Rasburicase

Trade Names:
Elitek
- Powder for injection, lyophilized 1.5 mg/vial

Pharmacology

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Catalyzes enzymatic oxidation of uric acid into an inactive and soluble metabolite (allantoin).

Pharmacokinetics

Distribution

Vd is 110 to 127 mL/kg (pediatrics).

Elimination

t _½ is about 18 h.

Indications and Usage

Initial management of plasma uric acid levels in pediatric 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.

Contraindications

Individuals with G-6-PD deficiency; known history of anaphylaxis or hypersensitivity; hemolytic or methemoglobinemia reactions to product or any of its excipients.

Dosage and Administration

IV 0.15 or 0.2 mg/kg, infused over 30 min, as a single dose for 5 days.

General Advice

• For IV infusion only. Not for intradermal, subcutaneous, IM, or IV bolus administration.
• Follow manufacturer's instructions for reconstituting the Powder for Injection and subsequent further dilution.
• Do not administer if particulate matter, cloudiness, or discoloration are noted.
• Do not use an in-line IV filter.

Storage/Stability

Store vials in refrigerator (36° to 46°F). Do not freeze. Protect from light. Store reconstituted solution in refrigerator for up to 24 h. Discard unused product after 24 h.

Drug Interactions

None well documented.

Incompatibility

Reconstitute with diluent provided and infuse through a different line than that used for the infusion of other concomitant medications. If separated line is not possible, flush line with at least 15 mL of saline solution prior to and after infusion.

Laboratory Test Interactions

At room temperature, causes enzymatic degradation of uric acid in blood/plasma/serum samples, potentially resulting in spuriously low plasma uric acid assay readings.

Adverse Reactions

Cardiovascular

Arrhythmia; cardiac failure; cardiac arrest; cerebrovascular disorder; MI.

CNS

Convulsions; headache.

Dermatologic

Rash.

EENT

Retinal hemorrhage.

GI

Diarrhea; ileus; intestinal obstruction; vomiting; nausea; abdominal pain; constipation.

Genitourinary

Acute renal failure.

Hematologic

Hemolysis; methemoglobinemia; neutropenia with and without fever; hemorrhage; pancytopenia; thrombosis.

Metabolic

Dehydration.

Respiratory

Respiratory distress; pneumonia; pulmonary edema; pulmonary hypertension.

Miscellaneous

Allergic reactions including anaphylaxis; sepsis; mucositis; cellulitis; chest pain; cyanosis; hot flashes; infection; paresthesia; rigors; thrombophlebitis; fever.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy was studied in pediatric patients ranging from 1 mo to 17 yr of age. Children younger than 2 yr of age had higher mean uric acid AUC than those 2 to 17 yr. In addition, children younger than 2 yr of age had a lower rate of success at achieving maintenance uric acid levels by 48 h. Children younger than 2 yr of age experienced more toxicity (eg, vomiting, diarrhea, fever, rash).

Anaphylaxis

Hypersensitivity reactions, including anaphylaxis may occur.

Hemolysis

Can cause severe hemolysis in patients with G-6-PD deficiency. Prior to use, screen patients at high risk of G-6-PD deficiency (eg, patients of African or Mediterranean ancestry).

Methemoglobinemia

May occur.

Overdosage

Symptoms

Low or undetectable plasma uric acid levels.

Patient Information

• Advise patient, family, or caregiver that medication will be prepared and administered by a health care professional in a medical facility.
• Advise patient or caregiver to report the following: dark urine, yellowing of skin or eyes, dizziness, nausea, headache, difficulty breathing, intolerable injection site reactions, any unusual symptoms to health care provider.

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