Medication Guide (133K/PDF)
Full Prescribing Information
Dear Healthcare Provider Letter (54K/PDF)

Rituxan® (Rituximab) is indicated for use in combination with methotrexate (MTX) for reducing signs and symptoms and slowing the progression of structural damage in adult patients with moderately- to severely-active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

Status Rituxan (Rituximab) received U.S. Food and Drug Administration approval in November 1997 for the treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma (NHL). In April 2001, a supplemental Biologics License Application was approved for Rituxan for these additional uses: retreatment of patients with Rituxan who have relapsed following initial Rituxan therapy, use of eight weekly doses (compared to original four) per course of treatment, treatment of patients with bulky disease (lesions > 10 cm). In February 2006, the FDA approved Rituxan for the first-line treatment of diffuse large B-cell, CD20-positive, non-Hodgkin's lymphoma (DLBCL- a type of NHL) in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens. Also in February 2006, the FDA approved Rituxan in combination with methotrexate for the treatment of moderately- to severely-active rheumatoid arthritis in patients who have had an inadequate response to one or more TNF antagonist therapies.

For additional detailed information, please see the Rituxan RA Fact Sheet.

Proposed Mechanism of Action Rituxan binds to the CD20 antigen on the surface of normal and malignant B cells. From there, it recruits the body's natural defenses to attack and kill the marked B cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B cells to regenerate after treatment and return to normal levels within several months.

Rheumatoid Arthritis RA is a systemic debilitating autoimmune disease that occurs when the immune system inappropriately attacks joint tissue, causing painful chronic inflammation and irreversible destruction of cartilage, tendons and bones, that often results in chronic pain, loss of function and disability, and can also lead to cardiovascular and pulmonary complications. Additionally, since RA is a systemic disease, it can have effects on other tissues and organs such as the lungs, eyes and bone marrow.