Elitek

2 mg/kg as an intravenous infusion over 30 minutes daily for up to 5 days. 1 ) Do not administer as an intravenous bolus. 2 mg/kg as a 30-minute intravenous infusion daily for up to 5 days. Dosing beyond 5 days or administration of more than one course is not recommended.

2 Reconstitution Procedure Elitek must be reconstituted with the diluent provided in the carton. 5 mg vial of Elitek with 1 mL of diluent. 5 mg vial of Elitek with 5 mL of diluent. Mix by swirling gently. Do not shake or vortex. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Discard solution if particulate matter is visible or product is discolored. 9% sterile sodium chloride, to achieve a final total volume of 50 mL. Infuse over 30 minutes through a separate line or flush line with at least 15 mL of normal saline prior to and after Elitek infusion.

Do not use filters during infusion of reconstituted Elitek drug product. Store reconstituted or diluted solution at 2°C–8°C. Discard unused product solution 24 hours following reconstitution.

3) ] Most common adverse reactions (incidence ≥20%), when used concomitantly with anticancer therapy are vomiting, nausea, fever, peripheral edema, anxiety, headache, abdominal pain, constipation, diarrhea, hypophosphatemia, pharyngolaryngeal pain, and increased alanine aminotransferase.

S. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data below reflect exposure to Elitek in 265 pediatric and 82 adult patients enrolled in one active-controlled trial (Study 1), two uncontrolled trials (Studies 2 and 3), and an uncontrolled safety trial (n=82). Additional data were obtained from an expanded access program of 356 patients, for whom data collection was limited to serious adverse reactions.

Among these 703 patients 63% were male, the median age was 10 years (range 10 days to 88 years), 73% were Caucasian, 9% African, 4% Asian, and 14% other/unknown. Among the 347 patients for whom all adverse reactions regardless of severity were assessed, the most frequently observed adverse reactions (incidence ≥10%) were vomiting (50%), fever (46%), nausea (27%), headache (26%), abdominal pain (20%), constipation (20%), diarrhea (20%), mucositis (15%), and rash (13%).

In Study 1, an active control study, the following adverse reactions occurred more frequently in Elitek-treated subjects than allopurinol-treated subjects: vomiting, fever, nausea, diarrhea, and headache. Although the incidence of rash was similar in the two arms, severe rash was reported only in one Elitek-treated patient.

Further studies, including one-active controlled study (Study 4) and four supportive studies, have been conducted in adult patients. In these studies, Elitek was administered to a total of 434 adult patients (58% male, 42% female; median age 56 years [range 18 years to 89 years]; 52% Caucasian, 7% African, 14% Asian, 28% other/unknown).

1 Hypersensitivity Reactions Elitek can cause serious and fatal hypersensitivity reactions including anaphylaxis. In clinical studies, anaphylaxis was reported in <1% patients receiving Elitek. This can occur at any time during treatment including the first dose.

Signs and symptoms of these reactions include bronchospasm, chest pain and tightness, dyspnea, hypoxia, hypotension, shock, and urticaria. 2) ] . The safety and efficacy of Elitek have been established only for a single course of treatment once daily for 5 days.

2 Hemolysis Elitek is contraindicated in patients with G6PD deficiency because hydrogen peroxide is one of the major by-products of the conversion of uric acid to allantoin. In clinical studies, hemolysis occurs in <1% patients receiving Elitek; severe hemolytic reactions occurred within 2–4 days of the start of Elitek.

Immediately and permanently discontinue Elitek administration in any patient developing hemolysis. , transfusion support). , patients of African or Mediterranean ancestry) prior to starting Elitek [see Boxed Warning , Contraindications (4) ] .

3 Methemoglobinemia In clinical studies, methemoglobinemia occurred in <1% patients receiving Elitek. These included cases of serious hypoxemia requiring intervention with medical support measures. It is not known whether patients with deficiency of cytochrome b 5 reductase (formerly known as methemoglobin reductase) or of other enzymes with antioxidant activity are at increased risk for methemoglobinemia or hemolytic anemia.

Immediately and permanently discontinue Elitek administration in any patient identified as having developed methemoglobinemia. , transfusion support, methylene-blue administration) [see Boxed Warning , Contraindications (4) ] . 4 Laboratory Test Interference At room temperature, Elitek causes enzymatic degradation of the uric acid in blood/plasma/serum samples potentially resulting in spuriously low plasma uric acid assay readings.

3) ] . 2) ] . History of the following reactions to rasburicase: anaphylaxis, severe hypersensitivity, hemolysis, methemoglobinemia. ( 4 ) Glucose-6-phosphate dehydrogenase (G6PD) deficiency. ( 4 )