About Rituxan
Safety Information
 

RITUXAN AND CLL Overview

RITUXAN is not chemotherapy. RITUXAN is a targeted therapy that works with FC chemotherapy. Together, they find and attack the cells where chronic lymphocytic leukemia (CLL) starts.

 
 

Keep in mind: Chemotherapy can be combined. Often in CLL, 2 chemotherapy drugs—fludarabine and cyclophosphamide—are combined into a treatment. This is called FC chemotherapy.

RITUXAN is given with FC chemotherapy for patients with CLL as an initial treatment or when the disease advances (relapse)

Results with RITUXAN

RITUXAN has been studied in CLL in 2 large clinical trials. The studies measured patient responses to RITUXAN plus FC chemotherapy. And for many patients—adding RITUXAN to FC chemotherapy meant more time without their cancer advancing.

 

You can find more information about these studies on the pages to come.

RITUXAN can cause serious side effects that can lead to death, including:

  • Infusion reactions
  • Kidney problems
  • Severe skin and mouth reactions
  • Hepatitis B virus (HBV) reactivation
  • Serious infections
  • Heart problems
  • Stomach and serious bowel problems

Common side effects during RITUXAN treatment include:

  • Infusion reactions
  • Chills
  • Infections
  • Body aches
  • Tiredness
  • Low white blood cells

Click here for more information about these side effects. These are not all of the side effects that are possible. Other rare, but serious, side effects can occur. Be sure to talk to your doctor about all of the side effects that are possible. And please see the full Prescribing Information, including Medication Guide.

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.