杨森制药的厄达替尼药品说明书

Janssen Pharmaceuticals drug instructions

Chinese name: Erdafitinib

Generic name: Erdafitinib

Product name: Balversa

Manufacturer: Janssen Pharmaceuticals

US launch date: 2019-04-12

Dosage form: tablets are available in 3mg/4mg/5mg.

Indications: Erdafitinib from Janssen Pharmaceuticals is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who: (1) have FGFR3 or FGFR2 gene mutations; (2) have disease progression during or after at least one prior platinum-based chemotherapy regimen, including within 12 months of neoadjuvant or adjuvant platinum-based chemotherapy regimens.

Recommended dose: The starting dose of Janssen Pharmaceuticals' erdafitinib is 8 mg once daily, taken orally on an empty stomach or with food. For patients whose serum phosphorus levels fall below the target value of 5.5 mg/dL between days 14 and 21, the dose is increased to 9 mg once daily until disease progression or intolerance. If vomiting occurs after taking the medicine, do not take it again. The next time you take the medicine, you should still follow the original interval. If you miss a dose, you can take it again according to the amount within the same day, and the next time you take the medicine, you should still follow the original interval.

Side effects: Fatal adverse reactions were acute myocardial infarction in 1% of patients, and serious adverse reactions such as eye disease (10%) occurred in 41% of patients. 13% of patients permanently discontinued the drug due to adverse reactions, most commonly eye disease (6%); 68% of patients experienced drug discontinuation due to adverse reactions Dosage interruption, the most common ones were hyperphosphatemia (24%), stomatitis (17%), eye disease (17%) and palmar erythema paralysis syndrome (8%); 53% of patients experienced dose reduction due to adverse reactions. The most common adverse reactions of dose reduction included eye disease, stomatitis, hyperphosphatemia, palmar-plantar erythema paralysis syndrome, paronychia and nail dystrophy.

Things to note:

(1) Eye diseases: Erdafitinib Balversa can cause central serous retinopathy/retinal pigment epithelial detachment (CSR/RPED). Have eye exams monthly for the first four months of treatment, every 3 months thereafter, and any time visual symptoms occur. Withhold Balversa if CSR/RPED occurs and permanently discontinue if there is no response within 4 weeks or if the severity reaches Grade 4.

(2) Hyperphosphatemia: The increase in blood phosphorus levels is caused by the pharmacodynamic effects of erdafitinib Balversa. Monitor serum phosphorus levels and adjust treatment dosage as needed.

(3) Embryo-fetal toxicity: Can cause fetal harm. Inform patients of the potential risk to the fetus and use effective contraception.

Storage: Should be stored at 20-25°C (68-77°F); permitted temperature is 15-30°C (59-86°F).

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Note: The above information comes from the Internet and is compiled and edited by Medical Companion Travel (please correct me if there are any errors or omissions). It is only to provide information on the latest drugs on the market in the world and help Chinese patients understand the latest international new drug trends. It is only for internal discussion among medical staff and does not serve as any basis for medication. For specific medication guidelines, please consult the attending physician.