Elafibranor Pregnancy and Breastfeeding Warnings

Brand names: Iqirvo

Elafibranor Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Based on findings from animal studies, this drug may cause fetal harm when administered to a pregnant woman. Insufficient data available on use of this drug in pregnant women to inform a drug-associated risk.

Comments:
-Verify that female patients of reproductive potential are not pregnant prior to initiating treatment.
-Counsel females of childbearing potential to use effective, non-hormonal contraception (or add a barrier method when using hormonal contraceptives) during treatment and for at least 3 weeks after last dose.
-Report pregnancies to Ipsen Pharmaceuticals, Inc. Adverse Event reporting line at 1-855-463-5127 and at https://www.ipsen.com/contact-us/

Animal studies have revealed evidence of embryolethality and fetal harm. Administration of this drug to pregnant animals during the period of organogenesis through lactation resulted in maternal toxicity, stillbirths, reduced postnatal survival, reduced fetal weights, fetal malformations, skeletal variations, caudal discoloration, and/or developmental delays. Adverse effects in pregnant animals and their offspring occurred at exposures ranging from below and up to 4.9 times the recommended dose based on AUC. 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.

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Elafibranor Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 3 weeks after the last dose.

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

Comments:
-There are no data on the presence of this drug in human milk or the effects of this drug on milk production.
-The effects in the nursing infant are unknown; there is a potential for serious adverse reactions.

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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