ide. This Medication Guide summarizes the most important information about Krystexxa. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Krystexxa that is written for health professionals.
For more information, go to www.Krystexxa.com or www.SAVIENT.com or call 1-888-579-7839.
What are the ingredients in Krystexxa?
Active ingredient: pegloticase
Inactive ingredients: disodium hydrogen phosphate dihydrate, sodium chloride, sodium dihydrogen phosphate dihydrate, and water for injection.
Product manufactured by:
Savient Pharmaceuticals, Inc.
400 Crossing Boulevard
Bridgewater, NJ 08807
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Code #: 1801
Revised: 04/2013
©2013 Savient Pharmaceuticals, Inc.
PRINCIPAL DISPLAY PANEL
NDC 54396-801-01
Krystexxa®
(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-C
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.
400 Crossing Blvd.
Bridgewater, NJ 08807
US License No. 1801
Peel-off sticker for patient's chart
SAVIENT®
PHARMACEUTICALS, INC.
Toll-free no.
1-888-579-7839
Revision Date 09/2012
© 2012
Krystexxa
pegloticase injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: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
Packaging
# Item Code Package Description
1 NDC:54396-801-01 1 VIAL in 1 CARTON
1 1 mL in 1 VIAL
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(54396-801)
Establishment
Name Address ID/FEI Operations
Biotechnology General (Israel) Limited 600004527 api manufacture(54396-801) |
