Tirbanibulin (Topical application)

Tirbanibulin (Topical application) is used to treat actinic keratosis on the face or scalp.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits for any side effects that may be caused by this medicine.

If your condition does not improve or if it gets worse, consult your doctor.

This medicine may cause serious skin reactions. Contact your doctor immediately if you experience blisters, peeling, pus, ulcers, cracking, redness, flaking, scaling, crusting, or swelling of the skin.

In deciding to use a medicine, you and your doctor will need to consider the risks of taking it compared to the benefits it may provide. Here are some important points to keep in mind for this medicine:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how age affects the use of tirbanibulin topical in children. Safety and effectiveness have not been established for this age group.

Geriatric

Studies conducted so far have not shown any specific problems in older adults that would limit the use of tirbanibulin topical. However, older patients may be more sensitive to the effects of this medicine compared to younger adults.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if there might be an interaction. In such situations, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food because interactions may happen. Drinking alcohol or using tobacco with certain medicines can also lead to interactions. Talk to your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may influence how this medicine works for you. Be sure to tell your doctor about any other medical issues, especially:

• Other skin problems (e.g., if you have had treatment with other medicines, procedures, or surgery) — This medicine should not be used until your skin has healed from other treatments.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects happen:

More common

• Cracking of the skin
• Crusting of the skin
• Dryness and peeling of the skin
• Flushing, redness of the skin
• Redness, blistering, peeling, or loosening of the skin
• Skin ulcers
• Swelling
• Unusually warm skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to share ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Less common

• Burning, stinging, or pain at the application site
• Itching skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Klisyri

Available Dosage Forms:

• Ointment

Therapeutic Class: Antineoplastic, Dermatological

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause your skin to become irritated.

This medicine is for use on the skin only. Do not get any of this medicine near or around your eyes, mouth, or lips. If it does get on these areas, rinse it off with water and check with your doctor right away, especially if you have red, sore eyes.

This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

To use the ointment:

• Use 1 single-dose packet with each application.
• Wash your hands with soap and water before and after using this medicine.
• Apply enough amount of the medicine to each affected area.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so 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.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (ointment): For actinic keratosis on the face or scalp: Adults—Apply to the affected area once a day for 5 consecutive days. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any open packet after use even if there is still medicine left in it.