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Updated: Jul 14, 2025

Development of an IFN-γ ELISpot Assay to Assess Varicella-Zoster Virus-specific Cell-mediated Immunity Following Umbilical Cord Blood Transplantation
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Varicella zoster virus reactivation reported with isatuximab use

Michelle Nadeau Nguyen1, Graça M Dores1, Afrouz Nayernama1

  • 1Division of Pharmacovigilance, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

Journal of Chemotherapy (Florence, Italy)
|October 6, 2023
PubMed

Insights

Isatuximab treatment may increase the risk of varicella zoster virus (VZV) reactivation in multiple myeloma patients. Postmarketing data led to updated prescribing information recommending antiviral prophylaxis.

Area of Science:

  • Pharmacovigilance
  • Oncology
  • Immunology

Background:

  • Isatuximab is a CD38-directed antibody used for multiple myeloma.
  • Multiple myeloma treatments can increase the risk of opportunistic infections.
  • Varicella zoster virus (VZV) reactivation is a known risk in immunocompromised patients.

Purpose of the Study:

  • To investigate the potential association between isatuximab and VZV reactivation.
  • To evaluate safety signals from postmarketing surveillance of isatuximab.

Main Methods:

  • Review of postmarketing case reports from FAERS, PubMed, and Embase.
  • Inclusion of cases meeting specific case definition and causality criteria.
  • Analysis of patient demographics, treatment, and risk factors.

Main Results:

  • Fifteen cases met the criteria for VZV reactivation associated with isatuximab.
  • Patients received isatuximab for hematologic neoplasms, including multiple myeloma.
  • Concomitant use of proteasome inhibitors and/or immunomodulatory drugs was common.

Conclusions:

  • Postmarketing analysis identified a potential risk of VZV reactivation with isatuximab.
  • U.S. Prescribing Information for isatuximab was updated with this safety information.
  • Antiviral prophylaxis is recommended for patients receiving isatuximab.
Keywords:
CD38-directed therapiesIsatuximabmultiple myelomavaricella zoster virus reactivation

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