ELITEK
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ELITEK (ELITEK).
Recombinant urate oxidase that catalyzes the oxidation of uric acid to allantoin, a more soluble and readily excreted metabolite, thereby reducing serum uric acid levels.
| Metabolism | Metabolized via peptide hydrolysis and possibly opsonization (not CYP450 mediated). |
| Excretion | Rasburicase is primarily eliminated via hepatic metabolism (proteolysis) and subsequent biliary excretion of inactive metabolites. Renal excretion of unchanged drug is minimal (<5%). |
| Half-life | The terminal elimination half-life is approximately 18 hours (range 12-24 hours) in adults and children. This supports once-daily dosing without accumulation. |
| Protein binding | Rasburicase is not significantly protein-bound; protein binding is less than 5%. |
| Volume of Distribution | The volume of distribution is approximately 0.12-0.14 L/kg, indicating distribution primarily within the intravascular space (plasma volume). |
| Bioavailability | Rasburicase is only administered intravenously; bioavailability is 100% by the IV route. |
| Onset of Action | Following intravenous infusion, reduction in plasma uric acid levels is observed within 4 hours, with maximal effect typically achieved by 24 hours. |
| Duration of Action | The uric acid-lowering effect persists for approximately 24 hours after a single dose, supporting daily dosing for up to 5 days. Uric acid levels begin to return to baseline within 24-48 hours after the last dose. |
0.2 mg/kg intravenously over 30 minutes once daily for up to 5 days.
| Dosage form | VIAL |
| Renal impairment | No dose adjustment required for any degree of renal impairment. |
| Liver impairment | No dose adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B). Insufficient data for severe hepatic impairment (Child-Pugh C). |
| Pediatric use | 0.2 mg/kg intravenously over 30 minutes once daily, based on actual body weight, for up to 5 days. |
| Geriatric use | No specific dose adjustment recommended; use same dosing as for adults. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ELITEK (ELITEK).
| Breastfeeding | Unknown if excreted in human milk. Caution advised; M/P ratio not available. |
| Teratogenic Risk | Insufficient human data; animal studies show no evidence of fetal harm at clinically relevant doses. Risk cannot be excluded; use only if clearly needed during pregnancy. |
| Fetal Monitoring | Monitor serum uric acid levels, renal function, and for hypersensitivity reactions (including anaphylaxis). Fetal monitoring per standard obstetric care. |
■ FDA Black Box Warning
Anaphylaxis: ELITEK can cause severe allergic reactions including anaphylaxis. Immediate discontinuation and permanent discontinuation are required if such reactions occur.
| Serious Effects |
["Known hypersensitivity to rasburicase or any component of the formulation","Glucose-6-phosphate dehydrogenase (G6PD) deficiency"]
| Precautions | ["Hypersensitivity reactions: severe allergic reactions including anaphylaxis, angioedema, bronchospasm, and urticaria","Hemolysis: contraindicated in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency due to risk of hemolytic anemia","Methemoglobinemia: may cause methemoglobinemia; monitor methemoglobin levels in at-risk patients","Interference with uric acid measurements: rasburicase degrades uric acid in blood samples; collect samples in pre-chilled tubes containing a stabilizing agent","Immunogenicity: development of antibodies may affect efficacy or safety"] |
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| Fertility Effects | No specific studies on fertility effects in humans; animal studies indicate no adverse effects on fertility or reproductive performance. |