Dabrafenib

The Basics

What is Dabrafenib?

Used alone or in combination to treat a certain types of melanoma.

Brand names for Dabrafenib

Tafinlar

How Dabrafenib is classified

Antineoplastic Agents, Enzyme Inhibitors, Protein Kinase Inhibitors, Signal Transduction Inhibitors

Dabrafenib During Pregnancy

Dabrafenib pregnancy category

Category Not AssignedNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Dabrafenib while pregnant

Based on findings from animal reproduction studies and its mechanism of action [see CLINICAL PHARMACOLOGY], TAFINLAR can cause fetal harm when administered to a pregnant woman. There is insufficient data in pregnant women exposed to TAFINLAR to assess the risks. Dabrafenib was teratogenic and embryotoxic in rats at doses three times greater than the human exposure at the recommended clinical dose of 150 mg twice daily (see Data). Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In a combined female fertility and embryo-fetal development study in rats conducted during the period of organogenesis, developmental toxicity consisted of embryo-lethality, ventricular septal defects, and variation in thymic shape at a dabrafenib dose of 300 mg/kg/day [approximately three times the human exposure at the recommended dose based on area under the curve (AUC)]. At doses of 20 mg/kg/day or greater (equivalent to the human exposure at the recommended dose based on AUC), rats demonstrated delays in skeletal development and reduced fetal body weight.

Taking Dabrafenib While Breastfeeding

What are recommendations for lactation if you're taking Dabrafenib?

No information is available on the clinical use of dabrafenib during breastfeeding. Because dabrafenib is more than 99% bound to plasma proteins, the amount in milk is likely to be low. The manufacturer recommends that breastfeeding be discontinued during dabrafenib therapy and for 2 weeks after the last dose.

Maternal / infant drug levels

No information is available on the clinical use of dabrafenib during breastfeeding. Because dabrafenib is more than 99% bound to plasma proteins, the amount in milk is likely to be low. The manufacturer recommends that breastfeeding be discontinued during dabrafenib therapy and for 2 weeks after the last dose.

Possible effects of Dabrafenib on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Dabrafenib

None listed