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

MInT Trial

Survival benefits extended to younger patients with NHL

MInT* trial: Younger, low-risk DLBCL patients1

Chart: MInT* trial: Younger, low-risk DLBCL patients

Percentages are based on calculations.
*MInT: MabThera® (Rituximab) International Trial.
†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).
‡In the MInT trial of younger adults, an age-adjusted IPI was used, which ranged from 0 to 3, and was derived by assigning 1 point for each of the following risk factors: Ann Arbor Stage III or IV, ECOG performance status ≥2, and elevated LDH. Per the protocol, patients were to have an IPI score of <2.

  • In the MInT trial, a Phase III trial, 823 DLBCL patients (ages 18–60 years) were randomized to receive either RITUXAN plus a standard anthracycline-containing chemotherapy regimen (CHEMO) or CHEMO alone as induction therapy2

MInT protocol: R-CHEMO x6 vs CHEMO x61

Chart: MInT protocol: R-CHEMO x6 vs CHEMO x6

  • Patients were randomized to receive either 6 three-week cycles of CHEMO plus RITUXAN 375 mg/m2 given on Day 1, or 6 three-week cycles of CHEMO alone2

RITUXAN+CHEMO significantly prolonged survival in younger DLBCL patients3

MInT overall survival (N=823)2,3

Chart: MInT overall survival (N=823)95% Overall survival at 2 years

  • At 2 years, RITUXAN+CHEMO increased OS from 86% to 95% compared with CHEMO alone3
  • RITUXAN+CHEMO significantly improved time to treatment failure, the primary study endpoint3

Most common adverse reactions observed in DLBCL patients age 18–60 years

  • Skin disorder was the only adverse reaction that was experienced with a ≥5% higher frequency among patients treated with induction R-CHEMO compared with those treated with induction CHEMO. The incidence of skin disorder was 34.4% (135/393) among CHEMO recipients versus 42.0% (174/414) among R-CHEMO recipients. All of these adverse reactions were Grade 1 or 2 in severity.1

View Indication and Safety Information
Previously Untreated Follicular NHL in Combination with CVP

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. Data on file, Genentech, Inc.
  2. Pfreundschuh M, Trümper L, Österborg A, et al. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group. Lancet Oncol. 2006;7:379-391.
  3. RITUXAN® (Rituximab) full prescribing information, Genentech, Inc., 2010.