ill give you the treatment.
You will receive KRYSTEXXA every 2weeks.
If you have side effects, your doctor may stop or slow the infusion and may give you medicine to help the side effects.
A doctor or nurse will watch you for side effects while you receive KRYSTEXXA and for some time afterwards.
Your doctor may stop your KRYSTEXXA if your uric acid levels do not become normal and stay controlled or you have certain side effects.
Your gout flares may increase in the first 3months when you start receiving KRYSTEXXA. Do not stop receiving KRYSTEXXA even if you have a flare as the amount of flares will decrease after 3months of treatment. Your doctor may give you other medicines to help reduce your gout flares for the first few months after starting KRYSTEXXA.
What are the possible side effects of KRYSTEXXA?
KRYSTEXXA may cause serious side effects. See "What is the most important information I should know about KRYSTEXXA".
The most common side effects of KRYSTEXXA include:
gout flares
allergic reactions. See "What is the most important information I should know about KRYSTEXXA."
bruising
sore throat
constipation
chest pain
vomiting
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all of the side effects of KRYSTEXXA. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Savient Pharmaceuticals at 1-888-579-7839.
General information about the safe and effective use of KRYSTEXXA.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide summarizes the most important information about KRYSTEXXA. If you would like more information, talk with your doctor. You can ask you 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 for:
Savient Pharmaceuticals, Inc.
One Tower Center Blvd, 14th Floor
East Brunswick, NJ 08816
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Code #: 1801
Issued September 2010
Last Modified: September 2010
©2010 Savient Pharmaceuticals, Inc.
PRINCIPAL DISPLAY PANEL
NDC 54396-801-01
KRYSTEXXA™
(pegloticase)
Injection
8mg/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 8mg/mL vial of pegloticase contains:
8mg uricase protein covalently linked to 24mg PEG
Disodium hydrogen phosphate dihydrate...2.18mg
Sodium chloride...8.77mg
Sodium dihydrogen phosphate dihydrate...0.43mg
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 Preserva
