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Pomalyst is commonly used to treat certain cancers. Common side effects include tiredness, low blood cell counts, and constipation. Call your health care provider right away if you have a fever, infection, or shortness of breath. Pomalyst is a capsule you will take by mouth.

Uses

What is Pomalyst used for?'

Pomalyst (pomalidomide) is commonly used to treat certain types of the following cancers. 

Pomalyst may also be used for other conditions as determined by your health care provider.

How does Pomalyst work (mechanism of action)?

Pomalyst contains the active medicine pomalidomide. It works by turning on your immune system so that your body can detect and kill cancer cells in your bone marrow. It also helps your bone marrow produce new blood cells that are normal. 

How is Pomalyst supplied (dosage forms)?

Brands and other names

  • Pomalyst

Dosage forms and strengths

  • 1 mg oral capsules
  • 2 mg oral capsules
  • 3 mg oral capsules
  • 4 mg oral capsules

How should I store Pomalyst?

Pomalyst should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Pomalyst?

The most common side effects of Pomalyst are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Tiredness or weakness
  • Low blood cell levels, including low neutrophil levels (neutropenia) (see below)
  • Constipation, nausea, diarrhea
  • Shortness of breath
  • Infection in the nose or throat, sore throat, fever, or common cold symptoms
  • Back pain
  • Altered kidney or liver function tests
  • High blood sugar
  • Rash

There may be other side effects of Pomalyst that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Pomalyst?

While less common, the most serious side effects of Pomalyst are described below, along with what to do if they happen.

Severe Allergic Reactions. Pomalyst may cause allergic reactions, including a specific type of allergic reaction called DRESS. DRESS stands for drug reaction with eosinophilia and systemic symptoms. It is also sometimes called multi-organ hypersensitivity. This is a reaction that can affect multiple parts of the body, including your liver, kidneys, and heart. Stop taking the medicine and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Shortness of breath, trouble swallowing, or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain
  • Dark colored urine
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Blood Clots. Pomalyst may cause blood clots in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism, including a blood clot in the lungs (pulmonary embolism) or deep venous thrombosis (DVT). Stop taking Pomalyst and get emergency help if you have any of the following signs of blood clots.

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech
  • Pain, swelling, or tenderness in your arm or leg
  • Vision loss
  • Bulging eyes
  • Double vision

Low Neutrophil Levels (Neutropenia). Pomalyst may cause low levels of a type of white blood cell (called neutrophils), which is known as neutropenia. Neutrophils help prevent infection. Having a low level of neutrophils may increase your risk of infection. Make sure to keep all appointments to have your blood cell counts checked, and tell your health care provider right away if you have any of the following symptoms of low neutrophil levels.

  • Fever, chills, or sweats
  • Tiredness
  • Sore throat, cough, or shortness of breath
  • Mouth or throat sores
  • Swollen lymph nodes

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Pomalyst. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Severe Skin Reactions. Pomalyst can cause severe skin reactions, called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), that can lead to death if not treated. If you develop a rash, stop Pomalyst and call your health care provider right away. Get emergency help if you have any of the following symptoms of SJS or TEN.

  • Painful red or purple skin that looks burned and peels off
  • Flat red rash or blisters on your skin, mouth, nose, and genitals
  • Red, painful, watery eyes
  • Flu-like symptoms, including fever, chills, and muscle aches

Dizziness and Confusion. Pomalyst can affect your alertness or coordination by causing dizziness and confusion. Do not drive or do other activities that require alertness or coordination until you know how Pomalyst affects you. It is also important to avoid taking other medicines that can also cause dizziness or confusion.

Cancer. Pomalyst can cause a new cancer to develop or cause a previously treated cancer to recur, such as acute myeloid leukemia (AML). Tell your health care provider about any new symptoms that you may get.

Tumor Lysis Syndrome. Pomalyst can cause a fast breakdown of cancer cells. This can lead to a condition called tumor lysis syndrome, which can be serious. It is important to drink plenty of water while taking Pomalyst and to keep all appointments for blood tests so your health care provider can see how your body is responding to Pomalyst. Tell your health care provider right away if you have any of the following signs of tumor lysis syndrome while taking Pomalyst.

  • Nausea and vomiting
  • Weakness
  • Swelling or fluid retention
  • Shortness of breath
  • Muscle cramps
  • Seizures

Warnings & Precautions

Who should not use Pomalyst?

Allergies to Ingredients. People who are allergic to any of the following should not take Pomalyst.

  • Pomalidomide
  • Pomalyst
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Pomalyst.

Pregnancy. Do not take Pomalyst if you are pregnant. If you become pregnant, contact your health care provider right away. See the Pregnancy section for more details.

What should I know about Pomalyst before using it?

Do not take Pomalyst unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Pomalyst with other people, even if they have the same condition as you. It may harm them.

Keep Pomalyst out of the reach of children.

Pomalyst is only available through a special program, from certain pharmacies, and to certain people. It is important that you keep all of your appointments, including labs or other testing, while taking Pomalyst. If you have any questions about this program, you can go to www.pomalystrems.com or call 888-423-5436.

Pomalyst should be taken with water. Do not break, chew, crush, or open the capsules. If powder from the capsule accidentally comes into contact with your skin, wash the area right away with soap and water. If powder from the capsule comes into contact with your eyes, nose, or mouth, rinse the area with water right away.

You should not donate blood while you are taking Pomalyst, even if you are taking a break from the medicine. You should also not donate blood for four weeks after your last dose.

What should I tell my health care provider before using Pomalyst?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Pomalyst is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Liver problems
  • Kidney problems, including if you are receiving dialysis
  • Previous or current blood clot
  • High blood pressure
  • If you smoke or have smoked in the past

Other Medicines and Supplements. Pomalyst may interact with other medicines and supplements. Before taking Pomalyst, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Pomalyst can harm a fetus. If you are able to get pregnant, your health care provider will make sure you are not pregnant before you start taking the medicine. The Pomalyst REMS program requires two negative pregnancy tests at certain times before you can start taking Pomalyst. While taking Pomalyst, you will need to use two forms of effective birth control for four weeks before starting, during your treatment (including if you take any breaks from treatment), and for at least four weeks after your last dose. You will also need to take regular pregnancy tests while taking Pomalyst. Tell your health care provider if you are pregnant or plan to become pregnant. If you think there is a chance you could be pregnant due to failed birth control while taking Pomalyst, call your health care provider right away. 

If you are able to get your partner pregnant, you will need to use effective birth control (condoms) while taking Pomalyst and for four weeks after your last dose. You will need to use condoms even if you have had a vasectomy. Do not donate sperm while taking Pomalyst and for four weeks after your last dose. If you get your partner pregnant while taking Pomalyst, call your health care provider right away.

Breastfeeding. It is not known if Pomalyst passes into breast milk. You should not take Pomalyst while breastfeeding. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Pomalyst?

For more information about Pomalyst, you can visit the drugmaker’s website at www.pomalyst.com or call them at 800-861-0048.

Interactions

Does Pomalyst interact with foods or drinks?

There are no known interactions between Pomalyst and foods or drinks.

It is unknown if drinking alcohol will affect Pomalyst, but heavy drinking can slow your immune response and make it harder for your body to fight infections and cancer.

Does Pomalyst interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Pomalyst.

  • Pembrolizumab, an immunotherapy medicine used to treat certain cancers
  • Fluvoxamine (Luvox), which is a medicine commonly used for obsessive-compulsive disorder (OCD)
  • Ciprofloxacin, an antibiotic used to treat bacterial infections

Some other medicines may alter the blood levels of Pomalyst. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Pomalyst. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Pomalyst?

If you or someone else has used too much Pomalyst, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Pomalyst?

If you miss a dose, take it as soon as you remember as long as it has been less than 12 hours from the usual time you take the dose. If it has been more than 12 hours, skip the missed dose and only take the next dose. Do not take double or extra doses.