rasburicase

REMS

Initial management of increased uric acid levels in patients with leukemia, lymphoma, or other malignancies who are being treated with antineoplastics, which are expected to produce hyperuricemia.

Action ⬆ ⬇

An enzyme that promotes the conversion of uric acid to allantoin, an inactive, water-soluble compound.
Produced by recombinant DNA technology.

Therapeutic effects:

Decreased sequelae of hyperuricemia (nephropathy, arthropathy).

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Well distributed to tissues.

Metabolism/Excretion: Unknown.

Half-Life: 18 hr.

Time/Action Profile ⬆ ⬇

(↓ in uric acid)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	unknown	4–24 hr

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Glucose-6–phosphate dehydrogenase (G6PD) deficiency (↑ risk of severe hemolysis);
Previous allergic reaction, hemolysis, or methemoglobinemia from rasburicase;
OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

None reported.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: rash

GI: abdominal pain, constipation, diarrhea, mucositis, nausea, vomiting

Hemat: HEMOLYSIS, METHEMOGLOBINEMIA, neutropenia

Neuro: headache

Resp: respiratory distress

Misc: fever, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), sepsis

Interactions ⬆ ⬇

Drug-drug:

None reported.

Route/Dosage ⬆ ⬇

IV (Adults and Children ): 0.2 mg/kg daily as a single dose for 5 days.

Availability ⬆ ⬇

Lyophilized powder for injection: 1.5 mg/vial; 7.5 mg/vial

Assessment ⬆ ⬇

Monitor patients for signs of allergic reactions and anaphylaxis (chest pain, dyspnea, hypotension, urticaria). If these signs occur, rasburicase should be immediately and permanently discontinued.

Lab Test Considerations:

Monitor patients for hemolysis. Screen patients at higher risk for G6PD deficiency (patients of African American or Mediterranean ancestry) prior to therapy. If hemolysis occurs, discontinue and do not restart rasburicase.
- Monitor patients for methemoglobinemia. Discontinue rasburicase and do not restart in patients who develop methemoglobinemia.
- May cause spuriously low uric acid levels in blood samples left at room temperature. Collect blood for uric acid levels in pre-chilled tubes containing heparin and immediately immerse and maintain in an ice water bath. Uric acid must be analyzed in plasma. Plasma samples must be assayed within 4 hr of collection.

Implementation ⬆ ⬇

Chemotherapy is initiated 4–24 hr after 1st dose of rasburicase.

IV Administration:

Intermittent Infusion: Determine number of vials of rasburicase needed based on patient's weight and dose/kg. Reconstitution: Reconstitute in diluent provided. Add 1 mL of diluent provided to each vial and mix by swirling very gently. Do not shake or vortex. Reconstitute 7.5 mg vial with 5 mL of diluent. Solution should be clear and colorless. Do not use solutions that are discolored or contain particulate matter. Diluent: Remove dose from reconstituted vials and inject into infusion bag of 0.9% NaCl for a final total volume of 50 mL. Administer within 24 hr of reconstitution. Store reconstituted or diluted solution in refrigerator for up to 24 hr.
Rate: Administer over 30 min. Do not administer as a bolus.
Y-Site Incompatibility: Infuse through a separate line. Do not use a filter with infusion. If separate line is not possible, flush line with at least 15 mL of 0.9% NaCl prior to rasburicase infusion.

Patient/Family Teaching ⬆ ⬇

Inform patient and family of purpose of rasburicase infusion.
Rep: May cause fetal harm. Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during and for 2 wk after last dose.

Evaluation/Desired Outcomes ⬆ ⬇

Decrease in plasma uric acid levels in pediatric patients receiving antineoplastics expected to result in tumor lysis and subsequent elevation of plasma uric acid levels. More than 1 course of therapy or administration beyond 5 days is not recommended.

US Brand Names ⬆ ⬇

Canadian Brand Names ⬆ ⬇

Code ⬆

NDC Code

0024- Sanofi-Aventis U.S. LLC
- 0024-5150- Elitek
  - 0024-5150-10- 3 KIT in 1 CARTON (0024-5150-10) > 1 KIT in 1 KIT * 1 mL in 1 AMPULE * 1 mL in 1 VIAL, SINGLE-USE

0024- Sanofi-Aventis U.S. LLC
- 0024-5151- Elitek
  - 0024-5151-75- 1 KIT in 1 CARTON (0024-5151-75) * 5 mL in 1 AMPULE * 5 mL in 1 VIAL, SINGLE-USE

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇