Tubulin polymerisation inhibitor Pregnancy: No available data in pregnant women to evaluate for a drug-associated risk. In animal reproduction studies, oral tirbanibulin caused increased fetal deaths and malformations in rats at systemic exposures at least 19 times the maximum recommended human dose, and reduced mean fetal weight and size in rabbits at 41 times the MRHD.

Tirbanibulin

Brand names: Klisyri

Tirbanibulin is a topical ointment used for the field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis of the face or scalp.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Apply evenly to cover up to a 100 cm2 treatment field, using 1 unit-dose packet of 1% ointment per application

Route: Topical (cutaneous) to the face or balding scalp; for topical use only — not for oral or ophthalmic use

Frequency: Once daily for 5 consecutive days

From US labelling (Klisyri 1% ointment, Almirall; no UK SPC in the fetched bundle) — verify against a UK SPC before use. Wash hands immediately with soap and water after application. Avoid washing and touching the treated area for approximately 8 hours after application; after that time the area may be washed with a mild soap. Avoid transfer to the periocular area and avoid application near and around the mouth and lips. Occlusion after application is more likely to result in irritation. Avoid use until skin is healed from any previous drug, procedure or surgical treatment. Unit-dose packets contain 2.5 mg tirbanibulin in 250 mg, or 3.5 mg in 350 mg, of ointment. Paediatric: safety and effectiveness for actinic keratosis in subjects under 18 years have not been established. Elderly: no overall differences in safety or effectiveness observed in subjects 65 years and older.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

None (US label section 4 states 'None')

Side effects

Local skin reactions — erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration in the treated area (may be severe)
Application site pruritus
Application site pain
Eye irritation on ocular exposure — flush eyes with water and seek medical care

Clinical monograph

How it works

It is a microtubule and Src kinase inhibitor that disrupts tubulin polymerisation, arresting proliferation and inducing death of the rapidly dividing atypical keratinocytes in actinic keratosis.

Prescribing in practice

Apply only to the treatment field for the short specified course and avoid the eyes, lips and inside of the nostrils, washing hands after application.
Expected local skin reactions include erythema, flaking, crusting and swelling that typically peak in the first week and then resolve.
Avoid applying to broken skin or using more than one treatment course on the same area concurrently without specialist advice.

Monitoring

No laboratory monitoring is required; review the treated field for resolution of lesions and of local reactions after the course.

Counselling the patient

Use for the short prescribed course only and do not cover the area with an occlusive dressing.
Local redness, flaking and crusting are expected and settle within a few weeks.
Avoid washing or touching the treated area for several hours after applying, and use sun protection.

Evidence & guidelines

Efficacy in actinic keratosis of the face and scalp was demonstrated in two phase 3 randomised controlled trials.

Reference: SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways