Klisyri Ointment

Pronunciation: klee-si-ree
Generic name: tirbanibulin ointment
Brand name: Klisyri
Dosage form: Ointment for topical use
Drug class: Topical antineoplastics

Medically reviewed by Carmen Pope, BPharm. Last updated on Jun 14, 2024.

What is Klisyri ointment?

Klisyri (tirbanibulin) ointment is a first-in-class microtubule inhibitor that may be used on the skin to treat actinic keratosis of the face or scalp. Actinic keratosis is a precancerous skin condition caused by damage from repeated exposure to ultraviolet light from the sun or indoor tanning.

Klisyri (tirbanibulin) targets tubulin which inhibits microtubule polymerization (a process that allows microtubules to adopt spatial arrangements that can change rapidly in response to cellular needs or sometimes to perform mechanical work), causing cell cycle arrest and cell death by apoptosis (a type of programmed cell death). This has an antiproliferative action (suppresses cell growth) and is thought to be the way that Klisyri works to clear actinic keratosis lesions.

Klisyri was FDA-approved on December 14, 2020.

Klisyri side effects

The most common side effects of Klisyri affecting 2% or more people include:

local skin reactions, such as redness, flaking, or peeling
itch at the site of the application
pain at the site of application.

Warnings and serious side effects

Get emergency medical help if you have signs of an allergic reaction to Klisyri such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Klisyri can cause serious side effects including:

Eye irritation if Klisyri gets into the eye. Avoid transfer of the drug into the eyes or applying it around the eye area. If accidental exposure occurs, flush your eyes with water and seek medical care
Severe local skin reactions can occur, such as blisters, pus, ulcers, or skin breakdown in the treated area. Do not start using Klisyri until your skin has healed from any previous drug or surgical treatment. Call your doctor at once if you have severe skin irritation or swelling. Some redness, flaking, scaling, or peeling of treated skin is to be expected.

It is not known if Klisyri ointment is safe and effective in children less than 18 years of age.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking this medicine

Tell your doctor about all other medicines or treatments you are receiving to treat actinic keratosis. You may need to delay starting Klisyri until your skin has healed from other treatments. Also, tell your doctor:

if you have other skin problems in the areas you will treat with this medicine
are pregnant or intending to become pregnant
are breastfeeding.

Pregnancy

There is no data on the use of Klisyri during pregnancy, but animal studies using many times the recommended dosage have shown an association with birth defects. Talk to your doctor about the risks versus benefits of using Klisyri during pregnancy.

Breastfeeding

It is not known if Klisyri passes into human milk. Talk to your doctor about the best way to feed your baby if you are breastfeeding.

How should I use Klisyri ointment?

Use Klisyri ointment exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Use Klisyri only on the face or scalp and only on the skin areas affected by actinic keratosis.

Do not take it by mouth or put it near your eyes. Rinse with water if this medicine gets in your mouth or on your lips. Wipe away from your eyes if it gets near your eyes.

Klisyri is usually applied once per day for 5 days in a row. Follow your doctor's dosing instructions very carefully.

Apply a thin layer of Klisyri to the affected area only enough Klisyri ointment to cover the skin area affected by actinic keratosis.
Do not cover the treated skin area with a bandage.
Avoid washing or touching the treated skin for at least 8 hours after applying this medicine.
Wash your hands with soap and water after applying this medicine.

Klisvri dosing information

Each single dose packet of Klisyri is for one day use. Throw away the packet after use, even if there is still medicine left inside.
Use another packet from the carton for the next day.
Apply Klisvri for 5 days in a row then stop applying it.
Only apply to affected areas on the face and scalp. Avoid the eyes, mouth, and nostrils.

There is enough Klisyri in a 1-unit dose packet to cover up to 25 cm² treatment field on the face or balding scalp.

Each carton of Klisyri contains 5 single-dose packets. Use one packet a day for 5 consecutive days. Throw away each packet after use, do not save for the next day.

What to avoid

Do not use Klisyri ointment in, around, or near your eyes, mouth, or lips. If contact does occur, rinse with water and call your doctor right away.

Do not share Klisyri with another person, even if they have the same symptoms you have.

What happens if I miss a dose?

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe skin reactions (redness, swelling, blistering, peeling, crusting, oozing, ulcers).

What other drugs will affect Klisyri?

Medicine used on the skin is not likely to be affected by other drugs you use. However many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.