Tirbanibulin topical is used to treat actinic keratosis, a skin condition caused by damage from repeated exposure to ultraviolet light from the sun and/or indoor tanning.

Tirbanibulin is used to treat actinic keratosis on the face or scalp.

Tirbanibulin topical may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not take by mouth. Topical medicine is for use only on the skin. Tirbanibulin topical is for use only on the face or scalp.

This medicine is usually applied once per day for 5 days in a row. Follow your doctor's dosing instructions very carefully.

Wash your hands with soap and water after applying this medicine.

Apply only enough medicine to cover the skin area affected by actinic keratosis.

Do not cover the treated skin area with a bandage.

Try not to get this medicine on other skin areas that are not affected by actinic keratosis. Rinse with water if this medicine gets in your mouth or on your lips.

Avoid washing or touching the treated skin for at least 8 hours after applying this medicine.

Each single dose packet of this medicine is for one use only. Throw away the packet after use, even if there is still medicine left inside.

Store at room temperature away from moisture and heat. Do not keep this medicine in a refrigerator or freezer.

Usual Adult Dose for Actinic Keratosis:

Evenly cover up to 25 cm2 on the face or scalp once a day

Comments:
-Treat for 5 consecutive days using on single-dose pack per application.
-For topical use only; not for oral or ophthalmic use.

Use: For the topical treatment of actinic keratosis on the face or scalp

Tell your doctor about all other medicines or treatments you are receiving to treat actinic keratosis. You may need to delay starting tirbanibulin topical until your skin has healed from other treatments.

Tell your doctor if you have other skin problems in the areas you will treat with tirbanibulin topical.

Tell your doctor if you are pregnant or breastfeeding.

Tirbanibulin is not approved for use by anyone younger than 18 years old.

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe skin reactions (redness, swelling, blistering, peeling, crusting, oozing, ulcers).

Do not get tirbanibulin topical in your eyes. If contact does occur, rinse with water and call your doctor right away.

Rinse with water if this medicine gets in your mouth or on your lips.

Do not share this medicine with another person, even if they have the same symptoms you have.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tirbanibulin topical may cause serious side effects. Call your doctor at once if you have:

• redness, swelling, flaking, scaling, peeling, or crusting of treated skin; or

• blisters, pus, ulcers, or breakdown of your skin.

Common side effects of tirbanibulin topical may include:

• itching or pain where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.