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🏅 FDA Orphan Designation

Elitek

rasburicase

Manufacturer: Sanofi-Synthelabo Research

Indicated for:
REN-related autosomal dominant tubulointerstitial kidney diseaseOrphanLymphomaTrehalase deficiencyAcute erythroid leukemia
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Black Box Warning (Boxed Warning)

A Boxed Warning is the FDA's strongest safety warning — it indicates serious or life-threatening risks identified during clinical trials or post-market surveillance. It does not mean the medication is unsafe for all patients; your prescriber weighs these risks against the benefits for your specific situation. Source: FDA-approved prescribing information.

View full prescribing information on DailyMed (NLM) ↗

FDA-Approved Indications (4)

Initial management of plasma uric acid levels in pediatric patients with leukemia,lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and sub

initial management of plasma uric acid levels in pediatric and adult patients with lymphoma who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma ur

Population: pediatric and adult

initial management of plasma uric acid levels in pediatric and adult patients with solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevat

Population: pediatric and adult

initial management of plasma uric acid levels in pediatric and adult patients with leukemia who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma ur

Population: pediatric and adult

Indications & Usage

1 INDICATIONS AND USAGE Elitek is indicated for the initial management of plasma uric acid levels in pediatric and adult 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. Elitek is a recombinant urate-oxidase indicated for initial management of plasma uric acid levels in pediatric and adult 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. ( 1 ) Limitations of use: Elitek is indicated only for a single course of treatment. ( 1 ) Limitations of Use Elitek is indicated only for a single course of treatment [see Warnings and Precautions (5.1) ] .

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Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.