Encorafenib Pregnancy and Breastfeeding Warnings

Brand names: Braftovi

Medically reviewed by Drugs.com. Last updated on Apr 28, 2025.

Encorafenib Pregnancy Warnings

Use should be avoided.

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

Risk summary: Based on findings from animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. No data available on use of this drug in pregnant women to inform a drug-associated risk.

Comments:
-Verify the pregnancy status of females of reproductive potential prior to initiating therapy.
-Counsel females of childbearing potential to use effective contraception during treatment and for at least 2 weeks to 1 month after the last dose.
-According to some authorities: Use of this drug is not recommended in females of reproductive potential not using contraception.
-Advise patients to use a non-hormonal method of contraception (e.g., barrier method) during treatment as this drug may decrease the efficacy of hormonal contraceptives.
-If this drug is used during pregnancy, ensure the benefit to the mother outweighs the risk to the fetus, and apprise the patient of the potential for fetal harm.
-Male fertility may be compromised by this drug.

Animal studies have revealed evidence of embryotoxicity, teratogenicity, and abortion. Administration of this drug to pregnant animals during the period of organogenesis resulted in maternal toxicity, decreased fetal weights, increased incidence of total skeletal variations, and increased post-implantation loss at doses ranging from 26 to 178 times the human exposure at the recommended clinical dose. Placental transfer of this drug was observed in animal studies. 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.

See references

Encorafenib Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 2 weeks after the last dose.

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

Comments:
-A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding for the child.
-The effects in the nursing infant are unknown; there is a potential for serious adverse reactions
-There are no data on the presence of this drug in human milk or the effects of this drug on milk production.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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