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 only for a single course of treatment.

Commitment to Patient Care With PACT+^®
Patient Assistance

Support for Your Patients

To help uninsured patient who require intervention with ELITEK^®(rasburicase), sanofi-aventis has designed the PACT+^® Patient Assistance Program.

Your Patient May Receive ELITEK (rasburicase) Free of Charge if:

The patient has no insurance or other third-party drug coverage
AND the patient is a legal US resident and meets financial criteria

A program consultant determines eligibility status and will notify you by telephone and in writing. Qualified patients will receive ELITEK (rasburicase) at no cost; sanofi-aventis will provide the medication, and the product will be sent directly to you.

ELITEK (rasburicase) is provided free of charge to patients who are uninsured and meet the program eligibility requirements. Call 1-800-996-6626 to learn more.

Additional Financial Assistance Information

Links to helpful information about other patient financial assistance programs:

Healthwell Foundation An independent, nonprofit organization that provides financial assistance to underinsured patients living with life-threatening diseases such as cancer.
Patient Advocate Foundation A national nonprofit organization that works to assure patients access to care, maintenance of employment, and preservation of financial stability.
Patient Access Network Foundation A copayment assistance program that helps underinsured patients access medical attention and treatment and sustain a reasonable quality of life.
Patient Services Incorporated (PSI) A charitable organization that helps people living with chronic conditions, including some cancers, locate suitable health insurance coverage and satisfy expensive co-payments.

Important Safety Information for ELITEK (rasburicase)

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 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.

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