Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Klisyri 10 mg/g ointment
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Tirbanibulin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Klisyri contains the active substance tirbanibulin. It is used for the treatment of mild actinic keratosis in adults. Actinic keratosis is a rough area of skin that has developed in people who have been exposed to too much sunshine over a long time. Klisyri should only be used for flat actinic keratosis on the face and scalp. 2.
What you need to know before you take it
e Klisyri
Do not use Klisyri • if you are allergic to tirbanibulin or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before using Klisyri • Do not use Klisyri until the area to be treated has healed from any previous medicine, procedure or surgical treatment. Do not apply Klisyri on open wounds or broken skin. • Wash your hands if you happen to touch the area where you applied the ointment. • Do not get Klisyri in your eyes. If it accidentally gets in your eye, rinse the eye thoroughly with plenty of water, seek medical assistance as soon as possible and take this leaflet with you.
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Do not apply the ointment internally, to the inside of the nostrils, the inside of the ear or on the lips. If the ointment accidentally touches any of these areas, wash it off by rinsing with water. Do not swallow this medicine. Drink plenty of water if you accidentally swallow this medicine, seek medical assistance and take this leaflet with you. Tell your doctor if you have problems with your immune system. Watch for any new scaly red patches, open sores, and raised or warty growths around the treatment area. If you see any, talk to your doctor immediately. After using Klisyri, avoid activities that might cause excessive sweating, and avoid exposure to sunlight as much as possible (including sunlamps and tanning beds). When outdoors, wear protective clothing and a hat. Do not cover the treated area with bandages after using Klisyri. Do not apply more ointment than your doctor has advised. Do not apply the ointment more than once a day. Do not allow other people or pets to touch the treated area for around 8 hours after applying the ointment. If the treated area is touched, the area of contact on the other person or pet should be washed. Contact your doctor if you get skin reactions to this medicine in the treated area that get severe (see section 4).
Children and adolescents Do not give this medicine to children and adolescents under 18 years of age because they do not get actinic keratosis. Other medicines and Klisyri Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. If you have previously used Klisyri or similar medicines, tell your doctor before starting the treatment. Pregnancy, breast-feeding, and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Klisyri should not be used during pregnancy. Driving and using machines This medicine is not expected to have any effect on your ability to drive or to use machines. Klisyri contains propylene glycol This medicine contains 222.5 mg propylene glycol in each sachet which is equivalent to 890 mg/g. 3.
How to take it
Klisyri
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. This medicine is intended to treat an area of up to 25 cm2 for only one treatment course of five days. If the treated area does not show complete clearance at about 8 weeks after the treatment cycle started, or new lesions develop within the treatment area, the treatment should be reconsidered by your doctor and other treatment options should be considered.
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Apply a thin layer of Klisyri to the affected area on the face or scalp once daily for 5 days in a row. One sachet contains enough ointment to cover the treatment area. Do not save the opened sachet for use on another day, even if there is still ointment left. Application instructions: 1. Wash your hands with soap and water before applying the ointment. 2. Wash the affected area with mild soap and water and dry it gently. 3. Open a new sachet each time you apply this medicine. 4. Open the sachet along the perforations (Figure 1). 5. Squeeze some ointment onto your fingertip (Figure 2). 6. Apply a thin layer of ointment evenly over the entire affected area (Figure 3). 7. Wash your hands with soap and water immediately after applying the ointment (Figure 4). 8. Do not wash or touch the treated area for about 8 hours. After this time, you may wash the treated area with mild soap and water. 9. Do not cover the treated area with bandages after you have applied Klisyri. 10. Repeat the above steps for each day of treatment at around the same time of the day.
If you use more Klisyri than you should Wash the treated area with mild soap and water. Please contact your doctor or pharmacist if you get severe skin reactions. If you forget to use Klisyri If you miss a dose, apply the ointment as soon as you remember and then continue with your regular schedule. Do not apply the ointment more than once a day. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. After using this medicine, you may get side effects on the skin where you apply the ointment. These side effects may get worse for up to 8 days after you start the treatment, and they typically go away within 2 to 3 weeks after completing the treatment. Contact your doctor if these side effects get severe. The most frequently occurring side effects in the treated area: Very common (may affect more than 1 in 10 people) • redness (erythema) • skin scaling (flaking) 3
• • •
scabs (crusting) swelling loss of the top layer of skin (erosion, ulcer)
Other possible side effects in the treated area: Common (may affect up to 1 in 10 people) • pain (tender, stinging, or burning feeling) • itching (pruritus) • blisters (vesicles, pustules) Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via The Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine. 5.
How to store it
Klisyri
Keep this medicine out of the sight and reach of children. Do not refrigerate or freeze. Do not use this medicine after the expiry date which is stated on the outer carton and the label after EXP. The expiry date refers to the last day of that month. For single use only. Do not re-use the sachets once opened. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
What Klisyri contains The active substance is tirbanibulin. Each sachet contains 2.5 mg of tirbanibulin in 250 mg ointment. Each gram of ointment contains 10 mg of tirbanibulin. The other ingredients are propylene glycol (E1520) and glycerol monostearate 40-55. What Klisyri looks like and contents of the pack Each Klisyri sachet contains 250 mg of white to off-white ointment. Each box contains 5 polyethylene/aluminium foil sachets. Marketing Authorisation Holder Almirall, S.A. Ronda General Mitre, 151 08022 Barcelona Spain
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Manufacturer Almirall Hermal GmbH Scholtzstrasse 3 21465 Reinbek Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: United Kingdom Almirall Limited Tel: +44 (0) 800 0087 399 (UK) This leaflet was last revised in April 2026
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Frequently asked questions about Klisyri 10 mg/g ointment
How do I take Klisyri 10 mg/g ointment?
Klisyri 10 mg/g ointment comes as ointment containing 10mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Klisyri 10 mg/g ointment?
The active substance in Klisyri 10 mg/g ointment is tirbanibulin.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Klisyri 10 mg/g ointment, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Klisyri 10 mg/g ointment without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: tirbanibulin
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Klisyri is indicated for the field treatment of non-hyperkeratotic, non‑hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults.
4.2. Posology and method of administration
Posology
Tirbanibulin ointment should be 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 cm2.
If a dose is missed, the patient should apply the ointment as soon as he/she remembers and then he/she should continue with the regular schedule. However, the ointment should not be applied more than once a day.
Tirbanibulin ointment should not be applied 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 (see section 4.4).
Therapeutic effect can be assessed approximately 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.
No clinical data on treatment for more than 1 treatment course of 5 consecutive days are available (see section 4.4). If recurrence occurs, or new lesions develop within the treatment area, other treatment options should be considered.
Special populations
Hepatic or renal impairment
Tirbanibulin has not been studied in patients with renal or hepatic impairment. Based on clinical pharmacology and in vitro studies, no dose adjustments are needed (see section 5.2).
Elderly population
No dose adjustment is required (see section 5.1).
Paediatric population
There is no relevant use of Klisyri in the paediatric population for the indication of actinic keratosis.
Method of administration
Tirbanibulin ointment is for external use only. Contact with eyes, lips, and the inside of nostrils or ears should be avoided.
Each sachet is for single use only and should be discarded after use (see section 6.6).
Treatment should be initiated and monitored by a physician.
Before applying tirbanibulin, patients should wash the treatment field with mild soap and water and dry it. Some ointment from 1 single‑use sachet should be squeezed onto a fingertip and a thin layer applied evenly over the entire treatment field of up to a maximal treatment area of 25 cm2.
The ointment should be applied at approximately the same time each day. The treated area should not be bandaged or otherwise occluded. Washing and touching of the treated area should be avoided for approximately 8 hours after application of tirbanibulin. After this period, the treated area may be washed with mild soap and water.
Hands should be washed with soap and water before and immediately after application of the ointment.
Tirbanibulin ointment is for application on the face or scalp. For information on incorrect route of administration, see section 4.4.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Incorrect route of administration
Contact with the eyes should be avoided. 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.
Tirbanibulin ointment must not be ingested. If accidental ingestion occurs, the patient should drink plenty of water and seek medical care.
Tirbanibulin ointment should not be used on the inside of the nostrils, on the inside of the ears, or on the lips.
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 (see section 4.2).
Local skin reactions
Local skin reactions in the treated area, including erythema, flaking/scaling, crusting, swelling, erosion/ulceration, and vesiculation/pustulation, may occur after topical application of tirbanibulin ointment (see section 4.8). Treatment effect may not be adequately assessed until resolution of local skin reactions.
Sun exposure
Due to the nature of the disease, excessive exposure to sunlight (including sunlamps and tanning beds) should be avoided or minimised.
Immunocompromised patients
Tirbanibulin ointment should be used with caution in immunocompromised patients.
Risk of progression to skin cancer
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.
Propylene glycol
This medicine contains 222.5 mg propylene glycol in each sachet which is equivalent to 890 mg/g.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Given the route of administration (topical), the short duration of dosing (5 days), the low systemic exposure (subnanomolar mean Cmax), and the in vitro data, there is low potential for interaction with tirbanibulin ointment at maximum clinical exposure.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of tirbanibulin in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).
Tirbanibulin ointment is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding
It is unknown whether tirbanibulin/metabolites are excreted in human milk.
A risk to the newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from tirbanibulin ointment therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility
No human data on the effect of tirbanibulin ointment on fertility are available. In a non‑clinical fertility and early embryonic development study in rats, changes considered indicative of male fertility toxicity occurred (see section 5.3).
4.7. Effects on ability to drive and use machines
Klisyri has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
The most frequently reported adverse reactions are local skin reactions. Local skin reactions included erythema (91 %), flaking/scaling (82 %), crusting (46 %), swelling (39 %), erosion/ulceration (12 %), and vesiculation/pustulation (8 %) at the application site. Furthermore, application site pruritus (9.1 %) and pain (9.9 %) have been reported in the treatment area.
Tabulated list of adverse reactions
Table 1 lists the adverse reactions that were reported in clinical studies. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (frequency cannot be estimated from the available data).
Table 1: Adverse reactions
MedDRA System Organ Class
Preferred term
Frequency
General disorders and administration site conditions
Application site erythema
Very common
Application site exfoliation (flaking and scaling)
Very common
Application site scab (crusting)
Very common
Application site swelling
Very common
Application site erosion (includes ulcer)
Very common
Application site paina
Common
Application site pruritus
Common
Application site vesicles (includes pustules)
Common
a) Application site pain includes pain, tenderness, stinging, and burning sensation at the application site.
Description of selected adverse reactions
Local skin reactions
Most local skin reactions were transient and mild to moderate in severity. Following the application of tirbanibulin ointment, the incidences of local skin reactions with a severity grade greater than baseline were erythema (91 %), flaking/scaling (82 %), crusting (46 %), swelling (39 %), erosion/ulceration (12 %), and vesiculation/pustulation (8 %). Severe local skin reactions occurred at an overall incidence of 13 %. Severe local skin reactions that occurred at an incidence >1 % were: flaking/scaling (9 %), erythema (6 %), and crusting (2 %). None of the local skin reactions required treatment.
Overall, local skin reactions peaked 8 days after starting the treatment and typically resolved within 2 to 3 weeks after completion of treatment with tirbanibulin ointment.
Site pruritus and pain
Events of application site pruritus and pain were mild to moderate in severity, transient in nature (mostly occuring during the first 10 days since the start of treatment), and the majority did not require treatment.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Overdose following topical application with tirbanibulin ointment may cause an increase in incidence and severity of local skin reactions. No systemic signs of overdose are expected following topical application of tirbanibulin ointment due to the low systemic absorption of tirbanibulin. Management of overdose should consist of treatment of clinical symptoms.
For information on incorrect routes of administration, see section 4.4.
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- KlisyriTirbanibulinum · skin / topical
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
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Ask anything about Klisyri 10 mg/g ointment. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.