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 Physician Support With PACT+®
Support for Your Practice
The PACT+® Program was established by sanofi-aventis to answer
general and specific questions regarding third-party payer coverage and reimbursement
for ELITEK®(rasburicase).
Reimbursement Through the PACT+® Program Is Easy
- Toll-free support can be reached at 1-800-996-6626 Monday through Friday, from 9:00 am
-8:00 pm Eastern Time.
- Or visit PACT+® Provider Portal at www.pactplusonline.com.
- Reimbursement counselors will respond to inquiries within 2 business days.
The PACT+® Program Can Provide Information About:
- Reimbursement
- Coverage policies for ELITEK (rasburicase) and drug information for ELITEK
(rasburicase)
- Coverage for a specific patient and uninsured patients
- Filing new claims or appealing previously submitted claims
- CPT®2, HCPCS, and ICD-9-CM3 codes
Because private payer policies are not always applied uniformly and benefits
often vary by contract, the PACT+® Program can be particularly
helpful in providing patient-specific information.
Additional Reimbursement Resources
Download a printable guide for filing claims and receiving reimbursement for ELITEK
(rasburicase).
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ELITEK (rasburicase) Billing Card provides billing information for administering
ELITEK (rasburicase) in both inpatient and outpatients settings, as well
as diagnosis codes and possible MS-DRG assignments for conditions where ELITEK (rasburicase)
may be used.
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ELITEK (rasburicase) Reimbursement Guide provides key information on
filing claims for ELITEK (rasburicase) therapy in order to receive appropriate
reimbursement.
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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.