Sorafenib

The Basics

What is Sorafenib?

Used to treat advanced renal cell carcinoma as well as used to treat hepatocellular carcinoma.

Brand names for Sorafenib

Nexavar

How Sorafenib is classified

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

Sorafenib During Pregnancy

Sorafenib 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 Sorafenib while pregnant

Based on findings from animal studies and its mechanism of action, NEXAVAR may cause fetal harm when administered to a pregnant woman [see CLINICAL PHARMACOLOGY]. There are no available data in pregnant women to inform a drug associated risk. In animal reproduction studies, oral administration of sorafenib to pregnant rats and rabbits during the period of organogenesis resulted in embryo-fetal toxicities at maternal exposures that were significantly lower than human exposures at the recommended dose of 400 mg twice daily . Apprise pregnant women and females of reproductive potential of the potential risk to a fetus. The 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 Sorafenib While Breastfeeding

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

No information is available on the clinical use of sorafenib during breastfeeding. Because sorafenib is 99.5% bound to plasma proteins, the amount in milk is likely to be low. However, its half-life is 25 to 48 hours and it might accumulate in the infant. The manufacturer recommends that breastfeeding be discontinued during sorafenib therapy and for 2 weeks after the last dose.

Maternal / infant drug levels

No information is available on the clinical use of sorafenib during breastfeeding. Because sorafenib is 99.5% bound to plasma proteins, the amount in milk is likely to be low. However, its half-life is 25 to 48 hours and it might accumulate in the infant. The manufacturer recommends that breastfeeding be discontinued during sorafenib therapy and for 2 weeks after the last dose.

Possible effects of Sorafenib on milk supply

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

Possible alternatives to Sorafenib

None listed