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 from a certified pharmacy under a special program. You must be registered in the program and agree to use birth control measures as required.

Never use Pomalyst you are pregnant. Even one dose of pomalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medicine at the time of conception or during pregnancy.

Use birth control to prevent pregnancy, whether you are a man or a woman. For women: Use two forms of birth control beginning 4 weeks before you start taking Pomalyst and ending 4 weeks after you stop taking it. For men: Use a condom to prevent pregnancy while you are taking Pomalyst, and for up to 4 weeks after you stop taking it.

Pomalyst may cause blood clots. Call your doctor at once if you have symptoms such as chest pain, shortness of breath, sudden numbness or weakness, problems with vision or speech, or swelling or redness in an arm or leg.

Before taking this medicine

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

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.

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

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

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.

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

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.

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.

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.