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U.S. Department of Health and Human Services

Safety

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Tafinlar (dabrafenib) Capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

December 2013

Summary View

ADVERSE REACTIONS

DRUG INTERACTIONS

Effects of Dabrafenib on Other Drugs
  • Dabrafenib induces CYP3A4 and CYP2C9. Dabrafenib decreased the systemic exposures of  midazolam (a CYP3A4 substrate), S-warfarin (a CYP2C9 substrate), and R-warfarin (a CYP3A4/CYP1A2 substrate) [see Clinical Pharmacology (12.3)]. Monitor international 1normalized ratio (INR) levels more frequently in patients receiving warfarin during initiation or discontinuation of dabrafenib. Co-administration of TAFINLAR with other substrates of these enzymes, including dexamethasone or hormonal contraceptives, can result in decreased concentrations and loss of efficacy [see Use in Specific Populations (8.1, 8.6)]. Substitute for these medications or monitor patients for loss of efficacy if use of these medications is unavoidable.