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Indication Prescribing Information

This site is intended for US audiences only.

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.

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Understanding the
multiple myeloma journey

Understanding the
multiple myeloma journey

No two multiple myeloma journeys are exactly alike. Knowing what to expect and understanding that relapse may occur can help.

Click the steps on the interactive journey below to learn more.*

  • 1

    DIAGNOSIS

    The words no one wants to hear: “You have cancer.” It can be an emotional time. Fortunately, multiple myeloma is a treatable cancer, and improvements in survival have been made over the past 10 years. Once you’re diagnosed as having multiple myeloma, you’ll be referred to a specialist, either a hematologist or an oncologist, who will consider your treatment options.

  • 2

    treatment
    SELECTION

    There are several treatment options, including injectable and oral medicines, chemotherapy, and stem cell transplants. Your doctor will discuss your treatment options with you and the associated risks and benefits of each.

  • 3

    ON
    treatment

    When treatment begins, it’s important to follow the advice of your doctors and nurses. Take your medicines as prescribed and for as long as they are prescribed. Ask questions when you don’t understand something, and try to stay organized with your treatment and appointments.

  • 4

    SIDE
    EFFECTS

    You may experience side effects while on treatment. Some of these side effects may be serious. If you have certain side effects, your doctor may adjust your treatment dose. Your doctor may also delay or stop treatment. Make sure to always discuss symptoms and side effects with your healthcare team.

  • 5

    RESPONSE

    When treatment helps manage your multiple myeloma and symptoms improve, doctors refer to this as a response. There are varying degrees of response, but millions of myeloma cells can still remain in your body, even with a complete response. The objective of treatment is to keep multiple myeloma controlled for as long as possible.

  • 6

    RELAPSE

    Myeloma cells that survive treatment can continue to multiply. This can lead to a relapse, meaning the disease returns. Make sure you tell your doctor about how you feel and any changes you’re experiencing. Your doctor will review your options, the risks and benefits, and help you create a treatment plan.

    Relapse is common but treatable. When a relapse occurs, ask your doctor about oral POMALYST® (pomalidomide) with convenient, once-daily dosing.†

    †POMALYST is taken in combination with dexamethasone on days 1-21 of a 28-day cycle.

*This is an example of the sequence of a multiple myeloma journey. Your journey may vary.

Although there is no cure for multiple myeloma, treatment has been evolving with a number of options. This includes IMiD® agents like REVLIMID® (lenalidomide) for newly diagnosed patients, and POMALYST® (pomalidomide) for patients relapsing on REVLIMID.

  • IMiD, immunomodulatory drug.

POMALYST is a prescription medicine, taken along with the medicine dexamethasone, used to treat people with multiple myeloma who have previously received at least 2 medicines to treat multiple myeloma, including a proteasome inhibitor and lenalidomide, and whose disease has become worse during treatment or within 60 days of finishing the last treatment. It is not known if POMALYST is safe and effective in children. POMALYST is only available through a restricted distribution program, POMALYST REMS®. Please see Important Safety Information for POMALYST below and full Prescribing Information, including Boxed WARNINGS and Medication Guide.

Hypothetical REVLIMID® (lenalidomide) patient with multiple myeloma holding their shoulder
Hypothetical REVLIMID® (lenalidomide) patient with multiple myeloma holding their shoulder

About relapsed/refractory multiple myeloma

Your doctor may have told you that your multiple myeloma has come back, also known as a relapse. This means your multiple myeloma is no longer responding to the medications you’re taking. At this point, your doctor may switch your treatment to POMALYST—another oral IMiD therapy that's proven to help you fight disease progression after relapse. POMALYST is a pill that offers convenient, once-daily dosing.‡

EXPLORE POMALYST
  • POMALYST is taken in combination with dexamethasone on days 1-21 of a 28-day cycle.
Important Safety Information

WARNINGS: Risk to unborn babies, and blood clots.

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

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

POMALYST can cause serious side effects, including:

  • Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or plan to become pregnant must not take POMALYST.
    • POMALYST is similar to the medicine thalidomide (THALOMID®), which is known to cause severe life-threatening birth defects. POMALYST has not been tested in pregnant females. POMALYST has harmed unborn animals in animal testing.
    • Females must not get pregnant:
      • For at least 4 weeks before starting POMALYST
      • While taking POMALYST
      • During any breaks (interruptions) in your treatment with POMALYST
      • For at least 4 weeks after stopping POMALYST
    • Females who can become pregnant:
      • Will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular. If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling.
      • Must agree to use 2 acceptable forms of effective birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in treatment, and for at least 4 weeks after stopping POMALYST.
      • Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy during and after treatment with POMALYST.
    • If you become pregnant while taking POMALYST, 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
      • Celgene Corporation, a Bristol-Myers Squibb Company, at 1-888-423-5436
    • There is a pregnancy exposure registry that monitors the outcomes of females who take POMALYST during pregnancy, or if their male partner takes POMALYST and they are exposed during pregnancy. You can enroll in this registry by calling Celgene Corporation, a Bristol-Myers Squibb Company, at the phone number listed above.
    • POMALYST 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 POMALYST, during any breaks (interruptions) in your treatment with POMALYST, and for 4 weeks after stopping POMALYST.
      • 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 POMALYST, during any breaks (interruptions) in your treatment, and for up to 4 weeks after stopping POMALYST. If a female becomes pregnant with your sperm, the baby may be exposed to POMALYST and may be born with birth defects.
    • Men, if your female partner becomes pregnant, you should call your healthcare provider right away.
    • Do not donate blood while you take POMALYST, during any breaks (interruptions) in your treatment, and for up to 4 weeks after stopping POMALYST. If someone who is pregnant gets your donated blood, her baby may be exposed to POMALYST and may be born with birth defects.
  • Blood clots in your arteries, veins, and lungs, heart attack, and stroke can happen if you take POMALYST.
    • Most people who take POMALYST will also take a blood thinner medicine to help prevent blood clots.
    • Before taking POMALYST, tell your healthcare provider:
    • If you have had a blood clot in the past.
    • If you have high blood pressure, smoke, or if you have been told you have a high level of fat in your blood (hyperlipidemia).
    • About all the medicines you take. Certain other medicines can also increase your risk for blood clots.

Call your healthcare provider or get medical help right away if you get any of the following during treatment with POMALYST:

  • 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.
  • 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 POMALYST:

  • 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
Who should not take POMALYST?

Do not take POMALYST if you:

  • Are pregnant, plan to become pregnant, or become pregnant during treatment with POMALYST. See “What is the most important information I should know about POMALYST?”
  • Are allergic to pomalidomide or any of the ingredients in POMALYST.
What should I tell my healthcare provider (HCP) before taking POMALYST?
  • If you smoke cigarettes (POMALYST may not work as well in people who smoke), have any other medical conditions, or are breastfeeding. Do not breastfeed during treatment with POMALYST—it is not known if POMALYST passes into breast milk and can harm the baby.
  • If you have liver problems
  • If you have kidney problems and are receiving hemodialysis treatment
  • Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. POMALYST and other medicines may affect each other, causing serious side effects. Talk with your HCP before taking any new medicines.
How should I take POMALYST?

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

  • Swallow POMALYST capsules whole with water 1 time a day. Do not break, chew, or open capsules.
  • Take POMALYST at the same time each day with or without food.
  • If you are on hemodialysis, take POMALYST after hemodialysis on hemodialysis days.
  • Do not open POMALYST capsules or handle them any more than needed. If you touch a broken POMALYST capsule or the medicine in the capsule, wash the area of your body right away with soap and water.
  • If you miss a dose of POMALYST and it has been less than 12 hours since your regular time, take POMALYST 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 POMALYST, call your healthcare provider (HCP) right away.
  • Do not share POMALYST with other people. It may cause birth defects and other serious problems.
What are the possible side effects of POMALYST?
  • See “What is the most important information I should know about POMALYST?”
  • POMALYST can cause serious side effects, including:
    • Low white blood cells (neutropenia), low platelets (thrombocytopenia), and low red blood cells (anemia) are common with POMALYST, but can also be serious. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your blood counts should be checked by your healthcare provider (HCP) weekly for the first 8 weeks of treatment and monthly after that.
    • Severe liver problems, including liver failure and death. Your HCP should do blood tests to check your liver function during your treatment with POMALYST. Tell your HCP right away if you develop any of the following symptoms: yellowing of your skin or the white parts 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, or feeling very tired.
    • Severe allergic and severe skin reactions can happen with POMALYST and may cause death.
    • Dizziness and confusion. Avoid taking other medicines that may cause dizziness and confusion during treatment with POMALYST. Avoid situations that require you to be alert until you know how POMALYST affects you.
    • Nerve damage. Stop taking POMALYST and call your HCP if you develop numbness, tingling, pain, or a burning sensation in your hands, legs, or feet.
    • New cancers (malignancies). New cancers, including certain blood cancers (acute myelogenous leukemia or AML) have been seen in people who received POMALYST. Talk with your HCP about your risk.
    • 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 HCP may do blood tests to check you for TLS.
  • The most common side effects of POMALYST include tiredness and weakness, constipation, nausea, diarrhea, shortness of breath, upper respiratory tract infection, back pain, and fever.
  • These are not all the possible side effects of POMALYST. Your HCP may tell you to stop taking POMALYST if you develop certain serious side effects during treatment.
    Call your HCP for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

Indication and 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 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 the REMS Call 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, a Bristol-Myers Squibb Company, 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, a Bristol-Myers Squibb Company, 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 up to 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 your female partner becomes pregnant, you should call your healthcare provider 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 or break 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 while taking REVLIMID, during any breaks (interruptions) in your treatment, and for up to 4 weeks after stopping REVLIMID.

  • 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) can happen with REVLIMID and may cause death. 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.

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.

  • 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. 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.