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1 REVLIMID (lenalidomide) is used to treat patients who have low- or intermediate-1 risk myelodysplastic syndromes (MDS) where part of chromosome 5 is missing (del 5q). These patients have low red blood cell counts (anemia) that require blood transfusions 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 getting involved Taking an active role REMS REVLIMID is only available through a restricted distribution program, REVLIMID REMS Please see accompanying full Prescribing Information, including Boxed WARNINGS and Medication Guide, in pocket and Important Safety Information on pages 2 and 3.

2 REVLIMID (lenalidomide) is used to treat patients who have low- or intermediate-1 risk myelodysplastic syndromes (MDS) where part of chromosome 5 is missing (del 5q). These patients have low red blood cell counts (anemia) that require blood transfusions 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 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 4 weeks before starting REVLIMID while taking REVLIMID during any breaks (interruptions) in your treatment with REVLIMID for 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). 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) 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 If you are being treated for del 5q MDS, your blood counts should be checked weekly during the first 8 weeks of treatment with REVLIMID and at least monthly thereafter Blood clots REVLIMID causes a higher chance for blood clots in your arteries, veins, and lungs 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 these signs or symptoms: 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 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 melphalan (a type of chemotherapy) and a blood stem cell transplant with the addition of REVLIMID have a higher risk of developing new cancers, including certain blood cancers (acute myelogenous leukemia or AML) 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 skin reactions and swelling under the skin that require immediate medical attention can happen with REVLIMID and may cause death. Call your healthcare provider right away if you have any skin reaction while taking REVLIMID 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, itching, rash, and tiredness 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 Other important information about REVLIMID Swallow REVLIMID capsules whole with water once a day. Do not break, chew, or open 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 or are on dialysis, be sure to talk with your doctor. He or she may need to adjust your dose of REVLIMID 2 REMS REVLIMID is only available through a restricted distribution program, REVLIMID REMS. Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, in pocket. 3

3 getting involved REVLIMID (lenalidomide) is used to treat patients who have low- or intermediate-1 risk myelodysplastic syndromes (MDS) where part of chromosome 5 is missing (del 5q). These patients have low red blood cell counts (anemia) that require blood transfusions 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 Taking an active role Taking an active role in your treatment with REVLIMID (lenalidomide) for del 5q MDS can mean: Having questions and knowing where to find answers Needing help and knowing where to turn for support Knowing who is on your treatment team and how to work closely with them 4 REMS Taking an active role can simply mean that you are getting involved in understanding your disease and your treatment. And that you re learning how to take care of yourself. All of these are important. Learning more can help This brochure and the Taking Care kit were created to help you take an active role in your treatment with REVLIMID for del 5q MDS. Read through everything and write down your questions to help you talk with your doctor and nurse. Getting involved in your treatment There are ways to get involved in your treatment. And there are important reasons for doing so. Ways to get involved in your treatment Understand how to take REVLIMID for del 5q MDS Take it exactly as prescribed Understand how to store and handle REVLIMID for del 5q MDS Understand the possible side effects with REVLIMID Follow the requirements of the RevAssist program Why it matters Taking your medicine as prescribed is a vital part of your treatment. Storing and handling REVLIMID for del 5q MDS correctly is important for your safety and the safety of others. Knowing about possible side effects with REVLIMID helps you watch for them so that you can talk with your doctor and nurse about them. The requirements of the REVLIMID REMS program (formerly known as the RevAssist program) are steps you need to take during your treatment with REVLIMID for del 5q MDS. Read this brochure to learn about: Your treatment Ways to take care of yourself Del 5q MDS Ways to work with your support team REVLIMID is only available through a restricted distribution program, REVLIMID REMS. Important Information about REVLIMID REMS To avoid serious risks to unborn babies, REVLIMID is only available through a restricted distribution program called REVLIMID REMS program (formerly known as the RevAssist program) Females: Do not get pregnant or breastfeed. 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 become 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 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 REVLIMID can pass into human semen. Males, including those who have had a vasectomy, must use a latex or synthetic condom every time during any sexual contact with a pregnant female or a female that 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) Males: 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 Only prescribers certified with REVLIMID REMS can prescribe REVLIMID Only pharmacies certified with REVLIMID REMS can dispense REVLIMID In order to receive REVLIMID, patients must enroll in REVLIMID REMS and agree to comply with the requirements of the REVLIMID REMS program. To learn more about REVLIMID and the REVLIMID REMS program, call Celgene Customer Care Center at or visit Important Information about REVLIMID REVLIMID is only for patients who understand and agree to all of the instructions in the REVLIMID REMS program If you are a woman who can become pregnant, you should have 2 pregnancy tests that show you are not pregnant before starting REVLIMID REVLIMID may cause serious side effects, including: Risk to unborn babies Low white blood cells and low platelets Blood clots in your arteries, veins, and lungs Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, in pocket and Important Safety Information on pages 2 and 3. 5

4 understanding the REVLIMID REMS program REVLIMID (lenalidomide) is used to treat patients who have low- or intermediate-1 risk myelodysplastic syndromes (MDS) where part of chromosome 5 is missing (del 5q). These patients have low red blood cell counts (anemia) that require blood transfusions 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 Women who can become pregnant Take first pregnancy test within 10 to 14 days Women who can become pregnant Confirm that you are not pregnant with second pregnancy test within 24 hours prior to prescribing All patients Counseling You will be instructed on why and how you and your partner should prevent pregnancy. Sign the agreement form You must understand, and you and your doctor must agree to comply with, the elements of the REVLIMID REMS program including the pregnancy prevention steps. The agreement form can be signed and faxed or generated, signed, and submitted digitally at 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 (lenalidomide). Once treatment has started and during dose interruptions, pregnancy testing for females of childbearing potential should occur weekly during the first 4 weeks of use, then pregnancy testing should be repeated every 4 weeks in females with regular menstrual cycles. If menstrual cycles are irregular, the pregnancy testing should occur every 2 weeks If you become pregnant while taking REVLIMID, stop taking it right away and call your healthcare provider Lenalidomide is contraindicated in pregnant women and women capable of becoming pregnant. Females of childbearing potential may be treated with lenalidomide provided adequate precautions are taken to avoid pregnancy REVLIMID can pass into human semen. Males, including those who have had a vasectomy, must use a latex or synthetic condom every time during any sexual contact with a pregnant female or a female that 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) 6 REMS REVLIMID is only available through a restricted distribution program, REVLIMID REMS. Complete surveys a You and your doctor will each complete a survey by phone or online, after which your doctor will receive an authorization number. Fax the prescription Now your doctor is ready to fax a prescription to a contract pharmacy. If registering online, the system will generate a printable prescription that can be faxed. a You and your doctor will be asked to complete additional surveys for each prescription. Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, in pocket and Important Safety Information on pages 2 and 3. 7

5 Learning about your treatment REVLIMID (lenalidomide) is used to treat patients who have low- or intermediate-1 risk myelodysplastic syndromes (MDS) where part of chromosome 5 is missing (del 5q). These patients have low red blood cell counts (anemia) that require blood transfusions 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 What should I avoid while taking REVLIMID? See What is the most important information I should know about REVLIMID? Females: Do not get pregnant or breastfeed Males: Do not donate sperm It is important to learn as much as you can about your REVLIMID (lenalidomide) for del 5q MDS. The more you know about your medicine, the better you can understand what to expect. How REVLIMID for del 5q MDS is used REVLIMID is used to treat patients with low- or intermediate-1 risk del 5q MDS who: Have low red blood cell counts (anemia) Require blood transfusions REVLIMID for del 5q MDS is an oral medicine Taking an oral medicine means that you need to remember to take it exactly as prescribed by your doctor. Swallow REVLIMID capsules whole with water once a day. Do not break, chew, or open 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 take too much REVLIMID or overdose, call your healthcare provider right away For more detailed information about how to take REVLIMID for del 5q MDS, read the Understanding Treatment brochure. You will also need to follow all the requirements of the REVLIMID REMS program. 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 8 REMS REVLIMID is only available through a restricted distribution program, REVLIMID REMS. Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, in pocket and Important Safety Information on pages 2 and 3. 9

6 UNDERSTANDING SIDE EFFECTS REVLIMID (lenalidomide) is used to treat patients who have low- or intermediate-1 risk myelodysplastic syndromes (MDS) where part of chromosome 5 is missing (del 5q). These patients have low red blood cell counts (anemia) that require blood transfusions 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 Important Information about REVLIMID 10 REVLIMID is only for patients who understand and agree to all of the instructions in the REVLIMID REMS program If you are a woman who can become pregnant, you should have 2 pregnancy tests that show you are not pregnant before starting REVLIMID REVLIMID may cause serious side effects, including: Risk to unborn babies Low white blood cells and low platelets Blood clots in your arteries, veins, and lungs You may experience side effects while taking REVLIMID (lenalidomide) for del 5q MDS. Some of these side effects may be serious. Talk with your doctor or nurse about what may happen when you are taking REVLIMID for del 5q MDS and when you should call your doctor. If you have certain side effects, your doctor will watch you closely. He or she may lower your dose, or delay or stop your treatment. Serious side effects Serious side effects of REVLIMID include birth defects, low blood counts, blood clots, serious skin reactions, and tumor lysis syndrome. 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. REVLIMID is similar to the medicine thalidomide (THALOMID ). We know thalidomide can cause severe life-threatening birth defects. REVLIMID has REMS not been tested in pregnant females. REVLIMID has harmed unborn animals in animal testing. If you are a woman who can become pregnant, you should have 2 pregnancy tests that show you are not pregnant before starting REVLIMID. Females must not get pregnant: for 4 weeks before starting REVLIMID while taking REVLIMID during any breaks (interruptions) in treatment with REVLIMID 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 Males: REVLIMID can pass into human semen. Males, including those who have had a vasectomy, must use a latex or synthetic condom every time during any sexual contact with a pregnant female or a female that 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) 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 or fevers. Low platelets (thrombocytopenia) Thrombocytopenia occurs when the level of REVLIMID is only available through a restricted distribution program, REVLIMID REMS. 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. Contact your doctor right away if you notice any unusual bleeding or bruising. Blood clots in the arteries (arterial thrombosis), vein (deep vein thrombosis) and in the lungs (pulmonary embolism) Treatment with REVLIMID increases the risk for developing blood clots. Blood clots that occur in the arteries are called arterial thrombosis. Blood clots that usually occur in the legs or lower body are called deep vein thrombosis or DVT. These blood clots can cause swelling, tenderness, pain, and redness in the legs. But they can occur in other parts of the body as well. The blood clots can break off and travel where they can block the flow of blood to the lungs. This is called a pulmonary embolism and can damage the lungs or cause death. 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 melphalan (a type of chemotherapy) and a blood stem cell transplant with the addition of REVLIMID have a higher risk of developing new cancers, including certain blood cancers (acute myelogenous leukemia or AML) 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 Call your doctor for medical advice about side effects. You may report side effects to FDA at FDA 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 skin reactions Serious skin reactions can happen with REVLIMID. These skin reactions may cause death. Contact your doctor right away if you have any skin reactions while taking REVLIMID. Allergic reactions Tell your healthcare provider if you are lactose intolerant as REVLIMID contains lactose. Tumor lysis syndrome Tumor lysis syndrome is a problem that can happen with treatment of cancer. It can sometimes happen even if the cancer isn t treated. It is a metabolic complication that is caused when cancer cells die. The dying cancer cells release substances into the bloodstream and may cause: Changes to blood chemistry Higher levels of potassium, phosphorus, and uric acid Lower levels of 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 for del 5q MDS include diarrhea, itching, rash, and tiredness. These are not all of the possible side effects of REVLIMID. Tell your healthcare provider about any side effect that bothers you or does not go away. Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, in pocket and Important Safety Information on pages 2 and 3. 11

7 having regular blood tests REVLIMID (lenalidomide) is used to treat patients who have low- or intermediate-1 risk myelodysplastic syndromes (MDS) where part of chromosome 5 is missing (del 5q). These patients have low red blood cell counts (anemia) that require blood transfusions 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 Knowing what you need to do and why Having del 5q MDS means that your red blood cell counts are too low. This causes you to have anemia. And being treated with REVLIMID (lenalidomide) for del 5q MDS causes most patients to have low white blood cell counts, which can increase your risk for infections. REVLIMID for del 5q MDS also causes most patients platelet counts to be too low, which can increase your risk for bleeding. It is important for your doctor to closely watch your blood counts. During your treatment with REVLIMID for del 5q MDS, you should have a blood test: Weekly during the first 8 weeks At least monthly after that Be sure to work with your doctor and nurse to schedule these tests. Then it s up to you to keep your appointments. Please remember these tests are important. The results of these tests give you and your doctor important information about your blood. For example, the results may show that you have too few red blood cells, white blood cells, or platelets. When this happens, you have a low blood count (also called cytopenia). It is important for you and your doctor to know if you have a low blood count. There may be steps your doctor wants you to take if your blood counts are too low. If you have questions about your blood tests or the results, be sure to talk with your doctor or nurse. Important Information about REVLIMID 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 What does the blood test measure? The blood test measures your complete blood count (or CBC). This is a common test. A CBC includes your: White blood cell count These cells help fight infection. Red blood cell count These cells carry oxygen to the tissues and organs of the body. Hemoglobin value Hemoglobin carries oxygen to organs in the body, such as the lungs and brain. You may have anemia if your hemoglobin level is low. Hematocrit value This is the amount (percentage) of red blood cells in your body compared with the total amount of blood that you have in your body. Platelet count Platelets help form blood clots and stop bleeding. MCV (mean corpuscular volume) This measures the average size of red blood cells. MCV is high when red blood cells are larger than normal. It is low when red blood cells are smaller than normal. Keeping track of your blood test results Knowing the results of your blood tests may be helpful to you during your treatment with REVLIMID for del 5q MDS. The results give you and your doctor important information about your blood, such as knowing if your blood counts are too low. Use the tracker you received in your Taking Care kit to keep track of your results. That way, you ll have the results in one place if you need to refer to them later. REVLIMID (lenalidomide) is used to treat patients who have low- or intermediate-1 risk myelodysplastic syndromes (MDS) where part of chromosome 5 is missing (del 5q). These patients have low red blood cell counts (anemia) that require blood transfusions. MEDICINE TRACKER Some people with low red blood cell counts may need a red blood cell transfusion. You may have a transfusion chart already. If so, you can use this tracker when your Always make sure you are taking the correct dose of REVLIMID (lenalidomide) for del 5q MDS chartasis filled in. Take it with you to your appointments. You and your doctor and prescribed by your doctor. Fill in the dosing chart below. nurse may refer to the tracker during your office visit. TRANSFUSION TRACKER It is important for your doctor to know about all the medicines, vitamins, and supplements you are taking (prescription and over-the-counter). You may find it helpful to write them down on this tracker. You can then take it with you to your next appointment and show your doctor or nurse. Dosing Chart and Calendar My dose of REVLIMID is. I will take REVLIMID at AM/PM (please circle one) every day. Month Monday Tuesday Wednesday Thursday Friday Saturday Date: Units transfused (pints/bag): Type (RBC, platelet): Iron level (serum ferritin): Medicine, vitamin, or supplement (prescription and over-the-counter): 10/2 2 units RBCs Iron levels normal Multivitamin Dose: Number of pills per day: Notes: 1 pill, once a day Take with food Sunday If you are being treated for del 5q MDS, your blood counts should be checked weekly during the first 8 weeks of treatment with REVLIMID and at least monthly thereafter 12 REMS REVLIMID is only available through a restricted distribution program, REVLIMID REMS. Use this calendar to keep track of your medicine, key dates, and information. Remember to follow your doctor s instructions REVLIMID is only available under a special restricted distribution program. Please see accompanying full Prescribing Information, including Boxed WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, and Medication Guide, and Important Safety Information on pages 4 to REVLIMID is only available under a special restricted distribution program. Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, in pocket and Important Safety Information on pages 2 and 3. 13

8 LEARNING MORE ABOUT del 5q MDS Understanding MDS MDS (myelodysplastic syndromes) is a group of diseases that affect the blood and bone marrow. Bone marrow is the soft, sponge-like tissue in the center of most bones that makes your blood cells. Bone marrow makes stem cells. These cells become white blood cells, red blood cells, and platelets: Red blood cells carry oxygen to tissues and organs of the body White blood cells help fight infection Platelets help form blood clots and stop bleeding In people with MDS, stem cells do not become healthy blood cells. Rather, these stem cells stay as immature cells called blasts. Blasts do not do the job that healthy blood cells do. Understanding del 5q MDS Some people have a type of MDS called del 5q MDS. This means that part of chromosome 5 is missing. Chromosomes are the part of the cell that tell it how to work. Doctors can find out if you have del 5q MDS by testing some of your bone marrow cells. Patients with del 5q MDS have low red blood cell counts (anemia) and may need blood transfusions. The symptoms of anemia include: Feeling weak and tired Dizziness Shortness of breath Heart palpitations (racing heartbeat) Pounding in your head Ringing in your ears Stem Cell Healthy Stem Cell Healthy Chromosome 5 Unhealthy Stem Cell Unhealthy Chromosome 5 Healthy Bone Marrow Platelets This is a picture of a healthy stem cell that has healthy chromosomes. In del 5q MDS, part of chromosome 5 is missing. Red Blood Cells White Blood Cell 14 REMS REVLIMID is only available through a restricted distribution program, REVLIMID REMS. Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, in pocket and Important Safety Information on pages 2 and 3. 15

9 WORKING WITH YOUR SUPPORT TEAM Information: what and how much Think about what kind of information is helpful to you. Think about how much of that information is helpful as well. Some people want to learn everything about their disease and treatment. Other people don t want to know as much. It s important to tell your doctor or nurse how much you want to know about your disease, your treatment, and your health. When you speak with them, ask open-ended questions. These are questions that do not have a yes or no answer. This will help you get more information. Members of your team can help you understand your del 5q MDS and your treatment. You may also need help with practical matters, such as getting to your office visits, paying for your medicine or other expenses, or keeping up with housework and other responsibilities. You may need emotional support if you feel overwhelmed or if you need someone who will simply listen to your concerns. When you speak openly and often with your team, you can become an active partner in your treatment. Here are some examples of open-ended questions, to get you started: How should I take my medicine and how often should I take it? What possible side effects of this medicine should I be aware of? What types of tests will I need to take during treatment? Where can I find out about support services that are available to me and my family? Reaching out to your support team Remember that you are not alone. Your doctor and nurse are there to support you. And there might be other members of your support team who can help you. Let s review who your team may include: Using active listening to communicate effectively A big part of talking with others is listening really listening to what others have to say. This is called active listening. Active listening can help you have an effective conversation with your support team. And this can help you better understand information and avoid confusion. Below are some tips for active listening Pay close attention. That way, he or she knows you are listening Repeat in your own words what the person said. This can help make sure that what you heard is what he or she really meant Sum up everything at the end to make sure you understood Oncologist/hematologist Oncology nurse/nurse practitioner Physician assistant Social worker Psychologist or psychiatrist Registered dietitian Specialty pharmacist Insurance case manager Support organizations Spiritual leader Family members Friends 16 REMS REVLIMID is only available through a restricted distribution program, REVLIMID REMS. Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, in pocket and Important Safety Information on pages 2 and 3. 17

10 TAKING CARE OF YOURSELF It is important to take care of yourself. The stress caused by your disease and its treatment can be challenging. It is important to take care of your physical and emotional needs. Take care of your mind Take care of your body One step at a time If you feel stressed or overwhelmed, take a moment to regroup. Pace yourself. Begin by getting the information and resources that you need for the next step of your treatment plan. Eat a balanced diet Make sure you eat small, healthy meals throughout the day. A registered dietitian can help you with menus and recipes. Ask for support Let your family and friends know how they can support you. Often people want to help, but they don t know how. Give them specific examples, like driving you to appointments or making meals. Stay involved Try to continue social activities, such as staying involved with the things you enjoy. Stay in touch with friends. Get in touch with people in your local community, religious group, or even people at work. Share Talk about your feelings, both positive and negative. Share your concerns with your support team. Sometimes sharing your thoughts can help you sort them out. Writing in a journal may help, too. Talk it over If you feel stress about your disease, your treatment, or other matters in your life, it s important to take care of it. Talk with your social worker or other members of your support team. Social workers, psychologists, and psychiatrists can help you with stress. They can give you tips to help you relax. Think positively Some people look to their spiritual beliefs, cultural customs, and family connections to stay positive. Some may speak with other patients to learn from their experiences. A positive outlook may help you handle challenges that you may face. Remember to make time for the things you enjoy. Your disease is only one part of your life. Stay organized Be prepared for appointments. It may also help to bring a family member or friend along to listen and take notes. Keep copies of your medical records handy so you know where they are when you need them. 18 REMS REVLIMID is only available through a restricted distribution program, REVLIMID REMS. Please see accompanying full Prescribing Information, including Boxed WARNINGS and Medication Guide, in pocket and Important Safety Information on pages 2 and 3. 19

11 REACHING OUT TO RESOURCES Your treatment team is your best source of information. But there are also many organizations that can provide information about your disease and its treatment. Below is a list of resources you may find helpful. Support organizations Aplastic Anemia & MDS International Foundation (AAMDS) Myelodysplastic Syndromes Foundation, Inc. (MDS Foundation) MDS-0839 ( ) American Cancer Society (ACS) ACS-2345 ( ) National Alliance for Caregiving (NAC) This list of independent organizations is provided as an additional resource for obtaining information related to your disease. This list does not indicate endorsement by Celgene Corporation of an organization or its communications. Celgene resources Celgene Corporation Celgene Customer Care Center Celgene Medical Services Celgene Patient Support Patient information for Revlimid (lenalidomide) Call your doctor for medical advice about side effects. You may report side effects to FDA at FDA Please see accompanying full Prescribing Information, including Boxed WARNINGS and Medication Guide, in pocket and Important Safety Information on pages 2 and 3. REMS REVLIMID is only available through a restricted distribution program, REVLIMID REMS REVLIMID, REVLIMID REMS, THALOMID, and Celgene Patient Support are registered trademarks of Celgene Corporation Celgene Corporation 09/14 US-REV130056(2)

12 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use REVLIMID safely and effectively. See full prescribing information for REVLIMID. REVLIMID [lenalidomide] capsules, for oral use Initial US Approval: 2005 WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM See full prescribing information for complete boxed warning. EMBRYO-FETAL TOXICITY Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study similar to birth defects caused by thalidomide in humans. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. Pregnancy must be excluded before start of treatment. Prevent pregnancy during treatment by the use of two reliable methods of contraception (5.1). REVLIMID is available only through a restricted distribution program called the REVLIMID REMS TM program (formerly known as the RevAssist program ) (5.2, 17). HEMATOLOGIC TOXICITY. REVLIMID can cause significant neutropenia and thrombocytopenia (5.3). For patients with del 5q myelodysplastic syndromes, monitor complete blood counts weekly for the first 8 weeks and monthly thereafter (5.3). VENOUS AND ARTERIAL THROMBOEMBOLISM Significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with multiple myeloma receiving REVLIMID with dexamethasone. Anti-thrombotic prophylaxis is recommended (5.4) RECENT MAJOR CHANGES Boxed Warning 09/14 Indication and Usage (1.1) 02/15 Dosage and Administration (2.1, 2.4) 02/15 Warnings and Precautions (5.3, 5.4, 5.6, 5.11) 02/ INDICATIONS AND USAGE REVLIMID is a thalidomide analogue indicated for the treatment of patients with: Multiple myeloma (MM), in combination with dexamethasone (1.1). Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2). Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (1.3). Limitations of Use: REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials (1.4) DOSAGE AND ADMINISTRATION MM: 25 mg once daily orally on Days 1-21 of repeated 28-day cycles. Refer to section 14.1 for dexamethasone dosing (2.1, 14.1). MDS: 10 mg once daily (2.2). MCL: 25 mg once daily orally on Days 1-21 of repeated 28-day cycles (2.3). Continue or modify dosing based on clinical and laboratory findings (2.1, 2.2, 2.3). Renal impairment: Adjust starting dose in patients with moderate or severe renal impairment and on dialysis (CLcr<60 ml/min) (2.4) WARNINGS AND PRECAUTIONS Increased mortality: serious and fatal cardiac adverse reactions occurred in patients with CLL treated with REVLIMID (5.5). Second Primary Malignancies (SPM): Higher incidences of SPM were observed in controlled trials of patients with multiple myeloma receiving REVLIMID (5.6). Hepatotoxicity: Hepatic failure including fatalities; monitor liver function. Stop REVLIMID and evaluate if hepatotoxicity is suspected (5.7). Allergic Reactions, including fatalities: Hypersensitivity, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis; discontinue REVLIMID if reactions are suspected. Do not resume REVLIMID if these reactions are verified (5.8). Tumor lysis syndrome (TLS) including fatalities: Monitor patients at risk of TLS (i.e., those with high tumor burden) and take appropriate precautions (5.9). Tumor flare reaction: Serious tumor flare reactions have occurred during investigational use of REVLIMID for chronic lymphocytic leukemia and lymphoma (5.10, 6.3). Impaired Stem Cell mobilization: A decrease in the number of CD34+ cells collected after treatment (> 4 cycles) with REVLIMID has been reported. Consider early referral to transplant center (5.11) ADVERSE REACTIONS MM: Most common adverse reactions ( 20%) include diarrhea, fatigue, anemia, constipation, neutropenia, peripheral edema, insomnia, muscle cramp/spasms, back pain, nausea, asthenia, pyrexia, upper respiratory tract infection, cough, rash, dyspnea, dizziness, decreased appetite, thrombocytopenia, and tremor (6.1). MDS: Most common adverse reactions (>15%) include thrombocytopenia, neutropenia, diarrhea, pruritus, rash, fatigue, constipation, nausea, nasopharyngitis, arthralgia, pyrexia, back pain, peripheral edema, cough, dizziness, headache, muscle cramp, dyspnea, pharyngitis, and epistaxis (6.1). MCL: Most common adverse reactions ( 15%) include neutropenia, thrombocytopenia, fatigue, diarrhea, anemia, nausea, cough, pyrexia, rash, dyspnea, pruritus, constipation, peripheral edema and leukopenia (6.1). To report SUSPECTED ADVERSE REACTIONS contact Celgene Corporation at or FDA at FDA-1088 or DRUG INTERACTIONS Digoxin: Periodic monitoring of digoxin plasma levels is recommended due to increased C max and AUC with concomitant REVLIMID therapy (7.1). Patients taking concomitant therapies such as erythropoietin stimulating agents or estrogen containing therapies may have an increased risk of thrombosis (7.2) USE IN SPECIFIC POPULATIONS Nursing Mothers: Discontinue drug or nursing taking into consideration the importance of the drug to the mother (8.3). Patients with Renal Insufficiency: Adjust the starting dose of REVLIMID with moderate or severe renal impairment and on dialysis (2.4). See 17 for PATIENT COUNSELING INFORMATION and Medication Guide Revised: 02/ DOSAGE FORMS AND STRENGTHS Capsules: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg (3) CONTRAINDICATIONS Pregnancy (Boxed Warning, 4.1, 5.1, 8.1). Demonstrated hypersensitivity to lenalidomide (4.2, 5.8).

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