Rituxan Rituximab
 

NHL Staging

Ann Arbor staging1,2

The Ann Arbor staging system describes the extent in patients with NHL. It is based primarily on the distribution lymphatic involvement with respect to the diaphragm presence of extralymphatic organ involvement.

International Prognostic Index (IPI) for aggressive NHL3

The IPI is a prognostic indicator for patients with DLBCL and other aggressive lymphomas. The IPI predicts the risk of disease recurrence and overall treatment outcome by taking into account five adverse prognostic risk factors.

Follicular Lymphoma International Prognostic Index (FLIPI)4

The FLIPI is similar to the IPI but applies to patients with follicular NHL, a type of indolent NHL. The FLIPI can be used to help predict the success of therapy in follicular NHL patients and is based on assigning one point for each adverse prognostic risk factor.

Additional Resources

This section provides links to relevant Web sites that will help you expand your knowledge about NHL and gain access to additional information that you may find useful in your practice. Genentech, Inc. and Biogen Idec Inc are neither affiliated with nor endorse any of the following organizations.

View Indication and Safety Information
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INDICATIONS AND IMPORTANT SAFETY INFORMATION

RITUXAN® (Rituximab) is indicated for the treatment of patients with:

  • Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)
  • Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
    • Weekly ×4
    • Weekly ×8
    • Bulky disease
    • Retreatment
  • Previously untreated follicular, CD20-positive, B-cell NHL in combination with CVP chemotherapy
  • Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent, after first-line CVP chemotherapy
  • Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens

RITUXAN is not recommended for use in patients with severe, active infections.

WARNING: FATAL INFUSION REACTIONS, TUMOR LYSIS SYNDROME (TLS), SEVERE MUCOCUTANEOUS REACTIONS, and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)

Infusion Reactions: RITUXAN administration can result in serious, including fatal, infusion reactions. Deaths within 24 hours of RITUXAN infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Carefully monitor patients during infusions. Discontinue RITUXAN infusion and provide medical treatment for Grade 3 or 4 infusion reactions.

Tumor Lysis Syndrome (TLS): Acute renal failure requiring dialysis with instances of fatal outcome can occur in the setting of TLS following treatment of non-Hodgkin’s lymphoma (NHL) with RITUXAN monotherapy.

Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving RITUXAN.

Progressive Multifocal Leukoencephalopathy (PML): JC virus infection resulting in PML and death can occur in patients receiving RITUXAN.

WARNINGS AND PRECAUTIONS

RITUXAN has also been associated with other serious and/or fatal adverse reactions. These include

  • hepatitis B reactivation with fulminant hepatitis; hepatic failure resulting in death
  • serious, including fatal, bacterial, fungal, and new or reactivated viral infections
  • cardiovascular events, including serious or life-threatening cardiac arrhythmias
  • severe, including fatal, renal toxicity
  • abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients receiving RITUXAN in combination with chemotherapy
Additional Important Safety Information
  • The most common adverse reactions of RITUXAN (incidence ≥25%) observed in clinical trials of patients with NHL were infusion reactions, fever, lymphopenia, chills, infection, and asthenia. The incidence of infusion reactions was highest during the first infusion (77%) and decreased with each subsequent infusion. These infusion reactions typically resolved with slowing or interruption of the infusion and with supportive care. The most frequent Grade 3 or 4 adverse reactions observed in NHL were cytopenias, including lymphopenia
  • The most common adverse reactions of RITUXAN (incidence ≥25%) observed in clinical trials of patients with CLL were infusion reactions and neutropenia. Infusion-related adverse reactions occurring during or within 24 hours of the start of infusion included nausea, pyrexia, chills, hypotension, vomiting, and dyspnea. Most patients treated with R-FC experienced at least one Grade 3 or 4 adverse reaction. The Grade 3 or 4 adverse reactions observed more frequently with R-FC compared with FC alone were neutropenia, leukopenia, febrile neutropenia, thrombocytopenia, infusion reactions, pancytopenia, hypotension, and hepatitis B
  • In clinical trials, CLL patients 70 years of age or older who received R-FC had more Grade 3 and 4 adverse reactions compared with younger CLL patients who received the same treatment

For additional safety information, please see the full prescribing information, including BOXED WARNINGS and Medication Guide.

Attention Healthcare Provider: Provide Medication Guide to patient prior to RITUXAN infusion.

References
  1. Rosen ST, Winter JN, Gordon LI, et al. Non-Hodgkin's lymphoma. In: Pazdur R, Coia LR, Hoskins WJ, et al, eds. Cancer Management: A Multidisciplinary Approach. 9th ed. Lawrence, Kan: CMP Healthcare Media; 2005:697-748.
  2. Surveillance, Epidemiology, and End Results (SEER) training Web site. Lymphoma staging scheme. Available at: http://training.seer.cancer.gov/module_staging_cancer/unit03_sec04_part07_ lymphoma.html. Accessed April 17, 2006.
  3. The International Non-Hodgkin&s Lymphoma Prognostic Project. A predictive model for aggressive non-Hodgkin's lymphoma. N Engl J Med. 1993;329:987-994.
  4. Solal-Céligny P, Roy P, Colombat P, et al. Follicular Lymphoma International Prognostic Index. Blood. 2004;104:1258-1265.