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THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT RITUXAN: INFUSION REACTIONS, SEVERE SKIN AND MOUTH REACTIONS, HEPATITIS B VIRUS (HBV) REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)

Prescribing Information

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RITUXAN therapy

Living with follicular lymphoma is a journey

Follicular lymphoma is the most common type of indolent (slow-growing) NHL. It makes up 20% of all NHL cases. Patients with follicular lymphoma often will notice an area of painless swelling on the body, such as on the neck, underarm or groin.

As a slow-growing type of NHL, follicular lymphoma does not always require immediate treatment.

You may not have any obvious symptoms of follicular lymphoma when you are diagnosed. When this is the case, your doctor may decide it’s best to just keep an eye on your health. This is called watch and wait.

When treatment is needed, your healthcare team will work with you to find treatment options. Some of the goals of treatment for follicular lymphoma are to:

Ultimately, you will want to try to get your cancer into remission. After a while, follicular lymphoma usually returns.

Your doctor may decide to prescribe RITUXAN® (rituximab).

For previously treated follicular lymphoma, RITUXAN is used in 2 ways:

  1. Initial treatment: get to remission
    RITUXAN is used in combination with chemotherapy. If treatment results in partial or complete remission, RITUXAN may be used as maintenance therapy.
  2. Maintenance therapy: stay in remission
    The goal of maintenance therapy is to help keep the disease in remission for a longer period of time. RITUXAN is used alone, without chemotherapy, during maintenance therapy.

Rituxan is available by prescription only.

INDICATIONS

RITUXAN® (Rituximab) is indicated for the treatment of: 

  • Low-grade or follicular CD20-positive Non-Hodgkin's lymphoma as a single-agent therapy in patients whose disease recurred or did not respond to initial treatment
  • Follicular CD20-positive Non-Hodgkin's lymphoma as an initial treatment with chemotherapy, and in patients whose initial treatment was successful, as a single-agent follow-up therapy
  • Low-grade CD20-positive Non-Hodgkin's lymphoma as a single agent follow-up therapy for patients who did not progress on initial treatment with CVP chemotherapy
  • CD20-positive diffuse large B-cell Non-Hodgkin's lymphoma as an initial treatment in combination with CHOP chemotherapy
  • 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.

It is not known if RITUXAN is safe or effective in children.

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.

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.

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.