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See other indications for POMALYST:

Kaposi sarcoma (KS)

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POMALYST is a prescription medicine, taken along with the medicine dexamethasone, used to treat adults 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.

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  • About POMALYST

POMALYST with dexamethasone is proven to continue the fight.

If your multiple myeloma (MM) stops responding to REVLIMID® (lenalidomide) and a proteasome inhibitor (PI), see if a regimen containing POMALYST could be the next step in your treatment journey.

It’s a pill that offers convenient once-daily dosing.*‖

It’s been used to treat more than 72,000 patients with
relapsed MM.†‡

Pomalidomide (POMALYST) is part of a treatment regimen that’s recommended by the National Comprehensive Cancer Network® (NCCN®).§1

Hypothetical doctor talking to a hypothetical POMALYST® (pomalidomide) patient with relapsed/refractory multiple myeloma while showing them their laptop
Hypothetical doctor talking to a hypothetical POMALYST® (pomalidomide) patient with relapsed/refractory multiple myeloma while showing them their laptop

Not an actual patient.

Start the conversation with
your doctor.

When relapse happens, make sure you talk with your doctor
about treatment options. Use our Why POMALYST? guide to
help get the conversation started.

get the guide

*Taken on Days 1-21 out of a 28-day cycle or as directed by your doctor.

†According to POMALYST Risk Evaluation and Mitigation Strategy (REMS) Program enrollments from February 2013-February 2023.

‡POMALYST may not work for everyone. Ask your doctor if POMALYST with dexamethasone is right for you. Individual results may vary.

§As part of a combination therapy for appropriate patients after one prior therapy including lenalidomide and a PI.
NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

HOW POMALYST WORKS

Taken in combination with dexamethasone, POMALYST
was shown to work in 3 ways in animal models and in vitro*:
STIMULATE

Helps enhance the function of certain cells used by the immune system to fight myeloma.
STRIKE

Targets and kills myeloma cells, even those resistant to REVLIMID.
STARVE

Helps reduce new myeloma cell growth by limiting blood supply.

*In vitro: in a test tube or glass; outside of a living organism.

A clinical trial proved POMALYST with dexamethasone was effective in patients with relapsed/refractory multiple myeloma.

Based on results of a clinical trial, the FDA has approved the use of POMALYST with low-dose dexamethasone.

A clinical trial studied 455 patients whose multiple myeloma had stopped responding to at least 2 prior medicines, including REVLIMID and a PI. A total of 302 patients received POMALYST with low-dose dexamethasone, and 153 patients received high-dose dexamethasone alone.

The phase 3 clinical trial was designed to determine if POMALYST with low-dose dexamethasone could be an effective treatment for relapsed multiple myeloma.

MEDIAN OVERALL SURVIVAL (OS) RESULTS

Median Overall Survival: Think of median as the middle value of a set of data points. Overall survival measures the amount of time patients were alive following the start of the trial.

Median overall survival results for POMALYST® (pomalidomide) with low-dose dexamethasone vs high-dose dexamethasone alone Median overall survival results for POMALYST® (pomalidomide) with low-dose dexamethasone vs high-dose dexamethasone alone

Study findings: Median OS for patients taking POMALYST with low-dose dexamethasone was 12.4 months. This is roughly 1.5 times longer than the 8 months that patients lived when they were given high-dose dexamethasone alone.

MEDIAN PROGRESSION-FREE SURVIVAL (PFS) RESULTS

Median Progression-Free Survival: Progression-free survival measures how long a patient lives without the disease getting worse. The main goal of the study was to measure median PFS.

Median progression-free survival results for POMALYST® (pomalidomide) with low-dose dexamethasone vs high-dose dexamethasone alone Median progression-free survival results for POMALYST® (pomalidomide) with low-dose dexamethasone vs high-dose dexamethasone alone

Study findings: Median PFS for patients taking POMALYST with low-dose dexamethasone was 3.6 months. This was 2 times longer than the 1.8 months that patients lived without their disease getting worse when they were given high-dose dexamethasone alone.

POMALYST may not work for everyone. Ask your doctor if POMALYST with dexamethasone is right for you. Individual results may vary.

Safety findings: Common side effects of POMALYST (≥30%) include low white blood cells, low red blood cells, tiredness and weakness, upper respiratory tract infection, low platelets, fever, shortness of breath, diarrhea, constipation, back pain, and nausea.

RRMM COMBINATION THERAPIES

POMALYST is used in several FDA-approved combinations
with dexamethasone, for patients who have received prior treatments that included REVLIMID and a PI.*2

Your doctor may discuss these other treatment options with you and the associated risks and benefits. Please see the Combinations page to learn more about relapsed multiple myeloma treatment options.

LEARN MORE

*Please see full Prescribing Information, including Boxed WARNINGS, for REVLIMID.

POMALYST may not work for everyone. Ask your doctor if POMALYST with dexamethasone is right for you. Individual results may vary.

Before taking POMALYST, you need to join the POMALYST REMS® program.

LEARN MORE

Get a comprehensive guide to POMALYST with the Treatment Overview Brochure.

Download

References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed May 10, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. 2. Pomalidomide [package insert]. Summit, NJ: Celgene Corp; 2022.

‖Important dosing information

  • 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 your capsules.
  • POMALYST may be taken with or without food.
  • Take POMALYST at about the same time each day.
  • If you are on hemodialysis, take POMALYST after hemodialysis, on hemodialysis days.
  • Do not open the 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 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 POMALYST, call your healthcare provider right away.
  • Do not share POMALYST with other people. It may cause birth defects and other serious problems.

POMALYST is a
once-daily capsule.*
See how to take it.

VIEW DOSING

*POMALYST is taken once a day on days 1-21
of a 28-day cycle.

 POMALYST is taken in combination with
dexamethasone.

POMALYST is a
once-daily capsule.*
See how to take it.

VIEW DOSING

*POMALYST is taken once a day on days 1-21
of a 28-day cycle.

 POMALYST is taken in combination with
dexamethasone.

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Indication and Important Safety Information

What is POMALYST® (pomalidomide)?

POMALYST is a prescription medicine used to treat adults with:

  • Multiple myeloma, taken along with the medicine dexamethasone, in patients 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.
  • AIDS-related Kaposi sarcoma (KS) when highly active antiretroviral therapy (HAART) has not worked well enough or stopped working (failed), or KS who do not have HIV infection (HIV negative). This approval for POMALYST was based on response rate. There is ongoing evaluation of clinical benefit of POMALYST for this use.

It is not known if POMALYST is safe and effective in children.

Important Safety Information

POMALYST is a prescription medicine used to treat adults with:

  • Multiple myeloma, taken along with the medicine dexamethasone, in patients 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.

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. For more information, call 1-888-423-5436 or go to www.pomalystrems.com. Before prescribing POMALYST, your healthcare provider (HCP) will explain the POMALYST REMS program to you and have you sign the Patient-Physician Agreement Form.

Before you begin taking POMALYST, you must read and agree to all of the instructions in the POMALYST REMS® program. For more information, call 1-888-423-5436 or go to www.pomalystrems.com. 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 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
      • REMS Call Center 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 the REMS Call Center at the phone number listed above.
    • 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 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
      • REMS Call Center 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 the REMS Call Center 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 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 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 in people with multiple myeloma include tiredness and weakness, constipation, nausea, diarrhea, shortness of breath, upper respiratory tract infection, back pain, and fever.
  • The most common side effects of POMALYST in people with Kaposi sarcoma include tiredness, diarrhea, abnormal kidney function tests, decreased phosphate and calcium in the blood, rash, nausea, constipation, increased blood sugar, and decreased albumin in the blood.
  • The most common side effects of POMALYST in people with multiple myeloma 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.

Bristol Myers Squibb™ homepage
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Multiple Myeloma Treatments from Bristol Myers Squibb

REVLIMID® (lenalidomide) homepage POMALYST® (pomalidomide) homepage EMPLICITI® (elotuzumab) homepage

Please read Medication Guide and full Prescribing Information
for REVLIMID and POMALYST including Boxed WARNINGS. Please read Patient
Information and full Prescribing Information for EMPLICITI.

POMALYST®, POMALYST REMS®, and associated logos are trademarks of Celgene Corporation, a Bristol Myers Squibb Company. Access Support® is a registered trademark of Bristol-Myers Squibb Company.

© 2023 Bristol-Myers Squibb Company.    
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POMALYST®, its associated logo, POMALYST REMS®, and IMiD® are registered trademarks of Celgene Corporation, a Bristol Myers Squibb company. EMPLICITI®, the related logo, and Access Support® are registered trademarks of Bristol-Myers Squibb Company.

© 2023 Bristol-Myers Squibb Company.   
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