Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Romosozumab
UCB Pharma S.A.
M05BX
romosozumab
Drugs for treatment of bone diseases
Osteoporosis
Evenity is indicated in treatment of severe osteoporosis in postmenopausal women at high risk of fracture.
Revision: 4
Authorised
2019-12-09
Draft 39 B. PACKAGE LEAFLET Draft 40 PACKAGE LEAFLET: INFORMATION FOR THE USER EVENITY 105 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN romosozumab 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. - You will be given a patient alert card, which contains important safety information you need to be aware of before and during your treatment with EVENITY. WHAT IS IN THIS LEAFLET 1. What EVENITY is and what it is used for 2. What you need to know before you use EVENITY 3. How to use EVENITY 4. Possible side effects 5. How to store EVENITY 6. Contents of the pack and other information 1. WHAT EVENITY IS AND WHAT IT IS USED FOR WHAT EVENITY IS EVENITY contains the active substance romosozumab, a medicine that helps to make the bones stronger, and reduce the risk of broken bones. WHAT EVENITY IS USED FOR EVENITY is used to treat severe osteoporosis in women after the menopause who are at high risk of broken bone (fracture). Osteoporosis is a disease that causes your bones to become thin and fragile. Many patients with osteoporosis have no symptoms, but they may be at increased risk of fractures. HOW EVENITY WORKS EVENITY is a monoclonal antibody. A monoclonal antibody is a type of protein that has been designed to recognize and attach to specific proteins in the body. EVENITY attaches to a protein called sclerosti Read the complete document
Draft 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Draft 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 EVENITY 105 mg solution for injection in pre-filled pen EVENITY 105 mg solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION EVENITY 105 mg solution for injection in pre-filled pen Each pre-filled pen contains 105 mg of romosozumab in 1.17 ml of solution (90 mg/ml). EVENITY 105 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 105 mg of romosozumab in 1.17 ml of solution (90 mg/ml). Romosozumab is a humanized 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) Clear to opalescent, colorless to light yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EVENITY is indicated in treatment of severe osteoporosis in postmenopausal women at high risk of fracture (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated and supervised by specialist physicians experienced in the management of osteoporosis. Posology The recommended dose is 210 mg romosozumab (administered as two subcutaneous injections of 105 mg each) once monthly for 12 months. Patients should be adequately supplemented with calcium and vitamin D before and during treatment (see sections 4.3 and 4.4). Patients treated with EVENITY should be given the package leaflet and the patient alert card. Draft 3 Following completion of romosozumab therapy, transition to antiresorptive therapy is recommended in order to extend the benefit achieved with romosozumab beyond 12 months. _Missed doses _ If the romosozumab dose is missed, administer as soon a Read the complete document