Trametinib Pregnancy and Breastfeeding Warnings

Brand names: Mekinist

Medically reviewed by Drugs.com. Last updated on Aug 28, 2023.

Trametinib Pregnancy Warnings

Use is not recommended.

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

Risk Summary: This drug was embryotoxic and abortifacient in animal studies.

Comments:
-Based on its mechanism of action and findings from animal reproduction studies, this drug can cause fetal harm when administered to a pregnant woman.
-Pregnancy status in females of reproductive potential should be verified prior to initiating treatment, and adequate methods of contraception should be encouraged during therapy and for 4 months following discontinuation of 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.

This drug was embryotoxic and abortifacient in animal studies at exposures 0.3 times the human clinical exposure at the recommended dose. 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.

See references

Trametinib Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-The effects in the nursing infant are unknown.
-The manufacturer recommends that breastfeeding be discontinued during therapy and for 4 months after the last dose.

No information is available on the clinical use of this drug during breastfeeding. Because it is 97% bound to plasma proteins, the amount in milk is likely to be low; however, its half-life is 3.9 to 4.8 days and it might accumulate in the infant.

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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