Odevixibat Pregnancy and Breastfeeding Warnings

Brand names: Bylvay

Medically reviewed by Drugs.com. Last updated on Sep 4, 2023.

Odevixibat Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk summary: There are no data available on use of this drug in pregnant women to inform a drug-related risk.

Comment: If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies have revealed evidence of cardiac malformations at maternal doses at least 2.1 times the recommended human 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

Odevixibat Breastfeeding Warnings

This drug should be used only if clearly needed.

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

Comments:
-This drug has low oral absorption when given orally.
-The effects in the nursing infant and on the milk production are unknown.
-If this drug is used, patients should be monitored and subsequently treated for fat-soluble vitamin deficiencies.

See references

Further information

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