Important Safety Information
for ELITEK (rasburicase)

 
 
 

WARNING

Anaphylaxis: ELITEK can cause severe hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue ELITEK in patients who experience a serious hypersensitivity reaction.

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ELITEK® is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. ELITEK is indicated only for a single course of treatment.

ELITEK (rasburicase) Dosing

Minimal delay to anticancer therapy

Dosing information for reliable results1,22,24-26

Therapy ELITEK Allopurinol
Approved dose 0.20 mg/kg daily 200–400 mg/m2 daily; maximum 600 mg daily
for IV, 600–800 mg daily for oral
Route of administration IV IV and oral
Duration of treatment Up to 5 days Up to 10 days
Dosing frequency Once daily 1–4 times daily for IV; up to 3 times daily for oral
Time to chemotherapy* No recommendation 24–48 hours after the 1st oral dose
Dose adjustments None In renally impaired patients
Alkalinization Not necessary Recommended
Hydration Not necessary Recommended

*In phase III clinical trials of ELITEK, cytoreductive therapy was initiated between 4 and 48 hours after the first dose of antihyperuricemic treatment.1,3

  • ELITEK may be dosed daily for up to 5 days1
  • ELITEK is indicated only for a single course of treatment1

ELITEK (rasburicase): Weight-based IV dosing for reliability and control1

Dosing and frequency Route of administration Duration of treatment
ELITEK 0.20 mg/kg, once daily IV infusion over 30 minutes Up to 5 days*

*Because the safety and effectiveness of other schedules have not been established, dosing beyond 5 days or administration of more than one course of ELITEK is not recommended.1

  • Do not administer ELITEK as a bolus injection11
  • Available in 2 vial sizes (1.5 mg and 7.5 mg)1

The average US man weighs about 195 lb, or 89 kg27

  • His approved ELITEK dose would be 18 mg1

The average US woman weighs about 165 lb, or 75 kg27

  • Her approved ELITEK dose would be 15 mg1

ELITEK (rasburicase) administration in 5 steps1

Step 1

ELITEK must by reconstituted with the diluent provided in the carton. Add 1 mL of the provided reconstitution diluent to each single-use 1.5-mg vial of ELITEK or 5 mL of the provided reconstitution diluent to each single-use 7.5-mg vial of ELITEK, and mix by swirling very gently. DO NOT SHAKE OR VORTEX.

Step 2

Inspect reconstituted ELITEK visually for particulate matter and discoloration prior to administraion. Discard solution if particulate matter is visible or product is discolored.

Step3

DO NOT ADMINISTER AS A BOLUS INJECTION.
Inject the calculated dose of reconstituted ELITEK solution into an infusion bag containing the appropriate volume of 0.9% sterile sodium chloride, achieving a final total volume of 50 mL.

Step 4

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 reconstitution or infusion of ELITEK.

Step 5

The reconstituted ELITEK contains no preservatives and must be administered within 24 hours of reconstitution. The reconstituted or diluted solution can be stored up to 24 hours at 2°C-8°C (36°F-46°F). Each vial is for single-use only. Discard any unused product 24 hours following reconstitution.

Important Safety Information for ELITEK (rasburicase)

WARNING

Anaphylaxis: ELITEK can cause severe hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue ELITEK in patients who experience a serious hypersensitivity reaction.

Hemolysis: Do not administer ELITEK to patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Immediately and permanently discontinue ELITEK in patients developing hemolysis. Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting ELITEK.

Methemoglobinemia: ELITEK can result in methemoglobinemia in some patients. Immediately and permanently discontinue ELITEK in patients developing methemoglobinemia.

Interference with Uric Acid Measurements: ELITEK enzymatically degrades uric acid in blood samples left at room temperature. Collect blood samples in pre-chilled tubes containing heparin and immediately immerse and maintain sample in an ice water bath. Assay plasma samples within 4 hours of collection.

Among the 347 (265 pediatric; 82 adult) patients for whom all adverse reactions regardless of severity were assessed in Studies 1, 2 and 3, as well as an uncontrolled safety trial, 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%).

Among the 275 adult patients in Study 4, hypersensitivity reactions occurred in 4.3% of patients treated with the ELITEK alone and 1.1% of patients treated with the ELITEK/oral allopurinol combination. Hypersensitivity reactions included arthralgia, injection site irritation, peripheral edema, and rash. The most common Grade 3 or 4 adverse reactions regardless of relationship to study drug in the 3 arms of Study 4 (ELITEK alone; ELITEK combined with oral allopurinol; oral allopurinol alone) were sepsis (5.4%; 6.5%; 4.4%), hypophosphatemia (4.3%; 6.5%; 6.6%), anxiety (3.3%; 0%; 0%), abdominal pain (3.3%; 4.3%; 2.2%), hyperbilirubinemia (3.3%; 2.2%; 4.4%), and increased alanine aminotransferase (3.3%; 4.3%; 2.2%), respectively.

The following serious adverse reactions occurred with a difference in incidence of greater than or equal to 2% in patients receiving ELITEK compared to patients receiving oral allopurinol in randomized studies (Study 1 and Study 4): pulmonary hemorrhage, respiratory failure, supraventricular arrhythmias, ischemic coronary artery disorders, and abdominal and gastrointestinal infections.

Indication

ELITEK® is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. ELITEK is indicated only for a single course of treatment.

Please click here for ELITEK (rasburicase) full prescribing information, including boxed WARNING.