Tirbanibulin Topical
Tirbanibulin is a topical microtubule inhibitor used to treat actinic keratosis 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 Topical: Patient Information Guide
A plain-language walkthrough of Tirbanibulin Topical — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Tirbanibulin topical is approved to treat actinic keratosis — sun-damaged skin patches that have a risk of progressing to skin cancer.
- Klisyri is indicated for the topical field treatment of actinic keratosis on the face or scalp in adults — applied across the full treatment area, not just individual spots
⚙️How it works▾
Tirbanibulin works as a microtubule inhibitor — it targets tiny tube-like structures inside cells that help them divide and replicate. By disrupting these structures, it interferes with the abnormal cell growth that makes up actinic keratosis lesions. The precise chain of events that leads to clearing of the skin patches is not yet fully understood.
💊How it's taken▾
Klisyri is applied to the skin once a day for 5 days in a row. Use one single-dose packet per application and spread the ointment evenly across the treatment area on your face or scalp.
- Apply only to the face or scalp — not to other body areas
- Wash hands with soap and water right after every application
- Avoid washing or touching the treated area for about 8 hours after applying; after that, a mild soap is fine
- Do not cover the treated area with bandages or dressings after application
Follow your prescriber's specific instructions, and do not use more or less than directed.
🤒Side effects — in detail▾
The most common reactions with Klisyri happen right at the treatment site and are usually mild to moderate.
- Skin redness (erythema)
- Flaking and scaling
- Crusting
- Swelling
- Itching at the application site
- Pain or discomfort at the application site
- Blistering or pustules
- Skin erosion or open sores
Severe skin reactions — such as deep sores or widespread blistering — are less common but do occur. Contact your doctor if you notice severe or worsening skin changes in the treated area.
⚠️Warnings & precautions▾
- Eye irritation: Klisyri can cause eye irritation if transferred to the eyes or the area around the eyes. Wash your hands right after every application. If it gets in your eyes, flush immediately with water and seek medical care.
- Local skin reactions: Reactions such as redness, scaling, crusting, swelling, blistering, and skin erosion can occur. Severe reactions are possible. Do not start Klisyri if the skin hasn't healed from a previous treatment, procedure, or surgery.
- Avoid occlusion: Covering the treated area with a dressing or bandage after application increases the risk of irritation.
- Avoid mouth and lip area: Do not apply near the mouth or lips.
🔀What it interacts with▾
Based on laboratory studies, Klisyri is not expected to have clinically meaningful interactions with most common medications. No clinical drug interaction studies have been conducted with Klisyri.
- Lab studies suggest tirbanibulin does not meaningfully affect the levels of drugs processed by common liver enzymes (CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A4), so significant interactions through this pathway are not anticipated
- Similarly, tirbanibulin is not expected to meaningfully affect drugs that rely on common drug transport proteins in the body
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: There are no safety data in pregnant people. Animal studies showed fetal harm (deaths and malformations) at exposures higher than the recommended human dose. Discuss the risks with your doctor if you are pregnant or planning to become pregnant.
- Breastfeeding: It is unknown whether tirbanibulin passes into breast milk or affects a nursing infant. Talk to your doctor about the risks and benefits.
- Children under 18: Safety and effectiveness in pediatric patients have not been established. Actinic keratosis is rarely seen in children.
- Older adults (65+): Most study participants were 65 or older, and no meaningful differences in safety or effectiveness were observed compared to younger adults, though some older individuals may be more sensitive.
- Healing skin: Do not use Klisyri if the treatment area is still healing from a previous drug treatment, procedure, or surgery — wait until the skin has fully recovered.
🔬Pharmacokinetics — how your body processes it▾
When Klisyri is applied to the face or scalp once daily for 5 days, a small amount of tirbanibulin is absorbed through the skin into the bloodstream — but systemic (whole-body) levels remain very low. Peak blood concentrations are typically reached around 6 hours after application. Once in the bloodstream, about 88% of tirbanibulin binds to proteins in the blood. The drug is broken down mainly by liver enzymes (primarily CYP3A4) into inactive metabolites; how the body fully eliminates tirbanibulin has not been completely characterized.
📦How to store it▾
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 Tirbanibulin Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. 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.
🩺 Pharmacist Counseling Corner
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 exactly is actinic keratosis, and why does it need to be treated? ▾
I only use it for 5 days — is that really enough? ▾
My skin is getting really red and flaky — is that normal? ▾
Do I need to be careful about getting this near my eyes? ▾
Can I use Klisyri if I'm pregnant or breastfeeding? ▾
Are there any medications I need to avoid while using Klisyri? ▾
Is Tirbanibulin Topical available over the counter? ▾
When was Tirbanibulin Topical first available? ▾
💬 Answers drafted from Tirbanibulin Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Tirbanibulin Topical 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.
Topical cream, ointment or gel
How this form is used
- Klisyri is used for the topical field treatment of actinic keratosis on the face or scalp in adults
- Klisyri is applied once daily for 5 consecutive days using one unit-dose packet per application
- Klisyri should be spread evenly to cover the entire treatment area (up to 100 cm²) on the face or balding scalp
- Wash hands immediately with soap and water after applying Klisyri, and avoid washing or touching the treated area for about 8 hours
- Keep Klisyri away from the eyes, the skin around the eyes, and the area around the mouth and lips
📊 Tirbanibulin Topical across the U.S. market
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.
🔍 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 × 4 listings | NDA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Tirbanibulin Topical NDCs →
📈 What people report — real-world data (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.
🏛️ The road to your pharmacy
How Tirbanibulin Topical went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 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.
Source: openFDA drug enforcement (recall) reports.
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.
📦 Supply & 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.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
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.
🔬 Where this comes from
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 we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Almirall, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.