INDICATION STATEMENT

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

• Previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to RITUXAN in combination with chemotherapy, as single-agent maintenance therapy
• Non-progressing (including stable disease), low‑grade, CD20‑positive, B‑cell NHL, as a single agent, after first‑line CVP chemotherapy
• Relapsed or refractory, low‑grade or follicular, CD20‑positive, B‑cell NHL as a single agent
  • Weekly x4
  • Weekly x8
  • Bulky disease
  • Retreatment
• 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.

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS

• RITUXAN administration can result in serious, including fatal, adverse reactions. These include infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (PML)

Warnings and Precautions

• RITUXAN can also result in serious, including fatal, adverse reactions. These include hepatitis B reactivation with fulminant hepatitis and hepatic failure resulting in death; other infections, including bacterial, fungal, new or reactivated viral infections; cardiovascular events; severe, including fatal, renal toxicity; and abdominal pain, bowel obstruction and perforation, in some cases leading to death

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 most frequent Grade 3 or 4 adverse reactions observed in NHL were cytopenias, including lymphopenia

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.

INDICATION STATEMENT

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)

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

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS

• RITUXAN administration can result in serious, including fatal, adverse reactions. These include infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, and progressive multifocal leukoencephalopathy (PML)

Warnings and Precautions

• RITUXAN can also result in serious, including fatal, adverse reactions. These include hepatitis B reactivation with fulminant hepatitis and hepatic failure resulting in death; other infections, including bacterial, fungal, new or reactivated viral infections; cardiovascular events; severe, including fatal, renal toxicity; and abdominal pain, bowel obstruction and perforation, in some cases leading to death

Additional Important Safety Information

• The most common adverse reactions of RITUXAN (incidence ≥25%) observed in clinical trials of patients with CLL were infusion reactions and neutropenia. Most patients treated with R-FC experienced at least one Grade 3 or 4 adverse reaction. The most frequently reported Grade 3 or 4 adverse reaction was neutropenia
• 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.

INDICATION STATEMENT

RITUXAN^® (Rituximab) in combination with methotrexate is indicated for the treatment of adult patients with moderately to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.

Rituxan is not recommended for treatment of patients with severe active infections.

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS

Fatal 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.

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) patients with Rituxan.

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 treated with Rituxan.

INFECTIOUS ADVERSE EVENTS

In RA clinical studies, 39% of patients in the Rituxan group experienced an infection of any type compared to 34% for placebo. The most common infections were nasopharyngitis, upper respiratory tract infections, urinary tract infections, bronchitis, and sinusitis.

The incidence of serious infections was 2% in the Rituxan patients and 1% in the placebo group. In the experience with Rituxan in 2578 RA patients, the rate of serious infection was 4.31 per 100 patient-years. The most common serious infections (≥0.5%) were pneumonia or lower respiratory tract infections, cellulitis and urinary tract infections. Fatal serious infections included pneumonia, sepsis, and colitis. Rates of serious infection remain stable in patients receiving subsequent courses.

COMMON ADVERSE EVENTS

The most common adverse events with greater incidence in the group receiving Rituxan (n=540) vs the placebo group (n=398) were hypertension (8% vs 5%), nausea (8% vs 5%), upper respiratory tract infection (7% vs 6%), arthralgia (6% vs 4%), pyrexia (5% vs 2%), and pruritus (5% vs 1%). These data are based on 938 patients treated in phase 2 and 3 studies of Rituxan (2 x 1000 mg) or placebo administered in combination with methotrexate.

Use in Patients With RA Who Had No Prior Inadequate Response to TNF Antagonists: While the efficacy of Rituxan was supported in 4 controlled trials in patients with RA with prior inadequate responses to nonbiologic DMARDs, and in a controlled trial in MTX-naive patients, a favorable risk-benefit relationship has not been established in these populations. The use of Rituxan in patients with RA who have not had prior inadequate response to one or more TNF antagonists is not recommended.

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

INDICATION STATEMENT

Rituxan^® (rituximab), in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA).

Rituxan is not recommended for treatment of patients with severe active infections.

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS

Rituxan administration can result in serious, including fatal, adverse reactions. These include:

• infusion reactions
• tumor lysis syndrome (TLS)
• severe mucocutaneous reactions
• progressive multifocal leukoencephalopathy (PML)

Warnings and Precautions

Rituxan administration can also result in additional serious, including fatal, adverse reactions including:

• hepatitis B reactivation
• other infections including bacterial, fungal, new or reactivated viral infections
• cardiovascular events

Use of concomitant immunosuppressants other than corticosteroids has not been studied in GPA or MPA patients exhibiting peripheral B-cell depletion following treatment with Rituxan.
Observe patients closely for signs of infection if immunosuppressants other than corticosteroids are used concomitantly.

Common adverse reactions include infections, nausea, diarrhea, headache, muscle spasms, anemia and peripheral edema

 

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