Rituxan (Rituximab) for Rheumatoid Arthritis and Non-Hodgkins Lymphoma

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INDICATIONS AND USAGE

Non-Hodgkin's Lymphoma (NHL)

Rituxan^® (rituximab) is indicated for the treatment of patients with:

Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
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

Rheumatoid Arthritis

Rituxan^® (rituximab) in combination with methotrexate is indicated to reduce signs and symptoms and to slow the progression of structural damage in adult patients with moderately-to severely- active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.

WARNINGS

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) 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 receiving Rituxan.

View the full Prescribing Information in HTML or PDF (745K) and the Medication Guide ( Adobe^® Reader^® required).