be monitored and their dose adjusted according to the increase in hemoglobin.
Aranesp Warnings and Precautions
Overview
In order to improve the traceability of erythropoiesis stimulating agents (ESAs), the commercial name of the ESA administered should be clearly recorded in the patient’s chart.
Blood pressure should be monitored in all patients, especially during the initiation phase of Aranesp therapy. If blood pressure is difficult to control after appropriate measures are taken, hemoglobin levels can be reduced by decreasing the dosage or by spacing Aranesp injections (see Dosage and Method of Administration ). . Cases of severe hypertension, including hypertensive crises, hypertensive encephalopathy, and seizures have been observed in CKD patients treated with Aranesp.
To ensure effective erythropoiesis, martial status should be controlled in all patients, before and during treatment, iron supplementation may be required.
The lack of response to treatment with Aranesp should lead quickly to investigate the causes. A deficiency of iron, folic acid or vitamin B12 decreases the effectiveness of ESAs and must be corrected. Intercurrent infections, inflammatory or traumatic episodes, occult blood loss, haemolysis, severe aluminum intoxication, underlying hematological disease or myelofibrosis may also alter the erythropoietic response. The count of reticulocytes is an element of evaluation of the medullary activity. If usual causes of no response have been excluded, and if the patient has reticulopenia, bone marrow examination should be considered. If the bone marrow biopsy is compatible with PRCA, a search for
Pure red cell aplasia due to neutralizing antibodies to erythropoietin has been reported with ESAs, including Aranesp. This has mainly been reported in patients with chronic renal failure treated subcutaneously. These neutralizing antibodies cross-react with other epoetins and Aranesp relay therapy should not be initiated in a patient for whom the presence of neutralizing antibodies is suspected or confirmed (see section 4.8 ).
A paradoxical decrease in hemoglobin and the development of severe anemia associated with a low number of reticulocytes should prompt rapid discontinuation of epoetin and an anti-erythropoietin antibody test. Cases have been reported in patients with hepatitis C treated with interferon and ribavirin when epoetins are used concomitantly. Epoetins are not indicated for the treatment of anemia associated with hepatitis C.
The existence of a progressive liver pathology was an exclusion criterion for all studies with Aranesp. Therefore, no data are available in patients with hepatic impairment. Since the liver is considered the main route of elimination of darbepoetin alfa and r-HuEPO, Aranesp should be used with caution in patients with liver disease.
Aranesp should also be used with caution in patients with sickle cell anemia.
Misuse of Aranesp in healthy subjects may result in an excessive increase in hematocrit. This can be associated with life-threatening cardiovascular complications.
The protective cap of the pre-filled syringe or pre-filled pen contains natural rubber (a derivative of the latex) that can cause allergic reactions.
Aranesp should be used with caution in patients with epilepsy. Seizures have been reported in patients treated with Aranesp.
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie it is considered essentially “sodium-free”.
Chronic renal failure patients
In patients with chronic renal impairment, the hemoglobin level during the maintenance phase should not exceed the upper limit of the target hemoglobin level recommended under Dosage and Method of Administration . In clinical studies, an increase in the number of deaths, serious cardiovascular or cerebrovascular events, including stroke, and vascular thrombosis at the access point was observed when ESAs were administered in order to achieve Hemoglobin targets greater than 12g / dl (7.5 mmol / l).
Caution should be exercised with dose escalation of Aranesp in patients with chronic renal failure, as high cumulative doses of epoetin may be associated with an increased risk of mortality and serious cardiovascular and cerebrovascular events. In patients aynt a poor response to epoetins, other factors behind the poor response should be considered (see Dosage and Administration and Pharmacodynamic properties ).
Controlled clinical trials did not demonstrate any significant benefits attributable to epoetin administration when hemoglobin levels were increased beyond values ​​to control the symptoms of anemia and to avoid the use of transfusions. blood.
Iron supplementation is recommended for all patients with serum ferritin levels below 100 pg / l or transferrin saturation <20%.
Serum potassium should be monitored regularly during treatment with Aranesp. Potassium elevation has been reported in a few patients treated with Aranesp, although the causal link has not been established. If there is a high level or an increase in serum potassium, discontinuation of Aranesp should be considered until serum potassium is normalized.
Cancer patients
Effect on tumor growth
Epoetins are growth factors that essentially stimulate the production of red blood cells. Erythropoietin receptors would be expressed on the surface of different types of tumor cells. Like any growth factor, epoetins may stimulate growth of tumors. In several controlled studies in which epoetins have been administered, there has been no improvement in overall survival or decreased risk of tumor progression in patients with cancer-associated anemia.
In controlled clinical studies, the use of Aranesp and other ESAs has shown:
a shortening of time to tumor progression in patients with advanced head and neck cancer receiving radiotherapy when ESAs were administered to achieve target hemoglobin levels greater than 14 g / dl (8.7 mmol / l). ESAs are not indicated for use in this patient population.
a decrease in overall survival and an increase in the number of deaths at 4 months, attributed to disease progression, in patients with metastatic breast cancer receiving chemotherapy, when ESAs were administered for the purpose of target hemoglobin levels of between 12 and 14 g / dl (7.5-8.7 mmol / l).
an increased risk of death when ESAs were administered to achieve a target hemoglobin level of 12 g / dl (7.5 mmol / l) in patients with active malignancy who were not receiving chemotherapy, nor radiotherapy. ESAs are not indicated for use in this patient population.
In view of the above information, in certain clinical situations, blood transfusion should be the preferred treatment for anemia in cancer patients. The decision to administer recombinant epoetins should be based on a benefit-risk assessment taking into account the patient’s opinion in its specific clinical context. Factors to be considered in this assessment should include the type of tumor and its stage, the degree of anemia, life expectancy, the environment in which the patient is treated and the patient’s preference (see section 5.1 ). .
If the hemoglobin level is greater than 12 g / dl (7.5 mmol / l) in patients with solid tumors or lymphoproliferative malignancies, strictly adhere to the dose adjustment described in section Dosage and method of administration , in order to minimize the possible risks of thromboembolic events. Platelet count and hemoglobin should also be monitored at regular intervals.
Drive and use machines
Aranesp has no or negligible influence on the ability to drive and use machines.
Aranesp and PREGNANCY / BREAST FEEDING
aranesp in pregnancy
There are no relevant and well-conducted studies regarding the use of Aranesp in pregnant women.
Animal studies have not shown deleterious effects on pregnancy, embryo-fetal development, parturition or postnatal development. No alteration of fertility was detected.
Caution is required when prescribing Aranesp in pregnant women.
Women whose pregnancies occur during treatment with Aranesp should be encouraged to enroll in the Amgen Pregnancy Surveillance Program. The contact details are in section 6 of the package leaflet.
aranesp in Breastfeeding
It is not known if Aranesp is excreted in breast milk. A risk for infants can not be ruled out.
The decision to discontinue breastfeeding or discontinue / abstain from treatment with Aranesp should be made with regard to the benefit of breastfeeding for the child and the benefit of treatment for the woman.
What should I do if I miss a dose?
If you inject yourself:
have you forgotten a dose and are you discovering it the same day? 
Use the dose as yet.
Do you discover it the next day? 
Consult your doctor.
 Never use a double dose.
What happens if I overdose from Aranesp ?
The maximum amount of Aranesp that can be safely administered at single or multiple doses has not been determined.
Aranesp treatment may result in polycythemia if the hemoglobin level is not closely monitored and the dose adjusted properly.
Cases of severe arterial hypertension have been observed after an overdose with Aranesp ( see Warnings and Precautions ).
In case of polycythemia, treatment with Aranesp should be temporarily interrupted ( see Dosage and Method of Administration ).
A bleeding can be performed in case of clinical need.
What is  Forms and Composition?
SC or IV solution for injection (clear, colorless) at 10 μg (25 μg / ml):   0.4 ml pre-filled syringe * with 27 G needle, unitary box. Injection solution SC or IV (clear, colorless) at 20 μg (40 μg / ml):   Pre-filled syringe * 0.5 ml secure with 27 G needle, unitary box.
SC or IV solution for injection (clear, colorless) at 30 μg (100 μg / ml):   0.3 ml pre-filled syringe * with 27 G needle, unitary box. SC or IV (clear, colorless) solution for injection at 40 μg (100 μg / ml):   0.4 ml secure * pre-filled syringe with 27 G needle, single unit.
Injection solution SC (clear, colorless) at 40 μg (100 μg / ml):   0.4 ml pre-filled pen * (SureClick) containing a 27 G needle syringe, unitary box.
Injection solution SC or IV (clear, colorless) at 50 μg (100 μg / ml):   Pre-filled syringe * 0.5 ml secure with 27 G needle, single box.
SC or IV solution for injection (clear, colorless) at 60 μg (200 μg / ml):   0.3 ml pre-filled syringe * with 27 G needle, unitary box.
Solution for injection SC (clear, colorless) at 60 μg (200 μg / ml):   0.3 ml pre-filled pen * (SureClick) containing a 27 G needle syringe, unitary box.
SC or IV injection solution (clear, colorless) at 80 μg (200 μg / ml):   0.4 ml secure * pre-filled syringe with 27G needle, single unit.
Injection solution SC (clear, colorless) at 80 μg (200 μg / ml):   0.4 ml pre-filled pen * (SureClick) containing a 27 G needle syringe, unitary box.
SC or IV solution for injection (clear, colorless) at 100 μg (200 μg / ml):   Pre-filled syringe * 0.5 ml secure with 27 G needle, single unit.
Solution for injection SC (clear, colorless) at 100 μg (200 μg / ml):   0.5 ml pre-filled * pen (SureClick) containing a 27 G needle syringe, unitary box.
SC or IV (clear, colorless) solution for injection at 130 μg (200 μg / ml):   0.65 ml pre-filled * safety syringe with 27 G needle, single unit.
SC or IV solution for injection (clear, colorless) at 150 μg (500 μg / ml):   0.3 ml pre-filled syringe * with 27 G needle, single box.
Solution for injection SC (clear, colorless) at 150 μg (500 μg / ml):   0.3 ml pre-filled * pen (SureClick) containing a 27 G needle syringe, unitary box.
SC or IV injection solution (clear, colorless) to 300 micrograms (500 micrograms / ml):   Pre-filled syringe * Secure 0.6 ml with 27 G needle, unitary box.
Solution for injection SC (clear, colorless) 300 μg (500 μg / ml):   * Prefilled pen * (SureClick) 0.6 ml containing a syringe with 27 G needle, unitary box.
Solution for injection SC or IV (clear, colorless) at 500 μg (500 μg / ml):   1 ml pre-filled syringe * with 27 G needle, unitary box.
Solution for injection SC (clear, colorless) 500 μg (500 μg / ml):   1 ml pre-filled *pen (SureClick) containing a 27 G needle syringe, unitary box.
*  The protective cap of the pre-filled syringe or pre-filled pen contains natural rubber (a derivative of the latex): see Warnings and Precautions for Use .
NOT’s
Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:
general information:
Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles
Additional information:
General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.
Special warnings:
For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.
Side effects:
It treats possible side effects and drug interactions that require attention and its effect on continuous use.
The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
The post Aranesp Uses, Dosage, Side Effects, Precautions & Warnings appeared first on Drug Online.
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edrugonline · 4 years
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Aranesp Uses, Dosage, Side Effects, Precautions & Warnings
Aranesp Uses, Dosage, Side Effects, Precautions & Warnings
Therapeutic class: Cancerology and hematology Active ingredients: Darbepoetin alfa
Important to know about Aranesp ?
Darbepoetin alfa injections stimulate the body to produce red blood cells.
In case of severe anemia (as can occur in certain kidney diseases), in cancer chemotherapy and prior to surgery if the doctors expect a lot of blood loss.
It takes 2 to 6 weeks for the number of red blood…
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meetlahane-blog · 5 years
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Erythropoietin is a hormone which is basically produced by the kidneys helping in production of red blood cells, which carry oxygen from the lungs to rest of the body. Erythropoietin drugs are injectable drugs used to cure anemia and other such diseases.
MARKET DYNAMICS
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cancermedicines1122 · 3 years
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darbepoetin alfa injection
Our goal is to improve the lives of our patients by meeting their healthcare needs with the highest level of service, quality, and convenience.
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Actorise 40 mcg
Actorise 40 mcg
Actorise Uses
Darbepoetin alpha is used to treat anemia (low hemoglobin and or reduced red blood cell count) associated with chronic kidney failure (inability for produce adequate urine) in adults and children, and symptomatic anemia in adult cancer patients receiving chemotherapy.
How Actorise works
Darbepoetin alfa belongs to a class of haematological agents called erythropoeisis stimulating agents (ESAs). It is a synthetic form of a human hormone (erythropoietin) produced by recombinant DNA technology, which increases the red blood cell production thereby helping in relieving the symptoms.
Common side effects of Actorise
Rash, Cough, Shortness of breath, Fatigue, Altered heart rate, Hoarseness of voice, Increased blood pressure, Injection site bruise, Injection site irritation, Itching, Skin redness, Stomach pain, Wheezing
 Contraindications
You should not take Actorise if you are allergic to epoetin alfa, darbepoetin alfa, or if you are suffering from: - Allergic reactions to albumin; - Allergic reactions to animal products; - High blood pressure;
Before you start taking Actorise, you must inform your physician if you are suffering from:
• A clotting or a blood cell, for example hemophilia or sickle cell anemia; - A history of heart attack, stroke, or blood clots; - Cancer; - Heart disorder, high blood pressure or congestive heart failure; - Kidney disease; - Seizure disorders (such as epilepsy); • If you are suffering from any of the conditions that have been mentioned here, you might not be allowed to take Actorise, you should take a lower dose of Actorise. Darbepoetin alfa (the human made protein) is made from plasma (human plasma); therefore it could contain infectious agents such as viruses that may lead to certain diseases. Although the human plasma that has been donated is tested, screened, and treated in order to reduce this risk, a small possibility that you could contact such an illness still remains. Ask your physician for further information. • Actorise is a category C FDA pregnancy drug. This means that taking Actorise during pregnancy could cause harm to the growing fetus. If you are pregnant, or if you are planning to be so soon, you should not start a treatment with Actorise. It has not been determined whether Actorise's components can pass into breast milk. However, if you are currently nursing a child, you must not start taking Actorise without your doctor's approval. You ought to take all the necessary precautions that your doctor tells you to. Actorise is known to increase the risk of developing circulation or other life threatening disorders (this includes stroke, heart attack). This risk is higher if you are following a long term treatment with Actorise. If you are experiencing any circulation or heart problems symptoms (such as heavy feeling, chest pain, pain that spreads to the shoulder or to the arm, breath shortness, slurred speech, or balance or vision problems) you should seek immediate medical care. • Inform your physician if you feel light-headed, weak, pale or short of breath, because this could be a sign that your organism no longer responds to your treatment with Actorise. Intake Guidelines Ask your doctor how and when you should take Actorise in order to get the best results from your treatment. You must not disobey any of the instructions that your doctor has given you. If you fail to understand any of them, you should address a pharmacist, a doctor or a nurse. Actorise should be taken in with food or milk in order to prevent stomach upset. You ought to store Actorise away from heat and moisture (preferably in the refrigerator). You must not allow the medicine to freeze. Actorise is administered as an injection. You must not shake the drug's bottle (vial), because you may ruin the drug. You must not draw Actorise into a syringe until you feel ready to have the injection.
Dosage
Ask your physician to tell you the dose of Actorise that works best for you. You must not take extra doses of Actorise without your doctor's consent.
Overdose
If you suspect that you could be suffering from an overdose with Actorise, you are probably in need of medical attention as soon as possible. Contact your local poison control center immediately. Alert your personal doctor as soon as you can. In case of Actorise overdose you might experience some of the following symptoms: dizziness, headache, itching, upper stomach fullness, face redness, vision problems, shortness of breath, etc.
Missed Dose
In order to get the best results from you treatment with Actorise, you should to take Actorise on a regular basis. If you happen to forget to take one of your doses of Actorise, you must ask your physician for further instructions.
Interactions
Ask your physician if you may take any other drugs during your treatment with Actorise.
Other Brand Names
In some countries Actorise may also be known as: • DARBEPOETIN; • Nespo;
FREQUENTLY ASKED QUESTIONS
Darbepoetin Alfa Q. Is darbepoetin alfa safe during pregnancy? Darbepoetin alfa should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. Please follow your doctor's advice regarding its use. Q. Is darbepoetin alfa safe during breasfeeding? Darbepoetin alfa should be given during breastfeeding only if the potential benefit justifies the potential risk to the infant. Please follow your doctor's advice regarding its use Q. What is darbepoetin alfa non-ESRD? Darbepoetin alfa is protein, it is similar to human erythropoietin. Darbepoetin alfa can be used for anemia in end stage renal disease (ERSD) which is the last stage of chronic kidney disease. Q. What is darbepoetin alfa used for? Darbepoetin alpha is used to treat anemia associated with chronic kidney failure in adults and pediatric patients, and symptomatic anemia in adult cancer patients receiving chemotherapy and anemia. Q. How does darbepoetin alfa work? Darbepoetin alfa works by stimulating bone marrow to produce more red blood cells thereby helps in reducing the symptoms of anemia. Read the full article
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