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Binimetinib Pregnancy and Breastfeeding Warnings

Binimetinib is also known as: Mektovi

Medically reviewed by Last updated on Dec 13, 2018.

Binimetinib Pregnancy Warnings

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.

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.

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.

-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

Binimetinib Breastfeeding Warnings

Use is not recommended.

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

-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.

See references

References for pregnancy information

  1. "Product Information. Mektovi (binimetinib)." Array BioPharma Inc., Boulder, CO.

References for breastfeeding information

  1. "Product Information. Mektovi (binimetinib)." 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.