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FOR THE FIELD TREATMENT OF AKs, TIRBANIBULIN (KLISYRI®) HAS A STRONG RECOMMENDATION IN THE AAD’S GUIDELINES OF CARE

KLISYRI® receives a strong recommendation with a high certainty of evidence
AK topical recommendation chart

Chart adapted from Focused update to the Guidelines of Care for the Management of Actinic Keratosis: Journal of the American Academy of Dermatology (2022).
This chart is not intended to suggest superiority, comparability, or interchangeability among AK treatments.

*For patients with AKs, nonsteroidal anti-inflammatory drugs (NSAIDs) carry a black box warning for cardiovascular and gastrointestinal side effects.
AK: actinic keratosis; AAD: American Academy of Dermatology.

KLISYRI®(TIRBANIBULIN) SHOWED STRONG CLINICAL OUTCOMES BASED ON THE CRITERIA THAT THE AAD WORKING GROUP RANKED AS CRITICAL1

table outcome chart

Chart adapted from Focused update to the Guidelines of Care for the Management of Actinic Keratosis: Journal of the American Academy of Dermatology (2022).

*From baseline to assessment.
†Complete clearance of all AKs within a defined field.
‡At least a 75% reduction in AKs in a predefined field.
Additional outcomes: Investigator global improvement index (participants rated as “completely improved’ by the investigator); Participant global improvement index (participants self-assessed as “completely improved”); and Adverse Events.

See the full AAD guideline update for the topical treatment of AKs.
In the AAD Work Group’s own words: “The Work Group determined that the overall balance of benefits and potential harms as reported at 57 days favors using tirbanibulin for the management of AK on the face and scalp and that the certainty of the available short-term evidence is high.”1

Important Safety Information

Indication

KLISYRI is a microtubule inhibitor indicated for the topical treatment of actinic keratosis of the face or scalp.

Important Safety Information

Warnings and Precautions

Ophthalmic Adverse Reactions

KLISYRI may cause eye irritation. Avoid transfer of the drug into the eyes and to the periocular area during and after application. Wash hands immediately after application. If accidental exposure occurs, instruct patient to flush eyes with water and seek medical care as soon as possible.

Local Skin Reactions

Local skin reactions, including severe reactions (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) in the treated area can occur after topical application of KLISYRI. Avoid use until skin is healed from any previous drug, procedure, or surgical treatment. Occlusion after topical application of KLISYRI is more likely to result in irritation.

Adverse Reactions

The most common adverse reactions (incidence ≥2%) were local skin reactions, application site pruritus, and application site pain.

Please see full Prescribing Information.

To report an adverse event or product complaint, call or email: Medical Affairs and Customer Relations • Phone: 1-866-665-2782 • Fax: 510-595-8183 • Email: almirallmc@eversana.com

Important Safety Information

Indication

KLISYRI is a microtubule inhibitor indicated for the topical treatment of actinic keratosis of the face or scalp.

Important Safety Information

Warnings and Precautions

Ophthalmic Adverse Reactions

KLISYRI may cause eye irritation. Avoid transfer of the drug into the eyes and to the periocular area during and after application. Wash hands immediately after application. If accidental exposure occurs, instruct patient to flush eyes with water and seek medical care as soon as possible.

Local Skin Reactions

Local skin reactions, including severe reactions (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) in the treated area can occur after topical application of KLISYRI. Avoid use until skin is healed from any previous drug, procedure, or surgical treatment. Occlusion after topical application of KLISYRI is more likely to result in irritation.

Adverse Reactions

The most common adverse reactions (incidence ≥2%) were local skin reactions, application site pruritus, and application site pain.

Please see full Prescribing Information.

To report an adverse event or product complaint, call or email: Medical Affairs and Customer Relations • Phone: 1-866-665-2782 • Fax: 510-595-8183 • Email: almirallmc@eversana.com

References:

1. Eisen DB, Dellavalle RP, Frazer-Green L, Schlesinger TE, Shive M, Wu PA. Focused Update: Guidelines of care for the management of actinic keratosis. JAAD. 2022. 2. Blauvelt A, Kempers S, Schlesinger T, et al. Tirbanibulin ointment 1% for actinic keratosis (AK): pooled data from two phase 3 studies. Presented at: 40th Annual Fall Clinical Dermatology Conference (Fall CDC 2020); Virtual Congress; October 29-November 1, 2020.3.Blauvelt A, et al. N Engl J Med . 2021;384:512-520.

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KLISYRI® is a registered trademark of Almirall, LLC. © Copyright 2005-2021. All Rights Reserved. Almirall, LLC, 101 Lindenwood Drive, Suite 200, Malvern, PA 19355 US-TIRBA-2200095 08/2022

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KLISYRI® is a registered trademark of Almirall, LLC. © Copyright 2005-2021. All Rights Reserved. Almirall, LLC, 101 Lindenwood Drive, Suite 200, Malvern, PA 19355 US-TIRBA-2200095 08/2022

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