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
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...