Table 4

Food and Drug Administration black box warnings for lymphoma immunotherapies

TherapyWarning due to
Alemtuzumab
  • Autoimmune conditions (immune thrombocytopenia, anti-glomerular basement membrane disease)

  • Severe infusion reactions

  • Anaphylaxis

  • Cancer (thyroid, melanoma, lymphoproliferative disorders)

  • Infections

Axicabtagene ciloleucel
  • CRS

  • ICANS

  • Do not administer to patients with active infection or inflammatory disorders

Brexucabtagene autoleucel
  • CRS

  • ICANS

  • Do not administer to patients with active infection or inflammatory disorders

Brentuximab vedotin
  • PML

Ibritumomab tiuxetan
  • Severe infusion reactions

  • Severe cytopenia

  • Severe cutaneous/mucocutaneous reactions

  • Do not administer if patient exhibits altered biodistribution

Lenalidomide
  • Embryo-fetal toxicity (pregnancy must be excluded prior to treatment)

  • Significant neutropenia, thrombocytopenia

Obinutuzumab
  • Hepatitis B virus reactivation

  • PML

Rituximab (and biosimilars)
  • Severe infusion reactions

  • TLS

  • Severe mucocutaneous reactions

  • PML

  • Hepatitis B virus reactivation

Tisagenlecleucel
  • CRS

  • ICANS

  • Do not administer to patients with active infection or inflammatory disorders

  • CNS, central nervous system; CRS, cytokine release syndrome; PML, progressive multifocal leukoencephalopathy; TLS, tumor lysis syndrome.