What are the contraindications for rituximab (Rituxan), a monoclonal antibody targeting CD19?

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Last updated: August 19, 2025View editorial policy

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Contraindications for Rituximab (Rituxan)

Rituximab has no absolute contraindications according to the FDA label, but several important relative contraindications and precautions must be considered before administration. 1

Primary Contraindications and Precautions

Infection-Related Precautions

  • Active infections: Withhold rituximab in patients with active, severe infections until the infection is controlled 1
  • Hepatitis B: Screen for hepatitis B before initiating therapy, as reactivation of occult hepatitis B infection has been reported 2
  • Progressive multifocal leukoencephalopathy (PML): Rare but serious complication that requires immediate discontinuation

Cardiac Precautions

  • Pre-existing cardiac conditions: Higher risk for severe infusion reactions in patients with cardiac disease 2
  • History of cardiopulmonary adverse reactions: Increased risk for severe infusion-related reactions 2

Hematologic Considerations

  • High circulating malignant cell count: Increased risk for severe infusion reactions and tumor lysis syndrome 2
  • Severe cytopenias: Use with caution in patients with pre-existing cytopenias

Special Population Considerations

Pregnancy and Lactation

  • Pregnancy: Can cause fetal harm; advise females of reproductive potential about risks 1
  • Lactation: Not recommended during treatment and for at least 6 months after the last dose 1

Pediatric Patients

  • Higher risk of serum sickness in pediatric patients with ITP 2
  • Increased infusion reactions: Approximately 47% of children experience chills, fever, and respiratory symptoms with first dose 2

Monitoring and Management

Pre-Treatment Assessment

  • Complete blood count
  • Hepatitis B screening
  • Immunoglobulin levels (baseline)
  • CD19+ B cell counts (when appropriate)

During Treatment

  • Monitor for infusion-related reactions, particularly during first infusion 2
  • For mild to moderate reactions: temporarily slow or interrupt infusion
  • For severe reactions: discontinue infusion and provide supportive care 2

Post-Treatment Monitoring

  • Regular monitoring of B-cell counts and immunoglobulin levels in patients receiving repeated courses 2
  • Monitor for hypogammaglobulinemia, especially with prolonged or repeated treatment 2

Disease-Specific Considerations

ANCA-Associated Vasculitis

  • In patients with severe renal disease (serum creatinine >4.0 mg/dL) or on mechanical ventilation for alveolar hemorrhage, comparability with cyclophosphamide has not been proven 3
  • Consider plasma exchange for patients with serum creatinine >3.4 mg/dL, requiring dialysis, or with diffuse alveolar hemorrhage with hypoxemia 3

Hairy Cell Leukemia

  • Consider avoiding rituximab in patients scheduled for SARS-CoV-2 vaccination due to potential reduced vaccine efficacy 3
  • The immunosuppressive effects of rituximab may outweigh benefits in certain clinical scenarios during infectious disease outbreaks 3

Risk Factors for Complications

Infection Risk

  • Combined use with other immunosuppressants (particularly antithymocyte globulin) 4
  • Higher number of rituximab courses 4
  • Higher pre-treatment CD19 and CD20 levels 4
  • Concomitant high-dose glucocorticoid therapy 5

Remember that while rituximab has no absolute contraindications per the FDA label, careful assessment of risk factors and appropriate monitoring are essential to minimize adverse events and optimize treatment outcomes.

References

Guideline

Rituximab Treatment Guidelines

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Rituximab Therapy and Infection Risk in Pediatric Renal Transplant Patients.

Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation, 2016

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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