Home About

Truxima

RITUXIMAB-ABBS

Manufacturer: Cephalon, Inc.

Score: 144.0

Quick Summary

Truxima (rituximab-abbs) is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. It is used for the treatment of adult patients with non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). The most common adverse reactions were infusion-related reactions, fever, lymphopenia, chills, infection, and asthenia. Important safety information includes fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B virus reactivation, and progressive multifocal leukoencephalopathy (PML).

Key Clinical Findings and Indications

  • Non-Hodgkin's lymphoma (NHL)
  • Chronic lymphocytic leukemia (CLL)
  • Rheumatoid arthritis (RA)
  • Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)

Important Safety Information

Warning

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

Contraindications

  • None

Adverse Reactions

  • Infusion-related reactions
  • Fever
  • Lymphopenia
  • Chills
  • Infection
  • Asthenia

Dosing Recommendations

General Guidance

No dose adjustment is necessary for patients with renal or hepatic impairment

NHL

Adult Dose

375 mg/m2 as an intravenous infusion

Pediatric Dose

Not established

CLL

Adult Dose

375 mg/m2 in the first cycle and 500 mg/m2 in cycles 2-6

Pediatric Dose

Not established

RA

Adult Dose

Two 1000 mg intravenous infusions separated by 2 weeks

Pediatric Dose

Not established

GPA and MPA

Adult Dose

375 mg/m2 once weekly for 4 weeks

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

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

Nursing Mothers

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

Pediatric Use

  • The safety and effectiveness of rituximab products have not been established in pediatric patients with NHL, CLL, or RA

Geriatric Use

  • No overall differences in effectiveness were observed between older and younger patients