Vismodegib

The Basics

What is Vismodegib?

Used to treat basal cell carcinoma in people with cancer that has spread to other parts of the body.

Brand names for Vismodegib

Erivedge

How Vismodegib is classified

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

Vismodegib During Pregnancy

Vismodegib pregnancy category

Category DNote 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 Vismodegib while pregnant

Based on its mechanism of action and findings from animal reproduction studies, ERIVEDGE can cause fetal harm when administered to a pregnant woman [see CLINICAL PHARMACOLOGY]. In animal reproduction studies, oral administration of vismodegib during organogenesis at doses below the 150 mg clinical dose resulted in embryotoxicity, fetotoxicity, and teratogenicity in rats (see Data). There are no human data on the use of ERIVEDGE in pregnant women. 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 an embryo-fetal toxicity study, pregnant rats were administered vismodegib orally at doses of 10, 60, or 300 mg/kg/day during the period of organogenesis. Pre- and post-implantation loss were increased at doses of ‚â• 60 mg/kg/day [approximately 2 times the human exposure at the 150 mg clinical dose based on area under the curve (AUC)], which included early resorption of 100% of the fetuses. A dose of 10 mg/kg/day [approximately 0.2 times the human exposure (AUC) at the recommended 150 mg clinical dose] resulted in malformations (including missing and/or fused digits, open perineum and craniofacial anomalies) and retardations or variations (including dilated renal pelvis, dilated ureter, and incompletely or unossified sternal elements, centra of vertebrae, or proximal phalanges and claws).

Taking Vismodegib While Breastfeeding

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

No information is available on the clinical use of vismodegib during breastfeeding. Because vismodegib is more than 99% bound to plasma proteins, the amount in milk is likely to be low. However, its half-life is 4 days and it might accumulate in the infant. The manufacturer recommends that breastfeeding be discontinued during vismodegib therapy and for 24 months after the final dose.

Maternal / infant drug levels

No information is available on the clinical use of vismodegib during breastfeeding. Because vismodegib is more than 99% bound to plasma proteins, the amount in milk is likely to be low. However, its half-life is 4 days and it might accumulate in the infant. The manufacturer recommends that breastfeeding be discontinued during vismodegib therapy and for 24 months after the final dose.

Possible effects of Vismodegib on milk supply

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

Possible alternatives to Vismodegib

None listed