Revefenacin Pregnancy and Breastfeeding Warnings

Brand names: Yupelri

Medically reviewed by Drugs.com. Last updated on Aug 21, 2023.

Revefenacin Pregnancy Warnings

Animal studies of subcutaneous administration of doses 209 times the maximum recommended human dose (MRHD) during organogenesis (gestation days 7 to 19) showed no teratogenicity and had no effect on fetal survival at doses up to 694 times the MRHD. Placental transfer of the drug and active metabolite were seen in rabbits. Studies of subcutaneous administration from organogenesis to lactation (gestation day 6 to lactation day 20) showed no adverse developmental effects at doses up to 196 the MRHD. 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.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Patients should contact their doctor if they become pregnant while on this drug.

See references

Revefenacin Breastfeeding Warnings

-This drug and its active metabolite were found in rat milk on lactation day 22 (drug administered from gestation day 6 to lactation day 20); milk to plasma concentration ratios were up to 10 for the drug and metabolite.

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
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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