This drug showed no evidence of developmental toxicity in animal studies. Fetal drug levels were 3% to 5% of maternal levels, indicating that this drug has the potential to be transmitted from the mother to the developing fetus. Exposure could not be achieved in animals at levels sufficient to fully address its potential toxicity in pregnant women. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

Use is not recommended.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary: Based on its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. There are no available data on use in pregnant women to determine the drug-associated risk; however, placental transfer of this drug to a fetus has been reported. Exposure to vemurafenib could not be achieved in animals at levels sufficient to fully address its potential toxicity in pregnant women. Advise pregnant women of the potential harm to a fetus.

Comments:
-This drug can harm a developing fetus.
-Advise females of reproductive potential to use effective contraception during therapy and for 2 weeks after.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

See references

Use is not recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-Because of the potential for serious adverse reactions in a breastfed infant, including malignancy, severe dermatologic reactions, QT prolongation, hepatotoxicity, photosensitivity, and ophthalmologic toxicity, women should not breastfeed during therapy and for 2 weeks after.

No information is available on the use of this drug during breastfeeding. Because it is more than 99% bound to plasma proteins, the amount in milk is likely to be low; however, its half-life is 57 hours and it might accumulate in the infant.

See references