s a prescription medicine used in adults to help reduce the signs and symptoms of gout that are not controlled by other treatments.
People with gout have too much uric acid in their body. Uric acid crystals collect in joints, kidneys, and other organs. This may cause pain, redness and swelling (inflammation). KRYSTEXXA works to lower blood levels of uric acid.
It is not known if KRYSTEXXA is safe and effective in children.
Who should not receive KRYSTEXXA?
Do not receive KRYSTEXXA if you have a rare blood problem called glucose 6-phosphate dehydrogenase (G6PD) deficiency or favism. Your doctor may test you for G6PD before you start KRYSTEXXA.
What should I tell my doctor before receiving treatment with KRYSTEXXA?
Before you receive KRYSTEXXA, tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of your medicines and show them to your doctor and pharmacist when you get a new medicine.
How will I receive 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:
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, 14 FloorEast Brunswick, NJ 08816
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Code #: 1801Issued September 2010Last Modified: September 2010©2010 Savient Pharmaceuticals, Inc.
PRINCIPAL DISPLAY PANEL
NDC 54396-801-01
KRYSTEXXAâ„¢ (pegloticase) Injection 8Â mg/mL For Intravenous Infusion
Single-use vial. Discard unused portionMust Be Diluted Prior To Administration
Dispense the enclosed Medication Guide to each patient
Rx Only
Lot #:Exp:
C-490-11-US-A
Each 8Â mg/mL vial of pegloticase contains:8Â mg uricase protein covalently linked to 24Â mg PEGDisodium hydrogen phosphate dihydrate...2.18Â mgSodium chloride...8.77Â mgSodium dihydrogen phosphate dihydrate...0.43Â mgWater for injection
See enclosed full prescribing information for dosage and administration.
No U.S. standard of pot |
