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IMBRUVICA® (ibrutinib) Has Helped Many People with CLL/SLL Live Longer Without Their Disease Progressing1

    IMBRUVICA®    

    Across several clinical trials described below, people treated with single-agent IMBRUVICA® lived longer than those taking another approved therapy.1 IMBRUVICA® will not work for every patient. Individual results may vary.

    During a clinical trial of 269 people aged 65 and older with CLL or SLL who had not been treated before:

    • People who took IMBRUVICA® had an 84% lower risk of disease progression or death compared to those taking a chemotherapy (chlorambucil). With a median follow-up of 18 months, 11% of IMBRUVICA® patients had disease progression or died compared to 48% taking a chemotherapy.
    • People who took IMBRUVICA® had a 56% lower risk of death compared to those taking chemotherapy. With a median follow-up of approximately 28 months, 8% of IMBRUVICA® patients died compared to 16% taking a chemotherapy

    During a different clinical trial of 391 previously treated people with CLL or SLL3:

    • People who took IMBRUVICA® had a 78% lower risk of disease progression or death compared to those taking an immunotherapy (ofatumumab). With a median follow-up of approximately 9 months, 18% of IMBRUVICA® patients had disease progression or died compared to 57% taking an immunotherapy
    • People who took IMBRUVICA® had a 57% lower risk of death. With a median follow-up of approximately 9 months, 8% of IMBRUVICA® patients died compared to 17% taking an immunotherapy

    In the same study, 127 previously treated people with CLL or SLL had chromosome 17p deletion (a mutation of chromosome 17).1 People with chromosome 17p deletion treated with IMBRUVICA® were 75% less likely to have their disease worsen or die compared to those taking another approved therapy for CLL/SLL.With a median follow-up of approximately 10 months, 25% of IMBRUVICA® patients had disease progression or died compared to 59% of ofatumumab patients

    IMBRUVICA® in combination with BR

    IMBRUVICA® may be prescribed by your doctor in combination with bendamustine and rituximab (BR) treatment

    In a clinical trial of 578 previously treated patients with CLL/SLL1:

    • Patients who took IMBRUVICA® + BR had an 80% lower risk of disease progression or death compared to those taking BR alone. With a median follow-up of 17 months, 19% of patients treated with IMBRUVICA® + BR had disease progression or died compared to 63% taking BR alone
    • BR is a commonly used chemoimmunotherapy regimen for adults with CLL/SLL2

    IMBRUVICA® in combination with obinutuzumab

    In a clinical trial described below, patients treated with IMBRUVICA® + obinutuzumab lived longer without disease progression or death than those taking another approved therapy.1

    During a clinical trial of 229 patients with CLL or SLL who had not been treated before, those treated with IMBRUVICA® + obinutuzumab had a 77% lower risk of disease progression or death. With a median follow-up of 31 months, 21% of patients treated with IMBRUVICA® + obinutuzumab had disease progression or died compared to 64% of patients treated with chlorambucil + obinutuzumab.1

    In this same study, 65% of the CLL/SLL patients had one or more of these high risk factors1

    • Unmutated IGHV (54%)
    • Chromosome 17p deletion/TP53 mutation (18%)
    • Chromosome 11q deletion (15%)

    When treated with IMBRUVICA® + obinutuzumab, these high-risk patients had an 85% reduction in risk of disease progression or death.1

    What you should know about the side effects of IMBRUVICA® (ibrutinib)1

    IMBRUVICA® may cause serious side effects, including1:

    • Bleeding problems (hemorrhage)    
    • High blood pressure (hypertension)
    • Infections    
    • Second primary cancers
    • Decrease in blood cell counts    
    • Tumor lysis syndrome (TLS)*
    • Heart rhythm problems (ventricular arrhythmias, atrial fibrillation, and atrial flutter)   

    *TLS is a disorder caused by the breakdown products of cancer cells, which can lead to kidney failure and other abnormalities. 
     

    The most common side effects in the clinical trials were:

    • Low white blood cell count
    • Low blood platelet count
    • Low red blood cell count
    • Diarrhea
    • Rash
    • Muscle and bone pain
    • Bruising
    • Nausea
    • Fatigue (tiredness)
    • Fever
    • Bleeding
    • Cough

    In the clinical trials, approximately 4%-10% of CLL or SLL patients stopped
    taking IMBRUVICA® because of side effects.
     

    This is not a complete list of side effects. Others may occur.
    Tell your doctor if you think you are experiencing side effects.

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      References:

      1. IMBRUVICA® (ibrutinib) Prescribing Information. Pharmacyclics LLC. 2019.
      2. Lymphoma Research Foundation. Getting the facts. https://www.lymphoma.org/aboutlymphoma/cll/clltreatment/. Accessed April 10, 2019. 
      3. Byrd JC, Brown JR, et al, Ibrutinib versus Ofatumumab in Previously Treated Chronic Lymphoid Leukemia, N Engl J Med 2014:371:213-23.

      IMPORTANT SIDE EFFECT INFORMATION

      Before taking IMBRUVICA®, tell your healthcare provider about all of your medical conditions, including if you:

      • have had recent surgery or plan to have surgery. Your healthcare provider may stop IMBRUVICA® for any planned medical, surgical, or dental procedure.
      • have bleeding problems.
      • have or had heart rhythm problems, smoke, or have a medical condition that increases your risk of heart disease, such as high blood pressure, high cholesterol, or diabetes.
      • have an infection.
      • have liver problems.
      • are pregnant or plan to become pregnant. IMBRUVICA® can harm your unborn baby. If you are able to become pregnant, your healthcare provider will do a pregnancy test before starting treatment with IMBRUVICA®.
        • Females should not become pregnant during treatment and for 1 month after the last dose of IMBRUVICA®.
        • Males should avoid getting female partners pregnant during treatment and for 1 month after the last dose of IMBRUVICA®.
      • are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take IMBRUVICA® or breastfeed.

      Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA® with certain other medicines may affect how IMBRUVICA® works and can cause side effects.

      How should I take IMBRUVICA®?

      • Take IMBRUVICA® exactly as your healthcare provider tells you to take it.
      • Take IMBRUVICA® 1 time a day.
      • Swallow IMBRUVICA® capsules and tablets whole with a glass of water.
      • Do not open, break, or chew IMBRUVICA® capsules.
      • Do not cut, crush, or chew IMBRUVICA® tablets.
      • Take IMBRUVICA® at about the same time each day.
      • If you miss a dose of IMBRUVICA® take it as soon as you remember on the same day. Take your next dose of IMBRUVICA® at your regular time on the next day. Do not take extra doses of IMBRUVICA® to make up for a missed dose.
      • If you take too much IMBRUVICA®, call your healthcare provider or go to the nearest hospital emergency room right away.

      What should I avoid while taking IMBRUVICA®?

      • You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) during treatment with IMBRUVICA®. These products may increase the amount of IMBRUVICA® in your blood

      What are the possible side effects of IMBRUVICA®?

      IMBRUVICA® may cause serious side effects, including:

      • Bleeding problems (hemorrhage) are common during treatment with IMBRUVICA®, and can also be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs of bleeding, including: blood in your stools or black stools (looks like tar), pink or brown urine, unexpected bleeding, or bleeding that is severe or that you cannot control, vomit blood or vomit looks like coffee grounds, cough up blood or blood clots, increased bruising, dizziness, weakness, confusion, change in your speech, or a headache that lasts a long time.
      • Infections can happen during treatment with IMBRUVICA®. These infections can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, weakness, confusion, or other signs or symptoms of an infection during treatment with IMBRUVICA®.
      • Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with IMBRUVICA®, but can also be severe. Your healthcare provider should do monthly blood tests to check your blood counts.
      • Heart rhythm problems (ventricular arrhythmias, atrial fibrillation and atrial flutter). Serious heart rhythm problems and death have happened in people treated with IMBRUVICA®, especially in people who have an increased risk for heart disease, have an infection, or who have had heart rhythm problems in the past. Tell your healthcare provider if you get any symptoms of heart rhythm problems, such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, chest discomfort, or you faint. If you develop any of these symptoms, your healthcare provider may do a test to check your heart (ECG) and may change your IMBRUVICA® dose.
      • High blood pressure (hypertension). New or worsening high blood pressure has happened in people treated with IMBRUVICA®. Your healthcare provider may start you on blood pressure medicine or change current medicines to treat your blood pressure.
      • Second primary cancers. New cancers have happened during treatment with IMBRUVICA®, including cancers of the skin or other organs.
      • Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.

      The most common side effects of IMBRUVICA® in adults with B-cell malignancies (MCL, CLL/SLL, WM and MZL) include:

      • diarrhea
      • muscle and bone pain
      • rash
      • bruising
      • nausea
      • tiredness
      • fever

      The most common side effects of IMBRUVICA® in adults with cGVHD include:

      • tiredness
      • bruising
      • diarrhea
      • mouth sores (stomatitis)
      • muscle spasms
      • nausea
      • pneumonia

      Diarrhea is a common side effect in people who take IMBRUVICA®. Drink plenty of fluids during treatment with IMBRUVICA® to help reduce your risk of losing too much fluid (dehydration) due to diarrhea. Tell your healthcare provider if you have diarrhea that does not go away.

      These are not all the possible side effects of IMBRUVICA®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

      General information about the safe and effective use of IMBRUVICA®

      Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IMBRUVICA® for a condition for which it was not prescribed. Do not give IMBRUVICA® to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about IMBRUVICA® that is written for health professionals.

      Please see the full Important Product Information.

      INDICATIONS

      What is IMBRUVICA® (ibrutinib)?

      IMBRUVICA® (ibrutinib) is a prescription medicine used to treat adults with:

      • Mantle cell lymphoma (MCL) who have received at least one prior treatment
      • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)
      • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion
      • Waldenström's macroglobulinemia (WM)
      • Marginal zone lymphoma (MZL) who require a medicine by mouth or injection (systemic therapy) and have received a certain type of prior treatment
      • Chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy 

      It is not known if IMBRUVICA® is safe and effective in children.

      IMPORTANT SIDE EFFECT INFORMATION

      INDICATIONS