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REVLIMID® (lenalidomide) capsules for the treatment of multiple myeloma

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Healthcare team overview

It can be overwhelming when you’ve been diagnosed with multiple myeloma, but remember that you have a healthcare team supporting you. Take the time to build strong partnerships as you move forward. With their help, you can spend more time focusing on the moment.

Build a strong partnership

A strong partnership with your doctor and nurse is built on communication and trust. This means that you feel comfortable speaking openly with them about your health issues. Use the following tips to make the most of your appointment time:

  • Be prepared for your appointment
    You might want to bring a calendar or bring a friend to help you take notes
  • Write down a list of questions you want to ask
    You may want to share the list with your doctor or nurse during your appointment
  • Write down any symptoms you may have
    Other helpful information includes the date(s) you had your symptoms, or any recent tests you’ve had

Your role as a patient

You may have several healthcare professionals on your team. But the most important member of your team is you. To make the best decisions as a team, you need to be involved in key decisions regarding your health and your treatment.

Your doctors and nurses want you to come to them with your questions about your condition and your treatment. Feel free to talk about any concerns you may have about treatment, how you are feeling, or any side effects you may be experiencing. If you are working with a caregiver, keep that person informed about how you are feeling as well.

Getting the information you need

Getting the information you need may require asking questions. At the start of a new treatment, you may have many questions for your healthcare team. Remember, it is okay to ask your questions. If there is something you want to know about your treatment, don’t be afraid to ask your doctor or nurse.

You may want to ask

  • Why do you think REVLIMID® (lenalidomide) with dexamethasone is right for me now?
  • What can I expect when I take REVLIMID with dexamethasone?
  • How long will I be taking REVLIMID with dexamethasone?
  • Who can I contact if I have concerns or questions after starting my new medication?

It may be helpful to write down any questions that arise about REVLIMID with dexamethasone. You can bring these questions with you to your next medical appointment and ask your doctor or nurse.

Ask open-ended questions

Asking open-ended questions can help you get more information. The more information you have, the stronger partnership you can build. Here are some examples:

Instead of asking “yes” or “no” questions… Ask open-ended questions…
Do I need to take my medicine every day? How should I take my medicine?
Will this medicine make me feel better?
Will this medicine make me feel worse?
What can I expect from this medicine?

Be an active listener

Active listening can help you have an effective conversation with your doctor or nurse. This may help you to better understand information and avoid confusion.

Below are some tips for active listening:

  • Pay close attention to the person who is talking
  • Repeat and summarize what the person said in your own words, to make sure that what you heard is what he or she really meant

Sharing information with your healthcare team is important. It helps them plan your treatment and take better care of you.

Providing information to your healthcare team

In order to provide you with the best care, your healthcare team also needs information from you. It’s important to keep an open dialogue with them, and to share any concerns you may have about treatment. If you are worried about how your treatment is affecting you, talk candidly with them. Your doctor may be able to adjust your dose, delay your dose, or stop treatment. Working together, you can discuss the different options you may have.

Getting to know your healthcare team

Since you received your diagnosis, your doctor may have been the person you talked with the most. But there are other people who may be able to help you during treatment.

They are all knowledgeable in certain areas. And together they can provide you with a lot of information. You may have spoken with some of them already. If not, keep your healthcare team in mind. They may be able to help you in the future.

Nurses play an important role in your care. They can provide information about your condition and treatment. Nurses may also monitor you for side effects. You may also have a nurse practitioner who is managing your overall care. Your nurses may be the people you talk with most about your questions and concerns.

You will get REVLIMID® (lenalidomide) through a pharmacy that is part of the REVLIMID REMS® program. You can talk with the pharmacist about your medicine. He or she can answer questions you may have about your medicine. It is important to let the pharmacist know about all other medicines you are taking.

You and your family may need emotional support at times during your treatment. Social workers may be able to offer you counseling and help you find support groups or resources where you live. You may also find it helpful to talk to a psychologist or psychiatrist. They are trained to help people cope with their emotions and concerns.

Cancer and/or its treatment may make it difficult to get enough of the calories, proteins, vitamins, and minerals that the body needs. A registered dietician or nutritionist can help you select a diet that may meet your nutritional needs.

A case manager is often a nurse or oncology specialist who coordinates a patient’s care. The case manager may help you handle insurance issues or find support resources.

Your family and friends can also help you throughout your treatment. They may be able to offer you support by helping you work with the members of your healthcare team.

NEXT: Information for caregivers

Indication

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.

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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).

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 1-888-668-2528 for medical information. Healthcare providers and patients should report all cases of pregnancy to: FDA MedWatch at 1-800-FDA-1088 and Celgene Corporation at 1-888-423-5436
  • 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
  • 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
  • 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

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

Other important information about REVLIMID

  • 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 or are on dialysis, be sure to talk with your doctor. He or she may need to adjust your dose of REVLIMID

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

TO REPORT SUSPECTED ADVERSE REACTIONS OR EMBRYO-FETAL EXPOSURE: CONTACT CELGENE CORPORATION AT 1-888-423-5436 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.

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Indication

REVLIMID® (lenalidomide) is used with dexamethasone to treat patients with multiple myeloma (MM).

Important Safety Information

WARNING: Risk to unborn babies, low blood counts, and blood clots

Before you begin taking REVLIMID, you must read