Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
Avalglucosidase alfa
Sanofi B.V.
A16
Avalglucosidase alfa
Other alimentary tract and metabolism products,
Glycogen Storage Disease Type II
Nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of patients with Pompe disease (acid α-glucosidase deficiency).
Revision: 2
Authorised
2022-06-24
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NEXVIADYME 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION avalglucosidase alfa 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, 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. See section 4. WHAT IS IN THIS LEAFLET 1. What Nexviadyme is and what it is used for 2. What you need to know before you are given Nexviadyme 3. How Nexviadyme is given 4. Possible side effects 5. How to store Nexviadyme 6. Contents of the pack and other information 1. WHAT NEXVIADYME IS AND WHAT IT IS USED FOR WHAT NEXVIADYME IS Nexviadyme contains an enzyme called avalglucosidase alfa – it is a copy of the natural enzyme called acid alpha-glucosidase (GAA) that is lacking in people with Pompe disease. WHAT NEXVIADYME IS USED FOR Nexviadyme is used to treat people of all ages who have Pompe disease. People with Pompe disease have low levels of the enzyme acid alpha-glucosidase (GAA). This enzyme helps control levels of glycogen (a type of carbohydrate) in the body. Glycogen provides the body with energy, but in Pompe disease high levels of glycogen build up in different muscles and damages them. The medicine replaces the missing enzyme so that the body can reduce the build-up of glycogen. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN NEXVIADYME _ _ DO NOT USE NEXVIADYME If you have had life-threatening allergic (hypersensitive) reactions to avalglucosidase alfa or any of the other ingredients of this medicine (listed in section 6) and these react Izlasiet visu dokumentu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 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 Nexviadyme 100 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 100 mg of avalglucosidase alfa. After reconstitution, each vial contains a total extractable volume of 10.0 ml at a concentration of 10 mg of avalglucosidase alfa* per ml. *Avalglucosidase alfa is a human acid α-glucosidase produced in Chinese hamster ovary cells (CHO) by recombinant DNA technology, which is subsequently conjugated with approximately 7 hexamannose structures (each containing two terminal mannose-6-phosphate (M6P) moieties) to oxidised sialic acid residues on the molecule, thereby increasing bis-M6P levels. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion White to pale yellow lyophilised powder 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of patients with Pompe disease (acid α-glucosidase deficiency). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Nexviadyme treatment should be supervised by a physician experienced in the management of patients with Pompe disease or other inherited metabolic or neuromuscular diseases. Posology Patients may be pre-treated with antihistamines, antipyretics, and/or corticosteroids to prevent or reduce allergic reactions. The recommended dose of avalglucosidase alfa is 20 mg/kg of body weight administered once every 2 weeks. _Dose modification for IOPD patients _ For IOPD (infantile-onset Pompe disease) patients who experience lack of improvement or insufficient response in cardiac, respiratory, and/or motor function while receiving Izlasiet visu dokumentu