Klisyri (tirbanibulin)

The most common side effects of Klisyri include:

• itching or pain in the treatment area.

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.

• 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.

• 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.