Country: European Union
Language: English
Source: EMA (European Medicines Agency)
tirbanibulin
Almirall, S.A.
D06BX03
tirbanibulin
Antibiotics and chemotherapeutics for dermatological use
Keratosis, Actinic
Klisyri is indicated for the field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults.
Revision: 1
Authorised
2021-07-16
19 B. PACKAGE LEAFLET 20 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT KLISYRI 10 MG/G OINTMENT tirbanibulin This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Klisyri is and what it is used for 2. What you need to know before you use Klisyri 3. How to use Klisyri 4. Possible side effects 5. How to store Klisyri 6. Contents of the pack and other information 1. WHAT KLISYRI IS AND WHAT IT IS USED 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 USE 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 Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Klisyri _ _ 10 mg/g ointment 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of ointment contains 10 mg of tirbanibulin. Each sachet contains 2.5 mg of tirbanibulin in 250 mg ointment. Excipients with known effects: Propylene glycol 890 mg/g ointment For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ointment. White to off-white ointment. 4. CLINICAL PARTICULARS 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 25cm 2 . 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 recu Read the complete document