In animal reproduction studies, administration of this drug during the organogenesis was embryotoxic and an abortifacient at doses greater than or equal to those resulting in exposures approximately 5 times the human exposure. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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 should be avoided.

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

Risk Summary: Based on animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. There are no available data on the use of this drug during pregnancy.

Comments:
-This drug can harm a developing fetus.
-Advise females of reproductive potential to use effective contraception during therapy with this drug and for at least 30 days after the final dose.
-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 should be avoided.

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

Comments:
-The effects in the nursing infant are unknown.
-Advise women not to breastfeed during treatment with this drug and for at least 3 days after the final dose.

No information is available on the use of this drug during breastfeeding. Because it is highly bound to plasma proteins, and the half-life is 3.5 hours, the amount in milk is likely to be low; however, the manufacturer recommends that breastfeeding be discontinued during therapy and for at least 3 days after. For patients taking the combination with encorafenib, the manufacturer recommends that breastfeeding be discontinued during therapy and for at least 2 weeks after.

See references