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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 a prescription medicine, used to treat people with multiple myeloma (MM) in combination with the medicine dexamethasone, or as maintenance treatment after autologous hematopoietic stem cell transplantation (a type of stem cell transplant that uses your own stem cells).
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.

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Important Safety Information

What is the most important information I should know about REVLIMID?

Before you begin taking REVLIMID, you must read and agree to all of the instructions in the REVLIMID REMS® program. Before prescribing REVLIMID, your healthcare provider will explain the REVLIMID REMS program to you and have you sign the Patient-Physician Agreement Form.

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®), which is known to cause severe life-threatening birth defects. REVLIMID has not been tested in pregnant females. REVLIMID has harmed unborn animals in animal testing.
    • 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 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, for at least 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for at least 4 weeks after stopping REVLIMID. Talk with your healthcare provider to find out about options for effective forms of birth control that you may use to prevent pregnancy.
      • If you had unprotected sex or if you think your birth control has failed, stop taking REVLIMID immediately and call your healthcare provider right away.
    • 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 Celgene Customer Care Center at 1-888-423-5436. 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. There is a pregnancy exposure registry that monitors the outcomes of females who take REVLIMID during pregnancy, or if their male partner takes REVLIMID and they are exposed during pregnancy. You can enroll in this registry by calling Celgene Corporation at the phone number listed above.
    • REVLIMID can pass into human semen. Males, including those who have had a vasectomy, must always use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking REVLIMID, during any breaks (interruptions) in your treatment with REVLIMID, and for up to 4 weeks after stopping REVLIMID.
      • If a female becomes pregnant with your sperm, you should call your HCP right away. The baby may be exposed to REVLIMID and may be born with birth defects.
      • 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.
      • Do not donate sperm while taking REVLIMID, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping 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. 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.
    Before taking REVLIMID, tell your healthcare provider:

    • If you have had a blood clot in the past
    • If you have high blood pressure, smoke, or if you have been told you have a high level of fat in your blood (hyperlipidemia)
    • About all the 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 during treatment with REVLIMID:

    • Signs or symptoms of a blood clot in the lung, arm, or leg may include: shortness of breath, chest pain, or arm or leg swelling
    • Signs or symptoms of a heart attack may include: chest pain that may spread to the arms, neck, jaw, back, or stomach area (abdomen), feeling sweaty, shortness of breath, feeling sick or vomiting
    • Signs or symptoms of stroke may include: sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech, or balance
Who should not take REVLIMID?
  • Do not take REVLIMID if you are pregnant, plan to become pregnant, or become pregnant during treatment with REVLIMID. See "What is the most important information I should know about REVLIMID?"
  • Do not take REVLIMID if you are allergic to lenalidomide or any of the ingredients in REVLIMID. See the Medication Guide for a complete list of ingredients in REVLIMID.
What should I tell my healthcare provider before taking REVLIMID?

Before you take REVLIMID, tell your healthcare provider about all of your medical conditions, including if you:

  • have liver problems
  • have kidney problems or receive kidney dialysis treatment
  • have thyroid problems
  • are lactose intolerant. REVLIMID contains lactose.
  • are breastfeeding. REVLIMID must not be used by females who are breastfeeding. It is not known if REVLIMID passes into your breast milk and can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. REVLIMID and other medicines may affect each other, causing serious side effects. Talk with your healthcare provider before taking any new medicines. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.

How should I take REVLIMID?

Take REVLIMID exactly as prescribed and follow all the instructions of the REVLIMID REMS program

  • Swallow REVLIMID capsules whole with water 1 time a day. Do not open, break, or chew your capsules.
  • REVLIMID may be taken with or without food.
  • Take REVLIMID at about the same time each day.
  • 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 right away 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, call your healthcare provider right away.
  • Do not share REVLIMID with other people. It may cause birth defects and other serious problems.
What should I avoid while taking REVLIMID?
  • See “What is the most important information I should know about REVLIMID?”
  • Females: Do not get pregnant and do not breastfeed while taking REVLIMID.
  • Males: Do not donate sperm
  • 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.
What are the possible side effects of REVLIMID?

REVLIMID can cause serious side effects, including:

  • See "What is the most important information I should know about REVLIMID?"
  • 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). An increase in new (second) cancers has happened in patients who received REVLIMID and melphalan, or a blood stem cell transplant, including certain blood cancers, such as acute myelogenous leukemia (AML), and myelodysplastic syndrome (MDS) and certain other types of cancers of the skin and other organs. 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. Your healthcare provider should do blood tests to check your liver function during your treatment with REVLIMID. Tell your healthcare provider right away if you develop any of the following symptoms of liver problems:
    • 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 (abdomen)
    • bleeding or bruising more easily than normal
    • feeling very tired
  • 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 a serious allergic reaction or serious skin reaction during treatment with REVLIMID:
    • swelling of your face, eyes, lips, tongue, throat
    • trouble swallowing
    • trouble breathing
    • skin rash, hives, or peeling of your skin
    • blisters
  • Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure and sometimes death. Your healthcare provider may do blood tests to check you for TLS.
  • Worsening of your tumor (tumor flare reaction). Tell your healthcare provider if you get any of these symptoms of tumor flare reaction while taking REVLIMID: tender swollen lymph nodes, low grade fever, pain, or rash.
  • Thyroid problems. Your healthcare provider may check your thyroid function before you start taking REVLIMID and during treatment with REVLIMID.

The most common side effects of REVLIMID include:

  • diarrhea
  • rash
  • nausea
  • constipation
  • tiredness
  • fever
  • itching
  • swelling of the limbs and skin
  • cough

These are not all the possible side effects of REVLIMID. Your healthcare provider may tell you to decrease your dose, temporarily stop or permanently stop taking REVLIMID if you develop certain serious side effects during treatment with REVLIMID. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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 a prescription medicine, used to treat people with multiple myeloma (MM) in combination with the medicine dexamethasone, or as maintenance

Important Safety Information

What is the most important information I should know about REVLIMID?

Before you begin taking REVLIMID, you must read and agree to all of the instructions in the REVLIMID REMS® program. Before prescribing REVLIMID,