Acirc; mg every 4Â weeks 41 8 (20%) [7%, 32%] 0.044
   Placebo 20 0 (0%)
Trial 2
   Pegloticase 8 mg every 2 weeks 42 16 (38%) [23%, 53%] <0.001
   Pegloticase 8 mg every 4 weeks 43 21 (49%) [34%, 64%] <0.001
   Placebo 23 0 (0%)
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
KRYSTEXXA is supplied as a clear, colorless, sterile solution in phosphate buffered saline intended for intravenous infusion after dilution. KRYSTEXXA is supplied in a single-use 2 mL glass vial with a Teflon® coated (latex-free) rubber injection stopper to deliver KRYSTEXXA as 8 mg of uricase protein in 1 mL volume.
Storage and Handling
Before the preparation for use, KRYSTEXXA must be stored in the carton and maintained at all times under refrigeration between 2° to 8°C (36° to 46°F). Protect from light. Do not shake or freeze.
Do not use beyond the expiration date stamped.
NDC# 54396-801-01
17 PATIENT COUNSELING INFORMATION
See Medication Guide
17.1 General Information
Provide and instruct patients to read the accompanying Medication Guide before starting treatment and before each subsequent treatment.
17.2 Anaphylaxis and Infusion Reactions
17.3 Glucose-6-phosphate dehydrogenase (G6PD) Deficiency
Inform patients not to take KRYSTEXXA if they have a condition known as G6PD deficiency. Explain to patients that G6PD deficiency is more frequently found in individuals of African or Mediterranean ancestry and that they may be tested to determine if they have G6PD deficiency, unless already known. [See Contraindications ( 4 )]
17.4 Gout Flares
Explain to patients that gout flares may initially increase when starting treatment with KRYSTEXXA, and that medications to help reduce flares may need to be taken regularly for the first few months after KRYSTEXXA is started. [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 )] Advise patients that they should not stop KRYSTEXXA therapy if they have a flare.
Manufactured by:Savient Pharmaceuticals, Inc.One Tower Center, 14 FloorEast Brunswick, NJ 08816
Medication Guide
KRYSTEXXAâ„¢ (Phonetic spelling: Kris-TEX-a) (pegloticase) Injection For Intravenous Infusion
Read this Medication Guide before you start receiving KRYSTEXXA and before each treatment. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk to your doctor if you have any questions about your treatment with KRYSTEXXA.
What is the most important information I should know about KRYSTEXXA?
Serious allergic reactions may happen in some people who receive KRYSTEXXA. These allergic reactions can be life threatening and usually happen within 2Â hours of the infusion.
KRYSTEXXA should be given to you by a doctor or nurse in a healthcare setting where serious allergic reactions can be treated. Your doctor or nurse should watch you for any signs of a serious allergic reaction during and after your treatment with KRYSTEXXA.
Tell your doctor or nurse right away if you have any of these symptoms during or after your treatment with KRYSTEXXA:
What is KRYSTEXXA?
KRYSTEXXA i |
