Vibegron Pregnancy and Breastfeeding Warnings

Brand names: Gemtesa

Vibegron Pregnancy Warnings

The manufacturer has no data available on pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

US FDA pregnancy category: Not assigned.

Comments:
-No effects on embryo-fetal development were observed in animal studies.

In animal studies, no effects on embryo-fetal development were observed following administration during the period of organogenesis at exposures approximately 275-fold and 285-fold greater than clinical exposure at the recommended daily dose. 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.

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Vibegron Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-No data are available regarding the presence of this drug in human milk, the effects on the breast-fed infant, or the effects on milk production.

No information is available on the use of this drug during breastfeeding. The presence of radioactivity was observed in milk and plasma collected at 1, 4, 12, and 24 hours after dosing in a lactational transfer study involving animals with a single oral dose of 10 mg/kg radiolabeled drug on postpartum day 10.

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Further information

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