Pomalyst

Pronunciation: POM-uh-list
Generic name: pomalidomide
Dosage form: oral capsule (1 mg, 2 mg, 3 mg, 4 mg)
Drug classes: Miscellaneous antineoplastics, Other immunosuppressants

Medically reviewed by Judith Stewart, BPharm. Last updated on Apr 2, 2025.

What is Pomalyst?

Pomalyst affects the immune system. It promotes immune responses to help slow tumor growth.

Pomalyst is used to treat multiple myeloma (cancer resulting from a progressive blood disease). It is usually given after at least two other medications have been tried without success.

Pomalyst is also used to treat AIDS-related Kaposi sarcoma (KS) when highly active antiretroviral therapy (HAART) has not worked well enough or stopped working. This medicine can also be used to treat Kaposi Sarcoma in adults who are HIV-negative.

Pomalyst is available only through a restricted program called PS-Pomalidomide REMS.  Before you begin taking this medicine, you must read and agree to all of the instructions in PS-Pomalidomide REMS. For more information, call 1-888-423-5436 or go to www.PS-PomalidomideREMS.com.

• Before prescribing Pomalyst, your healthcare provider will explain PS-Pomalidomide REMS to you and have you sign the Patient-Physician Agreement Form. 
• You must be registered in the program and agree to use birth control measures as required.

Warnings

Pregnancy

Pomalyst carries a Boxed Warning for harm to an unborn baby. Pomalyst is similar to the medicine thalidomide (THALOMID). We know thalidomide can 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 two acceptable forms of 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 Pomalyst
• Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy before, 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, and
• 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.

Blood clots

Pomalyst may cause blood clots. Blood clots in your arteries, veins, and lungs, and 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 of 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. 

Before taking this medicine

You should not use Pomalyst if you are allergic to pomalidomide, Pomalyst, thalidomide, or you are pregnant.

Pomalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or father is taking this medicine at the time of conception or during pregnancy. Even one dose of Pomalyst can cause major defects of the baby's arms and legs, bones, ears, eyes, face, and heart. Never use pomalidomide if you are pregnant. Tell your doctor right away if your period is late while taking this medicine.

For women (if you have not had a hysterectomy): Do not use Pomalyst if you are pregnant. Use two forms of birth control beginning 4 weeks before you start taking Pomalyst and ending 4 weeks after your last dose. Even women with fertility problems are required to use birth control while taking this medicine. You must also have a negative pregnancy test at 10 to 14 days before treatment and again at 24 hours before. While you are taking Pomalyst, you will have a pregnancy test every 2 to 4 weeks.

The birth control method must be proven highly effective (birth control pills, intrauterine device, tubal ligation, sex partner's vasectomy). The extra form must be a barrier method such as a latex condom, a diaphragm, or a cervical cap.

Stop using Pomalyst and call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant. Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.

For men: If a man fathers a baby while using pomalidomide, the baby may have birth defects. Use a condom to prevent pregnancy while taking Pomalyst, and for up to 4 weeks after your last dose. You must agree in writing to always use latex condoms when having sex with a woman who is able to get pregnant, even if you have had a vasectomy. Contact your doctor if you have had unprotected sex, even once, or if your sex partner may be pregnant.

This medicine may affect fertility (ability to have children) if you are a woman. However, it is important to use birth control to prevent pregnancy because pomalidomide can harm an unborn baby.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of pomalidomide on the baby.

To make sure Pomalyst is safe for you, tell your doctor if you have ever had

• liver disease (especially hepatitis B);

• kidney disease (or if you are on dialysis);

• risk factors for coronary artery disease (such as high blood pressure, high cholesterol, diabetes, menopause, smoking, a family history of coronary artery disease, being overweight, or being older than 40 and a man);

• if you also use pembrolizumab (Keytruda); or

• if you smoke (smoking may make pomalidomide less effective and may increase your risk of a stroke or blood clot while taking this medicine).

Pomalyst may cause other types of cancer, such as leukemia or lymphoma. Ask your doctor about this risk.

You should not breastfeed while using this medicine.

How should I take Pomalyst?

Take Pomalyst exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Never this medicine with another person.

Take each dose with a full glass of water. Take the medicine at the same time each day, with or without food. Swallow the capsule whole.

Do not break, chew, or open a Pomalyst capsule. The medicine from a broken pill can be dangerous if it gets in your mouth, eyes, or nose, or on your skin. If this happens, wash your skin with soap and water or rinse your eyes with water. Ask your pharmacist how to safely dispose of a broken pill.

You may need frequent blood tests.

Store at room temperature away from moisture and heat. Return any unused Pomalyst to your doctor, or as directed.

Dosing information

Usual Adult Dose for Multiple Myeloma:

4 mg orally once a day on Days 1 through 21 of repeated 28-day cycles in combination with dexamethasone until disease progression or unacceptable toxicity

Comments:
-Consult the manufacturer product information for dexamethasone dosing.

Use: In combination with dexamethasone for patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy

Usual Adult Dose for Kaposi's Sarcoma:

5 mg orally once a day on Days 1 through 21 of repeated 28-day cycles until disease progression or unacceptable toxicity.

Comments:
-Continue HAART as HIV treatment in patients with AIDS-related Kaposi sarcoma while taking this drug.

Uses:
-For adult patients with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART)
-Kaposi sarcoma (KS) in adult patients who are HIV-negative

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

Do not donate blood or sperm while you are using Pomalyst.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Pomalyst side effects

Get emergency medical help if you have signs of an allergic reaction to Pomalyst (hives, dizziness, fast heartbeats, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if you have:

• numbness, tingling, or burning pain in your hands or feet;

• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems;

• signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

• signs of a blood clot in your leg - swelling, warmth, or redness in an arm or leg; or

• signs of tumor cell breakdown - confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.

Common Pomalyst side effects may include:

• low blood cell counts;

• abnormal lab tests;

• rash;

• fever, weakness or feeling tired;

• nausea, diarrhea, constipation;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• back pain; or

• feeling short of breath.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Related/similar drugs

What other drugs will affect Pomalyst?

Taking Pomalyst with other drugs that cause dizziness or confusion can worsen these effects. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may interact with pomalidomide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Pomalyst only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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