Momelotinib Pregnancy and Breastfeeding Warnings

Brand names: Ojjaara

Momelotinib Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-According to some authorities: Use is contraindicated.

AU TGA pregnancy category: D
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 of a drug-related risk.
-Women of childbearing potential should avoid becoming pregnant while receiving this drug.
-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.
-Women using systemically acting hormonal contraceptives should add a barrier method during treatment and for at least 1 week after the last dose.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be advised to discontinue this drug and be apprised of the potential harm to the fetus.

Animal studies have revealed evidence of embryofetal toxicity and teratogenicity; 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. This drug impaired fertility in male and female rats. There are no controlled data in human pregnancy.

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

Momelotinib Breastfeeding Warnings

Breastfeeding is not recommended during the use of this drug and for at least 1 week after the last dose.
-According to some authorities: Use is contraindicated.

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

Comments:
-A risk to the breastfed child cannot be excluded.
-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.
-This drug is 91% bound to plasma proteins; the amount in milk is likely to be low.

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

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

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