Safety Information
 

The First RITUXAN Infusion and What to Expect

The first infusion of RITUXAN is given slowly. If there is a reaction, the infusion is slowed or stopped. The first treatment may take 4 to 6 hours or more.

Your doctor should prescribe medicines before each infusion of RITUXAN to reduce side effects of infusions (such as fever and chills).

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 feel faint
  • Palpitations (feel like your heart is racing or fluttering)
  • Chest pain

These are not all of the side effects that are possible. Other serious, side effects can occur. Be sure to talk to your doctor about all of the side effects that are possible, even after the first RITUXAN infusion.

  • Read the medication guide attached to the prescribing information—Talk to your doctor if you have any questions about your treatment with RITUXAN plus FC chemotherapy
  • Ask questions—Be sure to tell your doctor or nurse about any concerns you have before beginning your infusion
  • Pack something to eat or drink—There are no special rules about what you should eat or drink before an infusion. But you may be at the clinic most of the day. So you may want to bring some snacks or a packed meal
  • Bring activities—You may want to bring activities such as crossword puzzles or a book to read to help you pass the time
  • Arrange transportation—The medicines to reduce side effects may make you drowsy or dizzy, so it is a good idea to have someone else drive you home after treatments
  • Ask your doctor or nurse about your medicine—If you take any other medicines, remind your doctor or nurse. Your doctor may give you special instructions that day

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.

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INDICATIONS

RITUXAN® (Rituximab) is indicated for the treatment of:

  • CD20-positive chronic lymphocytic leukemia in combination with FC chemotherapy as an initial treatment or as a treatment after disease has recurred

People with serious infections should not receive RITUXAN.

Important Safety Information

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

Tell your doctor right away about any side effect you experience. RITUXAN can cause serious side effects that can lead to death, including:

  • Infusion Reactions: may occur during or within 24 hours of your infusion. Your doctor should give you medicines before your treatment. Symptoms can include hives, rash, itching, facial or oral swelling, sudden cough, shortness of breath, difficulty breathing, weakness, dizziness, feeling faint, racing heart, or chest pain
  • Severe Skin and Mouth Reactions: symptoms can include painful sores, ulcers, or blisters on your skin, lips or mouth; peeling skin; rash; or pustules
  • Hepatitis B Virus (HBV) Reactivation: may cause serious liver problems including liver failure and death. If you have had hepatitis B or are a carrier of HBV, receiving RITUXAN could cause the virus to become an active infection again. You should not receive RITUXAN if you have active HBV liver disease. Your doctor will do blood tests to check for HBV infection prior to treatment and will monitor you during and for several months following your treatment
  • Progressive Multifocal Leukoencephalopathy (PML): a rare, serious brain infection that can lead to severe disability and death and for which there is no known prevention, treatment, or cure. Symptoms can include difficulty thinking, loss of balance, changes in speech or walking, weakness on one side of your body, or blurred or lost vision

What are the additional possible serious side effects of RITUXAN?

Tell your doctor right away about any side effect you experience. RITUXAN can cause serious side effects that can lead to death, including:

  • Tumor Lysis Syndrome (TLS): may cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, and can lead to death. Your doctor may give you medicines before your treatment to help prevent TLS
  • Serious Infections: can happen during and after treatment and can lead to death. These infections may be bacterial, fungal, or viral. Symptoms can include fever; cold or flu symptoms; earache or headache; pain during urination; white patches in the mouth or throat; cuts or scrapes that are red, warm, swollen, or painful
  • Heart Problems: symptoms can include chest pain and irregular heartbeats that may require treatment. Your doctor may need to stop your treatment
  • Kidney Problems: your doctor should do blood tests to check how well your kidneys are working
  • Stomach and Serious Bowel Problems: can include blockage or tears in the bowel that can lead to death. Stomach area pain during treatment can be a symptom
  • Low Blood Cell Counts: your blood cell counts may be monitored during treatment

The most common side effects of RITUXAN are infusion reactions, chills, infections, body aches, tiredness, and low white blood cells.

Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. It is not known if RITUXAN may harm your unborn baby or pass into your breast milk. Women should use birth control while using RITUXAN and for 12 months after treatment.

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all of the possible side effects of RITUXAN. For more information, ask your doctor or pharmacist.

Please see the RITUXAN full Prescribing Information, including the Medication Guide, for additional important safety information at www.RITUXAN.com.

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.