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About RITUXAN

Important Safety Information

Treating Low-grade or Follicular Non-Hodgkin’s Lymphoma upon Relapse

RITUXAN® is indicated for the treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent.

If low-grade or follicular (indolent) NHL relapses, RITUXAN® may help. For many people, RITUXAN may help reduce tumor size—even if they have large tumors.

In clinical studies, RITUXAN shrunk tumors significantly for many people whose NHL had relapsed. There were 4 separate studies (with 60, 166, 37, and 31 patients each). In one of the studies, RITUXAN was proven to shrink tumors in patients who had also been treated with RITUXAN earlier in the course of their disease.

Important Safety Information:

  • RITUXAN can cause serious side effects that can lead to death, including: infusion reactions, tumor lysis syndrome (TLS; kidney failure due to fast breakdown of cancer cells), severe skin and mouth reactions, and progressive multifocal leukoencephalopathy (PML; a rare, serious brain infection).
  • RITUXAN has also been associated with serious and life-threatening side effects, including: the return of active hepatitis B virus infection with sudden and serious liver problems including liver failure, and death, other serious infections that can lead to death, heart problems, kidney problems, and stomach and serious bowel problems including blockage and tears in the bowel that can sometimes lead to death.
  • The most common side effects of RITUXAN seen in patients with non-Hodgkin’s lymphoma were infusion reactions, fever, chills, low white blood cells, infections, body aches, and tiredness. Before starting treatment with RITUXAN it is important to talk to your doctor about your medical history.
  • Tell your doctor about any side effect that bothers you or that does not go away. These are not all of the possible side effects with RITUXAN. For more information, ask your doctor

How RITUXAN Is Given

To treat low-grade or follicular (indolent) NHL after a relapse, you may receive a RITUXAN infusion:

  • Once weekly
  • For 4 weeks or for 8 weeks

This information does not take the place of talking with your doctor. Discuss with your doctor any questions you have about your medical condition or your treatment.

 

Indications and Important Safety Information

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

People with serious infections should not receive RITUXAN.

Important Safety Information:

  • RITUXAN can cause serious side effects that can lead to death, including: infusion reactions, tumor lysis syndrome (TLS; kidney failure due to fast breakdown of cancer cells), severe skin and mouth reactions, and progressive multifocal leukoencephalopathy (PML; a rare, serious brain infection).
  • RITUXAN has also been associated with serious and life-threatening side effects, including: the return of active hepatitis B virus infection with sudden and serious liver problems including liver failure, and death, other serious infections that can lead to death, heart problems, kidney problems, and stomach and serious bowel problems including blockage and tears in the bowel that can sometimes lead to death.
  • The most common side effects of RITUXAN seen in patients with non-Hodgkin’s lymphoma were infusion reactions, fever, chills, low white blood cells, infections, body aches, and tiredness. Before starting treatment with RITUXAN it is important to talk to your doctor about your medical history.
  • Tell your doctor about any side effect that bothers you or that does not go away. These are not all of the possible side effects with RITUXAN. For more information, ask your doctor

Please see full Prescribing Information, including Medication Guide.