Klisyri (Tirbanibulin Ointment)
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Fact Table
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| Formula | C26H29N3O3 |
| License | FDA approved (NDA 213189; initial U.S. approval 2020); EMA authorized 2021 |
| Bioavailability | Absolute bioavailability not established; low systemic exposure after topical application |
| Legal status | Prescription only (Rx-only) |
| Chemical Name | N-benzyl-2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)acetamide |
| Elimination half-life | Not stated in FDA label; about 4 hours reported for tirbanibulin |
| Dosage (Strength) | 1% ointment; apply once daily for 5 consecutive days using 1 unit-dose packet per application; 250 mg or 350 mg packets contain 2.5 mg or 3.5 mg tirbanibulin |
| Pregnancy | No available human pregnancy data; animal studies showed fetal harm at systemic exposures above the maximum recommended human dose |
| Brands | Klisyri; Onakta |
| Protein binding | 88% plasma protein bound |
| PubChem CID | 23635314 |
| MedlinePlus | a621013 |
| ChEBI | 231702 |
| ATC code | D06BX03 |
| DrugBank | DB06137 |
| KEGG | D11691 |
| Routes of administration | Topical; cutaneous ointment |
Klisyri (tirbanibulin) is an ointment used to treat actinic keratosis, which involves rough, scaly patches on the skin caused by sun damage. Actinic keratosis can become cancerous if left untreated and is often found on the face or scalp in adults. It works as a microtubule inhibitor that treats abnormal skin cells and prevents them from growing or dividing. Klisyri comes in single-use packets of a 1% ointment that is applied directly to the affected area of skin.
Directions
Apply Klisyri to the treatment area on the face or scalp once daily for 5 consecutive days. Use one unit-dose packet per application and spread evenly to cover the affected area (up to 100 cm²). Wash your hands immediately after applying. Avoid washing or touching the treated area for around 8 hours after application. After that, the area may be gently washed with mild soap. Do not cover the treatment area with a bandage or dressing. Avoid getting the ointment in or near the eyes.
Ingredients
The active ingredient in Klisyri is tirbanibulin 1% (10 mg per gram of ointment). Inactive ingredients include mono- and di-glycerides and propylene glycol.
Cautions
Before using this medication, you may want to consult a healthcare provider about the following:
- Any existing health conditions
- Any allergies
- A list of all medications currently being taken
Redness, flaking, crusting, swelling, or open sores may occur in the treated area during the 5-day course. This is expected to some extent, but severe reactions should be reported to a healthcare provider.
Avoid contact with the eyes and the area immediately around them. Wash hands thoroughly after each application.
Do not use Klisyri on skin that has not fully healed from a previous treatment or procedure in the same area.
Do not ingest or apply to areas other than the face or scalp.
Contraindications
There are no contraindications for Klisyri in the drug label. However, it should not be used in anyone with a known or suspected hypersensitivity to any ingredients in the medication.
Side Effects
Common side effects of Klisyri include:
- Local skin reactions at the application site, such as redness, flaking or scaling, crusting, and swelling
- Itching at the application site
- Pain or discomfort at the application site
More severe local reactions can occur in the treated area, including the formation of blisters or pustules and open sores or erosions of the skin.
These reactions are usually limited to the treatment area and resolve after the 5-day treatment period ends.
If severe eye irritation or extensive skin reactions occur, contact a healthcare provider.
Frequently Asked Questions about Klisyri
What is Klisyri used for?
Klisyri is a prescription 1% tirbanibulin ointment used on the skin for the topical field treatment of actinic keratosis on the face or scalp. It is for skin use only and should not be used in the eyes or taken by mouth.
How does Klisyri work?
Tirbanibulin is a microtubule inhibitor. Klisyri’s exact mechanism for treating actinic keratosis is not fully known, but that is the drug class listed in the prescribing information.
How is Klisyri applied?
The usual treatment is one application once daily for 5 consecutive days, using one unit-dose packet each time. It should be spread evenly over the treatment field, which can be up to 100 cm² on the face or scalp. Wash your hands right after applying it.
What should I avoid after applying Klisyri?
Avoid washing or touching the treated area for about 8 hours after application, then you may wash it with mild soap and water. Do not cover the area with a dressing, and avoid transferring the ointment to other parts of the body or to another person.
What are the most common side effects?
The most common side effects are itching and pain at the application site. In trials, local skin reactions were also common, especially redness, flaking or scaling, crusting, and swelling, and these were usually mild to moderate.
When should local skin reactions be a concern?
Klisyri can cause severe local skin reactions in some people. A clinician should be contacted if the treated area becomes much more inflamed than expected or if blisters, peeling, pus, ulcers, or skin breakdown develop.
What happens if Klisyri gets in the eyes, mouth, or lips?
Klisyri can irritate the eyes, so it should be kept away from the eyes and the surrounding area, as well as the mouth and lips. If it accidentally gets into the eyes, flush with water and seek medical care as soon as possible.
How well does Klisyri work?
In the two phase 3 studies, complete clearance of visible actinic keratosis lesions in the treated area at Day 57 occurred in 44% and 54% of people using Klisyri, compared with 5% and 13% using vehicle. Partial clearance of at least 75% occurred in 68% and 76% with Klisyri. Among people who achieved complete clearance and were followed, recurrence in the treated area by 12 months was reported in 73%, meaning new or returning lesions can still occur over time.
Who should not use Klisyri, or may need extra caution?
The label does not list formal contraindications, but Klisyri should not be used until the skin has healed from other drug treatments, procedures, or surgery in the same area. Safety and effectiveness have not been established in children younger than 18 years, while studies did not show overall differences in safety or effectiveness in older adults compared with younger adults.
What should patients know about pregnancy, breastfeeding, and storage?
There are no adequate human pregnancy data to define risk, and it is not known whether Klisyri passes into human milk, so pregnancy and breastfeeding should be discussed before use. Store it at room temperature, 68°F to 77°F, do not refrigerate or freeze, and throw away any opened packet after use, even if some ointment remains.
