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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

Non-Hodgkin's lymphoma

The 4 stages of NHL

Staging describes how far lymphoma has spread. Keep in mind that even the most advanced stages of NHL (stage III and stage IV) are common and can be treated.

Non-Hodgkin's lymphoma staging

One group of lymph nodes is affected either above or below the diaphragm.

Two or more groups of lymph nodes are affected either above or below the diaphragm.

Lymph nodes are affected both above and below the diaphragm.

Lymphoma is found in bone marrow and/or organs outside of the lymph nodes and spleen.

Diaphragm

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

It is not known if RITUXAN is safe and effective in children

Important Safety Information

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

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

  • Infusion Reactions:Infusion reactions are very common side effects of RITUXAN treatment. Serious infusion reactions can happen during your infusion or within 24 hours after your infusion of RITUXAN. Your healthcare provider should give you medicines before your infusion of RITUXAN to decrease your chance of having a severe infusion reaction.
    Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an infusion of RITUXAN:
    • Hives (red itchy welts) or rash
    • Itching
    • Swelling of your lips, tongue, throat, or face
    • Sudden cough
    • Shortness of breath, difficulty breathing, or wheezing
    • Weakness
    • Dizziness or feel faint
    • Palpitations (feel like your heart is racing or fluttering)
    • Chest pain
  • Severe Skin and Mouth Reactions: Tell your healthcare provider or get medical help right away if you get any of these symptoms at any time during your treatment with RITUXAN: 
    • Painful sores or ulcers on your skin, lips, or in your mouth
    • Blisters
    • Peeling skin 
    • Rash 
    • Pustules
  • Hepatitis B Virus (HBV) Reactivation: Before you receive your RITUXAN treatment, your healthcare provider will do blood tests to check for HBV infection. If you have had hepatitis B or are a carrier of hepatitis B virus, receiving RITUXAN could cause the virus to become an active infection again. Hepatitis B reactivation may cause serious liver problems, including liver failure, and death. Your healthcare provider will monitor you for hepatitis B infection during and for several months after you stop receiving RITUXAN.
    Tell your healthcare provider right away if you get worsening tiredness, or yellowing of your skin or white part of your eyes during treatment with RITUXAN
  • Progressive Multifocal Leukoencephalopathy (PML): PML is a rare, serious brain infection caused by a virus that can happen in people who receive RITUXAN. People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML.
    Tell your healthcare provider right away if you have new or worsening symptoms or if anyone close to you notices these symptoms:
    • Confusion 
    • Dizziness or loss of balance 
    • Difficulty walking or talking 
    • Decreased strength or weakness on one side of your body
    • Vision problems, such as blurred vision or loss of vision

What should I tell my healthcare provider before receiving RITUXAN?

Before receiving RITUXAN, tell your healthcare provider if you:

  • Have had a severe reaction to RITUXAN or a rituximab product 
  • Have a history of heart problems, irregular heartbeat, or chest pain 
  • Have lung or kidney problems 
  • Have had an infection, currently have an infection, or have a weakened immune system 
  • Have or have had any severe infections including:
    • Hepatitis B virus (HBV) 
    • Hepatitis C virus (HCV) 
    • Cytomegalovirus (CMV) 
    • Herpes simplex virus (HSV) 
    • Parvovirus B19 
    • Varicella zoster virus (chickenpox or shingles) 
    • West Nile Virus
  • Have had a recent vaccination or are scheduled to receive vaccinations. You should not receive certain vaccines before or during treatment with RITUXAN
  • Have any other medical conditions 
  • Are pregnant or plan to become pregnant. Talk to your healthcare provider about the risks to your unborn baby if you receive RITUXAN during pregnancy. Females who are able to become pregnant should use effective birth control (contraception) during treatment with RITUXAN and for 12 months after the last dose of RITUXAN. Talk to your healthcare provider about effective birth control. Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with RITUXAN 
  • Are breastfeeding or plan to breastfeed. It is not known if RITUXAN passes into your breast milk. Do not breastfeed during treatment and for at least 6 months after your last dose of RITUXAN 
  • Are taking any medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements

What are the possible side effects of RITUXAN?

RITUXAN can cause serious side effects, including:

  • Tumor Lysis Syndrome (TLS): TLS is caused by the fast breakdown of cancer cells. TLS can cause you to have:
    • Kidney failure and the need for dialysis treatment
    • Abnormal heart rhythm
    TLS can happen within 12 to 24 hours after an infusion of RITUXAN. Your healthcare provider may do blood tests to check you for TLS. Your healthcare provider may give you medicine to help prevent TLS. Tell your healthcare provider right away if you have any of the following signs or symptoms of TLS:
    • Nausea
    • Vomiting
    • Diarrhea
    • Lack of energy
  • Serious Infections: Serious infections can happen during and after treatment with RITUXAN, and can lead to death. RITUXAN can increase your risk of getting infections and can lower the ability of your immune system to fight infections. Types of serious infections that can happen with RITUXAN include bacterial, fungal, and viral infections. After receiving RITUXAN, some people have developed low levels of certain antibodies in their blood for a long period of time (longer than 11 months). Some of these patients with low antibody levels developed infections. People with serious infections should not receive RITUXAN. Tell your healthcare provider right away if you have any symptoms of infection: 
    • Fever 
    • Cold symptoms, such as runny nose or sore throat that do not go away 
    • Flu symptoms, such as cough, tiredness, and body aches 
    • Earache or headache 
    • Pain during urination 
    • Cold sores in the mouth or throat 
    • Cuts, scrapes, or incisions that are red, warm, swollen, or painful
  • Heart Problems: RITUXAN may cause chest pain, irregular heartbeats, and heart attack. Your healthcare provider may monitor your heart during and after treatment with RITUXAN if you have symptoms of heart problems or have a history of heart problems. Tell your healthcare provider right away if you have chest pain or irregular heart-beats during treatment with RITUXAN
  • Kidney Problems: especially if you are receiving RITUXAN for NHL. RITUXAN can cause severe kidney problems that lead to death. Your healthcare provider should do blood tests to check how well your kidneys are working
  • Stomach and Serious Bowel Problems That Can Sometimes Lead to Death: Bowel problems, including blockage or tears in the bowel can happen if you receive RITUXAN with chemotherapy medicines. Tell your healthcare provider right away if you have any stomach-area (abdomen) pain or repeated vomiting during treatment with RITUXAN

Your healthcare provider will stop treatment with RITUXAN if you have severe, serious, or life-threatening side effects.

What are the most common side effects during treatment with RITUXAN?

  • Infusion-related reactions
  • Infections (may include fever, chills)
  • Body aches
  • Tiredness
  • Nausea

Other side effects include:

  • Aching joints during or within hours of receiving an infusion 
  • More frequent upper respiratory tract infections

These are not all of the possible side effects with RITUXAN.

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.