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At a Glance

Klisyri (tirbanibulin) topical ointment is approved for field treatment of actinic keratosis on the face or scalp in adults 18 years of age and older.
This is a brand drug (Klisyri) with no generic or biosimilar.
Active ingredient: Tirbanibulin.
Available as a prescription only.
Administration route: Topical.
The usual dose is a thin layer applied once daily for 5 consecutive days, using one single-use packet each day to cover up to 100 cm² of affected face or balding scalp skin.

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How It Works

Klisyri contains tirbanibulin, a microtubule inhibitor; although its exact action in actinic keratosis is not fully known, it is thought to:
  • Disrupt internal structures (microtubules) that abnormal skin cells need to grow and divide.
  • Cause many actinic keratosis cells to stop growing and die so the body can clear them from the treated skin.
  • Act mainly where it is applied, with very low levels reaching the bloodstream.
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Treatment and Efficacy

Approved indications: Klisyri is a topical field therapy approved for actinic keratosis on the face or balding scalp in adults, treating a contiguous sun-damaged area rather than only individual spots.

Off-label uses: There are no widely accepted off-label uses; using tirbanibulin for other skin conditions, body sites, or in children is considered investigational and should only be done under specialist supervision.

Efficacy expectations: In phase 3 trials, a 5-day course led to complete clearance of all visible actinic keratoses in the treated area by about day 57 in roughly 44% to 54% of patients, and at least 75% lesion reduction in about 68% to 76% of patients.

Time course and durability: Redness and crusting typically peak around day 8 (about 3 days after the last dose) and then heal over 2 to 3 weeks; among patients who achieved complete clearance at day 57, about three-quarters had some recurrence of lesions in the treated field within 12 months, so ongoing skin checks remain important.

Comparison to other topical AK treatments: Compared with older options such as 5-fluorouracil or imiquimod, Klisyri offers a very short 5-day regimen with comparable field-clearance rates in trials and extensive real-world use, while still requiring long-term surveillance because new or recurrent actinic keratoses are common with all therapies.

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Dosage and Administration

Typical adult dosing: Apply a thin layer of Klisyri 1% ointment once daily for 5 consecutive days, using one single-use packet per day to evenly cover up to 100 cm² of the prescribed treatment field on the face or balding scalp.

How to apply: Begin with clean, dry skin; apply only to the area your clinician has identified, avoid the eyes, eyelids, mouth, and lips, do not cover with bandages or dressings, wash your hands immediately after application, and avoid washing or touching the treated area for about 8 hours before gently cleansing with mild soap and water if desired.

Special dosing instructions: Do not use more ointment than needed to cover the treatment field, do not apply it more than once per day or extend treatment beyond 5 days unless specifically instructed, and do not reuse or store opened packets.

Missed dose: If you miss a dose, apply it as soon as you remember on the same day; if it is almost time for your next scheduled dose, skip the missed dose and resume your regular schedule without applying extra ointment.

Overdose: Applying too much medicine or using it too often can cause marked local irritation (severe redness, swelling, blistering, or ulceration); if a large area has been treated excessively or the ointment has been swallowed, rinse the affected skin or mouth and contact a healthcare professional or Poison Control (1-800-222-1222 in the U.S.) or seek emergency care.

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Safety and Side Effects

Common side effects: The vast majority of patients develop local skin reactions in the treated area, including redness, flaking or scaling, crusting (scabbing), swelling, itching, and burning or pain; these usually begin within the first few days of treatment, peak around day 8, and typically resolve on their own within about 2 to 3 weeks after the 5-day course.

Serious or rare adverse effects: Severe local reactions with intense redness, swelling, blisters, pus, ulcers, or skin breakdown, or significant eye irritation if the ointment gets into the eyes, need prompt medical attention; rare allergic reactions (such as hives, trouble breathing, or swelling of the face, lips, tongue, or throat) require emergency care.

Warnings and precautions: Do not apply Klisyri on skin that has not healed from previous drug, procedural, or surgical treatments, and avoid use on infected or very inflamed skin; keep it away from the eyes, eyelids, mouth, and lips, and wash hands immediately after application to prevent transfer.

Use in pregnancy, breastfeeding, and special populations: There are no adequate data in pregnant or breastfeeding people, and animal studies at high systemic doses showed fetal harm, so use only if the potential benefit justifies the potential risk, and avoid applying to the breast or areas that might contact a nursing infant; Klisyri is not approved for patients under 18 years, and because systemic absorption is very low, no specific dose adjustment is recommended for kidney or liver disease, though data in severe impairment are limited.

Overall safety versus other therapies: Like other topical actinic keratosis treatments, Klisyri commonly causes local inflammation, but in clinical trials no patients discontinued because of side effects and systemic adverse effects were rare due to minimal bloodstream exposure.

Reporting and staying informed: In the United States, suspected side effects can be reported to the FDA MedWatch program or to the manufacturer (for example, via the Klisyri medical information line), and up-to-date safety communications are available through FDA and manufacturer drug-information websites.

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Interactions and Precautions

Drug and supplement interactions: Because Klisyri is applied to the skin and produces very low blood levels, it is not expected to significantly affect or be affected by most oral or injected prescription drugs, over-the-counter medicines, or dietary supplements, but you should still inform your clinician about everything you take.

Other topical products, cosmetics, and lifestyle factors: The ointment has not been systematically studied in combination with other topical treatments on the same area, so adding other medicated creams, peels, or harsh cleansers may increase irritation; many clinicians advise avoiding cosmetics or other products on the treated field during the 5-day course and until the skin has healed, while foods and alcohol have no known interactions with this topical medicine.

Conditions requiring caution: Tell your prescriber if you have had recent procedures, surgery, or other topical treatments for actinic keratoses in the same area, or if you have other skin diseases there, because Klisyri should be delayed until the skin has healed and should not be applied to open, infected, or severely inflamed skin.

Monitoring needs: Routine blood tests, liver or kidney monitoring, or heart tests are not generally required with Klisyri; follow-up skin examinations are important to confirm lesion clearance, manage local reactions, and detect any recurrence or new actinic keratoses or skin cancers.

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Common Questions and Answers

Q: How long will my skin look red or crusted after I use Klisyri?
A: Local skin reactions usually begin in the first few days, peak around day 8 (about 3 days after the last dose), and then heal, with most redness, crusting, and swelling resolving within about 2 to 3 weeks after you finish the 5-day course.

Q: When should I expect Klisyri to clear my actinic keratoses?
A: Your skin often looks worse before it looks better, but improvement becomes clearer as reactions heal, and your clinician will typically assess final clearance of actinic keratoses about 8 weeks after you start treatment.

Q: Can I use moisturizers, sunscreen, or makeup with Klisyri?
A: During the 5 treatment days many clinicians prefer that you avoid other products on the treated field to limit irritation; once the skin has healed, gentle moisturizers and broad-spectrum sunscreen are usually recommended, and makeup can often be resumed if the area is no longer broken or very inflamed.

Q: What should I do if I accidentally get Klisyri in my eyes or on my lips?
A: Immediately rinse the area thoroughly with water, avoid rubbing, and seek medical care promptly if you develop persistent pain, redness, vision changes, or other concerning symptoms.

Q: Can my actinic keratoses come back after a successful course of Klisyri?
A: Yes, even after complete clearance in the treated area, new or recurrent actinic keratoses are common over time because the surrounding sun-damaged skin remains at risk, so regular skin checks and ongoing sun protection are essential.

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Disposal Guidance

Storage: Store Klisyri ointment at room temperature 68°F to 77°F (20°C to 25°C); do not refrigerate or freeze, and keep packets in the original carton away from excess heat and light and out of the reach of children.

Use of packets: Each packet is single-use; open only when ready to apply, use the entire contents as directed on the treatment area, and do not save or reuse any leftover ointment.

Disposal: After each application, place the used packet (and any unused packets you are told not to keep) in household trash, preferably inside a sealed bag or container; do not flush the medicine or packaging down the toilet or pour it into drains unless local waste guidelines specifically allow this.

Content last updated on January 6, 2026. Always consult a qualified health professional before making any treatment decisions or taking any medications. Review our Terms of Service for full details.