STEPS

New Drug Reviews

Tirbanibulin (Klisyri) for the Treatment of Actinic Keratosis

 

Am Fam Physician. 2021 Nov ;104(5):519-520.

Author disclosure: No relevant financial affiliations.

Tirbanibulin (Klisyri) is a topical ointment labeled for the treatment of actinic keratosis (AK) on the face and scalp.1 It inhibits cell division by disrupting micro-tubules, similar to some types of chemotherapy. The goal of tirbanibulin therapy is resolution of lesions and prevention of recurrence.

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DrugDosageDose formCost*

Tirbanibulin (Klisyri)

Apply to the affected area on the face or scalp for five consecutive days

Single-dose packets of tirbanibulin 1% ointment

$1,000


*—Estimated retail price of one course of treatment based on information obtained at https://www.goodrx.com (accessed September 9, 2021; zip code: 66211).

DrugDosageDose formCost*

Tirbanibulin (Klisyri)

Apply to the affected area on the face or scalp for five consecutive days

Single-dose packets of tirbanibulin 1% ointment

$1,000


*—Estimated retail price of one course of treatment based on information obtained at https://www.goodrx.com (accessed September 9, 2021; zip code: 66211).

Safety

Adverse effects associated with tirbanibulin include vesiculation/pustulation (mild: 7%, moderate: less than 1%, severe: less than 1%) and erosion/ulceration (mild: 9%, moderate: 3%, severe: 0%) localized to the treated area of skin. These symptoms have been shown to resolve with discontinuation of therapy.1 There are no data on the use of tirbanibulin in pregnant patients or its effects on breastfed infants, milk production, or levels of tirbanibulin in breast milk.1 Animal studies indicate there are no adverse effects on offspring.

Tolerability

The most common adverse effects of tirbanibulin are localized skin reactions at the site of application. These reactions range from mild to severe and consist of erythema, flaking or scaling, crusting, and swelling.1 Overall, 91% of patients treated with tirbanibulin reported erythema and 82% reported flaking and scaling.2 Patients treated with tirbanibulin also reported pain (10%) and pruritus (9%) at the application site.2 The use of corticosteroids to minimize the inflammatory reaction caused by tirbanibulin has not been studied.

Effectiveness

Address correspondence to Kamini Geer, MD, MPH, FAAFP, at kamini.geer.md@adventhealth.com. Reprints are not available from the author.

Author disclosure: No relevant financial affiliations.

References

1. DailyMed. Drug label information. Klisyri—tirbanibulin ointment. Accessed February 18, 2021. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=589c8de8-b773-4d47-b60c-48471806cccc#s_0200

2. Blauvelt A, Kempers S, Lain E, et al.; Phase 3 Tirbanibulin for Actinic Keratosis Group. Phase 3 trials of tirbanibulin ointment for actinic keratosis. N Engl J Med. 2021;384(6):512–520.

3. Cramer P, Stockfleth E. Actinic keratosis: where do we stand and where is the future going to take us? Expert Opin Emerg Drugs. 2020;25(1):49–58.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

The series coordinator for AFP is Allen F. Shaughnessy, PharmD, MMedEd, assistant medical editor.

A collection of STEPS published in AFP is available at https://www.aafp.org/afp/steps.

 

 

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