Tirbanibulin (tir-ban-i-BUE-lin)

Treats actinic keratosis on the face or scalp.

Brand Name(s):

Klisyri

When This Medicine Should Not Be Used:

How to Use This Medicine:

Ointment

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine is for use only on your skin. Do not get any of this medicine near or around your eyes, mouth, or lips. Rinse it off right away if it does get on these areas.
• Use 1 single-dose packet with each application.
• Use this medicine only on your skin. Rinse it off right away if it gets on a cut or scrape. Do not get the medicine in your eyes, nose, or mouth.
• Wash your hands with soap and water before and after you use this medicine.
• Apply a thin, even layer of the medicine to cover the affected area (up to 100 cm2) on the face or scalp.
• Do not cover the treated area with a bandage unless directed by your doctor.
• Do not wash or touch the treated area for at least 8 hours after application. You may wash the area with mild soap and water after 8 hours.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Apply a dose as soon as you can. If it is almost time for your next dose, wait until then and apply a regular dose. Do not apply extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Throw away any open packet after use even if there is still medicine left in it.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have other skin problems (including patients who have received treatment with other medicine, procedure, or surgery).
• This medicine may cause the following problems:
  • Eye irritation
  • Serious skin reactions
• Do not use this medicine to treat a skin problem your doctor has not examined.
• Call your doctor if your symptoms do not improve or if they get worse.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blisters, peeling, pus, ulcers, or cracking of the skin
• Red, sore eyes
• Severe redness, flaking, scaling, crusting, or swelling of the skin

If you notice these less serious side effects, talk with your doctor:

• Pain or itching where the medicine is applied

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088