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Beremagene geperpavec topical Pregnancy and Breastfeeding Warnings

Brand names: Vyjuvek

Medically reviewed by Drugs.com. Last updated on Dec 4, 2023.

Beremagene geperpavec topical Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

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

Comments:
-Advise women of reproductive potential to use effective contraception during treatment with this drug.
-If a patient becomes pregnant during treatment, apprise the patient of the potential hazards to the fetus and neonate.
-Individuals who are pregnant should not prepare or apply this drug and should avoid direct contact with the treated wounds or dressings.

Animal developmental and reproductive toxicity studies have not been conducted with this drug. 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

Beremagene geperpavec topical Breastfeeding Warnings

Safety has not been established

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

Comments:
-There is no information on the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production.
-Animal lactation studies have not been conducted with this drug.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

See references

See also

References for pregnancy information

  1. (2023) "Product Information. Vyjuvek (beremagene geperpavec topical)." Krystal Biotech Inc.

References for breastfeeding information

  1. (2023) "Product Information. Vyjuvek (beremagene geperpavec topical)." Krystal Biotech Inc.

Further information

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

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