Tirbanibulin is used to treat actinic keratosis (flat, scaly growths on the skin caused by too much sun exposure) on the face or scalp. Tirbanibulin is in a class of medications called microtubule inhibitors. It works by killing fast-growing cells such as the abnormal cells associated with actinic keratoses.

Tirbanibulin comes as an ointment to apply to the face or scalp. It is usually applied once a day to the affected area for 5 days. Use tirbanibulin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use tirbanibulin exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Tirbanibulin ointment should be used only on the face or scalp. Do not apply tirbanibulin ointment in or near your eyes, lips, or mouth. If you get tirbanibulin ointment in your eyes, flush them with water right away, and get medical care as soon as possible.

Avoid washing and touching the treated area for approximately 8 hours after tirbanibulin application. Following this time, the area may be washed with a mild soap.

Do not cover the treated area with bandages or other dressings.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before using tirbanibulin,

• tell your doctor and pharmacist if you are allergic to tirbanibulin, any other medications, or any of the ingredients in tirbanibulin ointment. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever been treated for actinic keratosis with any other medication, procedure, or surgery. Also, tell your doctor if you have other skin problems in the treatment area.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using tirbanibulin, call your doctor.

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra ointment to make up for a missed dose.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

If someone swallows tirbanibulin, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• skin reactions

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not refrigerate or freeze it.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Tirbanibulin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness, flaking, scaling, crusting, or swelling of the skin
• pain, itching, or irritation of the treated skin

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• blisters, pus, ulcers, or other sores on the skin

Tirbanibulin may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Klisyri®