Rasburicase

What is Rasburicase?

• Rasburicase (Elitek) is a recombinant urate-oxidase used in combination with xanthine oxidase inhibitors in the therapy of severe hyperuricemia due to tumor lysis syndrome after initiation of cancer chemotherapy in treatment of malignant diseases.

Rasburicase

What are the uses of this medicine?

• Rasburicase (Elitek) is used 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.

Limitations of Use:

• Elitek is indicated only for a single course of treatment.

How does this medicine work?

• Rasburicase (ras bure’ i kase) is a DNA recombinant urate oxidase derived from the fungus Aspergillus flavus.
• Urate oxidase is an enzyme that catalyzes the metabolism of uric acid to allantoin, which is an inert and inactive molecule that, unlike uric acid, is rapidly excreted in the urine.
• Infusions of rasburicase lower serum uric acid levels by hastening its excretion and have been shown to be effective in rapidly lowering uric acid levels in patients with tumor lysis syndrome after initiation of cancer chemotherapy.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with a history of anaphylaxis or severe hypersensitivity to rasburicase
• with development of hemolytic reactions or methemoglobinemia with rasburicase
• in individuals deficient in glucose-6-phosphate dehydrogenase (G6PD)

What drug interactions can this medicine cause?

• At room temperature, Elitek causes enzymatic degradation of the uric acid in blood/plasma/serum samples potentially resulting in spuriously low plasma uric acid assay readings.
• Special sample handling procedure must be followed to avoid ex vivo uric acid degradation.

Is this medicine FDA approved?

• Rasburicase was approved for use in the treatment and prevention of hyperuricemia due to tumor lysis syndrome after cancer chemotherapy in the United States in 2002.

How should this medicine be used?

Recommended dosage:

• The recommended dose of Elitek is 0.2 mg/kg as a 30-minute intravenous infusion daily for up to 5 days.
• Dosing beyond 5 days or administration of more than one course is not recommended.

Administration:

• Elitek must be reconstituted with the diluent provided in the carton.
• Reconstitute the 1.5 mg vial of Elitek with 1 mL of diluent. Reconstitute the 7.5 mg vial of Elitek with 5 mL of diluent. Mix by swirling gently. Do not shake or vortex.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard solution if particulate matter is visible or product is discolored.
• Administer Elitek as an intravenous infusion only:
• Inject the calculated dose of reconstituted Elitek solution into an infusion bag containing the appropriate volume of 0.9% sterile sodium chloride, to achieve a final total volume of 50 mL.
• Infuse over 30 minutes through a separate line or flush line with at least 15 mL of normal saline prior to and after Elitek infusion.
• Do not use filters during infusion of reconstituted Elitek drug product.
• Store reconstituted or diluted solution at 2°C–8°C.
• Discard unused product solution 24 hours following reconstitution.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection, 1.5 mg, lyophilized powder in single-dose vial
• injection, 7.5 mg, lyophilized powder in single-dose vial

This medicine is available in fallowing brand namesː

• Elitek

What side effects can this medication cause?

The most common side effects of this medicine include:

• when used concomitantly with anticancer therapy are vomiting, nausea, fever, peripheral edema, anxiety, headache, abdominal pain, constipation, diarrhea, hypophosphatemia, pharyngolaryngeal pain, and increased alanine aminotransferase.

• Severe adverse reactions can include local infusion reactions, hypersensitivity reactions, anaphylaxis and hemolytic anemia with methemoglobinemia in patients with G6PD deficiency.

What special precautions should I follow?

• Elitek can cause serious and fatal hypersensitivity reactions including anaphylaxis. Immediately and permanently discontinue Elitek administration in any patient developing clinical evidence of a serious hypersensitivity reaction. The safety and efficacy of Elitek have been established only for a single course of treatment once daily for 5 days.
• Elitek is contraindicated in patients with G6PD deficiency because hydrogen peroxide is one of the major by-products of the conversion of uric acid to allantoin. Institute appropriate patient monitoring and support measures (e.g., transfusion support). Screen patients at higher risk for G6PD deficiency (e.g., patients of African or Mediterranean ancestry) prior to starting Elitek.
• In clinical studies, methemoglobinemia occurred in <1% patients receiving Elitek. Immediately and permanently discontinue Elitek administration in any patient identified as having developed methemoglobinemia. Institute appropriate monitoring and support measures (e.g., transfusion support, methylene-blue administration).
• At room temperature, Elitek causes enzymatic degradation of the uric acid in blood/plasma/serum samples potentially resulting in spuriously low plasma uric acid assay readings. Special sample handling procedure must be followed to avoid ex vivo uric acid degradation.
• Rasburicase has been associated with serum enzyme elevations during therapy and to rare instances of hypersensitivity reactions that can be accompanied by liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• decreased levels of blood potassium and blood albumin
• increased levels of carbon dioxide
• increased levels blood lactate dehydrogenase, blood urea, blood phosphorus, blood sodium, and blood alkaline phosphatase

Management of overdosage:

• Monitor patients who receive an overdose and initiate supportive measures if required.

Can this medicine be used in pregnancy?

• Based on findings in animals, Elitek may cause fetal harm when administered to pregnant women.
• The limited available data with Elitek use in pregnant women are insufficient to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal fetal outcomes.
• Consider the benefits and risks of Elitek and possible risks to the fetus when prescribing Elitek to a pregnant woman.

Can this medicine be used in children?

• The safety and effectiveness of Elitek have been established in pediatric patients ages 1 month to 17 years for initial management of plasma uric acid levels in 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.

What are the active and inactive ingredients in this medicine?

Active ingredient

• RASBURICASE

Inactive ingredients:

• MANNITOL
• ALANINE
• SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM

DILUENT: Inactive ingredients:

• WATER
• POLOXAMER 188

Who manufactures and distributes this medicine?

Manufactured by:

• sanofi-aventis U.S. LLC
• Bridgewater, NJ

What should I know about storage and disposal of this medication?

• The lyophilized drug product and the diluent for reconstitution should be stored at 2°C-8°C (36°F-46°F).
• Do not freeze.
• Protect from light.

• Dailymed label info on Rasburicase
• FDA Rasburicase

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