Acoramidis Pregnancy and Breastfeeding Warnings

Brand names: Attruby

Medically reviewed by Drugs.com. Last updated on Jan 14, 2025.

Acoramidis Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Available data is insufficient to establish a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

Animal studies in rats and rabbits showed no embryofetal abnormalities at exposures up to 34 times and 13 times the clinical exposure at the maximum recommended human dose, respectively. Oral administration of 200 mg/kg/day in pregnant rabbits throughout organogenesis, resulted in increased pre-implantation loss and maternal toxicity (26% reduced body weight). No embryofetal abnormalities were observed. 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

Acoramidis Breastfeeding Warnings

Safety has not been established.

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

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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