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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 2: John



John, a 14-year-old boy, was diagnosed with T-cell acute lymphoblastic leukemia and intermediate risk for developing tumor lysis syndrome (TLS). With the use of ELITEK®, John was able to complete his anti-cancer therapy without interruption.

Video Transcript
This next case involves a 14-year-old boy who presented with a history of weakness, lethargy, and shortness of breath. We can call him John.

John’s history indicated that he had been in excellent health up until 1 week before his hospital admission, at which point he noticed a decreased energy level, lethargy, and progressive shortness of breath—particularly when lying flat. Upon physical examination, it was noted that the patient had tachypnea when lying flat, accompanied by respiratory wheezing. He also showed evidence of cervical and supraclavicular adenopathy.

After a thorough laboratory investigation, we learned that our patient had a white blood cell count of 30,000, hemoglobin was 11.1 g/dL, and his platelet count was 80,000. The differential count demonstrated 70% lymphs, 15% lymphoblasts, 10% atypical lymphs, and 5% neutrophils. Initial serum chemistries revealed a uric acid level of 6.0, phosphate was 10.0, potassium was 4.1, creatinine was 0.8, and LDH was 2,500.

Due to the nature of the patient’s physical and laboratory findings, which included lethargy, a lumbar puncture was performed; this showed normal results. A bone marrow aspirate and biopsy were also conducted suggesting the diagnosis of T-cell acute lymphoblastic leukemia. A chest x-ray revealed a mediastinal mass 6 by 8 centimeters in size.

John was diagnosed with T-cell acute lymphoblastic leukemia. His serum chemistry levels combined with the fact that he had a bulky tumor also put him at an intermediate—or potential—risk for tumor lysis syndrome (TLS). We wanted to treat his leukemia but also mitigate his risk for tumor lysis syndrome (TLS) simultaneously.

Induction chemotherapy was started with vincrisine, prednisone, L-asparaginase, and doxorubicin. In this case, to mitigate the risk of clinical tumor lysis syndrome (TLS), hydration was initiated with IV saline and the patient was started on aluminum hydroxide (as Amphogel). ELITEK was also given at 0.2 mg/kg/day and was initially planned for 5 days for uric acid reduction.

4 hours after initiation of therapy, serum chemistries demonstrated a uric acid level of 1.1 (an 81.6% reduction from baseline), phosphate was 4.6, potassium was 4.1, and creatinine was 0.8. John completed his anti-cancer therapy without interruption.

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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