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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.

Educational Videos

Watch these videos to learn more about REVLIMID® (lenalidomide).

Learn how to receive your REVLIMID® (lenalidomide) prescription and about the REMS program

Download our Getting My Medication
brochure for helpful information regarding 
how to receive your medication.
Download

Getting My Medication

Follow the steps in this video to learn how to receive your REVLIMID prescription. You can learn more about the Lenalidomide Risk Evaluation and Mitigation Strategy (REMS) program here.

On-screen: 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.

On-screen: REVLIMID has a Black Box Warning. The warning is there because REVLIMID may cause serious side effects, including risk to unborn babies, risk of low blood counts and blood clots. Because of these safety considerations, REVLIMID is only available through a restricted distribution program called Lenalidomide REMS.

Please continue watching after this video for Important Safety Information about REVLIMID.

VO: Getting My Medication.

VO: To avoid serious risks to unborn babies, REVLIMID is only available through a restricted distribution program called Lenalidomide Risk Evaluation and Mitigation Strategy.

VO: It’s also known as the Lenalidomide REMS program.

VO: Before you begin taking REVLIMID, you must be enrolled in the Lenalidomide REMS program. Once you complete your counseling and enrollment with your healthcare provider, you will need to take the following steps to receive your prescription:

VO: Step 1. TAKE YOUR REMS SURVEY

*It’s available for both iPhone and Android users.

VO: Step 2. ANSWER YOUR PHONE. A specialty pharmacy will contact you to provide counseling on the serious risks and safe-use conditions of REVLIMID before you receive your prescription.

VO: A specialty pharmacy will then ship you your medication. They may call you from a number you don’t recognize, so make sure you answer your phone. Otherwise, your medication may be delayed. It may be helpful to save this phone number for future reference.

VO: Step 3. ARRANGE DELIVERY

VO: Tell your specialty pharmacy where it should send your medication. Make sure you, or someone 18 or older, are available to sign for it.


VO: Keep in mind…

VO: …you will need to repeat this process every month to refill your medication.

VO: To learn more about the Lenalidomide REMS program requirements and how to receive your medication,
1. Download the REMS Companion App*
2. Visit CelgeneRiskManagement.com
3. Call 1-888-423-5436 and press 1

On-screen super: *It’s available for both iPhone and Android users.

VO: Be sure to always follow your doctor’s instructions carefully about how to take REVLIMID.

VO: And talk with your doctor or nurse if you have questions.

VO:

What is REVLIMID® (lenalidomide)?

REVLIMID 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 Lenalidomide REMS program. Before prescribing REVLIMID, your healthcare provider will explain the Lenalidomide 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 Lenalidomide 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.

REVLIMID® and the REVLIMID logo are registered trademarks of Celgene Corporation, a Bristol-Myers Squibb Company.

© 2021 Bristol-Myers Squibb Company.
11/21 2003-US-2100372

Learn how REVLIMID® (lenalidomide) works

Download our Conversation Starter to find
ways to talk about REVLIMID.
Download

How REVLIMID Works

See how REVLIMID works to help fight multiple
myeloma (MM).

On-screen: 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.

On-screen: REVLIMID has a Black Box Warning. The warning is there because REVLIMID may cause serious side effects, including risk to unborn babies, risk of low blood counts and blood clots. Because of these safety considerations, REVLIMID is only available through a restricted distribution program called Lenalidomide REMS.

Please continue watching after this video for Important Safety Information about REVLIMID.

VO: How REVLIMID Works.

VO: REVLIMID is a once-daily capsule used to treat multiple myeloma, or MM for short.

VO: It’s also an immunomodulatory (IMiD®) agent. 

VO: This means it adjusts the responses of your immune system to help your body fight MM.

VO: Regardless of if you’re newly diagnosed and…

VO: Ineligible for an autologous hematopoietic stem cell transplant (auto-HSCT)…

VO: …or you’re taking REVLIMID for maintenance therapy following an auto-HSCT…

VO: …the medication works with your immune system to help fight MM.

VO: REVLIMID is thought to work in 3 ways in animal models and in vitro. In vitro means in a test tube or glass; outside of a living organism.

VO: It STIMULATES your immune system and helps it recognize and destroy myeloma cells.

VO: It STRIKES by targeting and killing the myeloma cells.

VO: And it STARVES the myeloma cells and prevents them from growing.

VO: Ask your doctor if REVLIMID may be right for you.

VO: Be sure to always follow your doctor’s instructions carefully about how to take REVLIMID.

VO: And talk to your doctor or nurse if you have questions.

VO:

What is REVLIMID® (lenalidomide)?

REVLIMID 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 Lenalidomide REMS program. Before prescribing REVLIMID, your healthcare provider will explain the Lenalidomide 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 Lenalidomide 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.

REVLIMID® and the REVLIMID logo are registered trademarks of Celgene Corporation, a Bristol-Myers Squibb Company. Access Support® is a registered trademark of Bristol-Myers Squibb Company.

© 2021 Bristol-Myers Squibb Company.
11/21 2003-US-2100373

Watch Dr. Fanning answer common questions
associated with maintenance therapy.

Learn how maintenance therapy is an important part of your multiple myeloma treatment journey

Download our Maintenance Therapy for
Multiple Myeloma brochure and see how
REVLIMID is used as maintenance therapy.
Download

Ask a Multiple Myeloma (MM) Doctor

Dr. Fanning is a hematology oncologist at the Prisma Health Cancer Institute. Here she talks about the role maintenance therapy plays in your MM treatment journey.

On-Screen Super: ASK A MULTIPLE MYELOMA DOCTOR Common questions about maintenance therapy.

Dr. Fanning: My name is Dr. Suzanne Fanning. I am the Director of Stem Cell Transplant for the Prisma Health Cancer Institute in Greenville, South Carolina. I have had the opportunity and privilege to care for multiple myeloma patients since completing my fellowship at the Cleveland Clinic in 2007.

On-Screen Super: Dr. Suzanne Fanning. Hematology Oncologist/Director of Stem Cell Transplant. Prisma Health Cancer Institute. Greenville, SC.

On-Screen Super: What is maintenance therapy?

Dr. Fanning: When patients go through a stem cell transplant, their disease burden, the amount of active cancer cells they have in the body, is reduced dramatically.
After transplant, your doctor may recommend another medication to be taken as maintenance therapy. Maintenance therapy is used to extend your body’s response to stem cell transplant. We do know that myeloma cells can remain in your body after a complete response to transplant and without maintenance, your immune system can weaken sooner and the myeloma may return earlier.

On-Screen Super: How long do I stay on maintenance therapy?

Dr. Fanning: Patients with multiple myeloma are very different and unique. It’s hard to say exactly how long any one patient will remain on maintenance therapy, but the aim for all patients is to remain on treatment for as long as your myeloma stays under control.

On-Screen Super: What are the side effects of maintenance therapy?

Dr. Fanning: Side effects are unwanted or unexpected events that occur as a result of taking a medication. Some of these side effects are common and manageable, while others may be serious. With maintenance therapy, side effects can include diarrhea, rash, peripheral neuropathy, among others. For some patients, writing down how they’re feeling on a daily basis in a journal or even on a calendar can be a useful way to keep track of any side effects.

On-Screen Super: Can side effects be managed?

Dr. Fanning: Side effects can be managed over time, and we also know that when using maintenance therapy, side effects can decrease over time. The more vocal you are about how you’re feeling, the better your healthcare team can understand your side effects and help you manage them. Which is why it’s very important that you talk to your healthcare team, tell them about any side effects you may be experiencing so that they can help you continue on your maintenance journey for as long as possible.

© 2022 Bristol-Myers Squibb Company        1/22     2003-US-2100386

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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 Lenalidomide REMS program. Before prescribing REVLIMID, your healthcare provider will explain the Lenalidomide 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 Lenalidomide 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.

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