Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
brodalumab
LEO Pharma A/S
L04AC12
brodalumab
Immunosuppressants
Psoriasis
Kyntheum is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.
Revision: 6
Authorised
2017-07-17
26 B. PACKAGE LEAFLET eDoc-000624731 - Version 28. 0 27 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT KYNTHEUM 210 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE brodalumab 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 Kyntheum is and what it is used for 2. What you need to know before you use Kyntheum 3. How to use Kyntheum 4. Possible side effects 5. How to store Kyntheum 6. Contents of the pack and other information 1. WHAT KYNTHEUM IS AND WHAT IT IS USED FOR Kyntheum contains the active substance brodalumab. Brodalumab is a monoclonal antibody, a specialised type of protein that recognises and attaches to certain proteins in the body. Brodalumab belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by blocking the activity of IL-17 proteins, which are present at increased levels in diseases such as psoriasis. Kyntheum is used to treat a skin condition called “plaque psoriasis”, which causes inflammation and scaly plaque formation on the skin. Kyntheum is used in adults with moderate to severe plaque psoriasis affecting large areas of the body. Using Kyntheum will benefit you by leading to improvements of skin clearance and reducing psoriasis signs and symptoms, such as itch, redness, scaling, burning, stinging, cracking, flaking and pain. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE KYNTHEUM DO NOT USE KYNTHEUM • if you are allergic to brodalumab or any of the other ingredients of this medicine (listed in section 6). If you think you may be Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS eDoc-000624731 - Version 28. 0 2 1. NAME OF THE MEDICINAL PRODUCT Kyntheum 210 mg solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 210 mg brodalumab in 1.5 ml solution. 1 ml solution contains 140 mg brodalumab. Brodalumab is a human 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, colourless to slightly yellow and free from particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kyntheum is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Kyntheum is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis. Posology The recommended dose is 210 mg administered by subcutaneous injection at weeks 0, 1, and 2 followed by 210 mg every 2 weeks. Consideration should be given to discontinuing treatment in patients who have shown no response after 12-16 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks. _Elderly (aged 65 years and over) _ No dose adjustment is recommended in elderly patients (see section 5.2). _Renal and hepatic impairment _ Kyntheum has not been studied in these patient populations. No dose recommendations can be made. _ _ _Paediatric population _ The safety and efficacy of Kyntheum in children and adolescents below the age of 18 years have not yet been established. No data are available. eDoc-000624731 - Version 28. 0 3 Method of administration Kyntheum is administered by subcutaneous injection. Each pre-filled syringe is for single use only. Kyntheum should not be injected into areas where the skin is tender, bruised, red Pročitajte cijeli dokument