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Your Initial RITUXAN Treatment

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Initial treatment therapy
Initial treatment infusion schedule for CLL
Select Important Safety Information

When it's time for therapy, your CLL journey turns to initial treatment

As initial treatment, RITUXAN plus FC chemotherapy may be given for CLL. These drugs work in different ways to find and attack the cells where cancer starts.

RITUXAN targets and attaches to the CD20 protein found on the surface of blood cells with cancer and some healthy blood cells. Once attached to the CD20 protein, RITUXAN is thought to work in different ways including:

  1. By helping your own immune system destroy the cancer cells
  2. By destroying the cancer cells on its own

In addition, RITUXAN can also harm healthy cells in your body.

FC chemotherapy attacks fast-growing cells. These include cancer cells and healthy cells like hair and the lining of your intestines.

Combining RITUXAN with FC chemotherapy may improve CLL treatment response.

In one study (called CLL8), patients who received RITUXAN plus FC chemotherapy as initial treatment experienced an average of 3.3 years without their cancer advancing compared with 2.6 years with FC chemotherapy by itself. Eighty-six percent of patients who received RITUXAN plus FC chemotherapy went into either partial or complete remission for a period of time, compared with 73% of patients who received FC chemotherapy by itself. These results were from a clinical trial and may not be the same as what you experience.

You will have up to 6 cycles, or rounds, of treatment. You will be given RITUXAN and FC chemotherapy at the beginning of each cycle. Each cycle is 28 days.

  • For Cycle 1, RITUXAN and FC chemotherapy are given on different days:
    • Your RITUXAN infusion is on the day before the 28-day cycle starts
    • In the first 3 days of the 28-day cycle, you will receive FC chemotherapy
  • For Cycles 2 through 6, RITUXAN and FC chemotherapy are given on the first day of each cycle. FC chemotherapy will also be given on Days 2 and 3

A full course of RITUXAN plus FC chemotherapy will take approximately 6 months to complete.

Initial treatment infusion schedule for CLL

Initial Rituxan treatment infusion schedule

Select Important Safety Information

RITUXAN for the treatment of CD20-positive chronic lymphocytic leukemia in combination with FC chemotherapy as an initial treatment

Severe side effects reported more often in patients receiving RITUXAN and FC chemotherapy vs. FC chemotherapy alone were infusion-related reactions; and decreased blood cell counts, including decreases in white blood cells with or without a fever. Severe side effects reported more commonly in the elderly (≥70 years of age) versus younger patients were decreased blood cell counts, including decreases in white blood cells with or without a fever and red blood cells.

CLL8 Treatment Considerations

Chronic lymphocytic leukemia patients 70 years of age or older were not shown to benefit from RITUXAN in combination with FC chemotherapy as an initial treatment.

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RITUXAN is available by prescription only.

Important Safety Information & Indications

INDICATIONS

What is RITUXAN?

RITUXAN is a prescription medicine used to treat adults with:

  • Non-Hodgkin’s Lymphoma (NHL): alone or with other chemotherapy medicines.
  • Chronic Lymphocytic Leukemia (CLL): with the chemotherapy medicines fludarabine and cyclophosphamide.

It is not known if RITUXAN is safe and effective in children with CLL.

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

RITUXAN can cause serious side effects that can lead to death, including:

  • Infusion-Related Reactions: Infusion-related reactions are very common side effects of RITUXAN treatment. Serious infusion-related reactions can happen during your infusion or within 24 hours after your infusion of RITUXAN. Your healthcare provider should give you medicines before your infusion of RITUXAN to decrease your chance of having a severe infusion-related reactions. Tell your healthcare provider 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
  • Severe Skin and Mouth Reactions: Tell your healthcare provider 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 you receive your RITUXAN treatment, your healthcare provider 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. Your healthcare provider will monitor you for hepatitis B infection during and for several months after you stop receiving RITUXAN.
    Tell your healthcare provider right away if you get worsening tiredness, or yellowing of your skin or white part of your eyes during treatment with RITUXAN
  • Progressive Multifocal Leukoencephalopathy (PML): PML is a rare, serious brain infection caused by a virus that can happen in people who receive RITUXAN. People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML.
    Tell your healthcare provider right away if you have new or worsening symptoms or if anyone close to you notices these symptoms:
    • Confusion
    • Dizziness or loss of balance
    • Difficulty walking or talking
    • Decreased strength or weakness on one side of your body
    • Vision problems, such as blurred vision or loss of vision

What should I tell my healthcare provider before receiving RITUXAN?

Before receiving RITUXAN, tell your healthcare provider if you:

  • Have had a severe reaction to RITUXAN or a rituximab product
  • Have a history of heart problems, irregular heartbeat, or chest pain
  • Have lung or kidney problems
  • Have had an infection, currently have an infection, or have a weakened immune system
  • Have or have had any severe infections including:
    • Hepatitis B virus (HBV)
    • Hepatitis C virus (HCV)
    • Cytomegalovirus (CMV)
    • Herpes simplex virus (HSV)
    • Parvovirus B19
    • Varicella zoster virus (chickenpox or shingles)
    • West Nile Virus
  • Have had a recent vaccination or are scheduled to receive vaccinations. You should not receive certain vaccines before or during treatment with RITUXAN
  • Have any other medical conditions
  • Are pregnant or plan to become pregnant. Talk to your healthcare provider about the risks to your unborn baby if you receive RITUXAN during pregnancy. Females who are able to become pregnant should use effective birth control (contraception) during treatment with RITUXAN and for 12 months after the last dose of RITUXAN. Talk to your healthcare provider about effective birth control. Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with RITUXAN
  • Are breastfeeding or plan to breastfeed. RITUXAN may pass into your breast milk. Do not breastfeed during treatment and for 6 months after your last dose of RITUXAN
  • Are taking any medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements

What are the possible side effects of RITUXAN?

RITUXAN can cause serious 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
    TLS can happen within 12 to 24 hours after an infusion of RITUXAN. Your healthcare provider may do blood tests to check you for TLS. Your healthcare provider may give you medicine to help prevent TLS. Tell your healthcare provider right away if you have any of the following signs or symptoms of TLS:
    • Nausea
    • Vomiting
    • Diarrhea
    • Lack of energy
  • Serious Infections: Serious infections can happen during and after treatment with RITUXAN, and can lead to death. RITUXAN can increase your risk of getting infections and 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 people 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. People with serious infections should not receive RITUXAN. Tell your healthcare provider 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
    • Cold sores in the mouth or throat
    • Cuts, scrapes, or incisions that are red, warm, swollen, or painful
  • Heart Problems: RITUXAN may cause chest pain, irregular heartbeats, and heart attack. Your healthcare provider may monitor your heart during and after treatment with RITUXAN if you have symptoms of heart problems or have a history of heart problems. Tell your healthcare provider right away if you have chest pain or irregular heart-beats during treatment with RITUXAN
  • Kidney Problems: especially if you are receiving RITUXAN for NHL. RITUXAN can cause severe kidney problems that lead to death. Your healthcare provider 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. Tell your healthcare provider right away if you have any stomach-area (abdomen) pain or repeated vomiting during treatment with RITUXAN

Your healthcare provider will stop treatment with RITUXAN if you have severe, serious, or life-threatening side effects.

What are the most common side effects during treatment with RITUXAN?

  • Infusion-related reactions
  • Infections (may include fever, chills)
  • Body aches
  • Tiredness
  • Nausea

Other side effects include:

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

These are not all of the possible side effects with RITUXAN.

Please see the RITUXAN full Prescribing Information, including the Medication Guide, for additional Important Safety Information.

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.