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Defibrotide formulations contain (1→3)-β-D-glucan that could influence clinical diagnostic testing

Bone Marrow Transplantation volume 55, pages 2045–2046 (2020)Cite this article

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Clinicians at our institution noted positive (1→3)-β-D-glucan (BG) results after defibrotide [1] administration in the absence of confirmed IFD. Given prior reports of medications that can cause false-positive BG results, we investigated whether defibrotide may be associated with elevated BG measurements.

We tested three different commercially-available defibrotide lots at four different concentrations: after vial reconstitution (80 mg/mL), a reconstituted concentration prepared to institutional standard (4 mg/mL), an intermediate concentration (0.38 mg/mL), and an estimated Cmax concentration (0.038 mg/mL) based on published literature [2]. Once prepared, the samples were labeled, placed in BG-free vials and frozen to −80 °C. All samples were sent to the Associates of Cape Cod (Falmouth, MA) for BG testing with the Fungitell® assay.

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References

  1. Jazz Pharmaceuticals. Defitelio (defibrotide sodium) Prescribing Information. 2016. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208114lbl.pdf.

  2. Tocchetti P, Tudone E, Marier J-F, Marbury T, Zomorodi K, Eller M. Pharmacokinetic profile of defibrotide in patients with renal impairment. Drug Des Dev Ther. 2016;ume 10:2631–41.

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  3. Richardson PG, Elias AD, Krishnan A, Wheeler C, Nath R, Hoppensteadt D, et al. Treatment of severe veno-occlusive disease with def ibrotide: compassionate use results in response without significant toxicity in a high-risk population. Blood. 1998;92:737–44.

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Acknowledgements

Defibrotide was donated by Brigham and Women’s Department of Pharmacy. Laboratory analysis was performed without charge by the Associates of Cape Cod (Falmouth, MA).

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Authors and Affiliations

  1. Anti-Infective Research Lab, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, MI, USA

    Sara Alosaimy

  2. Department of Pharmacy, Brigham and Women’s Hospital, Boston, MA, USA

    Mary Nauffal, David W. Kubiak & Anne M. McDonnell

  3. Department of Medical Oncology, Division of Hematologic Malignancies, Dana Farber Cancer Institute, Boston, MA, USA

    Robert Soiffer

  4. Department of Medical Oncology, Dana Farber Cancer Institute, Boston, MA, USA

    Brett Glotzbecker

  5. Jerome Lipper Multiple Myeloma Center, Boston, MA, USA

    Paul Richardson

  6. Department of Medical Oncology, Hematologic Malignancies, Dana Farber Cancer Institute, Boston, MA, USA

    Paul Richardson

  7. Division of Infectious Diseases, Medicine Brigham and Women’s Hospital, Boston, MA, USA

    Francisco M. Marty & Sophia Koo

Authors
  1. Sara Alosaimy
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  2. Mary Nauffal
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  3. Robert Soiffer
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  4. Brett Glotzbecker
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  5. David W. Kubiak
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  6. Paul Richardson
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  7. Francisco M. Marty
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  8. Sophia Koo
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  9. Anne M. McDonnell
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Corresponding author

Correspondence to Anne M. McDonnell.

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Conflict of interest

DWK, MN, BG, RS, and SK have no competing financial interests. AMM has served on advisory boards for Spectrum Pharmaceuticals, Heron Therapeutics and Takeda Pharmaceuticals. FMM has received research grant support from Astellas, Cidara, F2G, and Merck. FMM has also received consulting honoraria from Basilea, Merck, Pfizer and United Medical. PR has served on an advisory committee and received research funding from Jazz Pharmaceuticals.

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Alosaimy, S., Nauffal, M., Soiffer, R. et al. Defibrotide formulations contain (1→3)-β-D-glucan that could influence clinical diagnostic testing. Bone Marrow Transplant 55, 2045–2046 (2020). https://doi.org/10.1038/s41409-020-0872-y

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