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Rinboq
[Drug name] Generic name: Upadacitinib Sustained Tablets
Trade name: Ruifu
English name: Upadacitinib Sustained
[Ingredients] The main ingredient of this product is upadacitinib.
[Properties] This product is a purple (15mg specification) or red (30mg specification) oval biconvex film-coated tablet. After removing the coating, it is white to off-white to light yellow to gray-brown to light brown, and spots may appear.
[Indications] This product is suitable for adults and adolescents aged 12 years and above with refractory, moderate to severe atopic dermatitis who have poor response to other systemic treatments (such as hormones or biological agents) or are not suitable for the above treatments.
[Dosage and Administration] Treatment with upadacitinib should be initiated by and used under the guidance of a physician who has experience in the diagnosis and treatment of this product's indications. Dosage The starting dose for children aged 12 years and older and weighing ≥ 40 kg and adults up to 65 years of age is 15 mg once daily. If the response is poor, consider increasing the dose to 30 mg once daily. If the 30 mg dose does not achieve an adequate response, discontinue this product. The lowest effective dose required should be used to maintain the response. The safety and efficacy of this product has not been studied in adolescents weighing less than 40 kg. The recommended dose for adults aged 65 years and older is 15 mg once daily. Data for patients aged ≥ 75 years are limited. Recommended dose for patients with renal impairment or severe hepatic impairment Renal impairment Patients with mild or moderate renal impairment do not require dose adjustment. There are limited data on the use of upadacitinib in patients with severe renal impairment (see [Pharmacokinetics]). Upadacitinib 15 mg once daily should be used with caution in patients with severe renal impairment. Upadacitinib 30 mg once daily is not recommended in patients with severe renal impairment. Upadacitinib has not been studied in subjects with end-stage renal disease. No dose adjustment is required for patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment (see [Pharmacokinetics]). This product should not be used in patients with severe hepatic impairment (Child-Pugh C) (see [Contraindications]). Usage This product can be taken with or without food and at any time of the day. This product should be swallowed whole and should not be broken, crushed or chewed to ensure that the full dose is administered. Combined topical treatment This product can be initiated with or without topical corticosteroids It is not recommended to start treatment with this product in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm3, an absolute neutrophil count (ANC) less than 1000 cells/mm3, or a hemoglobin level less than 8 g/dL. (See [Precautions] and [Adverse Reactions]). Suspension of administration If a patient develops a serious infection, treatment with this drug should be suspended until the infection is under control.
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Serplulimab
Serplulimab (Hans) Instructions
[Drug Name]
Generic Name: Serplulimab Injection
Trade Name: Hans
English Name: Serplulimab Injection
[Drug Ingredients]
Active Ingredient: Serplulimab (recombinant anti-programmed death receptor 1 humanized monoclonal antibody made from Chinese hamster ovary cells by DNA recombination technology).
Excipients: citric acid, sodium citrate, sodium chloride, mannitol, polysorbate 80 and water for injection.
[Drug Properties]
This product is a clear to opalescent, colorless or light brown liquid.
[Indications]
It is suitable for adult patients with advanced solid tumors with unresectable or metastatic microsatellite high instability (MSI-H).
. Patients with advanced colorectal cancer who have experienced disease progression after previous treatment with fluorouracil, oxaliplatin and irinotecan;
. Patients with advanced gastric cancer who have experienced disease progression after at least two lines of treatment and have no satisfactory alternative treatment options;
. Patients with other advanced solid tumors who have experienced disease progression after at least one line of treatment and have no satisfactory alternative treatment options.
[Drug specifications]
100 mg (10 ml)/bottle.
[Usage and Dosage]
This product must be used under the guidance of a physician with experience in tumor treatment.
Before using this product for treatment, the status of MSI-H must first be clarified. A fully validated test method should be used to confirm the presence of MSI-H before this product can be used for treatment.
Recommended dose:
The recommended dose of this product is 3 mg/kg, intravenous infusion once every 2 weeks until disease progression or intolerable toxicity occurs.
Atypical reactions have been observed in tumors treated with this product (for example, temporary enlargement of the tumor or the appearance of new small lesions in the first few months of treatment, followed by tumor shrinkage). If the patient's clinical symptoms are stable or continue to improve, even if there is preliminary evidence of disease progression, based on the judgment of overall clinical benefit, continued treatment with this product can be considered until disease progression is confirmed.
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