Tirbanibulin Topical
Tirbanibulin Topical is a skin treatment used to treat actinic keratosis (rough, sun-damaged patches of skin) on the face or scalp.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Tirbanibulin (Klisyri) is a newer prescription skin treatment for actinic keratosis, the rough, sun-damaged patches on the face or scalp. It blocks microtubules (tiny support structures inside cells), though exactly how that clears the patches is not known. On the market since about 2020 and not available as a generic, its main draw is a five-day course where older creams take weeks. Most people see redness and flaking at the treated area, sometimes with itching, crusting or swelling, and the reaction is usually milder than with older field treatments. Keep it out of your eyes and mouth, and call your prescriber if the skin blisters, forms pustules or opens into sores.
Clinical pearls
- Spread it evenly over the whole treatment area, not just the visible spots, because it is meant to treat the field.
- Do not cover the treated skin with bandages or wraps, since covering it makes irritation more likely.
- Wait until skin has fully healed from freezing, laser or any earlier treatment before starting a course.
- Use a fresh single-use packet each day, throw away any leftover, and wash your hands right after applying.
Patient information guide A plain-language walkthrough of Tirbanibulin Topical, written from its FDA label.
What Tirbanibulin Topical is used for
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Tirbanibulin Topical is used for one skin condition.
- Klisyri is used as a topical field treatment of actinic keratosis on the face or scalp.
How Tirbanibulin Topical works
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Tirbanibulin is a microtubule inhibitor. Microtubules are small structures that help support cells. The label states that the exact way Klisyri works for actinic keratosis is unknown.
Tirbanibulin Topical dosage
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Klisyri is applied to the skin once a day for 5 days in a row. You use one single-use packet each time and spread it evenly over the treatment area on the face or balding scalp.
- Wash your hands right away after applying.
- Do not wash or touch the treated area for about 8 hours. Afterward, you may wash with a mild soap.
- Keep it away from your eyes, mouth and lips.
- It is for use on the skin only, never to be swallowed.
Dosing details from the FDA-approved label
From the Tirbanibulin Topical prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Treatment field on the face or balding scalp (up to 100 cm2)
- Apply KLISYRI evenly to cover up to 100 cm 2 treatment field on the face or balding scalp once daily for 5 consecutive days using 1 unit-dose packet per application
- Wash hands immediately with soap and water after application; avoid washing and touching the treated area for approximately 8 hours, after which the area may be washed with a mild soap
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION For topical use only; not for oral or ophthalmic use. Apply KLISYRI evenly to cover up to 100 cm 2 treatment field on the face or balding scalp once daily for 5 consecutive days using 1 unit-dose packet per application. Wash hands immediately with soap and water after application. Avoid washing and touching the treated area for approximately 8 hours after application of KLISYRI. Following this time, the area may be washed with a mild soap. Avoid transfer of KLISYRI to the periocular area [see Warnings and Precautions ( 5.1 )] . Avoid application near and around the mouth and lips. For topical use; not for oral or ophthalmic use. ( 2 ) Apply KLISYRI to the treatment field on the face or scalp once daily for 5 consecutive days using 1 unit-dose packet per application. ( 2 )
Read the full Dosage and Administration section on DailyMed →
Tirbanibulin Topical side effects
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The most common side effects happen on the treated skin.
Common side effects
- Local skin reactions at the treated area
- Redness (erythema)
- Flaking or scaling
- Itching where it is applied
- Pain where it is applied
- Crusting
- Swelling
When to get medical help
- Get medical care right away if the medicine gets in your eyes. Flush your eyes with water first.
- Call your doctor if skin reactions become severe, such as blisters or pustules, or open sores (erosions or ulcers).
- Tell your doctor if the treated skin is very irritated or does not seem to be healing.
Tirbanibulin Topical warnings and precautions
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- Eye irritation: Avoid getting it in your eyes or the skin around them. If this happens, flush with water and get medical care as soon as possible.
- Skin reactions: These can be severe, including blistering and open sores.
- Covering the area: Occlusion after application is more likely to cause irritation.
- Healing skin: Avoid use until skin has healed from earlier drug, procedure or surgical treatment.
Tirbanibulin Topical interactions
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No clinical interaction studies have been done with Klisyri.
- Lab studies suggest it is unlikely to meaningfully affect other medicines that use common liver enzymes (such as CYP3A4) or transporters.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Tirbanibulin Topical
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- There are no contraindications listed for Klisyri.
- Pregnancy: no human data. High oral doses in animals caused fetal harm.
- Breastfeeding: no data on passage into milk. Talk with your doctor about the benefits and risks.
- Children and teens under 18: safety and effectiveness have not been established.
- Older adults: no overall differences in safety or effectiveness were seen, but some may be more sensitive.
- Skin that has not healed from earlier treatment: wait until it has healed.
What Tirbanibulin Topical does in the body
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How tirbanibulin affects the body in actinic keratosis is not known.
How your body processes Tirbanibulin Topical
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Only a small amount of Klisyri gets into the bloodstream after it is applied to the skin. Blood levels peak about 6 hours after use. The drug is mostly bound to proteins in the blood (88%). In lab studies, it is broken down mainly by the liver enzyme CYP3A4, and the metabolites found were inactive. How it leaves the body has not been fully worked out.
How to store Tirbanibulin Topical
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Store at 20°C-25°C (68°F-77°F), excursions permitted to 15°C-30°C (59°F-86°F) . Do not refrigerate or freeze.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Tirbanibulin Topical
3 supplements and herbal products have documented interactions with Tirbanibulin Topical in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Moderate · 2
- Minor · 1
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Tirbanibulin Topical: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Tirbanibulin Topical — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
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How do I use it?
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What side effects should I expect?
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What if it gets in my eyes?
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Can I use it while pregnant or breastfeeding?
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Does it interact with my other medicines?
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Is Tirbanibulin Topical available over the counter?
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When was Tirbanibulin Topical first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Tirbanibulin Topical on HelloPharmacist
Tirbanibulin Topical forms and strengths (how it comes)
Tirbanibulin Topical is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Tirbanibulin Topical inactive ingredients by manufacturer.
Topical cream, ointment or gel
How this form is used
- Klisyri is used for topical field treatment of actinic keratosis on the face or scalp.
- Klisyri is applied once daily for 5 days in a row, using one unit-dose packet per application.
- Klisyri is not for oral or eye use. Avoid the mouth, lips and the skin around the eyes.
- After applying Klisyri, wash your hands right away with soap and water.
- Avoid washing or touching the area treated with Klisyri for about 8 hours. After that, you may wash with a mild soap.
Tirbanibulin Topical on the U.S. market: products, makers and brands
How Tirbanibulin Topical appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Tirbanibulin Topical product record with the FDA, mostly as topical cream, ointment or gel; the earliest marketing or approval year on record is 2020. Brand names on the directory include Klisyri; the rest are generics.
Compare Tirbanibulin Topical products
A representative set of FDA-listed product records for Tirbanibulin Topical — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Topical cream, ointment or gel | ||||
| 10 mg/g | Topical | Almirall, LLC | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Tirbanibulin Topical NDCs →
Tirbanibulin Topical side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Tirbanibulin Topical — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Tirbanibulin Topical in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Tirbanibulin Topical FDA approval history
How Tirbanibulin Topical went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Tirbanibulin Topical recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Tirbanibulin recalls since July 2021.
✅No Tirbanibulin recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2471078 1 dose form · 1 strength
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Dose form (SCDF) Topical Ointment RxCUI 2471094In current FDA listingsClinical drug / strength (SCD) 0.01 MG/MGRxCUI 2471095
Look up RxCUI 2471078 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Tirbanibulin Topical supply and shortage status
Whether Tirbanibulin Topical is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Tirbanibulin Topical brand names
Tirbanibulin Topical is sold under one brand name in the FDA directory — Klisyri. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Tirbanibulin Topical: manufacturers and labelers
One company lists Tirbanibulin Topical products with the FDA. By number of product records, the largest are Almirall, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Tirbanibulin Topical drug class (RxNorm)
Tirbanibulin Topical belongs to the Microtubule Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Tirbanibulin Topical page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Almirall, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →