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Tirbanibulin topical Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Feb 1, 2021.

Tirbanibulin topical is also known as: Klisyri

Tirbanibulin topical Pregnancy Warnings

Studies in rats and rabbits showed embryonic and fetal toxicity, including fetal malformations, at multiples of 22 times and 65 times greater than human exposure in the maximal use pharmacokinetic human study. Pre- and postnatal development observations in rats showed reductions in fertility and increased embryo-fetal lethality in the offspring of treated females. 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.

Use is not recommended during pregnancy and in women of childbearing potential not using contraception.

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. Animal studies have shown reproductive toxicity.

See references

Tirbanibulin topical Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, considering the importance of the treatment to the mother.

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

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. However, the risk to the infants cannot be excluded.
-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

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.