Klisyri (Tirbanibulin) - Topical

What Is Klisyri?

Klisyri (tirbanibulin) is topical medicine used to treat a precancerous skin problem called actinic keratosis on skin exposed to the sun (e.g., face, scalp). Actinic keratosis is a common skin condition caused by too much exposure to sunlight (ultraviolet rays). It happens more in Caucasians over 40 years of age. 

Tirbanibulin is a microtubule inhibitor. It works by stopping and preventing certain signals that increase in actinic keratosis. It's available as single-use ointment packets.

Drug Facts

Generic Name: Tirbanibulin

Brand Name(s): Klisyri

Drug Availability: Prescription

Therapeutic Classification: Antineoplastic Agent, Antimicrotubular

Available Generically: No

Controlled Substance: N/A

Administration Route: Topical

Active Ingredient: Tirbanibulin

Dosage Form(s): Ointment

What Is Klisyri Used For?

The U.S. Food and Drug Administration (FDA) approved Klisyri to treat actinic keratosis, a skin condition that can cause cancer (precancerous) on the face or scalp.

Applying Klisyri on the affected areas of your skin can lower your chances of precancerous cells getting worse.

How to Use Klisyri 

Apply the ointment to your skin on the affected area once daily, evenly covering up to a 25 square centimeters (cm2) area (about the size of four quarters lined up into a square shape) for five consecutive days. Do not use more than one single-dose packet for each application. Throw away any leftover ointment that you don't use. Do not cover the treated area with a dressing (bandage). Do not apply to unhealed skin.

After applying, immediately wash your hands with soap and water. Wait at least eight hours before washing or touching the treated area. After eight hours, you may clean or wash the affected area with a mild soap.

Use this drug only on your skin. Do not use it in your eye, nose or around your mouth and lips. It may burn or irritate these areas. If you touch your eyes by accident, flush them with cool water and talk with your healthcare provider.

Storage

The best storage temperature for this drug is at room temperature (68 to 77 degrees F). When traveling, you may store it between cool and mildly warm temperatures (59 to 86 degrees F). Do not refrigerate or freeze.

How Long Does Klisyri Take to Work?

It takes about seven hours for Klisyri to peak and about 72 hours to begin working on your affected skin.

What Are the Side Effects of Klisyri? 

This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

Many people who use Klisyri have no harmful side effects at all. Some people, however, may have issues while using the medicine. The most common side effect is skin reactions like scaling, flaking, redness or swelling. These reactions may appear within the first few days of use and may resolve within weeks.

Severe Side Effects

Klisyri may cause severe side effects. Tell your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you have a medical emergency. Severe side effects include:

  • Skin ulcers
  • Blisters
  • Severe skin reaction
  • Skin breakdown where this medicine is used
  • Pus where this drug was applied

Skin reactions: Skin reactions are usually mild. However, severe skin reactions can occur and may be triggered by:

  • Covering your treated area with a bandage
  • Applying this drug on skin that's not fully healed

Eye effects: Avoid contact in or around your eyes during and after applying Klisyri because it may irritate them.

This is not a list of all possible adverse effects. If you have any concerns, speak with your healthcare provider.

Report Side Effects

Klisyri may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much of Klisyri Should I Use?

Drug Content Provided and Reviewed by IBM Micromedex®

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

Apply the missed dose once you think of it. If it's too close to your next application, skip the missed dose. Return to your regular dosage schedule. Do not apply extra doses or use more than one single-use packet at a time.

Overdose: What Happens If I Use Too Much Klisyri? 

Overdose symptoms may include severe skin reactions.

What Happens If I Overdose on Klisyri?

Call your healthcare provider or the Poison Control Center right away if you think you or someone else may have ingested or overdosed on Klisyri. 

If someone collapses or isn't breathing after taking Klisyri, call 911 immediately.

Precautions 

Drug Content Provided and Reviewed by IBM Micromedex®

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

If your condition does not improve or if it become worse, check with your doctor.

This medicine may cause serious skin reactions. Check with your doctor right away if you have blisters, peeling, pus, ulcers, cracking, redness, flaking, scaling, crusting, or swelling of the skin.

What Are Reasons I Shouldn't Use Klisyri? 

Do not apply this ointment to unhealed areas of your skin.

It's not known if Klisyri is safe during pregnancy or while breastfeeding. Talk to your healthcare provider if you are or plan to become pregnant, or are breastfeeding.

Klisyri may be tolerated in older adults. However, we don't know how safe or effective this drug is in children less than 18 years old.

What Other Medications Interact With Klisyri? 

There are no known interactions with Klisyri. Be sure to speak with your healthcare provider or pharmacist about any questions or concerns that you may have about interactions with Klisyri.

What Medications Are Similar?

Other topical drugs similar to Klisyri used to treat actinic keratosis include:

This is a list of drugs also used to treat actinic keratosis. It is not a list of medicines recommended to use with Klisyri. You should not use these drugs together unless your healthcare provider tells you to. Ask your pharmacist or a healthcare practitioner if you have questions.

Frequently Asked Questions

  • What is Klisyri used to treat?

    Klisyri (tirbanibulin) is used to treat a precancerous skin problem called actinic keratosis.

  • What is a common side effect of Klisyri?

    A common side effect of Klisyri is local skin irritation.

  • Where should I store Klisyri?

    Store Klisyri at room temperature in a dry place. 

  • When can I touch or wash the affected area after applying Klisyri?

    Wait at least eight hours before touching or washing the affected area once you apply this ointment.

  • What should I do if I miss a dose of Klisyri?

    Apply the missed dose as soon as you think of it. If it is too close to your next dose, skip the missed dose. Return to your regular schedule. Do not double your dose or use extra applications.

How Can I Stay Healthy While Using Klisyri?

Taking care of your skin and avoiding sun (ultraviolet) exposure is important as you treat your precancerous skin condition with Klisyri. Although Klisyri causes little to no side effects in most people, some may experience local skin irritation. The chances of having a bad reaction while on this medicine increase if you use a dressing that covers your skin (like bandages) after applying medicine to the affected area. 

Remember to not apply this ointment on unhealed skin. If you feel that your skin condition is not getting better or is getting worse, contact your healthcare provider right away.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

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3 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Dao DD, Sahni VN, Sahni DR, Balogh EA, Grada A, Feldman SR. 1% tirbanibulin ointment for the treatment of actinic keratosesAnn Pharmacother. 2022;56(4):494-500. doi:10.1177/10600280211031329

  2. Reinehr CPH, Bakos RM. Actinic keratoses: review of clinical, dermoscopic, and therapeutic aspectsAn Bras Dermatol. 2019;94(6):637-657. doi:10.1016/j.abd.2019.10.004

  3. Food and Drug Administration. Klisyri label.