UNDERSTANDING MULTIPLE MYELOMA AND YOUR TREATMENT. It is not known if REVLIMID is safe and effective in children under 18 years of age My Moment

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1 TREATMENT OVERVIEW REVLIMID (lenalidomide) is used with dexamethasone to treat patients with multiple myeloma (MM) REVLIMID should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial It is not known if REVLIMID is safe and effective in children under 18 years of age My Moment Dressing up to spend a night with the one I love. UNDERSTANDING MULTIPLE MYELOMA AND YOUR TREATMENT Boxed WARNINGS and Medication Guide, in pocket and Important Safety Information on pages 4 10.

2 REVLIMID (lenalidomide) is used with dexamethasone to treat patients with multiple myeloma (MM) REVLIMID should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial It is not known if REVLIMID is safe and effective in children under 18 years of age 2

3 Read through this guide carefully. The information inside provides details you should know about precautions and side effects associated with REVLIMID. Speak with your doctor or nurse if you have questions or concerns about your treatment. 3

4 Important Safety Information IMPORTANT SAFETY INFORMATION WARNING: Risk to unborn babies, low blood counts, and blood clots Before you begin taking REVLIMID, you must read and agree to all of the instructions in the REVLIMID REMS program (formerly known as the RevAssist program). REVLIMID may cause serious side effects including: Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or who plan to become pregnant must not take REVLIMID. REVLIMID is similar to the medicine thalidomide (THALOMID ). We know thalidomide can cause severe life-threatening birth defects. REVLIMID has not been tested in pregnant females. REVLIMID has harmed unborn animals in animal testing. In females of childbearing potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Females must not get pregnant: for at least 4 weeks before starting REVLIMID while taking REVLIMID during any breaks (interruptions) in your treatment with REVLIMID for at least 4 weeks after stopping REVLIMID If you become pregnant while taking REVLIMID, stop taking it right away and call your healthcare provider. REVLIMID causes low white blood cells (neutropenia) and low platelets (thrombocytopenia) in most patients. REVLIMID causes a higher chance for blood clots in your veins (deep vein thrombosis), lungs (pulmonary embolism), and arteries (heart attack or stroke). Important Safety Information Risk to Unborn Babies REVLIMID may cause serious birth defects or death of an unborn baby. Do not get pregnant while taking REVLIMID Females who can become pregnant Will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling Must agree to use 2 different forms of effective birth control at the same time every time for 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID If you become pregnant while taking REVLIMID, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call for medical information. Healthcare providers and patients should report all cases of pregnancy to: FDA MedWatch at FDA-1088 and Celgene Corporation at Do not get pregnant and do not breastfeed while taking REVLIMID. REVLIMID must not be used by females who are pregnant or breastfeeding. It is not known if REVLIMID passes into your breast milk and harms your baby Males REVLIMID can pass into human semen. Males, including those who have had a vasectomy, must use a latex or synthetic condom during any sexual contact with a pregnant female or a female who can become pregnant. Males must do this while taking REVLIMID, during any breaks (interruptions) in your treatment with REVLIMID, and for 4 weeks after stopping REVLIMID. (If you or your partner are allergic to latex, please consult with your healthcare provider) 4 5

5 Important Safety Information Important Safety Information Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant. Men, if your female partner becomes pregnant, you should call your healthcare provider right away Do not donate sperm while taking REVLIMID, during any breaks (interruptions) in your treatment with REVLIMID, and for 4 weeks after stopping REVLIMID. If a female becomes pregnant with your sperm, the baby may be exposed to REVLIMID and may be born with birth defects Females and Males Do not share REVLIMID with other people. It may cause birth defects and other serious problems Do not donate blood while you take REVLIMID, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID. If someone who is pregnant gets your donated blood, her baby may be exposed to REVLIMID and may be born with birth defects Low white blood cells (neutropenia) and low platelets (thrombocytopenia) REVLIMID causes low white blood cells and low platelets in most people. You may need a blood transfusion or certain medicines if your blood counts drop too low Blood clots Blood clots in the arteries, veins, and lungs happen more often in people who take REVLIMID Risk is even higher for people with multiple myeloma taking REVLIMID with dexamethasone Heart attacks and stroke also happen more often in people taking REVLIMID with dexamethasone To reduce this increased risk, most people who take REVLIMID will also take a blood thinner medicine Before taking REVLIMID tell your healthcare provider: if you have had a blood clot in the past, have high blood pressure, you smoke, you have been told you have high level of fat in your blood (hyperlipidemia), and all medicines you take. Certain other medicines can also increase your risk for blood clots Call your healthcare provider or get medical help right away if you get any of the following signs or symptoms during treatment with REVLIMID: Blood clot in lung, arm or leg: shortness of breath, chest pain, or arm or leg swelling. Heart attack: chest pain that may spread to arms, neck, jaw, back or stomach area, feeling sweaty, shortness of breath, feeling sick or vomiting. Stroke: sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech or balance Your healthcare provider should check your blood counts often especially during the first several months of treatment with REVLIMID, and then at least monthly. Tell your healthcare provider if you develop any bleeding or bruising during treatment with REVLIMID 6 7

6 Important Safety Information Important Safety Information Other serious side effects Increased risk of death in people who have chronic lymphocytic leukemia (CLL). People with CLL who take REVLIMID have an increased risk of death compared with people who take the medicine chlorambucil. REVLIMID may cause you to have serious heart problems that can lead to death, including atrial fibrillation, heart attack, or heart failure. You should not take REVLIMID if you have CLL unless you are participating in a controlled clinical trial Risk of new cancers (malignancies). People with MM who receive REVLIMID and melphalan and a blood stem cell transplant have a higher risk of developing new cancers, including certain blood cancers (acute myelogenous leukemia or AML and myelodysplastic syndrome or MDS) and a type of lymphoma called Hodgkin lymphoma. Talk with your healthcare provider about your risk of developing new cancers if you take REVLIMID. Your healthcare provider will check you for new cancers during your treatment with REVLIMID Severe liver problems, including liver failure and death. Tell your healthcare provider right away if you develop any of the following symptoms: yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of your stomach area, bleeding or bruising more easily than normal and feeling very tired. Your healthcare provider will do blood tests to check your liver function during treatment with REVLIMID Serious allergic reactions and serious skin reactions can happen with REVLIMID and may cause death. Call your healthcare provider right away if you develop any of these signs or symptoms of serious allergic reaction or serious skin reaction: swelling of your face, eyes, lips, tongue, throat; trouble swallowing or breathing, skin rash, hives or peeling of your skin and blisters Allergic reactions. Tell your healthcare provider if you are lactose intolerant as REVLIMID contains lactose Tumor lysis syndrome. Metabolic complications that can occur during treatment of cancer and sometimes even without treatment. These complications are caused by the breakdown products of dying cancer cells and may include the following: changes to blood chemistry, high potassium, phosphorus, uric acid, and low calcium. This may lead to changes in kidney function, heartbeat, seizures, and sometimes death Worsening of your tumor (tumor flare reaction). Tell your healthcare provider if you get any of these symptoms while taking REVLIMID: tender swollen lymph nodes, low-grade fever, pain or rash Common side effects Common side effects of REVLIMID are diarrhea, constipation, itching, rash, tiredness, swelling of the limbs and skin, nausea, fever and cough These are not all the possible side effects of REVLIMID. Tell your healthcare provider about any side effect that bothers you or does not go away Drug interactions REVLIMID with or without dexamethasone may affect how certain other medicines work. Especially tell your healthcare provider if you take or use warfarin (a blood thinner) or digoxin (a medicine used to treat heart problems including abnormal heart beats). Your healthcare provider may want to test your blood more often Medicines that may cause blood clots, such as those that help make more red blood cells or those that contain estrogen, should be used cautiously in patients with MM who are taking REVLIMID with dexamethasone 8 9

7 Important Safety Information Other important information about REVLIMID Swallow REVLIMID capsules whole with water once a day. Do not open, break, or chew your capsules Table of Contents Do not open the REVLIMID capsules or handle them any more than needed. If you touch a broken REVLIMID capsule or the medicine in the capsule, wash the area of your body with soap and water If you miss a dose of REVLIMID, and it has been less than 12 hours since your regular time, take it as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time If you have kidney problems or are on dialysis, be sure to talk with your doctor. He or she may need to adjust your dose of REVLIMID Please see accompanying full Prescribing Information, including Boxed WARNINGS and Medication Guide. TABLE OF CONTENTS Page Learn about MULTIPLE MYELOMA...15 Learn about the REVLIMID REMS Program Learn about REVLIMID (lenalidomide) with dexamethasone Learn about SIDE EFFECTS of REVLIMID (lenalidomide) with dexamethasone Working with your HEALTHCARE TEAM Learn about RESOURCES Glossary Medication Guide Bolded words in the text are defined in the Glossary on pages 76 and

8 STARTING YOUR JOURNEY Your multiple myeloma and treatment may seem overwhelming at first. But the more you understand, the more active you can be in your treatment journey. So flip through the tabs to learn more about your condition, medications, and the resources that can help you along the way. Be informed to make decisions at each important moment. Sign up for more helpful MM information, resources, and updates at My Moment Giving family gatherings our own flavor

9 Welcome GETTING STARTED You may have a lot of questions about your multiple myeloma and your treatment. While your healthcare team is the best source of information for you, this guide may also provide you with the answers you are looking for. TAKING NOTES & KEEPING TRACK There s a lot to know and a lot to remember about multiple myeloma and your treatment. You ll find space to write down any questions you might have or thoughts you may want to remember in the Treatment Organizer included in this kit. TAKE A MOMENT TO LEARN ABOUT MULTIPLE MYELOMA The more you know about multiple myeloma, the more active you can be in your care. This section explains the basics of multiple myeloma. Multiple Myeloma 14 Boxed WARNINGS and Medication Guide, in pocket and Important Safety Information on pages

10 Multiple Myeloma WHAT IS MULTIPLE MYELOMA? Your doctor or nurse may have told you that multiple myeloma is a blood cancer that affects the plasma cells in your blood. It s important to understand how multiple myeloma affects other types of blood cells and other parts of your body. Here is some additional information about your condition. MULTIPLE MYELOMA & YOUR BLOOD CELLS Inside some of your bones there is a hollow area that is filled with a soft, spongy material called bone marrow. Inside the bone marrow are blood stem cells. Stem cells are immature cells that can divide into other cells. BLOOD STEM CELLS Blood stem cells divide and become 3 main types of blood cells. Red blood cells carry oxygen throughout the body White blood cells help fight infection There are several types of white blood cells, including neutrophils and B lymphocytes Neutrophils are a type of white blood cell that is one of the first types of cells to travel to the site of an infection B lymphocytes grow into plasma cells Plasma cells make substances that fight infections Platelets help blood clot and control bleeding Blood Stem Cell Multiple Myeloma White Blood Cells Red Blood Cells Neutrophil B Lymphocyte Platelets Healthy Bone Marrow Plasma Cell Boxed WARNINGS and Medication Guide, in pocket and Important Safety Information on pages

11 Multiple Myeloma PLASMA CELLS Plasma cells are a type of white blood cell that helps fight infection. Multiple myeloma develops when normal plasma cells become abnormal. The abnormal plasma cells are called myeloma cells. The myeloma cells build up in the bone marrow and crowd out normal blood cells. Healthy Bone Marrow With Normal Plasma Cells Red Blood Cells M PROTEINS AND MULTIPLE MYELOMA Multiple Myeloma Normal plasma cells make substances that help fight infections. These substances are called antibodies. Multiple myeloma cells are abnormal plasma cells. They make a large amount of one type of antibody, called a monoclonal protein, or M protein. This antibody cannot fight infections. Your doctor may have discovered your multiple myeloma when there were high levels of M protein on a routine blood or urine test. Your doctor can monitor your multiple myeloma by looking at how much M protein you have in your body. White Blood Cells Healthy Bone Marrow With Normal Plasma Cells Platelets Unhealthy Bone Marrow With Abnormal Plasma Cells (multiple myeloma) Plasma Cells M Protein Plasma Cells Unhealthy Bone Marrow With Abnormal Plasma Cells (multiple myeloma) Boxed WARNINGS and Medication Guide, in pocket and Important Safety Information on pages

12 Multiple Myeloma TREATMENT IS IMPORTANT In multiple myeloma, myeloma cells can build up in the body and cause damage. Multiple myeloma can cause: Bone damage People may have bone pain and weakened bones that may break easily Low red blood cell counts (anemia) Anemia can cause weakness, shortness of breath, and dizziness High levels of calcium in the blood Too much calcium may cause constipation, confusion, weakness, or kidney problems Kidney problems The kidneys may not be able to get rid of extra salt, fluid, and body waste. This can cause weakness and leg swelling Low white blood cell count (leukopenia) Leukopenia makes it hard for the body to fight infections There is no cure for multiple myeloma but it s important to treat it. One of the goals of treatment is to decrease the number of myeloma cells. IMPORTANT INFORMATION ABOUT REVLIMID Low white blood cells (neutropenia) and low platelets (thrombocytopenia) Multiple Myeloma REVLIMID causes low white blood cells and low platelets in most people. You may need a blood transfusion or certain medicines if your blood counts drop too low Your healthcare provider should check your blood counts often especially during the first several months of treatment with REVLIMID, and then at least monthly. Tell your healthcare provider if you develop any bleeding or bruising during treatment with REVLIMID Severe liver problems, including liver failure and death. Tell your healthcare provider right away if you develop any of the following symptoms: yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of your stomach area, bleeding or bruising more easily than normal and feeling very tired. Your healthcare provider will do blood tests to check your liver function during treatment with REVLIMID Have questions about what you ve read here? Use the Notes pages in the Treatment Organizer to help you keep any thoughts or questions for your doctor all in one place. Boxed WARNINGS and Medication Guide, in pocket and Important Safety Information on pages

13 My Moment Finding the perfect ingredients to a lovely afternoon. REVLIMID (lenalidomide) is used with dexamethasone to treat patients with multiple myeloma (MM) REVLIMID should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial It is not known if REVLIMID is safe and effective in children under 18 years of age LEARN ABOUT THE REVLIMID REMS PROGRAM REVLIMID REMS PROGRAM 22 23

14 REVLIMID with dexamethasone IMPORTANT INFORMATION ABOUT REVLIMID FOR FEMALES TAKING REVLIMID To avoid birth defects or death of an unborn baby, REVLIMID (lenalidomide) is only available under a restricted distribution program called the REVLIMID Risk Evaluation and Mitigation Strategy (REMS) Females: Do not get pregnant and do not breastfeed while taking REVLIMID. REVLIMID must not be used by females who are pregnant or breastfeeding. It is not known if REVLIMID passes into your breast milk and harms your baby Females who can get pregnant: Will have 2 negative pregnancy tests done by your healthcare provider. The first test should be done 10 to 14 days before your healthcare provider prescribes REVLIMID, and the second test should be done within 24 hours before REVLIMID is prescribed Will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular If you miss your period or have unusual menstrual bleeding, you must immediately stop taking REVLIMID and contact your healthcare provider. You will need to have a pregnancy test and receive counseling Must agree to use 2 different forms of reliable birth control at the same time, for at least 4 weeks before, while taking, during breaks (dose interruptions) in your treatment, and for at least 4 weeks after stopping REVLIMID If you get pregnant while taking REVLIMID, stop taking it right away and call your healthcare provider REVLIMID with dexamethasone IMPORTANT INFORMATION FOR FEMALE AND MALE PATIENTS Do not donate blood while you take REVLIMID, during breaks (dose interruptions) in your treatment, and for 4 weeks after stopping REVLIMID. If someone who is pregnant gets your donated blood, her baby may be exposed to REVLIMID and may die or be born with birth defects IMPORTANT INFORMATION ABOUT REVLIMID FOR MALES TAKING REVLIMID REVLIMID can pass into human semen: Males, including those who have had a vasectomy, must use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can get pregnant while taking REVLIMID, during breaks (dose interruptions) in your treatment with REVLIMID, and for 4 weeks after stopping REVLIMID Do not have unprotected sexual contact with a female who is pregnant or is able to get pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could get pregnant. Men, if your female partner gets pregnant, you should call your healthcare provider right away Do not donate sperm while taking REVLIMID, during breaks (dose interruptions) in your treatment, and for 4 weeks after stopping REVLIMID. If a female gets pregnant with your sperm, the unborn baby may be exposed to REVLIMID and may die or be born with birth defects 24 25

15 REVLIMID with dexamethasone UNDERSTANDING THE REVLIMID REMS PROGRAM To ensure the safety and efficacy of REVLIMID as a part of your multiple myeloma treatment, you will need to take part in the REVLIMID REMS Program. Once you and your doctor have enrolled in the program, you will be able to work with your pharmacy to receive your REVLIMID prescription at your home address. FEMALES Counseling Your doctor will counsel you on why and how you and your partner should prevent pregnancy Pregnancy Test #1 If you can get pregnant, you must take a pregnancy test within days before getting a REVLIMID prescription Pregnancy Test #2 If you can get pregnant, you must take another pregnancy test within 24 hours before getting a REVLIMID prescription Enrollment You and your doctor will then complete and submit the Patient- Physician Agreement Form MALES Counseling Your doctor will counsel you on why and how you and your partner should prevent pregnancy Enrollment You and your doctor will then complete and submit the Patient- Physician Agreement Form FEMALES Prescription Your doctor will send your prescription to a certified pharmacy Pharmacy Call The certified pharmacy will contact you to provide counseling on the serious risks and safe-use conditions of REVLIMID before you receive your prescription Receive REVLIMID REVLIMID will be shipped with a Medication Guide to the address you provide. A signature will be required to receive this shipment For each of your following prescriptions, you will need to follow a similar process. This may change slightly depending on your ability to get pregnant. For full detailed information about the REVLIMID REMS program requirements, please visit or review the Patient Guide to REVLIMID REMS Program. REVLIMID with dexamethasone UNDERSTANDING THE REVLIMID REMS PROGRAM (cont d) MALES Prescription Your doctor will send your prescription to a certified pharmacy Pharmacy Call The certified pharmacy will contact you to provide counseling on the serious risks and safe-use conditions of REVLIMID before you receive your prescription Receive REVLIMID REVLIMID will be shipped with a Medication Guide to the address you provide. A signature will be required to receive this shipment For each of your following prescriptions, you will need to follow a similar process. For full detailed information about the REVLIMID REMS program requirements, please visit or review the Patient Guide to REVLIMID REMS Program. Complete Mandatory Confidential Survey You and your doctor will each complete a survey. Visit or call and press 1 to take your survey Complete Mandatory Confidential Survey You will not have to take a survey for your first prescription, but will have to for the following ones. Visit or call and press 1 to take your survey If you have questions or thoughts about what you have just read, take a moment now to write them down in the Notes section of the Treatment Organizer in this kit

16 My Moment Planting some new memories with my favorite girl. REVLIMID (lenalidomide) is used with dexamethasone to treat patients with multiple myeloma (MM) REVLIMID should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial It is not known if REVLIMID is safe and effective in children under 18 years of age UNDERSTAND MULTIPLE MYELOMA AND YOUR TREATMENT Learn about REVLIMID

17 REVLIMID with dexamethasone REVLIMID with dexamethasone WHAT ARE REVLIMID (lenalidomide) AND DEXAMETHASONE? REVLIMID is an oral medicine used with dexamethasone to treat patients with multiple myeloma. REVLIMID is an immunomodulatory therapy with anti-cancer effects. Dexamethasone is a man-made steroid with anti-inflammatory effects. Together, REVLIMID and dexamethasone work to fight multiple myeloma. REVLIMID (lenalidomide) is used with dexamethasone to treat patients with multiple myeloma (MM). REVLIMID should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial. It is not known if REVLIMID is safe and effective in children under 18 years of age. How REVLIMID works REVLIMID has been shown to work in vitro in three ways. REVLIMID enhances the action of the immune system REVLIMID targets and kills certain cancer cells REVLIMID helps prevent cancer cells from growing by cutting off their blood supply Anti-inflammatory: reduces the redness, swelling, and pain that is a result of the body s reaction to irritation or injury Immune system: a network of cells and organs that protects the body from disease organisms, other foreign bodies, and cancers Immunomodulatory: any drug that has an effect on the function of the body s immune system to fight cancer cell growth In vitro: in a test tube or glass; outside of a living organism 30 31

18 REVLIMID with dexamethasone CLINICAL TRIALS OF REVLIMID (lenalidomide) WITH DEXAMETHASONE This section includes information about the clinical trial that studied REVLIMID with dexamethasone in newly diagnosed patients, and also two other studies of REVLIMID and dexamethasone in patients who had at least one other treatment. Clinical Trial in Newly Diagnosed Patients REVLIMID with dexamethasone was studied in a clinical trial called the MM-020 trial, which enrolled 1,623 newly diagnosed multiple myeloma patients who had not received a stem cell transplant. In this study, patients were divided into three groups and received one of these three treatments: 1) Rd Continuous: REVLIMID with dexamethasone, continued until the multiple myeloma got worse, or experienced unacceptable side effects 2) Rd18: REVLIMID with dexamethasone, for no longer than 18 months 3) MPT: Melphalan, prednisone, and thalidomide, for no longer than 18 months Results The trial evaluated progression-free survival (PFS), which is how long a patient lives with the disease without it getting worse. Compared with the other two groups of the trial, patients in the Rd continuous group: Had a longer PFS (progression-free survival) compared to patients in the MPT or Rd18 groups Lived longer than patients in the MPT group, when results were evaluated at 45.5 months REVLIMID with dexamethasone The trial also showed the overall response rate, which included the percentage of patients with a partial response, very good partial response, and complete response. 75% of patients responded to treatment with REVLIMID with dexamethasone in the Rd continuous group compared to 62% in the MPT group and 73% in the Rd18 group. WARNING: Risk to unborn babies, low blood counts, and blood clots Before you begin taking REVLIMID, you must read and agree to all of the instructions in the REVLIMID REMS program (formerly known as the RevAssist program). REVLIMID may cause serious side effects including: Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or who plan to become pregnant must not take REVLIMID. REVLIMID is similar to the medicine thalidomide (THALOMID ). We know thalidomide can cause severe lifethreatening birth defects. REVLIMID has not been tested in pregnant females. REVLIMID has harmed unborn animals in animal testing. In females of childbearing potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Females must not get pregnant: for at least 4 weeks before starting REVLIMID while taking REVLIMID during any breaks (interruptions) in your treatment with REVLIMID for at least 4 weeks after stopping REVLIMID If you become pregnant while taking REVLIMID, stop taking it right away and call your healthcare provider. REVLIMID causes low white blood cells (neutropenia) and low platelets (thrombocytopenia) in most patients. REVLIMID causes a higher chance for blood clots in your veins (deep vein thrombosis), lungs (pulmonary embolism), and arteries (heart attack or stroke)

19 REVLIMID with dexamethasone REVLIMID with dexamethasone Clinical Trials in Patients Who Received at Least One Prior Therapy REVLIMID with dexamethasone was studied in two other large clinical trials. Both trials enrolled patients who already had received at least one prior therapy. One trial enrolled 353 patients, and the other trial enrolled 351 patients. In both trials, patients were divided into two groups. One group took REVLIMID with dexamethasone, and the other group took placebo with dexamethasone. Treatment continued until the multiple myeloma got worse. Results The trials compared time to progression between the two groups, which is the length of time a patient was on therapy before their multiple myeloma started to get worse. In the trials, the group who took REVLIMID with dexamethasone had a longer time to progression than the group who took placebo with dexamethasone. Low white blood cells (neutropenia) and low platelets (thrombocytopenia) REVLIMID causes low white blood cells and low platelets in most people. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your healthcare provider should check your blood counts often especially during the first several months of treatment with REVLIMID, and then at least monthly. Tell your healthcare provider if you develop any bleeding or bruising, during treatment with REVLIMID. Blood clots Blood clots in the arteries, veins, and lungs happen more often in people who take REVLIMID. This risk is even higher for people with multiple myeloma who take the medicine dexamethasone with REVLIMID. Heart attacks and strokes also happen more often in people who take REVLIMID with dexamethasone. To reduce this increased risk, most people who take REVLIMID will also take a blood thinner medicine

20 REVLIMID with dexamethasone HOW TO TAKE REVLIMID (lenalidomide) WITH DEXAMETHASONE Before you are prescribed REVLIMID with dexamethasone, you must be enrolled in the REVLIMID REMS program. There are special requirements for men and women in the program. Your doctor will tell you how to take REVLIMID with dexamethasone. Follow your doctor s instructions carefully. Be sure to talk with your doctor or nurse if you have questions. Taking REVLIMID with dexamethasone REVLIMID The recommended starting dose of REVLIMID for multiple myeloma is 25 mg per day, but your doctor will tell you which dose is right for you REVLIMID is prescribed in 28-day cycles Take REVLIMID with water every day on days 1 to 21. It doesn t matter what time of day you take REVLIMID, but it is recommended that you take REVLIMID at the same time each day. REVLIMID may be taken with or without food DO NOT take REVLIMID on days 22 to 28. You will receive only 21 pills DEXAMETHASONE If you are newly diagnosed with multiple myeloma, the dose of dexamethasone in the clinical trial was 40 mg orally once daily on days 1, 8, 15, and 22 of repeated 28-day cycles. For patients > 75 years old, the dexamethasone dose was 20 mg orally once daily on days 1, 8, 15, and 22 of repeated 28-day cycles. If you are taking REVLIMID with dexamethasone after at least one prior therapy, the dose of dexamethasone in the clinical trial was 40 mg once daily on Days 1-4, 9-12, and of each 28-day cycle for the first 4 cycles of therapy and then 40 mg once daily orally on Days 1-4 every 28 days. If you have questions, make sure to ask your doctor or nurse for more information. For a Treatment Calendar that you can fill out and use, please see the Treatment Organizer booklet contained in this kit. REVLIMID with dexamethasone MORE INFORMATION ABOUT TAKING REVLIMID (lenalidomide) REVLIMID comes in 6 capsule strengths: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. Your doctor will tell you the dose that is right for you. Capsules shown are not actual size. Swallow REVLIMID capsules whole with water once a day. Do not open, break, or chew your capsules Do not open the REVLIMID capsules or handle them any more than needed. If you touch a broken REVLIMID capsule or the medicine in the capsule, wash the area of your body with soap and water If you miss a dose of REVLIMID, and it has been less than 12 hours since your regular time, take it as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time If you have kidney problems, be sure to talk with your doctor. He or she may need to adjust your dose of REVLIMID Your doctor may change your dose REVLIMID causes low white blood cells (neutropenia) in most patients. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your healthcare provider should check your blood counts often especially during the first several months of treatment with REVLIMID, and then at least monthly. Tell your healthcare provider if you develop any bleeding or bruising during treatment with REVLIMID

21 REVLIMID with dexamethasone MORE INFORMATION ABOUT TAKING REVLIMID (lenalidomide) The kidneys play a role in removing REVLIMID from your body. Tell your doctor if you have kidney problems or are on dialysis. Your doctor may start you on a lower dose of REVLIMID with dexamethasone. Your doctor will regularly check your lab tests. If needed, your doctor will adjust your dose, or delay or stop your treatment. Tell your doctor about all of your medical conditions and the medicines you may be taking. What should I avoid while taking REVLIMID? Females: Do not get pregnant and do not breastfeed while taking REVLIMID. Males: Do not donate sperm, see the Medication Guide, included on page 79 in this brochure, and refer to the following sections: What is the most important information I should know about REVLIMID?, Who should not take REVLIMID?, and What should I avoid while taking REVLIMID? How to store REVLIMID REVLIMID with dexamethasone It is important to store REVLIMID in a safe place away from children. And do not share your REVLIMID prescription with anyone. It may cause birth defects and other serious side effects. Keep REVLIMID in a cool, dry place. REVLIMID should be stored at room temperature, within a range of 68 F to 77 F (20 C to 25 C) with excursions permitted to 59 F to 86 F (15 C to 30 C). Keeping track of your lab tests While you are taking REVLIMID with dexamethasone, you will need to have certain tests. Because REVLIMID causes low white blood cells (neutropenia) and low platelet counts (thrombocytopenia), your doctor will want you to have blood tests regularly. Your healthcare provider should check your blood counts often especially during the first several months of treatment with REVLIMID, and then at least monthly. Tell your healthcare provider if you develop any bleeding or bruising during treatment with REVLIMID. Do not share REVLIMID with other people. It may cause birth defects and other serious problems Do not donate blood while you take REVLIMID, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping REVLIMID. If someone who is pregnant gets your donated blood, her baby may be exposed to REVLIMID and may be born with birth defects 38 39

22 REVLIMID with dexamethasone KEEPING TRACK OF YOUR MEDICATIONS It is important to take your medicines as prescribed each day. Use the calendar on the next page as an example of how to keep track of which days you should take your REVLIMID and which days you should take your dexamethasone. You will find blank calendars to make your own on pages in the Treatment Organizer in this kit. Your healthcare provider will give you an exact medication schedule. MONTH January S M T W Th F Sa Start cycle of REVLIMID 8 RD 9 R R R R R R REVLIMID with dexamethasone Below is an example of how a newly diagnosed patient might use a calendar to keep track of dosing For each day that you take REVLIMID, you can write an R or place a check mark on that day. When you take your dexamethasone dose, you can write a D or place a second check mark on that day. Once you take them, cross that day off. This will help you, or your caregiver, keep track of your medicine on any particular day. RD RD D R R 24 R R 25 R R 26 Do NOT take REVLIMID or dexamethasone R R R R 21 Finish cycle of REVLIMID 28 R R Start Next Cycle of REVLIMID RD R R For calendars that you can fill out and use, please see the Treatment Organizer booklet contained in this kit

23 REVLIMID with dexamethasone TALKING WITH YOUR DOCTOR ABOUT YOUR TREATMENT When you start a new treatment, it is important to get as much information as you can. Your doctor or nurse may have told you about REVLIMID (lenalidomide) with dexamethasone. But you may have more questions. Don t be afraid to ask your doctor or nurse. They are there to support you throughout your treatment. Below are some questions you may want to ask your doctor or nurse. There is also space for you to write down any other questions you may have. REVLIMID with dexamethasone TIPS FOR FOLLOWING YOUR DOCTOR S INSTRUCTIONS It is important that you follow your doctor s instructions about taking REVLIMID (lenalidomide) with dexamethasone. Sometimes it may be difficult to remember to take your medicine every day, especially if you are taking more than one medicine. Here are some tips to help you remember to take your medicine. Tips to help you remember to take your medicine Questions to ask your doctor Take your medicine at the same time every day What is the most important information I need to know about REVLIMID with dexamethasone? What should I avoid while taking REVLIMID with dexamethasone? What is the REVLIMID REMS program? Other questions: Use a calendar to keep track of your medicine, key dates, and information Put a reminder somewhere in your house. Try putting a sticky note on your refrigerator or bathroom mirror Set an alarm on your computer or cell phone to remind you to take your medicine Ask a family member or friend to help remind you to take your medicine If you have questions about what you have just read, take a moment now to write them down in the Notes section of the Treatment Organizer booklet in this kit

24 REVLIMID with dexamethasone PUTTING IT ALL TOGETHER This section provided a lot of information about REVLIMID (lenalidomide) with dexamethasone. You may need to read the section again. That s okay. While your doctor and nurse are the best source of information about REVLIMID with dexamethasone, this brochure can help you answer some of the questions you may have. Remember that throughout treatment you have to have certain tests. It is important that you stay on track and not miss any of these important dates. You also have other important dates to remember, such as doctor appointments. You may want to use a calendar to help you remember this information. The Treatment Organizer booklet provided in this kit can help you stay organized. REVLIMID (lenalidomide) is used with dexamethasone to treat patients with multiple myeloma (MM) REVLIMID should not be used to treat people who have chronic lymphocytic leukemia (CLL) unless they are participants in a controlled clinical trial It is not known if REVLIMID is safe and effective in children under 18 years of age LEARN ABOUT SIDE EFFECTS OF REVLIMID (lenalidomide) WITH DEXAMETHASONE It s important to be aware of how your body responds to your medicine and to express any concerns you may have to your healthcare team. Read through this section carefully to find out more about what side effects could occur. Side Effects 44 45

25 Side effects of REVLIMID with dexamethasone SIDE EFFECTS OF REVLIMID (lenalidomide) WITH DEXAMETHASONE You may experience side effects while taking REVLIMID (lenalidomide) with dexamethasone. Some of these side effects may be serious. Talk with your doctor or nurse about what may happen when you are taking REVLIMID with dexamethasone and when you should call your doctor. It is important for your doctor to know about any side effects you have while taking REVLIMID with dexamethasone. If you have certain side effects, your doctor may lower your dose. Your doctor may also delay or stop treatment. Serious side effects of REVLIMID with dexamethasone include birth defects, blood clots, low blood counts, serious allergic reactions, serious skin reactions, tumor lysis syndrome, liver damage, and risks of new cancers. Common side effects of REVLIMID with dexamethasone include diarrhea, constipation, itching, rash, tiredness, swelling of the limbs and skin, nausea, fever, and cough. These are not all of the possible side effects of REVLIMID with dexamethasone. Tell your doctor about any side effect that bothers you or that does not go away. In this section we will review these side effects and important information your healthcare team may need to know if you have any of them. SERIOUS SIDE EFFECTS OF REVLIMID WITH DEXAMETHASONE Risk to unborn babies Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or who plan to become pregnant must not take REVLIMID. Side effects of REVLIMID with dexamethasone REVLIMID is similar to the medicine thalidomide (THALOMID ). We know thalidomide can cause severe life-threatening birth defects. REVLIMID has not been tested in pregnant females. REVLIMID has harmed unborn animals in animal testing. If you are a female who can become pregnant, you are required to have 2 pregnancy tests that show you are not pregnant before starting REVLIMID. In females of childbearing potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Females must not get pregnant: for at least 4 weeks before starting REVLIMID while taking REVLIMID during any breaks (interruptions) in your treatment with REVLIMID for at least 4 weeks after stopping REVLIMID Females who can become pregnant must agree to use 2 different forms of effective birth control at the same time, every time, for 4 weeks before starting, while taking, during any breaks (interruptions) in treatment with, and for 4 weeks after stopping REVLIMID. REVLIMID can pass into human semen. Males, including those who have had a vasectomy, must use a latex or synthetic condom during any sexual contact with a pregnant female or a female who can become pregnant. Males must do this while taking REVLIMID, during any breaks (interruptions) in treatment with REVLIMID, and for 4 weeks after stopping REVLIMID. (If you or your partner are allergic to latex, please consult with your healthcare provider.) If you become pregnant while taking REVLIMID, stop taking it right away and call your healthcare provider. Healthcare providers and patients should report all cases of pregnancy to: FDA MedWatch at FDA-1088 and Celgene Corporation at

26 Side effects of REVLIMID with dexamethasone Side effects of REVLIMID with dexamethasone Treatment with REVLIMID with dexamethasone lowers white blood cell and platelet counts in most patients. If your blood counts become too low, you may develop neutropenia or thrombocytopenia. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your healthcare provider should check your blood counts often especially during the first several months of treatment with REVLIMID, and then at least monthly. Tell your healthcare provider if you develop any bleeding or bruising during treatment with REVLIMID. Low white blood cells (neutropenia) Neutropenia occurs when the level of a type of white blood cell, called a neutrophil, becomes too low. When the level of neutrophils becomes too low, it is difficult for the body to fight infections. Neutropenia is usually found when your doctor does a blood test to check the number of white blood cells in your blood. Your doctor may also think you have neutropenia if you get a lot of infections. It is important to watch for signs of infection. If your white blood cell count becomes too low, your doctor may lower your dose. Your doctor may also delay or stop your treatment. Your doctor may check your counts with blood tests. He or she will make treatment decisions based on your test results. Low platelets (thrombocytopenia) Thrombocytopenia occurs when the level of platelets in the blood becomes too low. If you develop thrombocytopenia, you may notice bleeding under the skin. This will look like tiny red dots on the skin. You may also get small bruises from minor bumps. Your gums may bleed when you brush your teeth and you may see blood in your urine or stool. If your platelet levels fall too low, your doctor may lower your dose. Your doctor may also delay or stop your treatment. Your doctor may check your counts with blood tests. He or she will make treatment decisions based on your test results. Contact your doctor right away if you notice any unusual bleeding or bruising. Tell your doctor right away if you have: Body temperature F or higher Shaking chills or sweats Sore throat Cough or shortness of breath Nasal congestion Burning or pain when passing urine Bloody or cloudy urine 48 49

27 Side effects of REVLIMID with dexamethasone Side effects of REVLIMID with dexamethasone Blood clots Blood clots in your arteries, veins, and lungs happen more often in people who take REVLIMID Risk is even higher for people with multiple myeloma taking REVLIMID with dexamethasone Heart attacks and stroke also happen more often in people taking REVLIMID with dexamethasone To reduce this increased risk, most people who take REVLIMID will also take a blood thinner medicine Before taking REVLIMID tell your healthcare provider: if you have had a blood clot in the past, have high blood pressure, you smoke, you have been told you have high level of fat in your blood (hyperlipidemia), and all medicines you take. Certain other medicines can also increase your risk for blood clots Call your healthcare provider or get medical help right away if you get any of the following signs or symptoms during treatment with REVLIMID: Blood clot in lung, arm or leg: shortness of breath, chest pain, or arm or leg swelling. Heart attack: chest pain that may spread to arms, neck, jaw, back or stomach area, feeling sweaty, shortness of breath, feeling sick or vomiting. Stroke: sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech or balance Increased risk of death in people who have chronic lymphocytic leukemia (CLL) People with CLL who take REVLIMID have an increased risk of death compared with people who take the medicine chlorambucil. REVLIMID may cause you to have serious heart problems that can lead to death, including atrial fibrillation, heart attack, or heart failure. You should not take REVLIMID if you have CLL unless you are participating in a controlled clinical trial. Risk of new cancers People with MM who receive REVLIMID and melphalan and a blood stem cell transplant have a higher risk of developing new cancers, including certain blood cancers (acute myelogenous leukemia or AML and myelodysplastic syndrome or MDS) and a type of lymphoma called Hodgkin lymphoma. Talk with your healthcare provider about your risk of developing new cancers if you take REVLIMID. Your healthcare provider will check you for new cancers during your treatment with REVLIMID. Severe liver problems, including liver failure and death Tell your healthcare provider right away if you develop any of the following symptoms: yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of your stomach area, bleeding or bruising more easily than normal and feeling very tired. Your healthcare provider will do blood tests to check your liver function during treatment with REVLIMID. Serious allergic reactions and serious skin reactions Serious allergic reactions and serious skin reactions can happen with REVLIMID and may cause death. Call your healthcare provider right away if you develop any of these signs or symptoms of serious allergic reaction or serious skin reaction: swelling of your face, eyes, lips, tongue, throat; trouble swallowing or breathing, skin rash, hives or peeling of your skin and blisters

28 Side effects of REVLIMID with dexamethasone Allergic reactions Tell your healthcare provider if you are lactose intolerant as REVLIMID contains lactose. Tumor lysis syndrome 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. Worsening of your tumor (tumor flare reaction) Tell your healthcare provider if you get any of these symptoms while taking REVLIMID: tender swollen lymph nodes, low-grade fever, pain or rash. Side effects of REVLIMID with dexamethasone SOME COMMON SIDE EFFECTS OF REVLIMID (lenalidomide) WITH DEXAMETHASONE Diarrhea Treatment with REVLIMID with dexamethasone can cause diarrhea. Diarrhea happens when your stools become watery and you go to the bathroom much more often than usual. Your doctor needs to know if you have diarrhea. Diarrhea can cause weight loss, fluid loss (dehydration), poor appetite, and weakness. Diarrhea may cause complications, such as Dizziness Fever TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT THE FDA AT FDA-1088 OR VISIT Sore or bleeding rectal area If you have any of these complications or if you have diarrhea and cramps for more than a day, call your doctor or nurse right away. If you have diarrhea, tell your doctor or nurse. He or she will want to know about any side effects you have. You may want to ask your doctor: Are there foods I should eat when I have diarrhea? Are there foods I should not eat when I have diarrhea? How much liquid should I drink each day? Is there medicine I can take to help with the diarrhea? 52 53

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