About Rituxan
Safety Information
 

For treatment after the disease advances (relapse)...

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

RITUXAN plus FC chemotherapy has been shown to be an effective treatment for certain patients after the disease advances (relapse). In fact, in a large clinical study (called REACH), 54% of patients who received RITUXAN plus FC chemotherapy went into either partial or complete remission for a period of time. These previously treated patients were in the later stages of disease and had not received RITUXAN during earlier treatments.

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. And when you've been treated before, your response may not be as good the second time around.

Adding RITUXAN to FC chemotherapy meant patients experienced an average of 2.2 years without their cancer advancing.

RITUXAN plus FC chemotherapy

The REACH study

About the patients

  • Average age: 63
  • 276 patients received RITUXAN plus FC chemotherapy
  • 276 patients received FC chemotherapy alone
  • These previously treated patients were in the later stages of disease and had not received RITUXAN during earlier treatments
  • The patients had few medical conditions in addition to CLL and were generally healthy enough to receive treatmen

REACH Treatment Considerations

Chronic lymphocytic leukemia patients 65 years of age or older were not shown to benefit from RITUXAN in combination with FC chemotherapy as a treatment after disease has recurred.

Select Important Safety Information

RITUXAN for the treatment of CD20-positive chronic lymphocytic leukemia in combination with FC chemotherapy as a treatment after disease has recurred

Severe side effects reported more often in patients receiving RITUXAN and FC chemotherapy vs. FC chemotherapy alone were infusion reactions; decreased blood cell counts, including decreases in white blood cells with or without a fever and platelets; low blood pressure; and hepatitis B. Severe side effects reported more commonly in the elderly (≥70 years of age) versus younger patients were infections; decreased blood cell counts, including decreases in white blood cells with or without a fever, red blood cells, and platelets.

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.