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 lead to death, including:
  • Infusion reactions: infusion reactions are the most common side effect of Rituxan treatment. Serious infusion reactions can happen during your infusion or within 24 hours after your infusion of Rituxan. Your doctor should give you medicines before your infusion of Rituxan to decrease your chance of having a severe infusion reaction

    Tell your doctor 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 feeling faint
    • Palpitations (feeling like your heart is racing or fluttering)
    • Chest pain
  • Severe skin and mouth reactions: tell your doctor 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 Rituxan treatment, your doctor 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. You should not receive Rituxan if you have active hepatitis B liver disease. Your doctor will monitor you for hepatitis B infection during and for several months after you stop receiving Rituxan
  • 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

    Tell your doctor right away if you have any of the following symptoms or if anyone close to you notices these symptoms:
    • Confusion or problems thinking
    • Loss of balance
    • Change in the way you walk or talk
    • Decreased strength or weakness on one side of your body
    • Blurred vision or loss of vision

What should I tell my doctor before receiving Rituxan?

Before receiving Rituxan, tell your doctor if you:
  • Have had a severe infusion reaction to Rituxan in the past
  • Have a history of heart problems, irregular heartbeat, chest pain, or lung or kidney problems
  • Have had an infection, currently have an infection, or have a weakened immune system
  • Have had a recent vaccination or are scheduled to receive vaccinations
  • Are pregnant or planning to become pregnant. Talk to your doctor about effective birth control
  • Are breast-feeding or plan to breast-feed
  • Are taking any medications, including prescription and nonprescription medicines, vitamins, and herbal supplements

What are the possible side effects of Rituxan?

Rituxan can cause serious and life-threatening 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
    Your doctor may do blood tests to check you for TLS. Your doctor may give you medicine to help prevent TLS.
  • Serious infections: serious infections can happen during and after treatment with Rituxan, and can lead to death. Rituxan 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 patients 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. Call your doctor 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
    • White patches in the mouth or throat
    • Cuts, scrapes, or incisions that are red, warm, swollen, or painful
  • Heart problems: Rituxan may cause chest pain and irregular heartbeat, which may need treatment, or your doctor may decide to stop your treatment with Rituxan
  • Kidney problems: especially if you are receiving Rituxan for NHL. Your doctor 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 to treat non-Hodgkin’s lymphoma. Tell your doctor right away if you have any stomach area pain during treatment with Rituxan
  • Low blood cell counts: your doctor may do blood tests during treatment with Rituxan to check your blood cell counts
    • White blood cells: white blood cells fight against bacterial infections. Low white blood cells can cause you to get infections, which may be serious
    • Red blood cells: red blood cells carry oxygen to your body tissues and organs
    • Platelets: platelets are blood cells that help your blood to clot

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

How will I receive Rituxan?

    • Rituxan is given by infusion through a needle placed in a vein (intravenous infusion) in your arm. Talk to your doctor about how you will receive Rituxan
    • Your doctor may prescribe medicines before each infusion of Rituxan to reduce side effects of infusions such as fever and chills
    • Your doctor should do regular blood tests to check for side effects of Rituxan

Before each Rituxan treatment, your doctor or nurse will ask you questions about your general health. Tell your doctor or nurse about any new symptoms.

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.

Please see the Rituxan Medication Guide including most serious side effects for additional important side effect information.

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.

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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 lead to death, including:
  • Infusion reactions: infusion reactions are the most common side effect of Rituxan treatment. Serious infusion reactions can happen during your infusion or within 24 hours after your infusion of Rituxan. Your doctor should give you medicines before your infusion of Rituxan to decrease your chance of having a severe infusion reaction

    Tell your doctor 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 feeling faint
    • Palpitations (feeling like your heart is racing or fluttering)
    • Chest pain
  • Severe skin and mouth reactions: tell your doctor 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 Rituxan treatment, your doctor 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. You should not receive Rituxan if you have active hepatitis B liver disease. Your doctor will monitor you for hepatitis B infection during and for several months after you stop receiving Rituxan
  • 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

    Tell your doctor right away if you have any of the following symptoms or if anyone close to you notices these symptoms:
    • Confusion or problems thinking
    • Loss of balance
    • Change in the way you walk or talk
    • Decreased strength or weakness on one side of your body
    • Blurred vision or loss of vision

What should I tell my doctor before receiving Rituxan?

Before receiving Rituxan, tell your doctor if you:
  • Have had a severe infusion reaction to Rituxan in the past
  • Have a history of heart problems, irregular heartbeat, chest pain, or lung or kidney problems
  • Have had an infection, currently have an infection, or have a weakened immune system
  • Have had a recent vaccination or are scheduled to receive vaccinations
  • Are pregnant or planning to become pregnant. Talk to your doctor about effective birth control
  • Are breast-feeding or plan to breast-feed
  • Are taking any medications, including prescription and nonprescription medicines, vitamins, and herbal supplements

What are the possible side effects of Rituxan?

Rituxan can cause serious and life-threatening 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
    Your doctor may do blood tests to check you for TLS. Your doctor may give you medicine to help prevent TLS.
  • Serious infections: serious infections can happen during and after treatment with Rituxan, and can lead to death. Rituxan 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 patients 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. Call your doctor 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
    • White patches in the mouth or throat
    • Cuts, scrapes, or incisions that are red, warm, swollen, or painful
  • Heart problems: Rituxan may cause chest pain and irregular heartbeat, which may need treatment, or your doctor may decide to stop your treatment with Rituxan
  • Kidney problems: especially if you are receiving Rituxan for NHL. Your doctor 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 to treat non-Hodgkin’s lymphoma. Tell your doctor right away if you have any stomach area pain during treatment with Rituxan
  • Low blood cell counts: your doctor may do blood tests during treatment with Rituxan to check your blood cell counts
    • White blood cells: white blood cells fight against bacterial infections. Low white blood cells can cause you to get infections, which may be serious
    • Red blood cells: red blood cells carry oxygen to your body tissues and organs
    • Platelets: platelets are blood cells that help your blood to clot

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

How will I receive Rituxan?

    • Rituxan is given by infusion through a needle placed in a vein (intravenous infusion) in your arm. Talk to your doctor about how you will receive Rituxan
    • Your doctor may prescribe medicines before each infusion of Rituxan to reduce side effects of infusions such as fever and chills
    • Your doctor should do regular blood tests to check for side effects of Rituxan

Before each Rituxan treatment, your doctor or nurse will ask you questions about your general health. Tell your doctor or nurse about any new symptoms.

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.

Please see the Rituxan Medication Guide including most serious side effects for additional important side effect information.