Important Safety Information
for ELITEK (rasburicase)

 
 
 

WARNING

Anaphylaxis: ELITEK can cause severe hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue ELITEK in patients who experience a serious hypersensitivity reaction.

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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 anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. ELITEK is indicated only for a single course of treatment.

Case Study: Acute Lymphoblastic Leukemia

Case Study: Acute Lymphoblastic Leukemia

Laura F, Age 14

Hypothetical patient profile
Model is for illustrative purposes only.

Diagnosis and Treatment

  • Diagnosis of T-cell acute lymphoblastic leukemia
  • Treated with vincristine, prednisone, L-asparaginase, and doxorubicin induction at standard doses and schedule; standard hydration and antiemetic

Patient has bulky tumor and is at risk of elevated uric acid.

Initial management of uric acid levels should be considered.

Physical Presentation:

  • Decreased energy level, lethargy, and progressive shortness of breath—particularly when lying flat—developing over the past week
  • Tachypnea when lying flat, accompanied by respiratory wheezing
  • Cervical and supraclavicular adenopathy

Laboratory Examination:

  • Anemia (Hgb 11.1 g/dL; normal range 12–16 g/dL)19
  • Elevated lactate dehydrogenase (2,500 IU/L; normal range 135–225 IU/L)17
  • Elevated WBC (30,000/μL; normal range 4,300–10,800/μL); 70% lymphs, 15% lymphoblasts, 10% atypical lymphs, and 5% neutrophils19

Biochemical Profile:

  • Uric acid within normal range (6.0 mg/dL; normal range 2.0–6.0 mg/dL)18,19
  • Elevated phosphorus (10.0 mg/dL; normal range 3.4–4.5 mg/dL)19
  • All other values within normal ranges: sodium, calcium, creatinine, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, BUN, and albumin

Lumbar Puncture:

Normal

Chest X-ray:

Mediastinal widening indicative of mediastinal mass

Bone Marrow Bx:

Positive for T-cell acute lymphoblastic leukemia

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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 anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. ELITEK is indicated only for a single course of treatment.

View Transcript

Important Safety Information for ELITEK (rasburicase)

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.

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 only for a single course of treatment.

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


Video Transcript

Hello, I'm Scott Howard of St. Jude Children's Research Hospital working in the Division of Leukemia and Lymphoma.

I'd like to present a patient case that shows how I would assess and manage a patient with acute lymphoblastic leukemia at who's risk for TLS and associated hyperuricemia.

Laura is a 14-year-old girl who presents with symptoms developing over the previous 2 weeks.

Her symptoms include decreased energy, lethargy, and progressive shortness of breath—particularly when lying flat.

Her physical exam shows tachypnea, respiratory wheezing, and evidence of cervical and supraclavicular adenopathy.

Laura is anemic, and her LDH and white cells counts are high. Her differential count shows 70% lymphs, 15% lymphoblasts, 10% atypical lymphs, and 5% neutrophils.

Her serum chemistries show elevated phosphorus—but other values, including uric acid, are still within normal ranges.

Based on Laura's physical and laboratory findings, which include lethargy, we performed a lumbar puncture, which showed normal results.

A chest x-ray revealed mediastinal widening that indicates a mediastinal mass, and a bone marrow biopsy was positive for T-cell acute lymphoblastic leukemia.

Laura's serum chemistry levels were normal and bulky tumor put her at intermediate—or potential—risk for TLS.

We want to treat her leukemia but also mitigate her risk of TLS and associated hyperuricemia. We'll start Laura on induction chemotherapy with vincristine, prednisone, L-asparaginase, and doxorubicin.

And to mitigate the risk of clinical TLS, we'll hydrate Laura and start her on Amphojel.

We'll also manage her uric acid with ELITEK at 0.2 mg/kg/day for up to 5 days.

Because Laura weighs 110 pounds, or 50 kilograms, so her dose would be 10 milligrams of ELITEK per day.

Laura's ancestry doesn't put her at higher risk for G6PD deficiency, but we will monitor her for methemoglobinemia and hypersensitivity.

How would you treat Laura?

Please see important safety information for Elitek, including boxed WARNING

Important Safety Information for ELITEK (rasburicase)

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.

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 only for a single course of treatment.

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