Fabrazyme (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Fabrazyme (agalsidase beta) for injection is supplied as a sterile, nonpyrogenic, white to off-white lyophilized cake or powder in single-dose vials.

35 mg vial: NDC 58468-0040-1

5 mg vial: NDC 58468-0041-1

Refrigerate vials of Fabrazyme at 2°C to 8°C (36°F to 46°F). Do not use Fabrazyme after the expiration date on the vial.

This product contains no preservatives. Reconstituted and diluted solutions of Fabrazyme should be used immediately. If immediate use is not possible, the reconstituted and diluted solution may be stored for up to 24 hours at 2°C to 8°C (36°F to 46°F) [see Dosage and Administration (2.2)].

17 PATIENT COUNSELING INFORMATION

Inform patients that a Registry has been established in order to better understand the variability and progression of Fabry disease in the population as a whole and in women [see Use in Specific Populations (8.1)] , and to monitor and evaluate long-term treatment effects of Fabrazyme. The Registry will also monitor the effect of Fabrazyme on pregnant women and their offspring. Encourage patients to participate. Advise patients that their participation is voluntary and may involve long-term follow-up. For more information, visit www. registrynxt.com or call 1-800-745-4447, extension 15500.

Manufactured by:
Genzyme Corporation
50 Binney Street
Cambridge, MA 02142
U.S. License Number: 1596

Fabrazyme and Genzyme are registered trademarks of Genzyme Corporation.

PRINCIPAL DISPLAY PANEL — 5 mg Vial Carton

NDC 58468-0041-1 Rx only

Fabrazyme® agalsidase beta

5 mg

For Intravenous Infusion Only

One single-dose vial

Discard unused portion

SANOFI GENZYME

PRINCIPAL DISPLAY PANEL -- 5 mg Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 35 mg Vial Carton

NDC 58468-0040-1 Rx only

Fabrazyme® agalsidase beta

35 mg

For Intravenous Infusion Only

One single-dose vial

Discard unused portion

SANOFI GENZYME

PRINCIPAL DISPLAY PANEL -- 35 mg Vial Carton
(click image for full-size original)
FABRAZYME agalsidase beta injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58468-0041
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AGALSIDASE BETA (AGALSIDASE BETA) AGALSIDASE BETA 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 33 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 3 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 8.8 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58468-0041-1 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
1 1 mL in 1 VIAL, GLASS This package is contained within the CARTON (58468-0041-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103979 12/17/2008
FABRAZYME agalsidase beta injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58468-0040
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AGALSIDASE BETA (AGALSIDASE BETA) AGALSIDASE BETA 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 222 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 20.4 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 59.2 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58468-0040-1 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
1 7 mL in 1 VIAL, GLASS This package is contained within the CARTON (58468-0040-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103979 12/17/2008
Labeler — Genzyme Corporation (025322157)
Establishment
Name Address ID/FEI Operations
Genzyme Corporation 926029653 ANALYSIS (58468-0040), ANALYSIS (58468-0041)
Establishment
Name Address ID/FEI Operations
Genzyme Corporation 968278916 API MANUFACTURE (58468-0040), API MANUFACTURE (58468-0041), ANALYSIS (58468-0040), ANALYSIS (58468-0041)
Establishment
Name Address ID/FEI Operations
Genzyme Corporation 050424395 LABEL (58468-0040), LABEL (58468-0041), PACK (58468-0040), PACK (58468-0041), ANALYSIS (58468-0040), ANALYSIS (58468-0041)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 030606222 MANUFACTURE (58468-0040), MANUFACTURE (58468-0041), ANALYSIS (58468-0040), ANALYSIS (58468-0041)
Establishment
Name Address ID/FEI Operations
Genzyme Corporation 968278874 API MANUFACTURE (58468-0040), API MANUFACTURE (58468-0041)
Establishment
Name Address ID/FEI Operations
Genzyme Corporation 968278932 API MANUFACTURE (58468-0040), API MANUFACTURE (58468-0041)
Establishment
Name Address ID/FEI Operations
Genzyme Corporation 943130096 API MANUFACTURE (58468-0040), API MANUFACTURE (58468-0041), ANALYSIS (58468-0040), ANALYSIS (58468-0041)
Establishment
Name Address ID/FEI Operations
Genzyme Corporation 034378252 ANALYSIS (58468-0040), ANALYSIS (58468-0041)
Establishment
Name Address ID/FEI Operations
Genzyme Corporation 968302658 ANALYSIS (58468-0040), ANALYSIS (58468-0041)
Establishment
Name Address ID/FEI Operations
Genzyme Corporation 078456891 ANALYSIS (58468-0040), ANALYSIS (58468-0041)
Establishment
Name Address ID/FEI Operations
Genzyme Ireland 985127419 MANUFACTURE (58468-0040), MANUFACTURE (58468-0041), ANALYSIS (58468-0040), ANALYSIS (58468-0041), LABEL (58468-0040), LABEL (58468-0041), PACK (58468-0040), PACK (58468-0041)

Revised: 11/2019 Genzyme Corporation

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