Skip to Content

Berotralstat Pregnancy and Breastfeeding Warnings

Berotralstat is also known as: Orladeyo

Medically reviewed by Drugs.com. Last updated on Jan 29, 2021.

Berotralstat Pregnancy Warnings

Benefit should outweigh risk.

US FDA pregnancy category: Unassigned

Comments:
-There is insufficient data on use during pregnancy to know this drug's risks, including the risk of fetal harm or reproductive effects.

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

References for pregnancy information

  1. "Product Information. Orladeyo (berotralstat)." BioCryst Pharmaceuticals Inc, Durham, NC.

References for breastfeeding information

  1. "Product Information. Orladeyo (berotralstat)." BioCryst Pharmaceuticals Inc, Durham, NC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.