Momelotinib Pregnancy and Breastfeeding Warnings

Brand names: Ojjaara

Medically reviewed by Drugs.com. Last updated on Nov 7, 2023.

Momelotinib Pregnancy Warnings

This drug should be used during pregnancy only if the benefits to the mother outweigh the potential risks to the fetus.

US FDA pregnancy category: Not assigned

Risk summary: Based on findings from animal studies, this drug may cause embryofetal toxicity when administered to a pregnant woman.

Comments:
-There is insufficient data on the use of this drug in pregnant women to inform a drug-related risk.
-Women of childbearing potential should be encouraged to use highly effective methods of contraception during therapy and for at least 1 week after the last dose.

Animal studies have revealed evidence of embryofetal toxicity; however, some of these reactions were observed at exposures over 3 times higher than the recommended human dose. In pregnant rats given this drug during organogenesis, embryofetal toxicity occurred at a dose associated with maternal toxicity, and skeletal variations occurred without maternal toxicity. No developmental toxicity was observed at a dose equivalent to the recommended dose. When administered to rats during the period of organogenesis through lactation, embryolethality, decreased pup body weight, and reduced pup survival were observed at doses 2 times the recommended human dose. There are no controlled data in human pregnancy.

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

Momelotinib Breastfeeding Warnings

Breastfeeding is not recommended during the use of this drug and for at least 1 week after the last dose.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-There are no data available on the presence of this drug or its metabolites in human milk.
-The effects on the nursing infant and on milk production are unknown.
-There is the potential for serious adverse reactions in the breastfed child.

When administered orally to lactating rats, this drug was found in the plasma of nursing pups which adversely affected pup survival.

See references

Further information

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