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 anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. ELITEK is indicated for only a single course of treatment.

ELITEK (rasburicase) Dosing

Dosing Information for Reliable Results^2,14,25-27

Therapy	ELITEK	Allopurinol
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	4 hours after the 1^st dose	24-48 hours after the 1^st oral dose
Dose adjustments	None required	Renally impaired patients

ELITEK (rasburicase) Once-Daily IV Dosing for Reliability and Control²

Dose 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 1 course of ELITEK is not recommended.

ELITEK is available in 1.5-mg and 7.5-mg vials.²
Do not administer ELITEK as a bolus injection.²
Treatment with ELITEK does not require a change in chemotherapy timing or schedule; chemotherapy may be started as early as 4 hours (up to 24 hours) after the 1^st dose of ELITEK.²
ELITEK therapy does not require concomitant alkalinization.¹
Patients on ELITEK should receive intravenous hydration according to standard medical practice.

ELITEK (rasburicase) requires special sample handling:

Uric acid must be analyzed in plasma. Blood must be collected into prechilled tubes containing heparin anticoagulant. Samples must be immediately immersed in an ice water bath. Plasma samples must be prepared by centrifugation in a precooled centrifuge (4˚C). Finally, the plasma must be maintained in an ice water bath and analyzed for uric acid within 4 hours of collection (see BOXED WARNINGS, Interference With Uric Acid Measurements).²

ELITEK (rasburicase) administration in 5 steps²:

ELITEK should be administered as an intravenous infusion over 30 minutes. DO NOT ADMINISTER AS A BOLUS INFUSION.
ELITEK should be infused through a different line than that used for concomitant medications; if use of a separate line is not possible, the line should be flushed with at least 15 mL of saline solution prior to and after infusion.
Add 1 mL of the provided reconstitution solution (diluent) to each single-use 1.5-mg vial of ELITEK or 5 mL of the provided reconstitution solution to each single-use 7.5-mg vial of ELITEK and mix by swirling very gently. Do not shake or vortex.¹
ELITEK must be reconstituted in the diluent provided. Using aseptic techniques and syringes of appropriate volume, remove the predetermined dose of ELITEK from the reconstituted vials and inject into an infusion bag containing the appropriate volume of 0.9% sterile sodium chloride, to achieve a final total volume of 50 mL.
This final solution for injection is to be infused over 30 minutes. NO FILTERS SHOULD BE USED FOR INFUSION.
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.

IMPORTANT SAFETY INFORMATION INCLUDING BOXED 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.

Continued below

Important Safety Information

BOXED WARNINGS

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 for only a single course of treatment.

Please see accompanying full Prescribing Information, including Boxed WARNING.

ELITEK® (rasburicase IV Infusion)

ELITEK (rasburicase) Dosing

Dosing Information for Reliable Results2,14,25-27

ELITEK (rasburicase) Once-Daily IV Dosing for Reliability and Control2