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Encorafenib Pregnancy and Breastfeeding Warnings

Encorafenib is also known as: Braftovi

Medically reviewed by Drugs.com. Last updated on May 6, 2020.

Encorafenib Pregnancy Warnings

Animal studies have revealed evidence of maternal toxicity, decreased fetal weights, increased incidence of total skeletal variations, and increased post-implantation loss. 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 its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. In animal studies, it caused embryofetal developmental changes and was an abortifacient at doses greater than or equal to those resulting in exposures approximately 26 times the human exposure at the clinical dose.

Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-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

Encorafenib Breastfeeding Warnings

Use is not recommended.

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

Comments:
-The effects in the nursing infant are unknown.
-Women should be advised not to breastfeed during therapy with this drug and for 2 weeks after the final dose.

See references

References for pregnancy information

  1. "Product Information. Braftovi (encorafenib)." Array BioPharma Inc., Boulder, CO.

References for breastfeeding information

  1. "Product Information. Braftovi (encorafenib)." Array BioPharma Inc., Boulder, CO.

Further information

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