Rituxan Rituximab
Extend overall survival

For previously untreated diffuse large B-cell, CD20-positive NHL (DLBCL)
in combination with CHOP or other anthracycline-based chemotherapy regimens

Diffuse Large B-cell NHL (DLBCL)

RITUXAN delivered significant survival benefits in DLBCL, as shown in three large-scale clinical trials1

  • Three randomized, controlled, multicenter studies with a collective enrollment of 1,854 previously untreated DLBCL patients provide powerful support for RITUXAN+CHOP1

RITUXAN+CHOP delivered durable survival benefits in DLBCL1

Chart: RITUXAN+CHOP delivered durable survival benefits in DLBCLProven OS Benefit in 3 Diffuse Large B-cell Lymphoma (DLBCL) trials

a Significant at p<0.05, 2-sided.
b NE=Not reliably estimable.
c Kaplan-Meier estimates.
d R-CHOP vs CHOP.
e CHEMO: Approximately 44% of trial patients in both study arms received CHOEP (CHOP plus etoposide), 49% received CHOP, 4% received MACOP-B (methotrexate, doxorubicin, cyclophosphamide, vincristine, prednisone, and bleomycin), and 4% received PMitCEBO (prednisone, mitoxantrone, cyclophosphamide, etoposide, bleomycin, and vincristine).2

  • Survival benefits proven across a wide range of ages, disease stages, and other prognostic factors1
  • The recommended dose of RITUXAN is 375 mg/m2 IV per infusion given on Day 1 of each cycle of chemotherapy for up to 8 infusions1

Safety summary:

  • In studies of elderly patients with DLBCL, the following adverse reactions, regardless of severity, were reported more frequently (≥5%) in patients ≥60 years of age receiving R-CHOP as compared with CHOP alone: pyrexia (56% vs 46%), lung disorder (31% vs 24%), cardiac disorder (29% vs 21%), and chills (13% vs 4%). Detailed safety data collection in these trials was primarily limited to Grade 3 and 4 adverse reactions and serious reactions. In one of the studies of elderly patients, GELA LNH 98-5, a review of cardiac toxicity determined that supraventricular arrhythmias or tachycardia accounted for most of the difference in cardiac disorders (4.5% for R-CHOP vs 1.0% for CHOP)2
  • The following Grade 3 or 4 adverse reactions occurred more frequently among patients in the R-CHOP arm compared with those in the CHOP arm: thrombocytopenia (9% vs 7%) and lung disorder (6% vs 3%). Other Grade 3 or 4 adverse reactions reported more frequently among patients receiving R-CHOP were viral infection (GELA LNH 98-5 study), neutropenia (GELA LNH 98-5 and MInT studies), and anemia (MInT study)1

Prolonging survival is one of the treatment goals in patients with DLBCL3,4

  • Overall survival (OS) is the definitive clinical endpoint in DLBCL3,4
  • The best opportunity to achieve durable survival benefits is in frontline therapy5
  • A complete response does not guarantee prolonged survival
  • RITUXAN is the first agent in combination with CHOP* to improve survival rates for DLBCL patients since the introduction of CHOP in 19721,5,6

View Indication and Safety Information
LNH 98-5 (GELA) NHL Trial

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.

RITUXAN has also been associated with other serious and/or fatal adverse reactions. These include hepatitis B reactivation with fulminant hepatitis, other infections, cardiovascular events, renal toxicity, and bowel obstruction and perforation.

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.

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. RITUXAN® (Rituximab) full prescribing information, Genentech, Inc., 2010.
  2. Data on file, Genentech, Inc.
  3. Armitage JO, Berg AR, Purtilo DT. Adult non-Hodgkin's lymphomas. In: Bick RL, ed-in-chief. Hematology: Clinical and Laboratory Practice. St. Louis, Mo: Mosby-Year Book, Inc; 1993:875-893.
  4. Sunderland MC, Coltman CA. Lymphomas. In: Weiss GR, ed. Clinical Oncology. Norwalk, Conn: Appleton & Lange; 1993:284-298.
  5. DeVita VT Jr, Canellos GP, Chabner B, et al. Advanced diffuse histiocytic lymphoma, a potentially curable disease. Lancet. 1975;1:248-250.
  6. Gribben JG, La Casce AS. Clinical manifestations, staging, and treatment of non-Hodgkin's lymphoma. In: Hoffman R, Benz EJ Jr, Shattil SJ, et al, eds. Hematology: Basic Principles and Practice. 4th ed. Philadelphia, Pa: Elsevier Churchill Livingstone; 2005:1397-1419.