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.

FAQs

Please keep in mind that the information provided here should not replace a conversation with your doctor.

Q & A

What is Rituxan?

Rituxan® (rituximab) is a prescription medicine, used along with methotrexate, in adults with moderate to severe active rheumatoid arthritis (RA), who have had an inadequate response to one or more anti-TNF treatments. Simply put, an inadequate response occurs when your treatment either stops working well or does not work well at all. But that could happen for a number of reasons. It could mean that your treatment has lost its effectiveness, that you cannot tolerate the side effects, that your symptoms haven't improved enough, or that you're experiencing new symptoms altogether.

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

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What potential benefits does Rituxan offer?

Rituxan is:

  • 6 months of relief: Rituxan is proven to provide 6 months of symptom improvement from 1 course of treatment (2 infusions given 2 weeks apart; each infusion lasts 4-6 hours). In fact, a study showed that at 6 months, 51% of the people taking Rituxan (plus methotrexate) experienced statistically significant symptom improvement (called an ACR20 response), as opposed to 18% of people taking methotrexate alone.

    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).
  • A unique dosing schedule: 1 course of Rituxan (2 infusions) is typically given every 6 months. So over the course of a year, Rituxan could help manage your RA with 4 infusions.
    View the dosing chart
  • Helps protect joints: Rituxan can slow the progression and damage of RA. A study showed that after 2 years of treatment with Rituxan (plus methotrexate), 57% of people did not experience any further joint damage. And taking Rituxan with methotrexate was proven more effective at preventing joint damage than methotrexate alone. Additionally, for the people who had no progression in the first year, 87% also had no progression in the second year.

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How soon can I expect to see results with Rituxan, and how long will they last?

In studies, people who were treated with Rituxan also received methotrexate and glucocorticoids, a type of steroid. At the time of their first checkup—8 weeks after starting treatment—many of those people had seen an improvement in their symptoms. And 6 months later, many were still experiencing improvement.

In fact, a study showed that at 6 months, 51% of the people taking Rituxan (plus methotrexate) experienced statistically significant RA symptom improvement (called an ACR20 response) as opposed to 18% of patients taking methotrexate alone.

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How do I know when it's time for my next course of treatment?

With Rituxan, you may experience symptom improvement that can last through 6 months. But RA is a chronic condition, and because there is no cure, you will eventually have to be treated again. Rituxan is typically given every 6 months, but it can be given as early as 4 months after the previous course. If your symptoms start to return before 6 months, talk with your rheumatologist. Together, you can evaluate if it's time for your next course of treatment.

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How is Rituxan thought to work?

RA occurs when the body's immune system attacks the body's joints. B-cells—a type of white blood cell found in the immune system—are thought to play an important role in this attack. Unlike other RA treatments, Rituxan works by targeting specific B-cells and reducing their count in the blood. This limits the immune system's attack, which limits the pain, symptoms, and joint damage of RA. Because B-cells usually help the body fight infection, treating with Rituxan may increase your risk of infection.

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What should I know about Rituxan's track record?

Although Rituxan works differently from other RA treatments, it has been tested extensively. In fact, Rituxan has more than 10 years of safety data across all approved uses.

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When, where, and how is Rituxan given?
  • First, your doctor's office will schedule appointments for your first course of Rituxan treatment (1 course = 2 infusions given 2 weeks apart), which will be given by a healthcare professional at your doctor's office, an infusion center, or a hospital
  • Each infusion could take 4 to 6 hours, so plan accordingly (see "How should I prepare for my infusions?")
  • Your second infusion may take slightly less time than your first, but again, it will most likely last several hours. If you experienced any side effects from your infusion, talk with your rheumatologist and/or the attending healthcare professional about how best to proceed with treatment
  • Before each infusion, you may be given additional medicine to decrease your chance of having a severe infusion reaction. Seek immediate medical attention if you experience any side effects during or after your infusions with your healthcare provider

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How should I prepare for my infusions?

A Rituxan infusion may last several hours, so you may want to bring along:

  • A book or some music to help pass the time
  • Some food, in case you get hungry (if the facility where you'll be receiving your infusion allows it)

Before every infusion, be sure to review the Rituxan Medication Guide that accompanies the full Prescribing Information with your healthcare provider.

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Can I take other medicines on the days of my infusions?

Your physician is your best source of information when it comes to your health. Talk with him or her to find out if you should take other medications on the days of your infusions.

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What are the possible side effects of Rituxan?

Rituxan can cause side effects that you should be aware of. The most serious side effects that can lead to death include:

  • Infusion reactions
  • Severe skin and mouth reactions
  • Hepatitis B virus (HBV) reactivation
  • Progressive multifocal leukoencephalopathy (PML)

Other serious and life-threatening side effects include:

  • Tumor lysis syndrome (TLS)
  • Serious infections
  • Heart problems
  • Kidney problems
  • Stomach and serious bowel problems that can sometimes lead to death
  • Low blood cell counts

Common side effects of Ritxuan include:

  • Infusion reactions
  • Chills
  • Infections
  • Body aches
  • Tiredness
  • Low white blood cell count

Other side effects with Rituxan include:

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

Please review the Rituxan Medication Guide for serious side effects and additional important side effect information.

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Where can I learn more?

If you have any additional questions about Rituxan or your RA, your doctor is your best source of information. You can also call the Rituxan Support Line at 1-877-474-8892 to speak to a nurse. Hours of operation are 9 AM-8 PM ET Monday-Friday with no Saturday hours.
For information about insurance coverage and reimbursement, you can contact Genentech Access Solutions® at 1-877-474-8892 or their Web site www.GenentechAccessSolutions.com.

back to FAQ list

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.