Nedosiran Pregnancy and Breastfeeding Warnings

Brand names: Rivfloza

Medically reviewed by Drugs.com. Last updated on Mar 29, 2024.

Nedosiran Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not Assigned

Risk Summary: Available data is insufficient to evaluate for a drug-associated risk.

Comments:
-There is insufficient data on use in pregnant women to know this drugs risks, including the risk of major defects, miscarriage, or other adverse maternal or fetal outcomes.

Animal studies showed no adverse developmental effects when this drug was administered to pregnant mice at doses up to 58 times the maximum recommended human dose (MRHD). However, subcutaneous administration to pregnant rabbits during organogenesis at doses approximating the MRHD resulted in increased fetal loss and maternal toxicity. Fetal cardiovascular and skeletal malformations were observed at a dose approximately 2 times the MRHD. This drug is not pharmacologically active in rabbits or mice, and the cause of these embryo-fetal toxicities is unclear. 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

Nedosiran Breastfeeding Warnings

Benefit should outweigh risk.

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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