Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
tildrakizumab
Almirall S.A
L04AC
tildrakizumab
Immunosuppressants, Interleukin inhibitors,
Psoriasis
Ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Revision: 10
Authorised
2018-09-17
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE USER ILUMETRI 100 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE tildrakizumab 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ilumetri is and what it is used for 2. What you need to know before you use Ilumetri 3. How to use Ilumetri 4. Possible side effects 5. How to store Ilumetri 6. Contents of the pack and other information 1. WHAT ILUMETRI IS AND WHAT IT IS USED FOR Ilumetri contains the active substance tildrakizumab. Tildrakizumab belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by blocking the activity of a protein called IL-23, a substance found in the body which is involved in normal inflammatory and immune responses and which is present at increased levels in diseases such as psoriasis. Ilumetri is used to treat a skin condition called plaque psoriasis, in adults with moderate to severe disease. Using Ilumetri will benefit you by improvements of skin clearance and reducing your symptoms. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ILUMETRI DO NOT USE ILUMETRI: - If you are allergic to tildrakizumab or any of the other ingredients of this medicine (listed in section 6). - If you have an infection which your doctor thinks is important, for example, active tuberculosis which is an infectious disease affecting mainly the lungs. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Ilumetri: - If you experience allergic reactions with symptoms such as che Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ilumetri 100 mg solution for injection in pre-filled syringe Ilumetri 200 mg solution for injection in pre-filled syringe Ilumetri 100 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Ilumetri 100 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 100 mg of tildrakizumab in 1 mL. Ilumetri 200 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 200 mg of tildrakizumab in 2 mL. Ilumetri 100 mg solution for injection in pre-filled pen Each pre-filled pen contains 100 mg of tildrakizumab in 1 mL. Tildrakizumab is a humanised IgG1/k monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection) The solution is clear to slightly opalescent and colourless to slightly yellow. The solution pH is in the range of 5.7 - 6.3 and the osmolality is between 258 and 311 mOsm/kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This medicinal product is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis. Posology The recommended dose is 100 mg by subcutaneous injection at weeks 0, and 4 and every 12 weeks thereafter. At the physician’s discretion, in patients with high disease burden or in patients above 90 kg of body weight a dose of 200 mg may provide greater efficacy. 3 Consideration should be given to discontinuing treatment in patients who have shown no response after 28 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 28 weeks. Missed dose If a dose is missed, the dose should be administ Læs hele dokumentet