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Safety

Before you start exploring, take the time to read the side effect information.

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What does Rituxan treat?

Rheumatoid arthritis (RA): with another prescription medicine called methotrexate, to reduce the signs and symptoms of moderate to severe active RA in adults, after treatment with at least one other medicine called a tumor necrosis factor (TNF) antagonist has been used and did not work well enough.

People with serious infections should not receive Rituxan. It is not known if Rituxan is safe or effective in children.

Important Side Effect Information

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

Rituxan can cause serious side effects that can be fatal, including:

  • Infusion reactions—infusion reactions are the most common side effect of Rituxan treatment. Serious infusion reactions can happen during or up to 24 hours after an infusion. During clinical trials, less than 1% of people taking Rituxan experienced serious infusion reactions
  • Severe skin and mouth reactions—painful sores or ulcers on your skin, lips, or in your mouth; blisters; peeling skin; rash; or small, pus-filled blisters
  • Return of hepatitis B virus (HBV)—if you previously had hepatitis B, Rituxan can cause the disease to become an active infection again, even if you are not showing any symptoms
  • PML (progressive multifocal leukoencephalopathy)—a rare but serious brain infection caused by a virus

What are the possible side effects of Rituxan?

Rituxan can cause serious and life-threatening side effects, including:

  • TLS (tumor lysis syndrome)—has occurred in patients using Rituxan to treat non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). It is caused by cancer cells breaking down and can lead to kidney failure and the need for dialysis treatment or cause abnormal heart rhythm
  • Serious infections—these can happen during and after treatment and can be fatal. During clinical trials, 2% of people taking Rituxan developed serious infections
  • Heart problems—Rituxan may cause chest pain and irregular heartbeat. Your doctor or healthcare team may provide treatment or decide to stop treating with Rituxan if you experience these symptoms
  • Kidney problems—especially if you are taking it for non-Hodgkin’s lymphoma (NHL). Your doctor should do blood tests to check how well your kidneys are working
  • Stomach and serious bowel problems that can sometimes be fatal—tell your doctor right away if you have any stomach area pain during treatment with Rituxan
  • Changes in blood cell counts—during treatment with Rituxan, your doctor or healthcare team should do regular blood tests to monitor your blood cell counts

What are common side effects during treatment with Rituxan?

  • infusion
    reactions
  • chills
  • infections
  • body aches
  • tiredness
  • low white blood
    cell count

Other side effects include:

  • aching joints during
    or within hours of
    receiving an infusion
  • more frequent
    upper respiratory
    tract infections

Tell your doctor about any side effect that bothers you or does not go away.
These are not all of the possible side effects with Rituxan. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at
1-800-FDA-1088 or www.FDA.gov/medwatch. Or to Genentech at 1-888-835-2555.

When to receive your next course

Rituxan® (rituximab) is generally given every 6 months. But if your symptoms return before then, Rituxan offers you and your doctor the flexibility to take your next course as early as 4 months later.

Based on how you're feeling and your other medical conditions, you and your doctor can determine if and when you should start another course of treatment. So if you feel your symptoms starting to return, be open and honest about it with your doctor. It'll help you make a more informed decision, together.

Sticking to your treatment plan

Whatever you and your doctor decide about how often you should be treated, it's important to follow that schedule. Not only could it help you get the most out of Rituxan, but it could also help keep your symptoms from returning.

A study also showed that, of the people who saw improvement from their first course of Rituxan (plus methotrexate) and then went on to receive a second course, 54% saw an additional 6 months of improvement (as opposed to 45% of people who received a second course of methotrexate alone).

And remember, even if you're not experiencing symptoms, RA can still cause damage to your joints if it's not properly treated.

Serious side effect information

Keep in mind that Rituxan can cause serious side effects that can lead to death, such as progressive multifocal leukoencephalopathy (PML). PML is a rare, serious brain infection caused by a virus. People with weakened immune systems can get PML. Your chance of getting PML may be higher if you are treated with Rituxan alone or with other medicines that weaken your immune system. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. For more information, please visit the important side effect information page.

What does Rituxan treat?

Rheumatoid arthritis (RA): with another prescription medicine called methotrexate, to reduce the signs and symptoms of moderate to severe active RA in adults, after treatment with at least one other medicine called a tumor necrosis factor (TNF) antagonist has been used and did not work well enough.

People with serious infections should not receive Rituxan. It is not known if Rituxan is safe or effective in children.

Important Side Effect Information

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

Rituxan can cause serious side effects that can be fatal, including:

  • Infusion reactions—infusion reactions are the most common side effect of Rituxan treatment. Serious infusion reactions can happen during or up to 24 hours after an infusion. During clinical trials, less than 1% of people taking Rituxan experienced serious infusion reactions
  • Severe skin and mouth reactions—painful sores or ulcers on your skin, lips, or in your mouth; blisters; peeling skin; rash; or small, pus-filled blisters
  • Return of hepatitis B virus (HBV)—if you previously had hepatitis B, Rituxan can cause the disease to become an active infection again, even if you are not showing any symptoms
  • PML (progressive multifocal leukoencephalopathy)—a rare but serious brain infection caused by a virus

What should I tell my doctor before receiving Rituxan?

It is important to tell your doctor or healthcare team if you:

  • Previously had serious infusion reactions to Rituxan
  • Have a history of other medical conditions including:
    • Heart problems
    • Irregular heartbeat
    • Chest pain
    • Lung or kidney problems
  • Have had an infection, currently have an infection, or have a weakened immune system
  • Have recently been given a vaccine, plan to get a vaccine, or are in contact with someone who is planning to get a vaccine
  • Are pregnant or plan to become pregnant. Talk to your doctor about effective birth control
  • Are breast-feeding or plan to breast-feed
  • Are taking other prescription or nonprescription medicines, especially anti-TNF (tumor necrosis factor) medicines or DMARDs (disease modifying anti-rheumatic drugs)

What are the possible side effects of Rituxan?

Rituxan can cause serious and life-threatening side effects, including:

  • TLS (tumor lysis syndrome)—has occurred in patients using Rituxan to treat non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). It is caused by cancer cells breaking down and can lead to kidney failure and the need for dialysis treatment or cause abnormal heart rhythm
  • Serious infections—these can happen during and after treatment and can be fatal. During clinical trials, 2% of people taking Rituxan developed serious infections
  • Heart problems—Rituxan may cause chest pain and irregular heartbeat. Your doctor or healthcare team may provide treatment or decide to stop treating with Rituxan if you experience these symptoms
  • Kidney problems—especially if you are taking it for non-Hodgkin’s lymphoma (NHL). Your doctor should do blood tests to check how well your kidneys are working
  • Stomach and serious bowel problems that can sometimes be fatal—tell your doctor right away if you have any stomach area pain during treatment with Rituxan
  • Changes in blood cell counts—during treatment with Rituxan, your doctor or healthcare team should do regular blood tests to monitor your blood cell counts

What are common side effects during treatment with Rituxan?

  • infusion
    reactions
  • chills
  • infections
  • body aches
  • tiredness
  • low white blood
    cell count

Other side effects include:

  • aching joints during
    or within hours of
    receiving an infusion
  • more frequent
    upper respiratory
    tract infections

Tell your doctor about any side effect that bothers you or does not go away.
These are not all of the possible side effects with Rituxan. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. Or to Genentech at 1-888-835-2555.

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Tips for infusions