trade;
(pegloticase)
Injection
8 mg/mL
For Intravenous Infusion
Single-use vial. Discard unused portion
Must Be Diluted Prior To Administration
Dispense the enclosed Medication Guide to each patient
Rx Only
Lot :
Exp:
C-490-11-US-A
Each 8 mg/mL vial of pegloticase contains:
8 mg uricase protein covalently linked to 24 mg PEG
Disodium hydrogen phosphate dihydrate...2.18 mg
Sodium chloride...8.77 mg
Sodium dihydrogen phosphate dihydrate...0.43 mg
Water for injection
See enclosed full prescribing information for dosage and administration.
No U.S. standard of potency.
Store in carton at 2°C-8°C (36°F-46°F).
Do not shake or freeze.
Protect from light.
No Preservative.
Manufactured by Savient Pharmaceuticals, Inc.
One Tower Center,
East Brunswick, NJ 08816
US License No. 1801
Peel-off sticker for patient's chart
SAVIENT™
PHARMACEUTICALS, INC.
Toll-free no.
1-888-579-7839
Revision Date 09/2010
© 2010
KRYSTEXXA
pegloticase injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 54396-801
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PEGLOTICASE (PEGLOTICASE) PEGLOTICASE 8 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
SODIUM CHLORIDE
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
WATER
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
NDC Package Description Multilevel Packaging
1 54396-801-01 1 VIAL In 1 CARTON contains a VIAL
1 1 mL In 1 VIAL This package is contained within the CARTON (54396-801-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125293 09/14/2010
Labeler - Savient Pharmaceuticals, Inc. (101113025)
Establishment
Name Address ID/FEI Operations
Savient Pharmaceuticals, Inc. 101113025 MANUFACTURE
Revised: 09/2010Savient Pharmaceuticals, Inc
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