Tirbanibulin

Class: Skin and Mucous Membrane Agents, Miscellaneous
Chemical Name: N-benzyl-2-[5-[4-(2-morpholin-4-ylethoxy)phenyl]pyridin-2-yl]acetamide
Molecular Formula: C₂₆H₂₉N₃O₃
CAS Number: 1038395-65-1
Brands: Klisyri

Medically reviewed by Drugs.com on Jan 11, 2021. Written by ASHP.

Introduction

Tirbanibulin, a microtubule inhibitor, is a skin or mucous membrane agent.

Uses for Tirbanibulin

Tirbanibulin has the following uses:

Tirbanibulin is indicated for the topical treatment of actinic keratosis of the face or scalp.

Tirbanibulin Dosage and Administration

General

Tirbanibulin is available in the following dosage form(s) and strength(s):

Ointment: 1% tirbanibulin, single-dose packets.

Dosage

It isessentialthat the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration

• For topical use; not for oral or ophthalmic use.

• Apply tirbanibulin to the treatment field on the face or scalp once daily for 5 consecutive days using 1 single-dose packet per application.

Cautions for Tirbanibulin

Contraindications

None.

Warnings/Precautions

Ophthalmic Adverse Reactions

Tirbanibulin 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 tirbanibulin. Avoid use until skin is healed from any previous drug, procedure, or surgical treatment. Occlusion after topical application of tirbanibulin is more likely to result in irritation.

Specific Populations

Pregnancy

Risk Summary: There are no available data with tirbanibulin use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

In animal reproduction studies, oral administration of tirbanibulin to pregnant rats during the period of organogenesis resulted in an increased incidence of fetal deaths and malformations at a systemic exposure that was at least 74 times the exposure associated with th...