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Trametinib Pregnancy and Breastfeeding Warnings

Trametinib is also known as: Mekinist

Medically reviewed on May 22, 2018

Trametinib Pregnancy Warnings

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.

Use is not recommended.

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

Risk Summary: This drug was embryotoxic and abortifacient in animals at doses greater than or equal to those resulting in exposures approximately 0.3 times the human exposure at the recommended clinical dose.

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.
-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.

See references

Trametinib Breastfeeding Warnings

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.

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.

See references

References for pregnancy information

  1. "Product Information. Mekinist (trametinib)." GlaxoSmithKline, Research Triangle Park, NC.

References for breastfeeding information

  1. "Product Information. Mekinist (trametinib)." GlaxoSmithKline, Research Triangle Park, NC.

Further information

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

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