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Another Name阿昔替尼,英利达,阿西替尼,Inlyta,Axitix
IndicationsRenal cell carcinoma
Reg No.08 L 1161/24
Inspection NO.
Axitinib, also known as axitinib, is an antineoplastic drug primarily used in adult patients with previously treated advanced renal cell carcinoma.
It is a highly selective vascular epidermal growth factor receptor inhibitor, which can reduce the proliferation and differentiation of tumor cells and inhibit tumor growth.
Axitinib is an oral VEGFR inhibitor that has significant efficacy on renal cell carcinoma and other tumors, and the adverse reactions are relatively mild.
Axitinib
Adults with advanced renal cell carcinoma (RCC).
When pregnant women take the drug, it may cause harm to the fetus, and women with fertility should be informed of the potential risks of this product to the fetus.
Before starting axitinib therapy, women of childbearing potential should have a pregnancy test. Women of childbearing potential are advised to use effective contraception during treatment with axitinib and for 1 week after the last dose. Men with female partners of childbearing potential are advised to use effective contraception during treatment and for 1 week after the last dose. Axitinib may impair fertility in fertile women and men.
The safety and efficacy of axitinib has not been studied in pediatric patients.
Although higher sensitivity cannot be ruled out in some older patients, no overall difference in the safety and efficacy of axitinib was observed between patients ≥ 65 years of age and younger than 65 years. Dose adjustment is not required in older patients.
There is no treatment for axitinib overdose. If an overdose is suspected, axitinib should be discontinued and supportive care should be given.
The storage temperature is 20°C to 25°C (68°F to 77°F), allowing for short transport between 15°C and 30°C (59°F and 86°F). Protect from moisture.
After a single oral administration at a dose of 5mg, the median Tmax ranged from 2.5~4.1 hours. According to the plasma half-life, it is expected to reach steady state within 2~3 days after administration. Compared to a single dose, axitinib is administered twice daily at 5 mg, resulting in approximately 1.4-fold drug accumulation. At steady state, axitinib exhibits linear pharmacokinetics in the dose range of 1mg~20mg. After the 5 mg dose orally, the average absolute bioavailability of axitinib is 58%.
FDA，2012.01
