IMPORTANT SIDE EFFECT INFORMATION

It is important to consider and talk to your doctor about the possible side effects of taking Rituxan® (rituximab). See below for important side effect information about Rituxan.

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.

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 

Severe Skin and Mouth Reactions: painful sores or ulcers on your skin, lips, or in your mouth; blisters, peeling skin, rash, or pustules

Hepatitis B Virus (HBV) Reactivation: 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

Progressive Multifocal Leukoencephalopathy (PML): a rare, serious brain infection caused by the JC virus

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 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. You should not get certain vaccines before or after receiving Rituxan. Some types of vaccines can spread to people with a weakened immune system and cause serious problems
  • Have taken Rituxan in the past
  • Have any other medical conditions
  • 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. Especially tell your doctor if you take or have taken:
    • A Tumor Necrosis Factor (TNF) inhibitor medicine
    • A Disease Modifying Anti-Rheumatic Drug (DMARD)

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 or may cause an abnormal heart rhythm

Serious Infections: Serious infections can happen during and after treatment with Rituxan and can lead to death

Heart Problems: Rituxan may cause chest pain and irregular heartbeats, 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: 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

What are common side effects during treatment with Rituxan?

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

Other side effects include:

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

Tell your doctor or healthcare team 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 (800) FDA‐1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835‐2555.

Please see the Rituxan Prescribing Information and Medication Guide including Most Serious Side Effects for additional Important Side Effect Information.

If you have any questions about this information, be sure to discuss them with your doctor.

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