Eflornithine Pregnancy and Breastfeeding Warnings

Brand names: Iwilfin

Medically reviewed by Drugs.com. Last updated on Feb 13, 2024.

Eflornithine Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Based on its mechanism of action and findings in animal models, this drug can cause fetal harm when administered during pregnancy. No data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-The patient should be apprised of the potential harm to the fetus.
-Pregnancy status of patients of childbearing potential should be verified before starting this drug.
-Females of reproductive potential should use effective contraception during treatment and for 1 week after the last dose.
-Males with female partners of reproductive potential should use effective contraception during treatment and for 1 week after the last dose.

Animal studies have revealed evidence of embryolethality after once daily oral dose of this drug to pregnant rats and rabbits during organogenesis; this occurred at doses equivalent to the recommended human dose. There are no controlled data in human pregnancy.

There was no clear evidence of this drug-related fetal malformations in rats or rabbits.

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

Eflornithine 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:
-No information is available on the clinical use of this drug during breastfeeding.

In clinical studies, maternal intravenous administration of this drug (400 mg/kg daily for 7 days) did not cause any serious adverse effects in breastfed infants.

See references

Further information

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

Medical Disclaimer