Eflornithine Pregnancy and Breastfeeding Warnings

Brand names: Iwilfin

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

Eflornithine Pregnancy Warnings

Use is not recommended; safety has not been established during pregnancy.

AU TGA pregnancy category: B3
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 including increased pre-implantation and post-implantation loss, increased early resorptions, reduced fetal body weights, and fetal skeletal variations, 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 and as low as one fifth the recommended human dose. However, there was no clear evidence of this drug-related fetal malformations in rats or rabbits. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain 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.

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.

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