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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 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.

Tumor Lysis Syndrome (TLS)
Case Study Video 3: Jenny



Watch Jenny’s story, a 7-year-old girl with Burkitt’s lymphoma and high risk for developing tumor lysis syndrome (TLS). Use of ELITEK® allowed Jenny to continue her chemotherapy as scheduled.

Video Transcript

The following is the case of a 7-year-old girl. We can call this patient, Jenny.

When I first met Jenny, she presented with a recent history of abdominal pain, abdominal distention, constipation, and decreased appetite. She had been well up until about 4 weeks prior to presentation when she noticed a protuberance in her abdomen, decreased appetite, constipation, and abdominal pain. Her physical examination demonstrated a distended and tender abdomen, as well as an abdominal mass and inguinal adenopathy. She had no evidence of hepatosplenomegaly.

Initial laboratory studies demonstrated a normal CBC with a white blood cell count of 6400, hemoglobin of 11.1 g/dL, and a platelet count of 175,000. Serum chemistries showed a uric acid level of 8.7, phosphate level of 10.0, potassium level of 4.8, a creatinine level of 3.0, and an LDH of 3500.

An abdominal ultrasound indicated a large abdominal mass measuring 10 x 12 centimeters, renal tumor infiltration, and mild splenomegaly. An excisional biopsy was also performed and the resulting diagnosis was Burkitt’s Lymphoma with typical cytogenetic features, that is the 8; 14 translocation.

Clinical investigation confirmed she had Burkitt’s lymphoma, and this particular diagnosis, combined with her serum chemistries, put her at high risk for the development of tumor lysis syndrome (TLS). In order to initiate chemotherapy as soon as possible, we first started the patient on hydration to alleviate her TLS risk with IV saline (3L/m2/day), aluminum hydroxide (as Amphogel), and ELITEK for uric acid reduction at a dose of 0.2 mg/kg/day x 5 days.

After 4 hours of this therapy, she was then started on cyclophosphamide, vincristine, and prednisone reduction chemotherapy also known as the COP regimen.

At this point, her chemistry profile demonstrated a uric acid level of 3.2, a phosphate level of 8.6, a potassium level of 3.6, and a creatinine level of 2.1.

After 24 hours, her chemistry parameters continued to improve and demonstrated a uric acid level of 1.8, a phosphate level of 6.0, a potassium level of 4.0, and a creatinine level of 1.6.

And after 48 hours, all chemistries exhibited substantial reductions. Her uric acid level was 1.0—an 88.6% reduction from baseline—phosphate was 4.2, potassium was 4.1, and creatinine was 1.1.

After multi-agent chemotherapy, LDH, levels decreased from 3500 to 900 in 48 hours—a 74% reduction from baseline.

Jenny continued on her chemotherapy as scheduled.

   Download Transcript (Case 3)

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.

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.

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US.RAS.10.03.020  Last Update: April 2010