Rasburicase: uses, dosing, side effects & brands
Rasburicase is a medicine sold in the U.S. under one brand, for tumor lysis syndrome and hyperuricemia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Tumor Lysis Syndrome and Hyperuricemia
- Available as
- Kit
- Sold as
- Elitek
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How rasburicase is dosed
From the FDA label for Elitek (application BLA103946). Other rasburicase products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administer at 0.2 mg/kg as an intravenous infusion over 30 minutes daily for up to 5 days. ( 2.1 ) Do not administer as an intravenous bolus. ( 2.3 ) 2.1 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. 2.2 Reconstitution Procedure 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. 2.3 Further Dilution and Administration 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.…
Rasburicase side effects
The following clinically significant adverse reactions are discussed in greater detail in other sections of the prescribing information: Anaphylaxis [see Boxed Warning , Contraindications (4) , Warnings and Precautions (5.1) ] Hemolysis [see Boxed Warning , Contraindications (4) , Warnings and Precautions (5.2) ] Methemoglobinemia [see Boxed Warning , Contraindications (4) , Warnings and Precautions (5.3) ] Most common adverse reactions (incidence ≥20%), 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data below reflect exposure to Elitek in 265 pediatric and 82 adult patients enrolled in one active-controlled trial (Study 1), two uncontrolled trials (Studies 2 and 3), and an uncontrolled safety trial (n=82). Additional data were obtained from an expanded…
Who shouldn’t take rasburicase
Elitek is contraindicated in patients with a history of anaphylaxis or severe hypersensitivity to rasburicase or in patients with development of hemolytic reactions or methemoglobinemia with rasburicase [see Boxed Warning , Warnings and Precautions (5.1 , 5.2 , 5.3) ] . Elitek is contraindicated in individuals deficient in glucose-6-phosphate dehydrogenase (G6PD) [see Boxed Warning , Warnings and Precautions (5.2) ] . History of the following reactions to rasburicase: anaphylaxis, severe hypersensitivity, hemolysis, methemoglobinemia. ( 4 ) Glucose-6-phosphate dehydrogenase (G6PD) deficiency. ( 4 )
Rasburicase drug interactions
Laboratory Test Interference 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. The following special sample handling procedure must be followed to avoid ex vivo uric acid degradation. Uric acid must be analyzed in plasma. Blood must be collected into prechilled tubes containing heparin anticoagulant. Immediately immerse plasma samples for uric acid measurement in an ice water bath. Plasma samples must be prepared by centrifugation in a precooled centrifuge (4°C). Finally, the plasma must be maintained in an ice water bath and analyzed for uric acid within four hours of collection [see Boxed Warning ] . Rasburicase does not metabolize allopurinol, cytarabine, methylprednisolone, methotrexate, 6-mercaptopurine, thioguanine, etoposide, daunorubicin, cyclophosphamide or vincristine in vitro. No metabolic-based drug interactions are therefore anticipated with these agents in patients.
Every rasburicase product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Elitek.
Rasburicase and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for rasburicase: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of rasburicase during breastfeeding. Because it is a large protein molecule with a molecular weight of about 34,000 Da, the amount in milk is likely to be very low and absorption is unlikely because it is probably partly destroyed in the infant's gastrointestinal tract. However, the manufacturer recommends that breastfeeding be discontinued during rasburicase therapy and for 2 weeks after the final dose. An alternate drug can be considered.
National Institute of Child Health and Human Development, record revised November 15, 2023. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about rasburicase
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2,067 reports naming rasburicase, and the FDA flagged 98% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- tumour lysis syndrome327 reports
- febrile neutropenia179 reports
- pyrexia141 reports
- acute kidney injury138 reports
- neutropenia124 reports
- cytokine release syndrome113 reports
- sepsis105 reports
- hypotension88 reports
Read these as a signal, not a rate. A report does not mean rasburicase caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
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Frequently asked questions
What is rasburicase?
Elitek (Rasburicase) is a medication used to treat Tumor Lysis Syndrome, Hyperuricemia.
Can you take rasburicase with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run rasburicase against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does rasburicase come in?
Across the brands we track, rasburicase is currently marketed as kit, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic rasburicase?
We do not currently list a generic-labelled rasburicase product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Rasburicase: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/rasburicase
- MLA
- “Rasburicase: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/rasburicase.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for rasburicase on DailyMed (NIH) ↗ — including its boxed warning in full.