Abbreviated Rasburicase Dosing for the Prevention and Treatment of Hyperuricemia in Adults at Risk for Tumor Lysis Syndrome

Ho, Viet Q.; Wetzstein, Gene A.; Patterson, Stephen G.; Bradbury, R

doi:10.3816/sct.2006.n.016

Cited by 12 publications

(16 citation statements)

References 16 publications

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“…Rasburicase has proved effective in managing TLS [103][104][105], which usually occurs 48-72 h after initiation of cancer therapy when large numbers of tumor cells undergo apoptosis in a short time, releasing their intracellular contents into the circulation. This causes an ionic imbalance involving hyperkalemia and hyperphosphatemia, secondary hypercalcemia and hyperuricemia, and possibly acute kidney injury and death [106,107].…”

Section: Rasburicasementioning

confidence: 99%

Enzymes Approved for Human Therapy: Indications, Mechanisms and Adverse Effects

Baldo¹

2015

BioDrugs

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Research and drug developments fostered under orphan drug product development programs have greatly assisted the introduction of efficient and safe enzyme-based therapies for a range of rare disorders. The introduction and regulatory approval of 20 different recombinant enzymes has enabled, often for the first time, effective enzyme-replacement therapy for some lysosomal storage disorders, including Gaucher (imiglucerase, taliglucerase, and velaglucerase), Fabry (agalsidase alfa and beta), and Pompe (alglucosidase alfa) diseases and mucopolysaccharidoses I (laronidase), II (idursulfase), IVA (elosulfase), and VI (galsulfase). Approved recombinant enzymes are also now used as therapy for myocardial infarction (alteplase, reteplase, and tenecteplase), cystic fibrosis (dornase alfa), chronic gout (pegloticase), tumor lysis syndrome (rasburicase), leukemia (L-asparaginase), some collagen-based disorders such as Dupuytren's contracture (collagenase), severe combined immunodeficiency disease (pegademase bovine), detoxification of methotrexate (glucarpidase), and vitreomacular adhesion (ocriplasmin). The development of these efficacious and safe enzyme-based therapies has occurred hand in hand with some remarkable advances in the preparation of the often specifically designed recombinant enzymes; the manufacturing expertise necessary for commercial production; our understanding of underlying mechanisms operative in the different diseases; and the mechanisms of action of the relevant recombinant enzymes. Together with information on these mechanisms, safety findings recorded so far on the various adverse events and problems of immunogenicity of the recombinant enzymes used for therapy are presented.

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Section: Rasburicasementioning

confidence: 99%

Enzymes Approved for Human Therapy: Indications, Mechanisms and Adverse Effects

Baldo¹

2015

BioDrugs

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“…The FDA‐approved dose of rasburicase is 0·15–0·2 mg/kg intravenously (IV) daily for 5 days. However, multiple reports (149–164) suggest that lower doses, whether fixed or weight based, and shorter courses of therapy, even single doses, may be effective (Table 8).…”

Section: Rasburicasementioning

confidence: 99%

A review of tumour lysis syndrome with targeted therapies and the role of rasburicase

Bose

Qubaiah

2011

Journal of Clinical Pharmacy and Therapeutics

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Summary What is known and Objective: Tumour lysis syndrome (TLS) is an oncologic emergency with potentially devastating consequences classically associated with cytotoxic chemotherapy. In recent years, molecularly targeted drugs have assumed an increasingly important role in cancer therapeutics. The possibility of TLS is often overlooked in this setting. Rasburicase, a recombinant urate oxidase, is remarkably effective in treating hyperuricemia, thought to be central to the pathogenesis of renal injury in TLS. Our objective is to review the literature on TLS especially as it pertains to targeted therapies and summarize current knowledge and provide future directions regarding the role of rasburicase in the management of TLS. Methods: A MEDLINE search was conducted using PubMed and the keyphrase ‘tumor lysis syndrome’ to identify articles describing TLS with a broad range of novel anti‐cancer agents. Meeting abstracts were also reviewed. Additionally, the biomedical literature was searched using the keyword ‘rasburicase’. Results and Discussion: Tumour lysis syndrome has been described with nearly every class of ‘targeted therapy’. This is not surprising as any drug causing death of cancer cells by any mechanism may lead to TLS in the appropriate setting. Although there is a wealth of evidence suggesting that rasburicase is extremely effective in correcting hyperuricemia, prospective trials showing that it improves hard outcomes such as acute renal failure, need for dialysis and mortality are lacking. Furthermore, much lower doses and durations of therapy than approved appear to be effective in controlling hyperuricemia, potentially leading to enormous cost savings. What is new and Conclusion: Any effective cancer therapy can lead to TLS. Physicians should consider the risk of TLS on a case‐by‐case basis and determine appropriate prophylaxis. The role of rasburicase continues to evolve. Randomized controlled trials evaluating clinically relevant outcomes are needed.

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“…In a study of 11 adult patients with hematologic malignancies, McDonnell et al reported that 6 mg of rasburicase was effective in lowering uric acid concentrations in 10 of 11 patients 25. However, in one morbidly obese patient who weighed 259 kg, the uric acid concentration decreased only from 17.4 mg/dL (1030 μmol/L) to 15.4 mg/dL (911 μmol/L) after the first dose, and a second dose of 12 mg (0.05 mg/kg) was necessary to reduce the uric acid concentration to 1.4 mg/dL (83 μmol/L) 25. Similarly, Hutcherson et al reported that 1 of 11 patients who received a single dose of rasburicase 6 mg experienced inadequate uric acid reduction and required a second 6 mg dose 26.…”

Section: Treatmentmentioning

confidence: 99%

“…At least some of the off-label treatment approaches using reduced doses or less frequent than recommended administration of rasburicase appeared to be motivated in part by the desire to minimize the substantial costs associated with rasburicase therapy 25–29. Based on its current average sales price, a single 6 mg dose of rasburicase would cost about US$1990,29 which is much less than the approximately US$21,000 cost of the FDA-approved regimen (5 days at 0.15 mg/kg, based on an average total body weight of 85 kg).…”

Section: Treatmentmentioning

confidence: 99%

Emerging role of rasburicase in the management of increased plasma uric acid levels in patients with hematologic malignancies

Kennedy¹,

Koontz²,

Rao³

2011

JBM

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Tumor lysis syndrome (TLS) is defined as a group of metabolic derangements that result from the massive and abrupt release of cellular components into the bloodstream after rapid lysis of tumor cells. Breakdown of released materials leads to a number of electrolyte abnormalities, including elevated uric acid concentrations in the blood (hyperuricemia), which carries potentially serious consequences. The diagnosis, prevention, and management of TLS is complicated by variability in definitions, differences in risk factors based on patient- and tumor-specific characteristics, and practitioner preferences in terms of pharmaceutical management strategies. The best prevention and management option for a particular patient depends on the patient’s baseline risk for TLS development, the severity of symptoms in the event of TLS development, practical management considerations, and financial implications of treatment.

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Abbreviated Rasburicase Dosing for the Prevention and Treatment of Hyperuricemia in Adults at Risk for Tumor Lysis Syndrome

Cited by 12 publications

References 16 publications

Enzymes Approved for Human Therapy: Indications, Mechanisms and Adverse Effects

Enzymes Approved for Human Therapy: Indications, Mechanisms and Adverse Effects

A review of tumour lysis syndrome with targeted therapies and the role of rasburicase

Emerging role of rasburicase in the management of increased plasma uric acid levels in patients with hematologic malignancies

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