IMBRUVICA (ibrutinib) Your ally to help fight previously treated CLL An oral therapy you take once a day, on your own, at a time and place convenient for you What is IMBRUVICA? IMBRUVICA is a prescription medicine used to treat people with: Chronic lymphocytic leukemia (CLL) who have received at least one prior treatment Chronic lymphocytic leukemia (CLL) with 17p deletion It is not known if IMBRUVICA is safe and effective in children. Important Safety Information IMBRUVICA may cause serious side effects, including: bleeding problems, infections, decrease in blood cell counts, heart rhythm problems, second primary cancers, tumor lysis syndrome and kidney problems. Please review the Important Product Information in back pocket. The information in this brochure is not intended to replace the advice of your doctor. If you have any questions about your IMBRUVICA treatment, be sure to contact your healthcare team. 8-10. Please review the accompanying Important Product Information.
Living with CLL CLL The following serious side effects have been reported in people taking : Bleeding problems can happen during treatment with that can be serious and may lead to death. 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, feel dizzy or weak, confusion, change in your speech, or a headache that lasts a long time. Your risk of bleeding may increase if you are also taking a blood thinner medicine. You have CLL, and by now you know what to expect. But here s a quick review of what happens with the disease. In leukemia, cancerous B cells grow out of control and crowd out the healthy blood cells. CLL is the most common type of leukemia in adults and usually progresses slowly. Infections can happen during treatment with. 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 while taking. Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with, 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, 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. Second primary cancers. New cancers have happened in people who have been treated with, 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. Kidney problems. Kidney failure and death have happened in people with MCL receiving treatment. This is not a complete list of side effects, and others may occur. Tell your doctor if you think you are experiencing side effects. CLL occurs when your body makes abnormal B cells, a type of white blood cell that makes antibodies to fight infections In CLL, abnormal B cells grow out of control and crowd out healthy blood cells About B CELLS is a medicine for patients with CLL who have had at least one earlier treatment A B cell is a type of white blood cell, also called a B lymphocyte, that makes antibodies to fight infections. is the first and only single-agent therapy specifically approved by FDA for the treatment of people with del 17p CLL DEL 17P You were prescribed because your CLL came back or didn t go away when you were previously treated for it. is an oral therapy you take once a day, on your own, at a time and place convenient for you For to work, it is very important to take it every day exactly the way your doctor tells you to works differently In some cases of CLL, part of a chromosome may be missing. This is called a deletion. One of the most common deletions occur in parts of chromosome 17. It works by blocking a specific protein in the blood, called Bruton s tyrosine kinase, or BTK By blocking BTK, may slow the spread of CLL But because BTK is also found in some normal cells, blocking it may cause side effects. These are explained later in this guide BTK A protein involved in communication signals within B cells. 2 3 About IMPORTANT SAFETY INFORMATION
Clinical trial experience with Because an oral medicine can be taken at home, this means that you have the responsibility to remember to take your medicine as directed by your doctor. In a clinical trial of approximately 400 people with previously treated CLL, more people who took did not get worse and/or lived longer than those taking another approved therapy. See page 6 for tips on remembering to take. In this trial, nearly 130 people had del 17p CLL; of those who had del 17p CLL, more of the 63 patients taking lived longer without their disease getting worse than patients taking the other treatment. is the first and only single-agent therapy specifically approved for the treatment of people with del 17p CLL. How to take CONSISTENT DOSING Do not change the dose or stop taking unless your doctor tells you to. Take capsules whole, by mouth, once a day with a full glass of water. Do not open, break, or chew CLL 3 CAPSULES DAILY Do not stop taking without talking to your doctor Try to take at approximately the same time each day Drink plenty of water throughout the day while you re taking is available only by prescription. Refill your prescription before you run out so you can take it as your doctor prescribed it Your doctor will monitor your response to treatment with Your doctor may obtain additional tests (such as blood tests and CT scans) to evaluate your response to You and your treatment team will decide on the best plan for you What should I know about side effects with? Store in its original container, with the lid tightly closed, at room temperature from 68 to 77 F (20 to 25 C). may cause side effects. In the clinical trial, approximately 5% of patients stopped taking the drug and 6% of patients took a lower dosage because of side effects. While taking : The most common side effects in the clinical trial Do not drink grapefruit juice Do not eat grapefruit Do not eat Seville oranges, which are often used in making marmalade These products may increase the amount of in your blood. Tell your doctor about any medicine, vitamins, or herbal supplements you are taking; some may interact with. 4 has helped many people live longer* Low blood platelet count Low white blood cell count Diarrhea Low red blood cell count Tiredness Muscle and bone pain Upper respiratory tract infection Rash Nausea Fever This is not a complete list of side effects. Others may occur. Tell your doctor if you think you are experiencing side effects. * was compared to a currently approved treatment. The people who took the other treatment experienced median time to disease progression of 8.1 months. Those who received did not reach a median for their disease progression. These study results represent a 78% reduction in the risk of disease progression or death. The study results also include a 57% risk reduction of death in previously treated people who took versus those who took the other drug. MEDIAN* The median is the middle number in a group of numbers that are arranged from lowest to highest. For example, in the group of numbers 1 to 11, 6 is the median. YOUR WHITE BLOOD CELL COUNT While taking, you may experience an increase in the number of a certain kind of white blood cell. Your doctor may call this increase lymphocytosis. In a clinical trial of 48 patients with CLL, lymphocytosis occurred in the first month of treatment. Lymphocytosis lasted a median* of 23 weeks, ranging from 1-104+ weeks for individual patients. Your doctor will monitor your blood counts and adjust your treatment if needed. Talk to your doctor about what your test results mean. 5 Taking IMBRUVICA (ibrutinib) An oral therapy you take once a day, on your own, at a time and place convenient for you
Establish a routine to remember your daily (ibrutinib) dose Keep in mind that your involvement is important to the success of your treatment. Because is a medication you take at home, only you can make sure that you re taking it every day the way your doctor prescribed it. It s helpful to develop a routine for taking, so you don t risk missing a dose. What to do if you miss a dose TALK TO YOUR HEALTHCARE TEAM ABOUT SIDE EFFECTS Tell your doctor about any upcoming surgeries Your doctor may stop for a brief time before or after any surgery, medical or dental procedure, or before starting some medications. Your doctor will tell you when to start taking again. Tips to help you remember to take Take your at the same time, morning or night, but always at the same time. REMEMBER TO TAKE EVERY DAY only works if you take it every day, the way your doctor directed, even if you are not having any symptoms. Keep a calendar or journal where you can record the time you take your dose each day. Set a watch alarm or your smartphone to alert you when it s time to take your. You are also part of a wider support community: Relationships with family and friends can provide valuable support as you manage your condition and treatment. Don t be afraid to turn to them for support. More formal support groups are also available, where you can meet other people living with CLL or other cancers. Your doctor and treatment facility should be able to provide you with contacts to groups in your area. Additionally, you can enroll in the YOU&iTM Support Program. See page 11 to learn more about this personalized support program that is available for people being treated with. Stay informed and motivated The online resources listed here are a good start for finding information about advances in treatment options for CLL, support groups, resources, and events in your area. American Cancer Society: www.cancer.org CancerCare: www.cancercare.org Cancer Support Community: www.cancersupportcommunity.org Leukemia & Lymphoma Society: www.lls.org Lymphoma Research Foundation: www.lymphoma.org Time your treatment to your daily walk. Ask a family member or friend to remind you when it s time to take your. National Comprehensive Cancer Network (NCCN): www.nccn.org/patients Patient Advocate Foundation: www.patientadvocate.org Patient Empowerment Network: www.powerfulpatient.org 6 As you move through your CLL treatment journey with, always keep in touch with your healthcare team and don t hesitate to ask questions. Your doctors, nurses, and pharmacists all bring specific types of expertise to your care and are ready to answer questions and provide you with support. Tips and Resources If you are having any side effects, remember to talk to your healthcare team. Your doctor may adjust your treatment. Mistakes can happen. If you forget a dose of, take it as soon as you remember on the same day. Do not take 2 doses of on the same day to make up for a missed dose. Call your doctor or pharmacist if you are not sure what to do. Surround yourself with support Advocacy Connector: www.advocacyconnector.com 7
IMPORTANT SAFETY INFORMATION WHAT SHOULD I TELL MY HEALTHCARE PROVIDER BEFORE TAKING (ibrutinib)? Before you take, 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 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. can harm your unborn baby. You should not become pregnant while taking. are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take or breastfeed. You should not do both. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking with certain other medicines may affect how works and can cause side effects. How should I take? Take exactly as your healthcare provider tells you to take it. Swallow capsules whole with a glass of water. Do not open, break, or chew capsules. Take 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 at your regular time on the next day. Do not take 2 doses of on the same day to make up for a missed dose. What should I avoid while taking? You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) while you are taking. These products may increase the amount of in your blood. may cause serious side effects, including: Bleeding problems can happen during treatment with that can be serious and may lead to death. 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, feel dizzy or weak, confusion, change in your speech, or a headache that lasts a long time. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Infections can happen during treatment with. 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 while taking. Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with, 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, 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. Second primary cancers. New cancers have happened in people who have been treated with, 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. Important Safety Information Take 1 time a day. WHAT ARE THE POSSIBLE SIDE EFFECTS OF? Kidney problems. Kidney failure and death have happened in people with MCL receiving treatment. The most common side effects of include: diarrhea, tiredness, muscle and bone pain, bruising, nausea, upper respiratory tract infection, and rash. Diarrhea is a common side effect in people who take. Drink plenty of fluids during treatment with 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. Please review the accompanying Important Product Information. 8 9
IMPORTANT SAFETY INFORMATION (Continued) GENERAL INFORMATION ABOUT THE SAFE AND EFFECTIVE USE OF Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use for a condition for which it was not prescribed. Do not give 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 that is written for health professionals. These are not all the possible side effects of. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. - Discover a World of Support The YOU&i Support program is a personalized program that includes information on access and affordability, nurse call support, and resources for patients being treated with. Access Support Provides you with rapid* benefit investigation *2 business days. Provides you information about the prior authorization process Provides you information about insurance appeals process Refers you to a specialty pharmacy for processing and delivery of your medication YOU&iTM Start - If you are experiencing an insurance coverage decision delay, this program may give you access to Eligible patients who have been prescribed for an FDA-approved indication, and who are experiencing an insurance coverage decision delay greater than 5 business days, can receive a free, 30-day supply of If decision delay persists, an additional free, 30-day supply may be provided The free product is offered to eligible patients without any purchase contingency or other obligation Affordability Support YOU&iTM Instant Savings Program: If you have commercial health insurance and meet eligibility requirements, you will pay no more than $10 per month for Month refers to a 30-day supply. Subject to a maximum benefit, 12 months after first prescription fill, 12 monthly fills (1-year supply), whichever comes first, unless the maximum dollar benefit has been reached. Not valid for patients enrolled in Medicare or Medicaid. Foundation Referral: If you need additional financial support, we can provide you information on independent foundations that may be able to provide financial support TO ENROLL IN YOU&iTM SUPPORT PROGRAM visit www. youandisupport. com or call 1-877-877-3536, Monday through Friday 8 AM 8 PM ET. Other Resource: Johnson & Johnson Patient Assistance Foundation, Inc. (JJPAF) is committed to providing access to medicines for uninsured individuals who lack the financial resources to pay for them. If you need and are uninsured and unable to pay for your medicine, please contact a JJPAF program specialist at 1-800-652-6227 from 9:00 am to 6:00 pm ET, or visit the foundation website at www.jjpaf.org to see if you might qualify for assistance. 10 11 YOU&i SupportTM program Please review the accompanying Important Product Information. Nurse Call Support & Resources Informational phone calls with YOU&iTM nurses about and your disease Ongoing tips, tools, and other resources sent through mail, email and text Patient Starter Kits for new patients
See the inside back cover to learn about the YOU&i Support TM program To receive more information as it becomes available, visit www.imbruvica.com or call 1-877-877-3536. Pharmacyclics, Inc. 2015 Janssen Biotech, Inc. 2015 01/15 PRC-00862