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Tirbanibulin topical Pregnancy and Breastfeeding Warnings

Tirbanibulin topical is also known as: Klisyri

Tirbanibulin topical Pregnancy Warnings

When administered orally to pregnant animals, this drug-induced fetal death and external, visceral, and skeletal malformations during the period of organogenesis at doses greater than or equal to 1.25 mg/kg/day. This drug has no apparent effects on fetal development in animals at a dose of 0.5 mg/kg/day.

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.

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Comment: There are no available data using this drug in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

See references

Tirbanibulin topical 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, the developmental and health benefits of breastfeeding, and any potential adverse effects on the breastfed child.

Excreted into human milk: Data not available
Excreted into animal milk: Data not available

-The effects on the nursing, or the effects on milk production, are unknown.
-Do not apply this drug to the breast or nipple and ensure the infant's skin does not come in direct contact with the treated area.

There are no data on lactational transfer to human or animal milk. This drug is 88% bound to plasma, and after topical administration, the serum concentration is very low; therefore, the amounts of milk are likely to be very low.

See references

References for pregnancy information

  1. "Product Information. Klisyri (tirbanibulin topical)." Almirall, Exton, PA.

References for breastfeeding information

  1. "Product Information. Klisyri (tirbanibulin topical)." Almirall, Exton, PA.

Further information

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