Lumizyme: Package Insert and Label Information (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

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.

17 PATIENT COUNSELING INFORMATION

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.

Pompe Registry

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:
Genzyme Corporation
Cambridge, MA 02142
1-800-745-4447 (phone)

U.S. License Number: 1596

LUMIZYME and GENZYME are registered trademarks of Genzyme Corporation.

PRINCIPAL DISPLAY PANEL — 50 mg Vial Carton

Lumizyme® (alglucosidase alfa)

50 mg/vial

For Injection

For Intravenous Infusion Only

Rx only

Contains No Preservatives

SANOFI GENZYME

PRINCIPAL DISPLAY PANEL -- 50 mg Vial Carton
(click image for full-size original)
LUMIZYME alglucosidase alfa injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58468-0160
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALGLUCOSIDASE ALFA (ALGLUCOSIDASE ALFA) ALGLUCOSIDASE ALFA 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 20 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 2.97 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 0.94 mg in 1 mL
POLYSORBATE 80 0.05 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58468-0160-1 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 10.5 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (58468-0160-1)
2 NDC:58468-0160-2 10 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
2 10.5 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (58468-0160-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125291 05/24/2010
Labeler — Genzyme Corporation (025322157)
Establishment
Name Address ID/FEI Operations
Genzyme Flanders 372153895 ANALYSIS (58468-0160), MANUFACTURE (58468-0160), API MANUFACTURE (58468-0160)
Establishment
Name Address ID/FEI Operations
Genzyme Ireland Limited 985127419 ANALYSIS (58468-0160), MANUFACTURE (58468-0160), PACK (58468-0160), LABEL (58468-0160)
Establishment
Name Address ID/FEI Operations
Genzyme Corporation 050424395 LABEL (58468-0160), PACK (58468-0160)
Establishment
Name Address ID/FEI Operations
Eurofins Biopharma Product Testing Ireland Limited 238239933 ANALYSIS (58468-0160)

Revised: 05/2022 Genzyme Corporation

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