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Using IMBRUVICA® Using IMBRUVICA®

IMBRUVICA® for CLL/SLL

IMBRUVICA® (ibrutinib) is a once-daily, oral CLL medication
that can be taken with or without chemotherapy

Understanding chronic lymphocytic leukemia (CLL) and small
lymphocytic lymphoma (SLL)

Researchers continue to learn more about how changes in blood cells occur in chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). A diagnosis of CLL/SLL may seem overwhelming at first, but understanding it can help you feel more at ease.

Desktop_CLL_abnormal cell
In CLL/SLL, the abnormal B cells
crowd out healthy B cells.

B cells are a type of white blood cell. They are an important part of your immune system—your body’s defense against infection. In CLL, abnormal B cells grow out of control and may crowd out healthy B cells in the lymph nodes, bone marrow, and other organs. When this happens, you are more likely to get infections and experience other symptoms mentioned below.1,3

What is the difference between CLL and SLL?

The main difference is where the cancer cells are found. In CLL, most of the cancer cells are in the blood and bone marrow. In SLL, the cancer cells are mainly in the lymph nodes.4

Chronic symptoms of CLL may include1,3:

  • Enlarged lymph nodes

  • Frequent infections

  • Fever

  • Abdominal pain or fullness

  • Night sweats

  • Tiredness

  • Unexpected weight loss

  • Easy bruising and bleeding


Read more about CLL/SLL

Want to learn more about CLL/SLL?

 

Read the brochure for patients with CLL/SLL

IMBRUVICA® (ibrutinib) has helped many people with CLL/SLL live longer

In a clinical trial of 269 people (65 years and older) with CLL or SLL who had not yet received any prior therapy5:

  • Patients treated with IMBRUVICA® were 84% less likely to have their disease worsen or die during the trial compared to another approved therapy for CLL

  • Patients treated with IMBRUVICA® were 56% less likely to die during this trial compared to another approved therapy for CLL

In a clinical trial of 391 previously treated people with CLL or SLL5:

  • Patients treated with IMBRUVICA® were 78% less likely to have their disease worsen or die during the trial compared to another approved therapy for CLL

  • Patients treated with IMBRUVICA® were 57% less likely to die during the trial compared to another approved therapy for CLL

Want to learn more about CLL/SLL?

 

Read the brochure for patients with CLL/SLL

IMBRUVICA® may enhance your bendamustine and rituximab treatment

Patients who took IMBRUVICA® + BR (bendamustine + rituximab) were 80% less likely to have their disease worsen or die compared to those taking BR alone5

  • BR is a commonly used chemoimmunotherapy regimen for people with CLL/SLL4

  • 578 people with CLL or SLL who had received prior treatment were in the clinical trial5

What you should know about IMBRUVICA® side effects?

IMBRUVICA® may cause serious side effects, including5:

  • Bleeding problems

  • High blood pressure (hypertension)

  • Infections

  • Secondary primary cancers

  • Decrease in blood cell counts

  • Tumor lysis syndrome (TLS)*

  • Heart rhythm problems (atrial fibrillation and atrial flutter)

*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 CLL/SLL clinical trials were5:

  • Low white blood cell count

  • Rash

  • Low blood platelet count

  • Bruising

  • Low red blood cell count

  • Fatigue (tiredness)

  • Diarrhea

  • Fever

  • Muscle and bone pain

  • Bleeding

  • Nausea

In clinical trials, 4%-10% of CLL/SLL patients stopped taking the drug because of side effects.4

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

 

References: 1. American Cancer Society. Chronic lymphocytic leukemia. http://www.cancer.org/acs/groups/cid/documents/webcontent/003111-pdf.pdf. Accessed October 30, 2015. 2. American Cancer Society. Non-Hodgkin lymphoma. Atlanta, GA: American Cancer Society, 2014. 3. Leukemia and Lymphoma Society. The CLL Guide: Information for patients and caregivers. Chronic lymphocytic leukemia. Revised 2014. https://www.lls.org/sites/default/files/file_assets/cllguide.pdf. Accessed August 6, 2015. National Cancer Institute. 4. Lymphoma Research Foundation. Getting the Facts. http://www.lymphoma.org/atf/cf/%7Baaf3b4e5-2c43-404c-afe5-fd903c87b254%7D/LRF_FACTSHEET_CLL_SLL_2013.PDF. Accessed May 11, 2016. 5. IMBRUVICA® (ibrutinib) Prescribing Information. Pharmacyclics LLC. 2016.

 

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IMPORTANT SIDE EFFECT INFORMATION

What should I tell my healthcare provider before taking IMBRUVICA®?

Before you take 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 whole with a glass of water. Do not open, break, or chew IMBRUVICA® capsules
  • 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 2 doses of IMBRUVICA® on the same day 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 can happen during treatment with IMBRUVICA® that can 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 (atrial fibrillation and atrial flutter). Heart rhythm problems 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
  • 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 in people who have been treated 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® include: diarrhea, muscle and bone pain, rash, nausea, bruising, tiredness, and fever.

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.

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.

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.

Please review the full Important Product Information.

INDICATIONS

What is IMBRUVICA® (ibrutinib)?

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

  • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL)
  • Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion
  • Waldenström's macroglobulinemia (WM)
  • Mantle cell lymphoma (MCL) who have received at least one prior treatment
    • For MCL, IMBRUVICA® is approved on response. Data are not yet available to show if IMBRUVICA® improves survival or symptoms

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


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IMBRUVICA® (ibrutinib) capsules are covered by U.S. Pat. Nos. 7,514,444; 8,008,309; 8,497,277; 8,476,284; 8,697,711 and 8,703,780.

© Pharmacyclics LLC. 2016

© Janssen Biotech, Inc. 2016

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