Elitek Generic Name & Formulations
Legal Class
Rx
General Description
Rasburicase (recombinant) 1.5mg, 7.5mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution; contains mannitol.
Pharmacological Class
Urate oxidase.
How Supplied
Single-dose vials 1.5mg—3 (w. diluent); 7.5mg—1 (w. diluent)
Manufacturer
Generic Availability
NO
Elitek Indications
Indications
Single course treatment for initial management of plasma uric acid levels in 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 Dosage and Administration
Adults and Children
Give by IV infusion over 30 mins. 0.2mg/kg daily for 5 days. Dosing >5 days or more than one course of treatment: not recommended.
Elitek Contraindications
Contraindications
History of anaphylaxis, or development of hemolytic reactions or methemoglobinemia to rasburicase. G6PD deficiency.
Elitek Boxed Warnings
Boxed Warning
Anaphylaxis. Hemolysis. Methemoglobinemia. Interference with uric acid measurements.
Elitek Warnings/Precautions
Warnings/Precautions
Discontinue permanently if serious hypersensitivity reactions (including anaphylaxis), hemolysis, or methemoglobinemia develops. Screen high risk patients (eg, African or Mediterranean ancestry) for G6PD deficiency prior to initiation. Pregnancy. Nursing mothers: not recommended (during and for 2 weeks after the last dose).
Elitek Pharmacokinetics
See Literature
Elitek Interactions
Interactions
Interferes with uric acid measurements in blood samples left at room temperature.
Elitek Adverse Reactions
Adverse Reactions
GI upset, pyrexia, peripheral edema, anxiety, headache, abdominal pain, constipation, hypophosphatemia, hyperbilirubinemia, mucositis, sepsis; anaphylaxis, hemolysis, methemoglobinemia.
Elitek Clinical Trials
See Literature
Elitek Note
Not Applicable
Elitek Patient Counseling
See Literature