Regorafenib

The Basics

What is Regorafenib?

Used to treat colon and rectal cancer that has spread to other parts of the body; also used to treat gastrointestinal stromal tumors.

Brand names for Regorafenib

Stivarga

How Regorafenib is classified

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

Regorafenib During Pregnancy

Regorafenib 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 Regorafenib while pregnant

Based on animal studies and its mechanism of action, STIVARGA can cause fetal harm when administered to apregnant woman. There are no available data on STIVARGA use in pregnant women. Administration of regorafenib was embryolethal and teratogenic in rats and rabbits at exposures lower than human exposures at the recommended dose, with increased incidences of cardiovascular, genitourinary, and skeletal malformations . Advise pregnant women of the potential hazard to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 % and 15 to 20%, respectively

Taking Regorafenib While Breastfeeding

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

No information is available on the clinical use of regorafenib during breastfeeding. Because regorafenib is 99.5% bound to plasma proteins, the amount in milk is likely to be low. However, one of its metabolites has a half-life of up to 70 hours, and might accumulate in the infant. The manufacturer recommends that breastfeeding be discontinued during regorafenib therapy and for 2 weeks after the final dose.

Maternal / infant drug levels

No information is available on the clinical use of regorafenib during breastfeeding. Because regorafenib is 99.5% bound to plasma proteins, the amount in milk is likely to be low. However, one of its metabolites has a half-life of up to 70 hours, and might accumulate in the infant. The manufacturer recommends that breastfeeding be discontinued during regorafenib therapy and for 2 weeks after the final dose.

Possible effects of Regorafenib on milk supply

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

Possible alternatives to Regorafenib

None listed