- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Topical formulation of tirbanibulin.
Treatment of actinic keratoses
Field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults.
Applied to the affected field on the face or scalp once daily for one treatment cycle of 5 consecutive days.
A thin layer of ointment should be applied to cover the treatment field of up to 25 centimetres squared.
Therapeutic effect can be assessed 8 weeks after treatment starts. If the treated area does not show complete clearance at the follow-up examination, about 8 weeks after the treatment cycle started or thereafter, the treatment should be re-evaluated and management re-considered.
Additional Dosage Information
If a dose is missed, the patient should apply the ointment as soon as they remember and then continue with the regular schedule. The ointment should not be applied more than once a day.
Tirbanibulin is for external use on the face or scalp only.
Before application, patients should wash the treatment field with mild soap and water and dry it.
Tirbanibulin should be applied at the same time each day. The treatment area should not be bandaged or otherwise occluded.
Children under 18 years
Precautions and Warnings
Females of childbearing potential
Treatment to be initiated and supervised by a specialist
Contains propylene glycol: may cause irritation
Avoid application to broken skin
Avoid contact with ears
Avoid contact with eyes
Avoid contact with nostrils or mouth
Avoid occlusive dressings
If accidental contact with the eyes occurs, rinse thoroughly with water
Do not use for longer than 5 consecutive days
Advise patient not to wash treated area for 8 hours after application
Advise patient to avoid exposure to sunlight and UV rays during treatment
Advise patient to wash hands before and after use
If accidental ingestion occurs, the patient should drink plenty of water and seek medical care.
Tirbanibulin ointment may cause eye irritation. In the event of accidental contact with the eyes, the eyes should be rinsed immediately with large amounts of water, and the patient should seek medical care as soon as possible.
Application of tirbanibulin ointment is not recommended until the skin is healed from treatment with any previous medicinal product, procedure or surgical treatment and should not be applied to open wounds or broken skin where the skin barrier is compromised.
Changes in the appearance of actinic keratosis could suggest progression to invasive squamous cell carcinoma. Clinically atypical lesions for actinic keratosis or suspicious for malignancy should be appropriately managed.
Pregnancy and Lactation
Tirbanibulin is contraindicated during pregnancy.
The manufacturer does not recommend using tirbanibulin during pregnancy. At the time of writing there is no or limited data from the use of tirbanibulin in pregnant women. Animal studies have shown reproductive toxicity.
Tirbanibulin is contraindicated during breastfeeding.
The manufacturer advises that the patient either discontinues breastfeeding or discontinues tirbanibulin. It is unknown whether tirbanibulin or its metabolites are excreted in human breast milk. A risk to newborns/infants cannot be excluded.
Crusting of skin
Erythema at application site
Formation of pustules
Pain at application site
Ulceration (application site)
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: December 2021
Summary of Product Characteristics: Klisyri 10mg/g ointment. Almirall Limited. Revised August 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 24 December 2021
Already a member? Log in
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.