About Rituxan
Safety Information
 

For initial treatment...

Adding RITUXAN to Fludarabine and Cyclophosphamide (FC) Chemotherapy May Improve CLL Treatment Response

RITUXAN is used along with FC chemotherapy as an initial treatment for CLL. In fact, in a large clinical study (called CLL8), 86% of patients who received RITUXAN plus FC chemotherapy went into either partial or complete remission for a period of time.

RITUXAN plus FC chemotherapy

 
 

Keep in mind: Remission can be partial or complete. Partial remission means the cancer is significantly improved, but evidence of the cancer remains. Complete remission means all evidence of the cancer is gone for a period of time.

Adding RITUXAN to FC chemotherapy meant patients experienced an average of 3.3 years without their cancer advancing.

RITUXAN plus FC chemotherapy

The CLL8 study

About the patients

  • Average age: 61
  • 408 patients received RITUXAN plus FC chemotherapy
  • 409 patients received FC chemotherapy alone
  • These previously untreated patients were in the later stages of disease
  • The patients had few medical conditions in addition to CLL and were generally healthy enough to receive treatment

Important treatment considerations

  • Remember that results are different for different people. Some results from this study suggest that patients 70 years or older may not benefit from the addition of RITUXAN to FC chemotherapy. Please talk to your doctor about the potential benefits and risks for RITUXAN plus FC chemotherapy
  • Most patients treated with RITUXAN plus FC chemotherapy experienced at least one serious side effect
  • In previously untreated patients, serious side effects included infusion reactions, low white blood cells, fever, low red blood cells, low platelets, and infections
  • Serious side effects were reported more often in patients over 70 years of age who received RITUXAN plus FC chemotherapy (compared to patients younger than 70)

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

RITUXAN® (Rituximab) is indicated in combination with fludarabine and cyclophosphamide (FC chemotherapy) for the treatment of patients with:

  • Previously untreated CD20-positive CLL
  • Previously treated CD20-positive CLL

People with serious infections should not receive RITUXAN.

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 clinical trials of patients with CLL were infusion reactions and low white blood cells, which can increase the risk of infections. Before starting treatment with RITUXAN it is important for you 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, in PDF format.