sanofi-aventis

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 1: Tommy



Learn about Tommy, an 8-year-old boy with acute myeloid leukemia (AML) and intermediate risk for developing tumor lysis syndrome (TLS). Use of ELITEK® allowed Tommy to receive chemotherapy for his AML without interruption.

Video Transcript

One patient case of interest is one that involves an 8-year-old boy. We’ll call him Tommy.

When I first saw Tommy, he presented with a history of fevers, weight loss, bleeding under his skin as well as in the mouth, mucosa, and pallor. The patient had been in excellent health up until 2 weeks before his admission, at which point he developed signs of skin petachiae, decreased appetite, intermittent fevers, and decreased energy.

Upon examination, the patient showed significant and widespread petachiae and pallor. He also presented with evidence of splenomegaly and abdominal distention. We conducted a thorough laboratory investigation which revealed a white blood cell count of 25,000, hemoglobin of 4.6 g/dL, and a platelet count of 4,000. The white blood cell differential showed 20% myeloblasts, 10% myelocytes, 30% lymphocytes, 10% monocytes, and 30% neutrophils. Serum chemistries showed a uric acid level of 7.5, phosphate was 11.0, potassium was 4.6, serum creatinine was 2.6, and LDH was 880.

Due to the nature of Tommy’s symptoms, a bone marrow aspirate and biopsy were performed. Results revealed a bone marrow picture consistent with acute myeloid leukemia. And we wanted to start chemotherapy promptly.

His cancer diagnosis combined with his white blood cell count and uric acid level put him at a potential—or intermediate— risk for tumor lysis syndrome (TLS). Due to the nature of his TLS risk, we started him on hydration with IV saline along with ELITEK for uric acid reduction and aluminum hydroxide (as Amphogel). We conducted frequent serum monitoring and initiated chemotherapy with Ara-C and doxorubicin. After just 4 hours, the serum chemistry tests demonstrated a uric acid level of 1.8, while phosphate was 7.2, potassium was 4.8, and creatinine was 1.6.

On Day 2, Tommy’s uric acid level was 2.0, phosphate was 6.1, potassium was 4.6, and creatinine was 1.2. On Day 3, the uric acid was reduced to 1.9, phosphate was 4.6, potassium was 4.1, and creatinine was 0.7. All chemistries demonstrated reductions from baseline, most notably, uric acid, which exhibited a 75% reduction from baseline.

In this case, the risks for tumor lysis syndrome (TLS) were mitigated right from the start, and chemotherapy continued, uninterrupted.

   Download Transcript (Case 1)

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.

©2002 - 2010 sanofi-aventis U.S. LLC. All rights reserved.
Legal Disclaimer Information and Privacy Policy
Questions or Comments? Click here to contact us.
This site intended for U.S. Healthcare Professionals Only.
US.RAS.10.03.020  Last Update: April 2010