Revumenib Pregnancy and Breastfeeding Warnings

Brand names: Revuforj

Medically reviewed by Drugs.com. Last updated on Jan 16, 2025.

Revumenib Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Based on findings in animals and its mechanism of action, this drug can cause fetal harm. No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Negative pregnancy status should be verified in females of childbearing potential within 7 days before initiating therapy.
-Pregnant patient should be apprised of the potential harm to the fetus.
-This drug may impair fertility.
-Males and females of reproductive potential should be advised to use effective contraception during therapy and for 4 months after the last dose.

Animal studies have revealed evidence of fetal harm. In an embryofetal development study in rats, oral administration of this drug at doses of 30, 100, and 300 mg/kg/day during organogenesis caused adverse developmental outcomes, including embryofetal mortality, malformations, and altered fetal growth. At 300 mg/kg/day, total litter resorption and eye malformations were observed. At 30 mg/kg/day, maternal exposure was about 0.5 times the human exposure at the recommended 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

Revumenib Breastfeeding Warnings

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

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

Comments:
-The effects in the nursing infant are unknown.
-There are no data on the presence of this drug in human milk or the effects of this drug on milk production.

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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