Cobimetinib

The Basics

What is Cobimetinib?

Used in combination with vemurafenib, a BRAF inhibitor, to treat melanoma.

Brand names for Cobimetinib

Cotellic

How Cobimetinib is classified

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

Cobimetinib During Pregnancy

Cobimetinib pregnancy category

Category N/ANote 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 Cobimetinib while pregnant

Based on findings from animal reproduction studies and its mechanism of action, COTELLIC can cause fetal harm when administered to a pregnant woman [see CLINICAL PHARMACOLOGY]. There are no available data on the use of COTELLIC during pregnancy. In animal reproduction studies, oral administration of cobimetinib in pregnant rats during organogenesis was teratogenic and embryotoxic at exposures (AUC) that were 0.9 to 1.4-times those observed in humans at the recommended human dose of 60 mg . 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.

Taking Cobimetinib While Breastfeeding

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

No information is available on the clinical use of cobimetinib during breastfeeding. Because cobimetinib is 90% bound to plasma proteins, the amount in milk is likely to be low. However, its half-life is about 44 hours and it might accumulate in the infant. The manufacturer recommends that breastfeeding be discontinued during cobimetinib therapy and for 2 weeks after the last dose.

Maternal / infant drug levels

No information is available on the clinical use of cobimetinib during breastfeeding. Because cobimetinib is 90% bound to plasma proteins, the amount in milk is likely to be low. However, its half-life is about 44 hours and it might accumulate in the infant. The manufacturer recommends that breastfeeding be discontinued during cobimetinib therapy and for 2 weeks after the last dose.

Possible effects of Cobimetinib on milk supply

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

Possible alternatives to Cobimetinib

None listed