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Risk of Anaphylaxis with Repeated Courses of Rasburicase: A Research on Adverse Drug Events and Reports (RADAR) Project

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Abstract

Background

Rasburicase, a recombinant urate oxidase, is used to rapidly metabolize uric acid in patients with hyperuricaemia. Rasburicase is an immunogenic therapeutic protein, which has been shown to elicit antibody response in 64 % of healthy volunteers within 1–6 weeks after the initial course, with persistent antibodies for over 1 year. Drug labelling indicates that anaphylaxis rarely occurs (in <1 % of patients) after a single course of therapy with rasburicase, but there are no data available on the incidence of anaphylaxis in patients receiving a subsequent rasburicase course.

Objective

The objective of this study was to determine the incidence of anaphylaxis after multiple treatment courses of rasburicase.

Methods

A retrospective chart review was performed on 97 consecutively treated patients who received repeated courses of rasburicase for hyperuricaemia.

Results

None of the 97 patients who were reviewed experienced anaphylaxis during the first rasburicase course; however, six patients (6.2 %) experienced anaphylaxis during a subsequent rasburicase treatment course (p = 0.03).

Conclusion

Anaphylaxis after a second course of rasburicase appears to occur more frequently than described in the US Food and Drug Administration-approved package insert for initial treatment courses. Given the serious nature of anaphylactic events, caution is advised when administering repeated courses of rasburicase.

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References

  1. Howard SC, Jones DP, Pui CH. The tumor lysis syndrome. N Engl J Med. 2011;364(19):1844–54.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  2. Rasburicase [package insert]. Bridgewater: Sanofi-Aventis US LLC; 2009.

  3. Abu-Alfa AK, Younes A. Tumor lysis syndrome and acute kidney injury: evaluation, prevention, and management. Am J Kidney Dis. 2010;55(5 Suppl 3):S1–13.

    Article  PubMed  Google Scholar 

  4. Chester KA, Baker M, Mayer A. Overcoming the immunologic response to foreign enzymes in cancer therapy. Expert Rev Clin Immunol. 2005;1(4):549–59.

    Article  CAS  PubMed  Google Scholar 

  5. Schellekens H. Factors influencing the immunogenicity of therapeutic proteins. Nephrol Dial Transplant. 2005;20(Suppl 6):63–9.

    Google Scholar 

  6. Bennett CL, Nebeker JR, Yarnold PR, et al. Evaluation of serious adverse drug reactions: a proactive pharmacovigilance program (RADAR) vs safety activities conducted by the Food and Drug Administration and pharmaceutical manufacturers. Arch Intern Med. 2007;167(10):1041–9.

    Article  PubMed  Google Scholar 

  7. Bennett CL, Nebeker JR, Lyons EA, et al. The Research on Adverse Drug Events and Reports (RADAR) project. JAMA. 2005;293(17):2131–40.

    Article  CAS  PubMed  Google Scholar 

  8. Trifilio SM, Pi J, Zook J, et al. Effectiveness of a single 3-mg rasburicase dose for the management of hyperuricemia in patients with hematological malignancies. Bone Marrow Transplant. 2011;46(6):800–5.

    Article  CAS  PubMed  Google Scholar 

  9. Trifilio S, Gordon L, Singhal S, et al. Reduced-dose rasburicase (recombinant xanthine oxidase) in adult cancer patients with hyperuricemia. Bone Marrow Transplant. 2006;37(11):997–1001.

    Article  CAS  PubMed  Google Scholar 

  10. Cairo MS, Bishop M. Tumour lysis syndrome: new therapeutic strategies and classification. Br J Haematol. 2004;127(1):3–11.

    Article  PubMed  Google Scholar 

  11. Shimada M, Johnson RJ, May WS Jr, et al. A novel role for uric acid in acute kidney injury associated with tumour lysis syndrome. Nephrol Dial Transplant. 2009;24(10):2960–4.

    Article  CAS  PubMed  Google Scholar 

  12. Ejaz AA, Mu W, Kang DH, et al. Could uric acid have a role in acute renal failure? Clin J Am Soc Nephrol. 2007;2(1):16–21.

    Article  CAS  PubMed  Google Scholar 

  13. Dingermann T. Recombinant therapeutic proteins: production platforms and challenges. Biotechnol J. 2008;3(1):90–7.

    Article  CAS  PubMed  Google Scholar 

  14. Pui CH. Rasburicase: a potent uricolytic agent. Pharmacother. 2002;3(4):433–42.

    CAS  Google Scholar 

  15. Kessler M, Goldsmith D, Schellekens H. Immunogenicity of biopharmaceuticals. Nephrol Dial Transplant. 2006;21(Suppl5):v9–12.

    Article  CAS  PubMed  Google Scholar 

  16. Rasburicase [package insert]. New York: Sanfoi-Synthelabo Inc; 2002.

Download references

Acknowledgments

Steven M. Belknap and Dennis P. West are partially supported by the National Institute of Health [Grant numbers R01CA125077 and R01CA102713 to Dennis P. West]. Steven M. Trifilio served as a consultant with an honorarium at the Elitek Virtual Work Meeting 2014. Katherine C. Allen, Amanda H. Champlain, Jonathan A. Cotliar and Jayesh Mehta have no conflicts of interest to declare.

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Authors and Affiliations

  1. Pharmacy Department, Northwestern Memorial Hospital, Chicago, IL, USA

    Katherine C. Allen & Steven M. Trifilio

  2. Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

    Amanda H. Champlain, Jonathan A. Cotliar, Steven M. Belknap & Dennis P. West

  3. Department of Medicine and Division of Hematology–Oncology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

    Jayesh Mehta

  4. Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA

    Jonathan A. Cotliar, Dennis P. West & Jayesh Mehta

  5. 251 E. Huron LC-700, Chicago, IL, 60611, USA

    Katherine C. Allen

  6. 676 N. Saint Clair Street, Suite 1600, Chicago, IL, 60611, USA

    Amanda H. Champlain, Jonathan A. Cotliar, Dennis P. West & Jayesh Mehta

  7. 680 N. Lake Shore Drive, Suite 1400, Chicago, IL, 60611, USA

    Steven M. Belknap

  8. 250 E. Superior, Chicago, IL, 60611, USA

    Steven M. Trifilio

Authors
  1. Katherine C. Allen
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  2. Amanda H. Champlain
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  3. Jonathan A. Cotliar
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  4. Steven M. Belknap
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  5. Dennis P. West
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  6. Jayesh Mehta
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  7. Steven M. Trifilio
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Corresponding author

Correspondence to Dennis P. West.

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Allen, K.C., Champlain, A.H., Cotliar, J.A. et al. Risk of Anaphylaxis with Repeated Courses of Rasburicase: A Research on Adverse Drug Events and Reports (RADAR) Project. Drug Saf 38, 183–187 (2015). https://doi.org/10.1007/s40264-014-0255-7

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  • DOI: https://doi.org/10.1007/s40264-014-0255-7

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