Your Health, We Care
Another NameZelboraf、维罗非尼、维莫非尼
IndicationsVemurafenib can treat melanoma and Erdheim Chester Disease.
Reg No.
Inspection NO.
Vemurafenib was developed by Roche and obtained FDA approval for marketing in the United States in 2011.
Before using Vimafenib, doctors need to conduct a comprehensive health assessment of patients and inform them of possible side effects and monitoring methods.
Vemurafenib is an oral small molecule inhibitor targeting BRAF V600 mutant tumors, which has significant anti-tumor efficacy. However, attention should also be paid to its possible side effects and safety issues during use.
Vemurafenib
Adult patients with Melanoma and Erdheim Chester Disease.
Based on its mechanism of action, Vemurafenib can cause fetal harm when administered to a pregnant woman. There are no available data on the use of Vemurafenib in pregnant women to determine the drug-associated risk; however, placental transfer of vemurafenib to a fetus has been reported. Exposure to vemurafenib could not be achieved in animals at levels sufficient to fully address its potential toxicity in pregnant women. Advise pregnant women of the potential harm to a fetus.
There is no information available regarding the presence of vemurafenib in human milk, effects on the breastfed infant, or effects on milk production. Because of the potential for serious adverse reactions in a breastfed infant, including malignancy, severe dermatologic reactions, QT prolongation, hepatotoxicity, photosensitivity, and ophthalmologic toxicity, advise women not to breastfeed during treatment with Vemurafenib and for 2 weeks after the final dose.
Based on its mechanism of action, Vemurafenib can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with Vemurafenib and for 2 weeks after the final dose.
The safety and effectiveness of Vemurafenib in pediatric patients have not been established.
Clinical studies of Vemurafenib did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
No formal clinical study has been conducted to evaluate the effect of hepatic impairment on the pharmacokinetics of vemurafenib. No dose adjustment is recommended for patients with mild and moderate hepatic impairment based on a population pharmacokinetic analysis. The appropriate dose of Vemurafenib has not been established in patients with severe hepatic impairment.
No formal clinical study has been conducted to evaluate the effect of hepatic impairment on the pharmacokinetics of vemurafenib. No dose adjustment is recommended for patients with mild and moderate hepatic impairment based on a population pharmacokinetic analysis. The appropriate dose of Vemurafenib has not been established in patients with severe hepatic impairment.
There is no information on overdosage of Vemurafenib.
Store at room temperature 20°C–25°C (68°F–77°F); excursions permitted between 15°C and 30°C (59°F and 86°F), See USP Controlled Room Temperature. Store in the original container with the lid tightly closed.
The mean bioavailability of vemurafenib at steady state was 64% (56% CV). The median time to reach maximum plasma vemurafenib concentration (Tmax) was 3 hours following multiple doses.
from FDA，2020.12
