Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Burosumab
Kyowa Kirin Holdings B.V.
M05BX05
burosumab
Drugs for treatment of bone diseases
Hypophosphatemia, Familial; Hypophosphatemic Rickets, X-Linked Dominant; Osteomalacia
Crysvita is indicated for the treatment of X-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults.Crysvita is indicated for the treatment of FGF23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.
Revision: 11
Authorised
2018-02-19
41 B. PACKAGE LEAFLET 42 PACKAGE LEAFLET: INFORMATION FOR THE USER CRYSVITA 10 MG SOLUTION FOR INJECTION CRYSVITA 20 MG SOLUTION FOR INJECTION CRYSVITA 30 MG SOLUTION FOR INJECTION burosumab 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What CRYSVITA is and what it is used for 2. What you need to know before you use CRYSVITA 3. How to use CRYSVITA 4. Possible side effects 5. How to store CRYSVITA 6. Contents of the pack and other information 1. WHAT CRYSVITA IS AND WHAT IT IS USED FOR WHAT CRYSVITA IS CRYSVITA contains the active substance burosumab. This is a type of medicine called a human monoclonal antibody. WHAT IS CRYSVITA USED FOR CRYSVITA is used to treat X-linked hypophosphataemia (XLH). It is used in children and adolescents aged 1 to 17 years, and in adults. CRYSVITA is used to treat Tumour-induced Osteomalacia (TIO) where the tumour causing this condition cannot be successfully removed or found, in children and adolescents aged 1 to 17 years and in adults. WHAT IS X-LINKED HYPOPHOSPHATAEMIA (XLH) X-Linked Hypophosphataemia (XLH) is a genetic disease. • People with XLH have higher levels of a hormone called fibroblast growth factor 23 (FGF23). • FGF23 lowers the amount of phosphate in the blood. • The low level of phosphate may: - lead to bones that may not harden properly and, in children and adolescents, cannot grow properly - result in pain and stiffness in bones and joints WHAT IS TUMOUR-INDUCED OSTEOMALACIA (TIO) • People with TIO have higher levels of a hormone called FGF23 Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT CRYSVITA 10 mg solution for injection CRYSVITA 20 mg solution for injection CRYSVITA 30 mg solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CRYSVITA 10 mg solution for injection Each vial contains 10 mg of burosumab in 1 ml solution. CRYSVITA 20 mg solution for injection Each vial contains 20 mg of burosumab in 1 ml solution. CRYSVITA 30 mg solution for injection Each vial contains 30 mg of burosumab in 1 ml solution. Burosumab is a recombinant human monoclonal IgG1 antibody for FGF23 and is produced by recombinant DNA technology using Chinese hamster ovary (CHO) mammalian cell culture. Excipient with known effect Each vial contains 45.91 mg sorbitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear to slightly opalescent, colourless to pale brownish-yellowish solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CRYSVITA is indicated for the treatment of X-linked hypophosphataemia, in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease, and in adults. CRYSVITA is indicated for the treatment of FGF23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated by a physician experienced in the management of patients with metabolic bone diseases. 3 Posology Oral phosphate and active vitamin D analogues (e.g. calcitriol) should be discontinued 1 week prior to initiation of treatment. Vitamin D replacement or supplementation with inactive forms may be started or continued as per local guidelines under monitoring of serum calcium and phosphate. At initiation, fasting serum phosphate concentration should be below the reference range for age (see section 4.3). _ _ X-LINKED HYPOPHOSPHATAEMIA (X Pročitajte cijeli dokument