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(raz-BYOOR-ih-kays)
Elitek
Powder for injection, lyophilized: 1.5 mg/vial
Class: Antimetabolite

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

 Indications 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.

 Route/Dosage

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

 Interactions None well documented. INCOMPATIBILITIES: 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.

 Lab Test Interferences 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

CV: Arrhythmia; cardiac failure; cardiac arrest; cerebrovascular disorder; MI. CNS: Convulsions; headache. DERM: Rash. EENT: Retinal hemorrhage. GI: Diarrhea; ileus; intestinal obstruction; vomiting; nausea; abdominal pain; constipation. GU: Acute renal failure. HEMA: Hemolysis; methemoglobinemia; neutropenia with and without fever; hemorrhage; pancytopenia; thrombosis. META: Dehydration. RESP: Respiratory distress; pneumonia; pulmonary edema; pulmonary hypertension. OTHER: Allergic reactions including anaphylaxis; sepsis; mucositis; cellutitis; 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. Children under 2 yr had higher mean uric acid AUC than those 2 to 17 yr. In addition, children under 2 yr had a lower rate of success at achieving maintenance uric acid levels by 48 hr. Children under 2 yr 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.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

  • For IV infusion only. Not for intradermal, SC, 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.
  • Infuse diluted solution over 30 min 4 to 24 hr before chemotherapy is started.
  • Do not use an in-line IV filter.
  • Store vials in refrigerator (36° to 46°F). Do not freeze. Protect from light. Store reconstituted solution in refrigerator for up to 24 hr. Discard unused product after 24 hr.

 Assessment/Interventions

  • Obtain patient history, including drug history and any known allergies. Note history of G-6-PD deficiency, previous anaphylactic or hypersensitivity reactions, hemolytic reactions, or methemoglobinemia reactions to rasburicase.
  • Ensure that patient at high risk of G-6-PD deficiency (eg, African or Mediterranean ancestry) is screened for G-6-PD deficiency prior to starting therapy.
  • Monitor patient for signs and symptoms of hemolysis (eg, dark urine, jaundice) and methemoglobinemia (eg, dizziness, nausea, headache, dyspnea, confusion, seizures). Immediately discontinue infusion and inform health care provider if noted.
  • When collecting blood for uric acid measurements, carefully follow the procedure recommended by the manufacturer.
  • Monitor patient for signs and symptoms of anaphylactic or serious allergic reactions. Immediately discontinue infusion, notify health care provider and be prepared to treat appropriately.
  • Monitor patient for CNS, GI, and general body side effects. Report to health care provider if noted and significant.
OVERDOSAGE: SIGNS & SYMPTOMS
  Low or undetectable plasma uric acid levels

 Patient/Family Education

  • Explain name, dose, action, and potential side effects of drug.
  • 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.
  • Instruct women to inform health care provider if they are pregnant or breastfeeding.

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