See other indications for REVLIMID:
This site is intended for US audiences only.
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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Relapse is a common, expected part of the multiple myeloma (MM) journey.
It happens when your MM no longer responds to the treatment you’re taking. Over time, many people with MM will go through periods of response to treatment and periods of relapse. To find out how your disease is progressing, your doctor will monitor the levels of M protein in your blood. A large increase in this protein, or M spike, can indicate a relapse.
Learn about POMALYST® (pomalidomide) at relapse.
When a relapse occurs, it’s important to understand your options. POMALYST is a treatment option that’s proven to help fight myeloma progression after relapse on REVLIMID® (lenalidomide) and a proteasome inhibitor (PI).
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
Please see Important Safety Information for POMALYST below and full Prescribing Information, including Boxed WARNINGS and Medication Guide.
- *POMALYST is taken in combination with dexamethasone on Days 1-21 of a 28-day cycle.
- 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 at least 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.
Start the conversation with your doctor.
Use our Why POMALYST? guide to discuss some of the key benefits of moving to a POMALYST treatment regimen after relapse.
get the guidePOMALYST 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®.
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.
FAQs about MM relapse
Your doctor may repeat certain tests to make sure your results are accurate. If your MM has come back, you and your healthcare team will discuss available treatment options and decide on what’s best for you.
A “response” means a lower number of myeloma cells or M protein in your body as a result of treatment. Response types generally differ by degree or levels. Talk to your healthcare team about how they determine response.
A relapse can happen months or years after your initial treatment. MM relapse can cause worse symptoms than when the cancer first appeared. Worse symptoms can be a sign of a more aggressive cancer. Most people with MM can expect to have a relapse.
For patients with standard-risk disease, the first period of response can last 2-3 years or even longer.
People may experience these signs and symptoms of MM:
- Low red blood cells. Feeling tired, sometimes with weakness, pale skin, and dizziness
- Low white blood cells. More infections than normal
- Low platelets. Easily bruised and more bleeding than normal when cut or scraped
- High blood calcium. Increased thirst and frequent urination, loss of appetite and constipation, feeling sleepy and sometimes confused
- Increased M protein. The blood thickens and becomes sticky, which causes shortness of breath, chest pain, and confusion
- Pain
It’s a good idea to talk to your doctor about treatment goals in the event of a relapse. Your doctor will help explain what relapse is, discuss different options and decide which treatment or combination of treatments will be most appropriate for you.
Ask your doctor about pomalidomide (POMALYST). It’s proven to help fight myeloma progression at relapse and is part of a treatment regimen that’s recommended by the National Comprehensive Cancer Network® (NCCN®).*1
- *As part of a combination therapy for appropriate patients after at least one prior therapy including lenalidomide and a PI.
You’ll find several resources and tools to support you and your caregiver on the POMALYST Patient Resources page. This page includes links to educational and patient videos, organizations for patients and caregivers, and brochures that cover almost every aspect of treatment.
IMiD, immunomodulatory drug; M protein, monoclonal protein; MM, multiple myeloma; PI, proteasome inhibitor.
Reference: 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 February 15, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.
§Important dosing information for 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 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.