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POMALYST® (pomalidomide) 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.

Some common side effects

These are not all the possible side effects of POMALYST. Your healthcare provider may adjust your dose or have you temporarily or permanently stop taking POMALYST if you develop certain serious side effects. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Below are some of the most common side effects of POMALYST.*

*Includes side effects occurring in 30% of patients receiving POMALYST.

Low white blood cells

 

Low white blood cells 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 weekly for the first 8 weeks of treatment, and monthly after that.

Low red blood cells

 

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 weekly for the first 8 weeks of treatment and monthly after that.

Tiredness and weakness

 

Fatigue is a common side effect of treatment with POMALYST with dexamethasone. Sometimes people describe fatigue as feeling tired, weak, exhausted, heavy, or slow. Fatigue can affect people physically, mentally, and emotionally.

 

If you feel tired, tell your doctor or nurse. You should always talk to your doctor or nurse about any side effects you may experience.

 

You may want to ask your doctor:

 

  • Should I change my activity level?
  • Would exercise help me feel less tired?
  • Will sleeping more help my fatigue?

Upper respiratory tract infection

 

Treatment with POMALYST and dexamethasone can cause upper respiratory tract infections or bronchitis. People with bronchitis often cough up discolored, thick mucus.

 

If you have an upper respiratory tract infection, tell your doctor or nurse. You should always talk to your doctor or nurse about any side effects you may experience. 

Low platelets

 

Low platelets 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 weekly for the first 8 weeks of treatment and monthly after that.

Fever

 

Treatment with POMALYST with dexamethasone can cause a fever. A fever is a body temperature that is higher than normal, which is 98.6° F for an adult.

 

If you have a fever, tell your doctor or nurse. He or she will want to know about any side effects you have.

 

You may want to ask your doctor:

  • Are there any dietary restrictions I should follow?
  • Should I drink more or less water or liquids?

Some tips for fever:

  • Get plenty of rest
  • Stay hydrated by drinking water
  • If you feel hot, consider placing a cold compress on your head

These are just some tips for fever. You should always talk to your doctor or nurse about any side effects you may experience. 

Shortness of breath

 

Treatment with POMALYST and dexamethasone can cause shortness of breath. If you experience a shortness of breath, you are not able to get enough air into your lungs.

 

If you have shortness of breath, tell your doctor or nurse. You should always talk to your doctor or nurse about any side effects you may experience. 

Diarrhea

 

Treatment with POMALYST with dexamethasone can cause diarrhea. Diarrhea happens when your stools become watery and you go to the bathroom much more often than usual. Your doctor needs to know if you have diarrhea. Diarrhea can cause weight loss, fluid loss (dehydration), poor appetite, and weakness.

 

Diarrhea may cause complications such as:

  • Dizziness
  • Fever
  • Sore or bleeding rectal area

If you have any of these complications or if you have diarrhea and cramps for more than a day, call your doctor or nurse right away.

 

If you have diarrhea, tell your doctor or nurse. He or she will want to know about any side effects you have.

 

You may want to ask your doctor:

  • Are there foods I should eat or avoid when I have diarrhea?
  • How much liquid should I drink each day?

Some tips for diarrhea:

  • Drink plenty of clear fluids, such as water
  • Eat frequent, smaller meals
  • Eat foods high in potassium, such as bananas
  • Avoid caffeine or alcohol

These are just some tips for diarrhea. You should always talk to your doctor or nurse about any side effects you may experience. 

Constipation

 

Treatment with POMALYST and dexamethasone can cause constipation. When you have constipation, you do not have as many bowel movements as you normally do. You may also feel bloated and uncomfortable and have hard, painful bowel movements.

 

If you have constipation, tell your doctor or nurse. He or she will want to know about any side effects you may have.

 

You may want to ask your doctor:

  • Are there foods I should eat or avoid when I have constipation?
  • Should I drink more water or liquids?
  • Would exercise help?
  • Should I keep track of my bowel movements?

Some tips for constipation:

  • Drink plenty of fluids
  • Eat high-fiber foods
  • Talk with your healthcare provider about creating a light exercise plan
  • Avoid foods or drinks that may cause gas, such as cabbage, broccoli, and carbonated drinks
  • Avoid foods that lead to constipation (like cheese or eggs)

These are just some tips for constipation. You should always talk to your doctor or nurse about any side effects you may experience. 

Back pain

 

Treatment with POMALYST with dexamethasone can cause back pain. Symptoms of back pain may include muscle aches, pain that shoots down the leg, and pain that worsens with walking.

 

If you have back pain, tell your doctor or nurse. You should always talk to your doctor or nurse about any side effects you may experience.

Nausea

 

Treatment with POMALYST with dexamethasone can cause nausea. Nausea is an uneasy or unsettled feeling in the stomach. It often occurs at the same time with the urge to vomit, but doesn’t always lead to vomiting. Some other ways people describe nausea are “feeling sick to my stomach,” “queasy,” or “upset stomach.”

 

If you have nausea, tell your doctor or nurse. He or she will want to know about any side effects you may have.

 

You may want to ask your doctor: 

  • Are there foods I should eat or avoid when I have nausea?
  • Should I drink more or less water or liquids?
  • Would exercise help?

Some tips for nausea:

  • Eat and drink slowly and take small portions
  • Dry toast and ginger ale, among others, may help
  • Eat smaller meals and snack throughout the day
  • Avoid greasy, very rich or spicy foods

These are just some tips for nausea. You should always talk to your doctor or nurse about any side effects you may experience.

Talk to your doctor about common side effects

Talking with your doctor about POMALYST.

Your doctor or nurse is there to help you throughout your treatment. They are also there to answer any questions you may have about side effects that may happen with treatment. See what other questions you may want to ask with our customizable Conversation Starter.

CONVERSATION STARTER

Questions? Browse our
Frequently Asked Questions
page for answers.

LEARN MORE

What is POMALYST® (pomalidomide)?

POMALYST® (pomalidomide) 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.

WARNING: Risk to unborn babies, risk of low blood counts 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 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 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 include tiredness, 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.