Elafibranor Pregnancy and Breastfeeding Warnings

Brand names: Iqirvo

Elafibranor Pregnancy Warnings

Safety has not been established during pregnancy.
-According to some authorities: Use is not recommended during pregnancy or in women of childbearing potential not using contraception.

AU TGA pregnancy category: D
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 women of childbearing potential to use effective, non-hormonal contraception (or to add a barrier method when using hormonal contraceptives) during treatment and for at least 3 weeks after last dose.
-Women planning to become pregnant should consult with their physician regarding alternate treatment options.

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 from 0.6 to 4.9 times the recommended human dose based on AUC. 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

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: Yes

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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