tirbanibulin
Klisyri · ATC code D06BX03
- Key facts
- Active substance
- tirbanibulin
- ATC code
- D06BX03
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Klisyri 10 mg/g ointment
- Marketing authorisation holder
- Almirall, S.A.
- Information as of
- 2026-10-28
Key facts
Tirbanibulin is a microtubule inhibitor for use on the skin. It is used as an ointment for field treatment of actinic keratosis on the face or scalp in adults.
What it is used for
- Field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults.
Dosing
- Klisyri (ointment): apply a thin layer once daily for one treatment cycle of 5 consecutive days to a treatment field of up to 25 cm2.
- If a dose is missed, apply as soon as remembered, but not more than once a day.
- Assess the effect approximately 8 weeks after starting; no data on more than one treatment course.
- Wash the field with mild soap and dry before applying; do not occlude; avoid washing or touching for approximately 8 hours; wash hands before and after application.
- No dose adjustment for the elderly or in renal or hepatic impairment.
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
Important warnings
- Avoid contact with the eyes, lips and inside of the nostrils or ears; after eye contact rinse immediately with plenty of water and seek medical care. Must not be ingested.
- Do not apply to open wounds or broken skin, or before skin has healed from previous treatment.
- Local skin reactions (erythema, flaking/scaling, crusting, swelling, erosion/ulceration, vesiculation/pustulation) may occur.
- Avoid excessive sun exposure (including sunlamps and tanning beds); use with caution in immunocompromised patients.
- Changes in lesions could suggest progression to invasive squamous cell carcinoma. Contains propylene glycol.
Side effects
- Most frequent local skin reactions: erythema (91 %), flaking/scaling (82 %), crusting (46 %), swelling (39 %), erosion/ulceration (12 %), vesiculation/pustulation (8 %).
- Also application site pruritus (9.1 %) and pain (9.9 %).
Interactions
- No interaction studies; given low systemic exposure, the potential for interaction is low.
Pregnancy and breastfeeding
- Not recommended during pregnancy or in women of childbearing potential not using contraception.
- Breast-feeding: a risk to the infant cannot be excluded.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- KlisyriAlmirall, S.A. · EMEA/H/C/005183
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Klisyri
- Liechtenstein
- Klisyri
- Norway
- Klisyri
EMA – Article 57 product data (EU/EEA), 2026-10-29
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Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Klisyri – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/klisyri-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.