TAFINLAR (dabrafenib)
TAFINLAR (dabrafenib) capsules, in combination with MEKINIST® (Tramatinib) tablets, are indicated: For the treatment of patients with involuntary or metastatic melanoma with BRF V600E or V600K mutations detected by FAR-approved testing For adjuvant treatment of patients with melanoma with BRF V600E or V600K mutations, as revealed by FDA-approved testing, and lymph node (s) involvement after complete resection. For the treatment of metastatic non-small cell lung cancer (NSCLC) patients with Brett V600E mutation as revealed by FAR-approved testing Limitations of use: TAFINLAR is not indicated for the treatment of patients with wild-type BRF melanoma or wild-type BRF NSCLC. Important safety information New primary malaise, dermal and non-dermal. Perform dermatologic evaluation every 2 months before initiation of therapy, and up to 6 months after discontinuation of the combination. Closely monitor patients for signs or symptoms of nonfatal malformations. Permanently discontinue TAFINLAR ...