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
  • Severe skin and mouth reactions
  • Hepatitis B virus (HBV) reaction
  • Progressive Multifocal Leukoencephalopathy (PML)
  • Tumor Lysis Syndrom (TLS)
  • Serious infections
  • Heart problems
  • Kidney problems
  • Stomach and serious bowl problems
  • Low blood cell counts

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 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 for the treatment of:

  • CD20-positive chronic lymphocytic leukemia in combination with FC chemotherapy as an initial treatment or as a treatment after disease has recurred

People with serious infections should not receive RITUXAN.

Important Safety Information

What is the most important information I should know about RITUXAN?

Tell your doctor right away about any side effect you experience. RITUXAN can cause serious side effects that can lead to death, including:

  • Infusion Reactions: may occur during or within 24 hours of your infusion. Your doctor should give you medicines before your treatment. Symptoms can include hives, rash, itching, facial or oral swelling, sudden cough, shortness of breath, difficulty breathing, weakness, dizziness, feeling faint, racing heart, or chest pain
  • Severe Skin and Mouth Reactions: symptoms can include painful sores, ulcers, or blisters on your skin, lips or mouth; peeling skin; rash; or pustules
  • Hepatitis B Virus (HBV) Reactivation: may cause serious liver problems including liver failure and death. If you have had hepatitis B or are a carrier of HBV, receiving RITUXAN could cause the virus to become an active infection again. You should not receive RITUXAN if you have active HBV liver disease. Your doctor will do blood tests to check for HBV infection prior to treatment and will monitor you during and for several months following your treatment
  • Progressive Multifocal Leukoencephalopathy (PML): a rare, serious brain infection that can lead to severe disability and death and for which there is no known prevention, treatment, or cure. Symptoms can include difficulty thinking, loss of balance, changes in speech or walking, weakness on one side of your body, or blurred or lost vision

What are the additional possible serious side effects of RITUXAN?

Tell your doctor right away about any side effect you experience. RITUXAN can cause serious side effects that can lead to death, including:

  • Tumor Lysis Syndrome (TLS): may cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, and can lead to death. Your doctor may give you medicines before your treatment to help prevent TLS
  • Serious Infections: can happen during and after treatment and can lead to death. These infections may be bacterial, fungal, or viral. Symptoms can include fever; cold or flu symptoms; earache or headache; pain during urination; white patches in the mouth or throat; cuts or scrapes that are red, warm, swollen, or painful
  • Heart Problems: symptoms can include chest pain and irregular heartbeats that may require treatment. Your doctor may need to stop your treatment
  • Kidney Problems: your doctor should do blood tests to check how well your kidneys are working
  • Stomach and Serious Bowel Problems: can include blockage or tears in the bowel that can lead to death. Stomach area pain during treatment can be a symptom
  • Low Blood Cell Counts: your blood cell counts may be monitored during treatment

The most common side effects of RITUXAN are infusion reactions, chills, infections, body aches, tiredness, and low white blood cells.

Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. It is not known if RITUXAN may harm your unborn baby or pass into your breast milk. Women should use birth control while using RITUXAN and for 12 months after treatment.

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 of RITUXAN. For more information, ask your doctor or pharmacist.

Please see the RITUXAN full Prescribing Information, including the Medication Guide, for additional important safety information at www.RITUXAN.com.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Genentech at (888) 835-2555.