LUMIZYME 50 mg vials are supplied as a sterile, nonpyrogenic, white to off-white lyophilized cake or powder in single-dose vials.
NDC 58468-0160-1 (Carton of one single-dose vial)
NDC 58468-0160-2 (Carton of ten single-dose vials)
Store LUMIZYME under refrigeration between 2°C and 8°C (36°F and 46°F). Do not use LUMIZYME after the expiration date on the vial.
Anaphylaxis, Hypersensitivity, and Immune-Mediated Reactions
Advise the patients and caregivers that reactions related to administration and infusion may occur during and after alglucosidase alfa treatment, including life-threatening anaphylaxis, hypersensitivity reactions, and immune-mediated reactions. Patients who have experienced anaphylaxis or hypersensitivity reactions may require close observation during and after alglucosidase alfa administration. Inform patients of the signs and symptoms of anaphylaxis, hypersensitivity reactions, and immune-mediated reactions and have them seek medical care should signs and symptoms occur.
Risk of Acute Cardiorespiratory Failure
Advise patients and caregivers that patients with underlying respiratory illness or compromised cardiac or respiratory function may be at risk of acute cardiorespiratory failure. Patients with compromised cardiac or respiratory function may require close observation during and after alglucosidase alfa administration.
Inform patients and their caregivers that the Pompe Registry has been established in order to better understand the variability and progression of Pompe disease, and to continue to monitor and evaluate long-term treatment effects of alglucosidase alfa. The Pompe Registry will also monitor the effect of alglucosidase alfa on pregnant women and their offspring [see Use in Specific Populations (8.1)]. Patients and their caregivers should be encouraged to participate in the Pompe Registry and advised that their participation is voluntary and may involve long-term follow-up. For more information regarding the registry program, visit www.registrynxt.com or call 1-800-745-4447, extension 15500.
LUMIZYME is manufactured and distributed by:
Cambridge, MA 02142
U.S. License Number: 1596
LUMIZYME and GENZYME are registered trademarks of Genzyme Corporation.
Lumizyme® (alglucosidase alfa)
For Intravenous Infusion Only
Contains No Preservatives
|LUMIZYME alglucosidase alfa injection, powder, for solution|
|Labeler — Genzyme Corporation (025322157)|
|Genzyme Flanders||372153895||ANALYSIS (58468-0160), MANUFACTURE (58468-0160), API MANUFACTURE (58468-0160)|
|Genzyme Ireland Limited||985127419||ANALYSIS (58468-0160), MANUFACTURE (58468-0160), PACK (58468-0160), LABEL (58468-0160)|
|Genzyme Corporation||050424395||LABEL (58468-0160), PACK (58468-0160)|
|Eurofins Biopharma Product Testing Ireland Limited||238239933||ANALYSIS (58468-0160)|
Revised: 05/2022 Genzyme Corporation
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