Berotralstat Pregnancy and Breastfeeding Warnings

Brand names: Orladeyo

Medically reviewed by Drugs.com. Last updated on Jan 19, 2024.

Berotralstat Pregnancy Warnings

Benefit should outweigh risk. Some authorities do not recommend its use during pregnancy.

US FDA pregnancy category: Unassigned

Comments:
-There is insufficient data on use in pregnant women to know this drug's risks, including the risk of fetal harm or reproductive effects.
-Some authorities recommend that women of childbearing potential use effective contraception during treatment with this drug and for at least 1 month following the last dose, and do not recommend the use of this drug in women of childbearing potential not using contraception

Animal studies showed no evidence of structural alterations when this drug was administered orally to pregnant rats and rabbits during organogenesis at doses up to approximately 10 times the maximum recommended human dose.

There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

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

Berotralstat Breastfeeding Warnings

Benefit should outweigh risk.

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

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references

Further information

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