Vibegron Pregnancy and Breastfeeding Warnings

Brand names: Gemtesa

Vibegron Pregnancy Warnings

According to some authorities: This drug should not be used during pregnancy or in patients of childbearing potential not using contraception.

US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-According to some authorities: When pregnancy is planned or diagnosed, this drug should be discontinued; if appropriate, alternative therapy should be started.

Animal studies have failed to reveal evidence of embryofetal toxicity, except for at maternotoxic doses. After oral dosing in pregnant rats during organogenesis, no embryofetal developmental toxicity was observed at exposures up to 275-fold higher than clinical exposure at the recommended human dose (RHD); because maternal toxicity occurred at exposures 1867-fold higher than exposure at the RHD, treatment with the high dose was stopped. After oral dosing in pregnant rabbits during organogenesis, no embryofetal developmental toxicity was observed at exposures up to 285-fold higher than exposure at the RHD; maternal toxicity (reduced food intake), reduced fetal body weight, and increased incidence of delayed skeletal ossification were seen at exposures about 898-fold higher than exposure at the RHD. 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

Vibegron Breastfeeding Warnings

If use of this drug is required, it is not a reason to discontinue breastfeeding.
-According to some authorities: Use is not recommended.

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

Comments:
-No information is available on the use of this drug during breastfeeding.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-The breastfed infant should be monitored for urinary retention.

See references

Further information

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

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