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REVLIMID® (lenalidomide) is a prescription medicine, used to treat adults 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.

You’re not alone with multiple myeloma

MEET ALLAN, JULIE, TIFFANY, AND THOMAS

Patients with multiple myeloma share their stories,
no matter where they are in their journeys.

DIAGNOSIS
Hear Allan’s story about his diagnosis and experience with multiple myeloma

Allan reflects about hearing from his doctor that he had multiple myeloma.

After you watch Allan’s story, learn more about multiple myeloma.

Allan: My name is Allan and I’m from Massachusetts.

Deb: And my name is Deb and I am his wife.

Allan: I was very fortunate that I spent my career of 35 years in the field of education.

Deb: I also came from the field of education when Allan and I first met. As Allan says, I was his boss and now he says I still am.

Allan: I really credit my primary care physician with my early diagnosis. I started with some back pain, lower back pain. I thought maybe I had pulled a muscle or worst-case scenario I thought, maybe I had a herniated disc. I went to see my primary care physician and he examined me, and he kind of agreed he felt that it was just a muscular problem. So, he told me if it wasn’t better in a week to give him a call. Well, about five days later the pain was pretty excruciating. So, I gave him a call and he sent me for an MRI. The MRI showed something on my spine that wasn’t supposed to be there. And further evaluation proved that it was a plasmacytoma. Which is common with multiple myeloma patients and then again, more testing and I got the diagnosis of multiple myeloma.

On screen super: Allan and Deb were compensated for their time in the creation of this video.

Allan: Deb and I started on our way home after that appointment. And I think like most people getting a diagnosis like that I was very angry. You know, I lived my life right—I don’t deserve this. But I realized quite quickly that I couldn’t spend the rest of my life being angry. So, before we got home that day, I had had that shift.

Deb: The ride home after diagnosis was challenging. But I think what has helped me from the very beginning is Allan’s positive attitude.

Allan: I love life and I wasn’t about to give it up. When I first got the diagnosis, my oncologist warned us about using the internet. And I remember his words exactly. He said, “half of what’s on the internet about multiple myeloma is outdated and the rest of it is just plain wrong.” But he also knew we were going to look for information. So, he gave us four or five websites where we could get reliable information. And we turned to those websites to get as much information as we possibly could.

Deb: Knowledge gave us power. Which was I think very helpful for both of us.

Allan: The first treatment I had was radiation to get rid of the plasmacytoma that was on my spine. After that my oncologist spoke to me about several different treatment options. And what the oncologist recommended was REVLIMID and dexamethasone. When I was on REVLIMID the side effects I experienced were some gastro-intestinal problems. I had fatigue and also neuropathy.

On Screen Super: Individual results with REVLIMID will vary. Always consult your doctor about any side effects.

Deb: I think the diagnosis has made us better people. Its changed us, I think it’s made us realize that we’re stronger than we thought we were, and we have met so many inspiring people.

Allan: When I speak to other patients, particularly newly diagnosed patients, I always tell them that this is going to be tough, but you can do it and you have to do it. Boy she didn’t know what she was getting into. But I often ask her if she would do it again? And she would. It’s an old cliché but it’s absolutely true, now I stop and smell the roses much more than I ever did before.

Lead-in VO: Please listen to the following Important Safety Information for REVLIMID.

Important Safety Information

What is REVLIMID® (lenalidomide)?

REVLIMID® (lenalidomide) is a prescription medicine, used to treat adults 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.

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

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 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 before, during, and after treatment with REVLIMID.
    • 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.
    • 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. If a female becomes pregnant with your sperm, the baby may be exposed to REVLIMID and may be born with birth defects.

Men: If a female becomes pregnant with your sperm, you should call your HCP right away.

  • 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); and
    • 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?”
  • 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
  • have had a serious skin rash with thalidomide treatment. You should not take REVLIMID.
  • are lactose intolerant. REVLIMID contains lactose.
  • are breastfeeding. Do not breastfeed during treatment with REVLIMID. 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 powder from the REVLIMID capsule comes in contact with:
    • your skin, wash the skin right away with soap and water.
    • inside of your eyes, nose, or mouth, flush well with 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.

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 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.

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), myelodysplastic syndromes (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
  • Severe skin reactions and severe allergic reactions can happen with REVLIMID and may cause death.
    Call your healthcare provider right away if you develop any of the following signs or symptoms during treatment with REVLIMID:

    • a red, itchy, skin rash
    • peeling of your skin or blisters
    • severe itching
    • fever

Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with REVLIMID:

    • swelling of your lips, mouth, tongue, or throat
    • trouble breathing or swallowing
    • raised red areas on your skin (hives)
    • a very fast heartbeat
    • You feel dizzy or faint
  • 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.
  • Risk of early death in MCL. In people who have mantle cell lymphoma (MCL), there may be a risk of dying sooner (early death) when taking REVLIMID. Talk with your healthcare provider about any concerns and possible risk factors.

The most common side effects of REVLIMID include:

  • diarrhea
  • rash
  • nausea
  • constipation
  • tiredness or weakness
  • fever
  • itching
  • swelling of your arms, hands, legs, feet, and skin
  • sleep problems (insomnia)
  • headache
  • muscle cramps or spasms
  • shortness of breath
  • cough, sore throat, and other symptoms of a cold
  • upper respiratory tract infection or bronchitis
  • inflammation of the stomach and intestine (“stomach flu”)
  • nose bleed
  • shaking or trembling (tremor)
  • joint aches
  • pain in your back or stomach area (abdomen)

These are not all of 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, on REVLIMID.com

REVLIMID®, and REVLIMID REMS® are registered trademarks of Celgene Corporation.
© Celgene Corporation 1/20 [US-REV-19-0422]

TREATMENT PLAN
Hear Julie’s story about her treatment plan and experience with multiple myeloma

Julie and her doctor chose REVLIMID to treat Julie’s multiple myeloma. Watch her story.

After you watch Julie’s story, learn more about REVLIMID.

Julie: Before I was diagnosed, I actually thought that life was a pretty straight line. So, you got born, then you went to school, then you got a job, and then you retired and then you died. End of story. And what I found out was sometimes life happens in between.

Julie: My name is Julie and I’m from Oregon.

Julie: When I was first diagnosed with multiple myeloma, I didn’t even know what it was. But once I found out that it was a form of cancer and that they didn’t actually have a cure yet, I decided I’m going to quit trying to build my own business and decided instead I would just concentrate on my own health. If this is going to happen to me, I better take an active role.

On screen super: Julie was compensated for her time in the creation of this video.

Julie: My doctor did give to me various options. In my case when my numbers went up at one point my doctor said I think it’s time for you to try REVLIMID and dexamethasone, and the oral option suited me well.

On Screen Super: Individual results with REVLIMID will vary

Julie: The factors that were important in deciding the treatment plan included was it covered by insurance. And was it effective for my disease. When I started treatment my biggest fear probably is what if this doesn’t work. And it turns out if it doesn’t work you speak up and you see what else you can do.

On Screen Super: Individual results with REVLIMID will vary.

Julie: I try to listen to my own body and so that when I get a side effect that I am more aware of it and then I have something that I can communicate with my health care team. In my case I had dry mouth and fatigue. So, the biggest thing I would recommend is simply speaking to your oncologist or doctor. And If there’s any dosage adjustments or any medication adjustments then they can help you with that.

On Screen Super: Individual results with REVLIMID will vary. Always consult your doctor about any side effects.

Julie: If multiple myeloma patients initially are feeling overwhelmed part of it to simply to step back and take a breath.

Julie: For me when I started treatment, one of my biggest fears was would I be missing out on life with family, and how would that affect for example my daughter. Maybe there would be fewer memories or maybe those memories would be bad memories.

Julie: I would say I became more of a human-being instead of a human-doing. Instead of just a task list of things that I have to do today. Sometimes now I’ll cheat, and I’ll simply write a list at the end of the day of the things that I accomplished and then I can check them all off.

Julie: I decided that if I could tell my own story and help other people then that would hopefully provide them with hope and recognition that there is life. Even after you’ve been diagnosed.

Lead-in VO: Please listen to the following Important Safety Information for REVLIMID.

Important Safety Information

What is REVLIMID® (lenalidomide)?

REVLIMID® (lenalidomide) is a prescription medicine, used to treat adults 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.

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

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 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 before, during, and after treatment with REVLIMID.
    • 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.
    • 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. If a female becomes pregnant with your sperm, the baby may be exposed to REVLIMID and may be born with birth defects.

Men: If a female becomes pregnant with your sperm, you should call your HCP right away.

  • 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); and
    • 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?”
  • 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
  • have had a serious skin rash with thalidomide treatment. You should not take REVLIMID.
  • are lactose intolerant. REVLIMID contains lactose.
  • are breastfeeding. Do not breastfeed during treatment with REVLIMID. 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 powder from the REVLIMID capsule comes in contact with:
    • your skin, wash the skin right away with soap and water.
    • inside of your eyes, nose, or mouth, flush well with 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.

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 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.

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), myelodysplastic syndromes (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
  • Severe skin reactions and severe allergic reactions can happen with REVLIMID and may cause death.
    Call your healthcare provider right away if you develop any of the following signs or symptoms during treatment with REVLIMID:

    • a red, itchy, skin rash
    • peeling of your skin or blisters
    • severe itching
    • fever

Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with REVLIMID:

    • swelling of your lips, mouth, tongue, or throat
    • trouble breathing or swallowing
    • raised red areas on your skin (hives)
    • a very fast heartbeat
    • You feel dizzy or faint
  • 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.
  • Risk of early death in MCL. In people who have mantle cell lymphoma (MCL), there may be a risk of dying sooner (early death) when taking REVLIMID. Talk with your healthcare provider about any concerns and possible risk factors.

The most common side effects of REVLIMID include:

  • diarrhea
  • rash
  • nausea
  • constipation
  • tiredness or weakness
  • fever
  • itching
  • swelling of your arms, hands, legs, feet, and skin
  • sleep problems (insomnia)
  • headache
  • muscle cramps or spasms
  • shortness of breath
  • cough, sore throat, and other symptoms of a cold
  • upper respiratory tract infection or bronchitis
  • inflammation of the stomach and intestine (“stomach flu”)
  • nose bleed
  • shaking or trembling (tremor)
  • joint aches
  • pain in your back or stomach area (abdomen)

These are not all of 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, REVLIMID.com

REVLIMID®, and REVLIMID REMS® are registered trademarks of Celgene Corporation.
© Celgene Corporation 1/20 [US-REV-19-0465]

ON REVLIMID
Hear Tiffany’s story about her experience with multiple myeloma and REVLIMID®

Tiffany describes her experience with maintenance therapy.

After you watch Tiffany’s story, learn more about REVLIMID.

Tiffany: My name is Tiffany. I’m from South Carolina.

Adrian: My name is Adrian and I’m from South Carolina also.

Tiffany: I learned of my multiple myeloma diagnosis pretty soon after experiencing severe back pain. Although I had a career and background in healthcare, none of it had been focused on cancer treatment or caring for patients with cancer. So, I had very little knowledge of what to expect. I remember being told it’s incurable but treatable. And those were the words that really stuck out for me.

Adrian: Hearing the words that it was treatable gave me a hope to build off of.

On Screen Super: Tiffany and Adrian were compensated for their time in the creation of this video.

Tiffany: Autologous stem cell transplant was a part of my treatment plan. The decision of the treatment options itself, I relied heavily on my care team for that. I was really anxious about starting treatment. Very nervous, and I remember being nauseous on the way to treatment. But once we got through the first day my anxiety was relieved.

Adrian: Yeah, I think the team made it a lot easier. Once we got in there it went well afterwards.

Tiffany: So residual disease is the amount of the disease that remains in the blood after stem cell transplant. REVLIMID was my maintenance therapy to prolong the response.

On Screen Super: Individual results with REVLIMID will vary.

Tiffany: REMS is the REVLIMID Risk Evaluation and Mitigation Strategy Program. Every month I complete the REMS survey, the oncology nurse sends my REVLIMID prescription down to my specialty pharmacy. And then my pharmacist reaches out to me to schedule setup for it, and then they will mail that prescription out to me.

Tiffany: I think the most important tip that I can give other patients about coordinating and receiving their REVLIMID prescription is to establish really good communication with their oncology team—specifically the nurse. As well as, the specialty pharmacy.

Tiffany: Shortly after starting REVLIMID I experienced some neuropathy in my foot and shared those concerns with my doctor, and he decreased the dosage. So that I could remain on therapy because that was very important to me.

On Screen Super: Individual results with REVLIMID will vary. Always consult your doctor about any side effects.

Tiffany: For me personally the most challenging part of living with multiple myeloma has been the physical changes. Being vibrant and you know, really healthy to having medical challenges that, you know, sometimes leaves me in bed for two or three days. Just watching, feeling my body change, has been difficult.

Adrian: The advice that I would give other care partners would be to just be strong. To be there for the patient that you’re caring for. And to show them as much support and love as you can.

Tiffany: My family 100% keeps me motivated. Adrian and my children they give me hope every day that I get up. Adrian has been my rock throughout this journey. He has always been so optimistic from the very beginning. He held on to the words treatable when I held on to the word’s incurable. And so, he often reminded me to see the positive when sometimes I was pulling back toward the fearful terms. As tough as it is, I think it’s easier because of his support.

Adrian: All the ups and downs is just a part of a chapter in our life that I would not give it up for anything else in the world.

Lead-in VO: Please listen to the following Important Safety Information for REVLIMID.

Important Safety Information

What is REVLIMID® (lenalidomide)?

REVLIMID® (lenalidomide) is a prescription medicine, used to treat adults 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.

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

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 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 before, during, and after treatment with REVLIMID.
    • 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.
    • 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. If a female becomes pregnant with your sperm, the baby may be exposed to REVLIMID and may be born with birth defects.

Men: If a female becomes pregnant with your sperm, you should call your HCP right away.

  • 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); and
    • 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?”
  • 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
  • have had a serious skin rash with thalidomide treatment. You should not take REVLIMID.
  • are lactose intolerant. REVLIMID contains lactose.
  • are breastfeeding. Do not breastfeed during treatment with REVLIMID. 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 powder from the REVLIMID capsule comes in contact with:
    • your skin, wash the skin right away with soap and water.
    • inside of your eyes, nose, or mouth, flush well with 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.

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 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.

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), myelodysplastic syndromes (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
  • Severe skin reactions and severe allergic reactions can happen with REVLIMID and may cause death.
    Call your healthcare provider right away if you develop any of the following signs or symptoms during treatment with REVLIMID:

    • a red, itchy, skin rash
    • peeling of your skin or blisters
    • severe itching
    • fever

Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with REVLIMID:

    • swelling of your lips, mouth, tongue, or throat
    • trouble breathing or swallowing
    • raised red areas on your skin (hives)
    • a very fast heartbeat
    • You feel dizzy or faint
  • 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.
  • Risk of early death in MCL. In people who have mantle cell lymphoma (MCL), there may be a risk of dying sooner (early death) when taking REVLIMID. Talk with your healthcare provider about any concerns and possible risk factors.

The most common side effects of REVLIMID include:

  • diarrhea
  • rash
  • nausea
  • constipation
  • tiredness or weakness
  • fever
  • itching
  • swelling of your arms, hands, legs, feet, and skin
  • sleep problems (insomnia)
  • headache
  • muscle cramps or spasms
  • shortness of breath
  • cough, sore throat, and other symptoms of a cold
  • upper respiratory tract infection or bronchitis
  • inflammation of the stomach and intestine (“stomach flu”)
  • nose bleed
  • shaking or trembling (tremor)
  • joint aches
  • pain in your back or stomach area (abdomen)

These are not all of 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, REVLIMID.com

REVLIMID®, and REVLIMID REMS® are registered trademarks of Celgene Corporation.
© Celgene Corporation 1/20 [US-REV-19-0468]

RELAPSE
Hear Thomas’s story about his experience with multiple myeloma and relapse

Thomas shares how he stays motivated after his relapse.

After you watch Thomas’ story, learn more about relapse.

Thomas: To be a fighter is to never give up. I was in a place where I was feeling healthy. I was almost feeling like I was back to my normal self, but relapse knocked me back down. I am Thomas and I am from North Carolina.

Thomas: The oncologist diagnosed me with a plasmacytoma, so I told him to break that down for me. He said that’s a cancerous tumor that’s isolated in one area. And I heard the word cancer, and I really didn’t hear anything else that he said.

On Screen Super: Thomas was compensated for his time in the creation of this video.

Thomas: One of the first things I had to do was tell my family. My family accepted it very well. They knew that I am a pillar of strength. Relapse probably had to be the most difficult part of my myeloma journey. I felt that I had overcome the disease. I felt that I was bigger than the disease you know, but when I relapsed, that made me realize that I’m not the person that I thought I was when I’m dealing with multiple myeloma. That’s when I said multiple myeloma is bigger than me.

Thomas: My family played an enormous role in my journey with multiple myeloma. My daughters are my focal point. They were the reasons that I wanted to fight. I want my daughters to learn from me that even through adversity you can overcome things.

Thomas: After I relapsed, my doctor said that she thinks REVLIMID with dexamethasone would be the best option for me. I was down for the suggestions that she had made because I was willing to do what it takes.

On Screen Super: Individual results with REVLIMID will vary.

Thomas: One of the main side effects that I experienced was peripheral neuropathy along with insomnia.

On Screen Super: Individual results with REVLIMID will vary. Always consult your doctor about any side effects.

Thomas: Multiple myeloma has changed my life. It showed me how to become an advocate for my own healthcare and it also showed me how to be an advocate for others. It put me in a position where I never thought I’d be. Where someone would look up to me as a role model outside of my family and I really want to use that platform so I can expand and educate others about my journey with multiple myeloma. Everyone’s story is different, and your story may affect someone else and they may take your journey and uplift themselves.

Thomas: Live your life to the fullest. Cherish every day as if it’s your last. And have patience because patience brings peace.

Lead-in VO: Please listen to the following Important Safety Information for REVLIMID.

Important Safety Information

What is REVLIMID® (lenalidomide)?

REVLIMID® (lenalidomide) is a prescription medicine, used to treat adults 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.

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

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 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 before, during, and after treatment with REVLIMID.
    • 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.
    • 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. If a female becomes pregnant with your sperm, the baby may be exposed to REVLIMID and may be born with birth defects.

Men: If a female becomes pregnant with your sperm, you should call your HCP right away.

  • 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); and
    • 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?”
  • 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
  • have had a serious skin rash with thalidomide treatment. You should not take REVLIMID.
  • are lactose intolerant. REVLIMID contains lactose.
  • are breastfeeding. Do not breastfeed during treatment with REVLIMID. 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 powder from the REVLIMID capsule comes in contact with:
    • your skin, wash the skin right away with soap and water.
    • inside of your eyes, nose, or mouth, flush well with 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.

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 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.

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), myelodysplastic syndromes (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
  • Severe skin reactions and severe allergic reactions can happen with REVLIMID and may cause death.
    Call your healthcare provider right away if you develop any of the following signs or symptoms during treatment with REVLIMID:

    • a red, itchy, skin rash
    • peeling of your skin or blisters
    • severe itching
    • fever

Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with REVLIMID:

    • swelling of your lips, mouth, tongue, or throat
    • trouble breathing or swallowing
    • raised red areas on your skin (hives)
    • a very fast heartbeat
    • You feel dizzy or faint
  • 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.
  • Risk of early death in MCL. In people who have mantle cell lymphoma (MCL), there may be a risk of dying sooner (early death) when taking REVLIMID. Talk with your healthcare provider about any concerns and possible risk factors.

The most common side effects of REVLIMID include:

  • diarrhea
  • rash
  • nausea
  • constipation
  • tiredness or weakness
  • fever
  • itching
  • swelling of your arms, hands, legs, feet, and skin
  • sleep problems (insomnia)
  • headache
  • muscle cramps or spasms
  • shortness of breath
  • cough, sore throat, and other symptoms of a cold
  • upper respiratory tract infection or bronchitis
  • inflammation of the stomach and intestine (“stomach flu”)
  • nose bleed
  • shaking or trembling (tremor)
  • joint aches
  • pain in your back or stomach area (abdomen)

These are not all of 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, REVLIMID.com

REVLIMID®, and REVLIMID REMS® are registered trademarks of Celgene Corporation.
© Celgene Corporation 1/20 [US-REV-19-0467]

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What is REVLIMID® (lenalidomide)?
REVLIMID® (lenalidomide) is a prescription medicine, used to treat adults 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.

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

 

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 arepregnant or who plan to become pregnant must not take REVLIMID.

    REVLIMID is similar to the medicine thalidomide
    which is known to cause severelife-threatening birth defects. REVLIMID has not been tested in pregnant females. REVLIMID has harmedunborn 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 before, during, and after treatment with REVLIMID.
    • 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.
    • 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. If a female becomes pregnant with your sperm, the baby may be exposed to REVLIMID and may be born with birth defects.

    Men: If a female becomes pregnant with your sperm, you should call your HCP right away.

  • 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); and
    • 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?”
  • 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
  • have had a serious skin rash with thalidomide treatment. You should not take REVLIMID.
  • are lactose intolerant. REVLIMID contains lactose.
  • are breastfeeding. Do not breastfeed during treatment with REVLIMID. 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 powder from the
    REVLIMID capsule comes in contact with:
    • your skin, wash the skin right away with soap and water.
    • inside of your eyes, nose, or mouth, flush well with 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.

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 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.

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), myelodysplastic syndromes (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
  • Severe skin reactions and severe allergic reactions can happen with REVLIMID and may cause death.
    Call your healthcare provider right away if you develop any of the following signs or symptoms during treatment with REVLIMID:

    • a red, itchy, skin rash
    • peeling of your skin or blisters
    • severe itching
    • fever

Get emergency medical help right away if you develop any of the following signs or symptoms
during treatment with REVLIMID:

  • swelling of your lips, mouth, tongue, or throat
  • trouble breathing or swallowing
  • raised red areas on your skin (hives)
  • a very fast heartbeat
  • You feel dizzy or faint
  • 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.
  • Risk of early death in MCL. In people who have mantle cell lymphoma (MCL), there may be a risk of dying sooner (early death) when taking REVLIMID. Talk with your healthcare provider about any concerns and possible risk factors.

The most common side effects of REVLIMID include:

  • diarrhea
  • rash
  • nausea
  • constipation
  • tiredness or weakness
  • fever
  • itching
  • swelling of your arms, hands, legs, feet, and skin
  • sleep problems (insomnia)
  • headache
  • muscle cramps or spasms
  • shortness of breath
  • cough, sore throat, and other symptoms of a cold
  • upper respiratory tract infection or bronchitis
  • inflammation of the stomach and intestine (“stomach flu”)
  • nose bleed
  • shaking or trembling (tremor)
  • joint aches
  • pain in your back or stomach area (abdomen)

These are not all of 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, for REVLIMID.