País: Israel
Idioma: anglès
Font: Ministry of Health
AVALGLUCOSIDASE ALPHA
SANOFI ISRAEL LTD
A16AB22
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
AVALGLUCOSIDASE ALPHA 100 MG/VIAL
I.V
Required
GENZYME IRELAND LTD
AVALGLUCOSIDASE ALPHA
Nexviazyme is indicated long-term enzyme replacement therapy (ERT) for the treatment of patients with Pompe disease (acid α-glucosidase deficiency)
2022-10-25
IMMUNOTESTING SERVICES - HCP GUIDE NEXVIAZYME ® (AVALGLUCOSIDASE ALFA) GUIDANCE FOR HEALTH CARE PROFESSIONALS ON IMMUNOLOGY TESTING SERVICES PROVIDED WITH NEXVIAZYME ® ADMINISTRATION MAT-IL-2300268 _YOU ARE ENCOURAGED TO REPORT ANY SUSPECTED ADVERSE EVENTS_ _TO MINISTRY OF HEALTH _ _ACCORDING TO THE NATIONAL REGULATION BY USING AN ONLINE FORM _ _HTTPS://SIDEEFFECTS.HEALTH.GOV.IL/ _ Page 2 of 8 1. Objectives and goals 2. Key contacts 3. Testing recommendations 4. Testing practicalities 4.1. Description of the Immunotesting services 4.2. Procedure to access the Immunotesting services 5. Reporting adverse events AE Adverse Event HCP Health Care Professional IAR Infusion-Associated Reaction ADA Antidrug Antibodies SmPC Summary of Product Characteristics CONTENTS ABBREVIATIONS Page 3 of 8 AIMS OF THE IMMUNOTESTING SERVICES GUIDE Nexviazyme ® (avalglucosidase alfa) treatment should be supervised by a physician experienced in the management of patients with Pompe disease or other inherited metabolic or neuromuscular diseases The Nexviazyme® Immunotesting services guide is part of the educational materials provided to physicians involved in managing patients with Pompe disease treated with Nexviazyme®. Treating physicians may make this material available to other health care professionals (HCPs) involved in the management of the disease as required. The main purposes of the Immunotesting service guide are to: 1. Guide HCPs to carry out immunological testing which will help to further characterize the potential mechanism of infusion-associated reactions (IARs) and hypersensitivity reactions, and appropriately manage patients experiencing loss of treatment response due to antidrug antibodies (ADA). 2. Provides information on the Sanofi Rare Disease Specialty Testing program, for immunological testing practicalities. 1. OBJECTIVES AND GOALS Page 4 of 8 • TO REPORT ADVERSE EVENT(S) (AE) OCCURRING IN ASSOCIATION WITH THE USE OF NEXVIAZYME®: Please contact the Ministry of Health by using an online form https://sideeffe Llegiu el document complet
1 NEXVIAZYME 1. NAME OF THE MEDICINAL PRODUCT Nexviazyme 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 Nexviazyme (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 Nexviazyme 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 patients who experience lack of improvement or insufficient response in cardiac, respiratory, and/or motor function while receiving 20 mg/kg, a dose increase to 40 mg/kg every other week should be considered in the absence of safety concerns (e.g., severe hypersensitivity, anaphylactic reactions, or risk of fluid overload). 2 In patients who do not tolerate avalglucosidase alfa at 40 mg/kg every other week (e.g., severe hypersensitivity, anaphylactic reactions, or risk of fluid overload), consider decre Llegiu el document complet