Generic drug: tirbanibulin

Brand name: Klisyri

What is Klisyri (tirbanibulin), and how does it work?

Klisyri (tirbanibulin) is a prescription medicine used on the skin to treat actinic keratosis on the face or scalp. Typically caused by years of sun damage, actinic keratosis can later turn into skin cancer if left untreated.

It is not known if Klisyri is safe and effective in children less than 18 years of age.

What are the side effects of Klisyri?

The most common side effects of Klisyri include:

These are not all of the possible side effects of Klisyri. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the dosage for Klisyri?

  • For topical use only; not for oral or ophthalmic use.
  • Apply sufficient amount of Klisyri to evenly cover up to 25 cm² treatment field on the face or scalp once daily for 5 consecutive days using 1 single-dose packet per application.
  • Wash hands immediately with soap and water after application.
  • Avoid washing and touching the treated area for approximately 8 hours after application of Klisyri. Following this time, the area may be washed with a mild soap.
  • Avoid transfer of Klisyri to the periocular area.
  • Avoid application near and around the mouth and lips.

What drugs interact with Klisyri?

No Information Provided

Is Klisyri safe to use while pregnant or breastfeeding?

  • There are no available data with Klisyri use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
  • There are no data on lactational transfer of Klisyri to human or animal milk. The effects of Klisyri on the breastfed infant, or its effects on milk production, are unknown.
  • The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Klisyri and any potential adverse effects on the breastfed child from tirbanibulin or from the underlying maternal condition.

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Summary

Klisyri (tirbanibulin) is a prescription cream used on the skin to treat actinic keratosis on the face or scalp. Typically caused by years of sun damage, actinic keratosis can later turn into skin cancer if left untreated. The most common side effects of Klisyri include itching or pain in the treatment area.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Medically Reviewed on 3/10/2021
References
All sections courtesy of the U.S. Food and Drug Administration