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Klisyri® Is A Novel Topical Therapy For AK1

KLISYRI® Is A Microtubule Inhibitor Indicated For The Topical Treatment Of Actinic Keratosis Of Face Or Scalp1

Klisyri proposed mechanism of action

Owned by Almirall, LLC.

The mechanism of action of KLISYRI® for the topical treatment of actinic keratosis is unknown1

MOA: mechanism of action.
AK: actinic keratosis.

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. KLISYRI [package insert]. Exton, PA: Almirall, LLC, 2020. 2. Smolinski MP, Bu Y, Clements J, et al. Discovery of novel dual mechanism of action Src signaling and tubulin polymerization inhibitors (KX2-391 and KX2-361). J Med Chem. 2018;61(11):4704-4719. 3. Kempers S, DuBois J, Forman S, et al. Tirbanibulin ointment 1% as a novel treatment for actinic keratosis: phase 1 and 2 results. J Drugs Dermatol. 2020;19(11):1093-1100. 4. Nui L, Yang J, Yan W, et al. Reversible binding of the anticancer drug KXO1 (tirbanibulin) to the colchicine-binding site of β-tubulin explains KXO1’s low clinical toxicity. J Biol Chem. 2019;294(48):18099-18108. 5. Yavel R, Overcash S, Zhi J, Cutler E, Cutler D, Fang J. Phase I maximal use pharmacokinetic study of tirbanibulin ointment 1% in subjects with actinic keratosis. Presented at: 40th Annual Fall Clinical Dermatology Conference (Fall CDC 2020); Virtual Congress; October 29-November 1, 2020.

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KLISYRI® is a registered trademark of Almirall, LLC. © Copyright 2005-2021. All Rights Reserved. Almirall, LLC, Exton, PA 19341 US-TIRBA-2100057 02/2021

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KLISYRI® is a registered trademark of Almirall, LLC. © Copyright 2005-2021. All Rights Reserved. Almirall, LLC, Exton, PA 19341 US-TIRBA-2100057 02/2021

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