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Monomethyl fumarate Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Nov 7, 2022.

Monomethyl fumarate is also known as: Bafiertam

Monomethyl fumarate Pregnancy Warnings

Animal studies have revealed evidence of increased lethality, persistent reductions in body weight, delayed sexual maturation (male and female pups), reduced testicular weight, neurobehavioral impairment, and maternal toxicity. 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: Animal studies revealed adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function when this drug was administered during pregnancy at clinically relevant doses.

-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

Monomethyl fumarate 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

-The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Retevmo (selpercatinib)." Lilly, Eli and Company (2020):

References for breastfeeding information

  1. "Product Information. Retevmo (selpercatinib)." Lilly, Eli and Company (2020):

Further information

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