Generic Name and Formulations:
Dabrafenib 50mg, 75mg; caps.

Company:
GlaxoSmithKline Pharmaceuticals

RECENT UPDATES
09/09/13
Monograph added.
Indications for TAFINLAR:
Treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation, as detected by an FDA-approved test. Limitation of use: not indicated for the treatment of patients with wild-type BRAF melanoma.

Adult Dose for TAFINLAR:
Confirm presence of BRAF V600E mutation prior to initiation. Swallow whole. Take at least 1 hour before or 2 hours after a meal. 150mg twice daily, about 12 hours apart until disease progression or unacceptable toxicity. Dose modifications or reductions: see full labeling.

Children's Dose for TAFINLAR:
Not established.

Pharmacological Class:
Kinase inhibitor.

Warnings/Precautions:
Increased incidence of new primary cutaneous malignancies; perform skin eva luation prior to initiation, every 2 months during therapy, and up to 6 months after discontinuation. Withhold if fever ≥101.3°F or any serious febrile drug reaction occurs and eva luate for infection; prophylaxis with antipyretics may be needed when resuming. Pre-existing diabetes or hyperglycemia; monitor serum glucose levels. Monitor for visual signs/symptoms of uveitis. Closely monitor patients with G6PD deficiency for signs of hemolytic anemia. Males (risk of infertility). Embryo-fetal toxicity. Females of reproductive potential should use highly effective non-hormonal contraception during and for 4 weeks after treatment. Pregnancy (Cat. D). Nursing mothers: not recommended.

Interactions:
Concomitant strong inhibitors (eg, ketoconazole, nefazodone, clarithromycin, gemfibrozil) or inducers (eg, rifampin, phenytoin, carbamazepine, phenobarbital, St John's wort) of CYP3A4 or CYP2C8: not recommended; if unavoidable, monitor closely. Drugs that affect gastric pH (eg, PPIs, H2-blockers, antacids) may decrease dabrafenib exposure. May antagonize effects of CYP3A4, CYP2B6, CYP2C8, CYP2C9, CYP2C19, UGT, transporters, or other substrates (eg, midazolam, warfarin, dexamethasone, hormonal contraceptives).

Adverse Reactions:
Hyperkeratosis, headache, pyrexia, arthralgia, papilloma, alopecia, palmar-plantar erythrodysesthesia syndrome.

How Supplied:
Caps—120