País: Unión Europea
Idioma: inglés
Fuente: EMA (European Medicines Agency)
pegloticase
Crealta Pharmaceuticals Ireland Limited
M04AX02
pegloticase
Antigout preparations
Gout
Krystexxa is indicated for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated.
Revision: 3
Withdrawn
2013-01-08
20 B. PACKAGE LEAFLET Medicinal product no longer authorised 21 PACKAGE LEAFLET: INFORMATION FOR THE USER KRYSTEXXA 8 MG CONCENTRATE FOR SOLUTION FOR INFUSION pegloticase 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. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What KRYSTEXXA is and what it is used for 2. What you need to know before you receive KRYSTEXXA 3. How to use KRYSTEXXA 4. Possible side effects 5. How to store KRYSTEXXA 6. Contents of the pack and other information 1. WHAT KRYSTEXXA IS AND WHAT IT IS USED FOR KRYSTEXXA contains the active substance pegloticase. Pegloticase belongs to the class anti-gout medicines. Pegloticase is used to treat severe long-term gout in adult patients who also have one or more painful deposits of uric acid crystals under the skin that cause difficulty in carrying out daily activities and who do not respond or cannot take other anti-gout medicines. HOW KRYSTEXXA WORKS People with gout have too much uric acid in their body. Uric acid deposits as crystals in joints, kidneys, and other organs which may cause profound pain, redness and swelling (inflammation). KRYSTEXXA contains an enzyme called uricase that transforms the uric acid into a substance called allantoin, which can be removed easily in the urine. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE KRYSTEXXA DO NOT USE KRYSTEXXA • If you are allergic to pegloticase, or other uricases or any of the other ingredients of this medicine (listed in section 6). • If you have a rare blood problem called glucose 6-phosphate dehydrogenase (G6PD) deficiency or favism. Your doctor may test you for G6PD before you start KRYSTEXXA. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR NURSE BEFORE USING KRYSTEXXA: - IF Y Leer el documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT KRYSTEXXA 8 mg concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 8 mg of pegloticase (8 mg/ml concentrate). The strength indicates the quantity of the uricase moiety of pegloticase without consideration of the PEGylation. The active substance pegloticase is a covalent conjugate of uricase produced by a genetically modified strain of Escherichia coli and monomethoxypoly (ethylene glycol). The potency of this product should not be compared to the one of another pegylated or non-pegylated protein of the same therapeutic class. For the full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear to slightly opalescent, colourless solution at pH 7.3±0.3. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS KRYSTEXXA is indicated for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated (see section 4.4). The decision to treat with KRYSTEXXA should be based on an on-going assessment of the benefits and risks for the individual patient (see section 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of severe refractory chronic gout. The medicinal product should be administered in a healthcare setting and by healthcare professionals prepared to manage anaphylaxis and infusion reactions. Close monitoring is required during the infusion and for at least 2 hours after the end of the infusion. Availability of resuscitation equipment must be ensured. Delayed-type hypersensitivity reactions have also been reported. Posology The recommended dose is 8 mg pegloticase given Leer el documento completo