Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
erenumab
Novartis Europharm Limited
N02CD01
erenumab
Analgesics
Migraine Disorders
Aimovig is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month when initiating treatment with Aimovig.
Revision: 11
Authorised
2018-07-26
42 B. PACKAGE LEAFLET 43 PACKAGE LEAFLET: INFORMATION FOR THE USER AIMOVIG 70 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE AIMOVIG 140 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE erenumab 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 Aimovig is and what it is used for 2. What you need to know before you use Aimovig 3. How to use Aimovig 4. Possible side effects 5. How to store Aimovig 6. Contents of the pack and other information 1. WHAT AIMOVIG IS AND WHAT IT IS USED FOR Aimovig contains the active substance erenumab. It belongs to a group of medicines called monoclonal antibodies. Aimovig works by blocking the activity of the CGRP molecule, which has been linked to migraine (CGRP stands for calcitonin gene-related peptide). Aimovig is used to prevent migraine in adults who have at least 4 migraine days per month when starting treatment with Aimovig. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE AIMOVIG DO NOT USE AIMOVIG - if you are allergic to erenumab or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor before using Aimovig: - if you have ever had an allergic reaction to rubber latex. The container of this medicinal product contains latex rubber within the cap. - if you suffer from a cardiovascular disease. Aimovig has not been studied in patients with certain cardiovascular diseases. 44 Talk to your doctor or get emergency medical help immediately: - if you get any symptoms of a serious allergic reaction, such Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Aimovig 70 mg solution for injection in pre-filled syringe Aimovig 140 mg solution for injection in pre-filled syringe Aimovig 70 mg solution for injection in pre-filled pen Aimovig 140 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Aimovig 70 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 70 mg erenumab. Aimovig 140 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 140 mg erenumab. Aimovig 70 mg solution for injection in pre-filled pen Each pre-filled pen contains 70 mg erenumab. Aimovig 140 mg solution for injection in pre-filled pen Each pre-filled pen contains 140 mg erenumab. Erenumab is a fully human IgG2 monoclonal antibody produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection) The solution is clear to opalescent, colourless to light yellow. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aimovig is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated by physicians experienced in the diagnosis and treatment of migraine. Posology Treatment is intended for patients with at least 4 migraine days per month when initiating treatment with erenumab. The recommended dose is 70 mg erenumab every 4 weeks. Some patients may benefit from a dose of 140 mg every 4 weeks (see section 5.1). 3 Each 140 mg dose is given either as one subcutaneous injection of 140 mg or as two subcutaneous injections of 70 mg. Clinical studies have demonstrated that the majority of patients responding to therapy showed clinical benefit within 3 months. Consideration should be given to discontinuing treatment in patients who have shown no response after 3 months of treatment. Evaluation of the need to continue treat Aqra d-dokument sħiħ