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Rituxan

RITUXIMAB

Manufacturer: Genentech, Inc.

Score: 144.0

Quick Summary

Rituxan (RITUXIMAB) is a monoclonal antibody used to treat various conditions, including non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris. It works by targeting the CD20 antigen on B cells, leading to their depletion. The drug has shown efficacy in several clinical trials, but it also carries important safety information, including warnings about fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B virus reactivation, and progressive multifocal leukoencephalopathy. Dosing recommendations vary by condition, and special population considerations include use during pregnancy, nursing, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Non-Hodgkin's lymphoma
  • Chronic lymphocytic leukemia
  • Rheumatoid arthritis
  • Granulomatosis with polyangiitis
  • Microscopic polyangiitis
  • Pemphigus vulgaris

Important Safety Information

Warning

Fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B virus reactivation, and progressive multifocal leukoencephalopathy

Contraindications

  • None

Adverse Reactions

  • Infusion-related reactions
  • Severe mucocutaneous reactions
  • Hepatitis B virus reactivation
  • Progressive multifocal leukoencephalopathy

Dosing Recommendations

General Guidance

Dose adjustments may be necessary based on individual patient response and tolerability

Non-Hodgkin's lymphoma

Adult Dose

375 mg/m^2 as an intravenous infusion

Pediatric Dose

375 mg/m^2 as an intravenous infusion for pediatric patients aged 6 months and older

Chronic lymphocytic leukemia

Adult Dose

375 mg/m^2 on the day prior to the initiation of FC chemotherapy, then 500 mg/m^2 on Day 1 of cycles 2-6

Pediatric Dose

Not established

Rheumatoid arthritis

Adult Dose

Two 1000 mg intravenous infusions separated by 2 weeks

Pediatric Dose

Not established

Granulomatosis with polyangiitis and microscopic polyangiitis

Adult Dose

375 mg/m^2 once weekly for 4 weeks

Pediatric Dose

375 mg/m^2 once weekly for 4 weeks for pediatric patients aged 2 years and older

Pemphigus vulgaris

Adult Dose

Two 1000 mg intravenous infusions separated by 2 weeks

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Rituxan can cause adverse developmental outcomes, including B-cell lymphocytopenia in infants exposed to Rituxan in-utero

Nursing Mothers

  • It is not known whether Rituxan is excreted in human milk

Pediatric Use

  • Rituxan is indicated for the treatment of pediatric patients aged 6 months and older with mature B-cell non-Hodgkin's lymphoma
  • Rituxan is not indicated in pediatric patients less than 2 years of age with granulomatosis with polyangiitis or microscopic polyangiitis

Geriatric Use

  • No overall differences in efficacy were observed between patients 65 years old and over and younger patients
  • The overall incidence and rate of all serious adverse events was higher in patients 65 years old and over