Your Health, We Care
Another NameTafinlar、甲磺酸达拉非尼胶囊、泰菲乐、达拉非尼
IndicationsPatients with unresectable or metastatic melanoma with BRAF V600E mutation.
Reg No.10 L 1025/23
Inspection NO.
Dabrafenib is a potent and selective BRAF inhibitor, available in two drug sizes of 50mg and 75mg.
On May 29, 2013, the US Food and Drug Administration approved Dabrafenik for the treatment of metastatic melanoma and inoperable melanoma. On June 22, 2017, the US Food and Drug Administration expanded the indications for Dabrafenib.
Dabrafenib is a BRAF inhibitor that can specifically block the activity of BRAF proteins, inhibit tumor cell proliferation and survival.
Dabrafenib
BRAF V600 mutation positive patients with unresectable or metastatic melanoma.
Based on its mechanism of action, Dabrafenib can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
It is not known whether this drug is present in human milk. Because many drugs are present in human milk and because of the potential for serious adverse reactions from Dabrafenib in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
The safety and effectiveness of Dabrafenib have not been established in pediatric patients.
One hundred and twenty-six (22%) of 586 patients in clinical trials of Dabrafenib and 40 (21%) of the 187 patients receiving Dabrafenib in Trial 1 were ≥65 years of age. No overall differences in the effectiveness or safety of Dabrafenib were observed in the elderly in Trial 1.
Advise female patients to use highly effective contraception during treatment and for 4 weeks following discontinuation of treatment.
Advise male patients of potential risk for impaired spermatogenesis.
Dose adjustment is not recommended for patients with mild hepatic impairment.An appropriate dose has not been established for patients with moderate to severe hepatic impairment.
Dose adjustment is not recommended for patients with mild or moderate renal impairment. An appropriate dose has not been established for patients with severe renal impairment.
Drug overdose is not yet clear.
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
After oral administration, median time to achieve peak plasma concentration (Tmax)is 2 hours.
from FDA,2013.05
