, 32%] 0.044
Placebo 20 0 (0%)
Trial 2
Pegloticase 8mg every 2weeks 42 16 (38%) [23%, 53%] <0.001
Pegloticase 8mg every 4weeks 43 21 (49%) [34%, 64%] <0.001
Placebo 23 0 (0%)
The effect of treatment on tophi was a secondary efficacy endpoint and was assessed using standardized digital photography, image analysis, and a Central Reader blinded to treatment assignment. Approximately 70% of patients had tophi at baseline. A pooled analysis of data from Trial1 and Trial2 was performed as pre-specified in the protocols. At Month6, the percentage of patients who achieved a complete response (defined as 100% resolution of at least one target tophus, no new tophi appear and no single tophus showing progression) was 45%, 26%, and 8%, with KRYSTEXXA 8mg every 2weeks, KRYSTEXXA 8mg every 4weeks, and placebo, respectively. The difference between KRYSTEXXA and placebo was statistically significant for the every 2week dosing regimen, but not for the every 4week dosing regimen.
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 2mL glass vial with a Teflon® coated (latex-free) rubber injection stopper to deliver KRYSTEXXA as 8mg of uricase protein in 1mL 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
Anaphylaxis and infusion reactions can occur at any infusion while on therapy. Counsel patients on the importance of adhering to any prescribed medications to help prevent or lessen the severity of these reactions.
Educate patients on the signs and symptoms of anaphylaxis, including wheezing, peri-oral or lingual edema, hemodynamic instability, and rash or urticaria.
Educate patients on the most common signs and symptoms of an infusion reaction, including urticaria (skin rash), erythema (redness of the skin), dyspnea (difficulty breathing), flushing, chest discomfort, chest pain, and rash.
Advise patients to seek medical care immediately if they experience any symptoms of an allergic reaction during or at any time after the infusion of KRYSTEXXA. [see Warnings and Precautions (5.1, 5.2), Adverse Reactions (6.1)]
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 an |