Pomalidomide

Pomalidomide is used to treat multiple myeloma (a type of cancer caused by a progressive blood disease). Pomalidomide is usually given after at least two other medications have been tried without success.

Pomalidomide is also used to treat AIDS-related Kaposi sarcoma when other medications have not worked or have stopped working. Pomalidomide can also be used to treat Kaposi Sarcoma in adults who are HIV-negative.

Pomalidomide 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.

Pomalidomide may also be used for purposes not listed in this medication guide.

Never share pomalidomide with another person.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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 pomalidomide 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 pomalidomide to your doctor, or as directed.

Never use pomalidomide if 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 pomalidomide and ending 4 weeks after you stop taking it. For men: Use a condom to prevent pregnancy while you are taking pomalidomide, and for up to 4 weeks after you stop taking it.

Pomalidomide 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.

You should not use pomalidomide if you are allergic to it 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 pomalidomide 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 pomalidomide.

For women (if you have not had a hysterectomy): Do not use pomalidomide if you are pregnant. Use two forms of birth control starting 4 weeks before you begin taking pomalidomide and continuing for 4 weeks after your last dose. Even women with fertility problems must use birth control while taking pomalidomide. You must also have a negative pregnancy test 10 to 14 days before treatment and again 24 hours before treatment starts. While you are taking pomalidomide, 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, or your partner’s vasectomy). The second form must be a barrier method such as a latex condom, diaphragm, or cervical cap.

Stop using pomalidomide and call your doctor immediately if you stop 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 pomalidomide 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 can become pregnant, even if you have had a vasectomy. Contact your doctor if you have had unprotected sex, even once, or if your 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 included in a pregnancy registry to track the effects of pomalidomide on the baby.

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).

Pomalidomide 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.

Get emergency medical help if you notice signs of an allergic reaction, such as hives, dizziness, fast heartbeats, trouble breathing, or swelling in your face or throat, or if you have a severe skin reaction, which may include fever, sore throat, burning eyes, skin pain, or a red or purple skin rash that blisters and peels.

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

Pomalidomide may lead to serious side effects. Contact your doctor immediately if you experience:

• numbness, tingling, or burning pain in your hands or feet;
• heart attack symptoms such as chest pain or pressure, pain spreading to your jaw or shoulder, nausea, or sweating;
• low blood cell counts, which may include fever, chills, tiredness, mouth sores, skin sores, unusual bleeding, pale skin, cold hands and feet, or feeling light-headed or short of breath;
• signs of a stroke, including sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, or balance issues;
• signs of a blood clot in the lung, such as chest pain, sudden cough, wheezing, rapid breathing, or coughing up blood;
• signs of a blood clot in your leg, including swelling, warmth, or redness in an arm or leg; or
• signs of tumor cell breakdown, such as confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, or tingling in your hands and feet or around your mouth.

Common side effects of pomalidomide may include:

• low blood cell counts;
• abnormal lab tests;
• rash;
• fever, weakness, or feeling tired;
• nausea, diarrhea, or constipation;
• cold symptoms like stuffy nose, sneezing, or sore throat;
• back pain; or
• feeling short of breath.

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

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 toxicityComments: -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

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

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

Do not donate blood or sperm while you are taking pomalidomide.

Avoid driving or doing dangerous activities until you understand how pomalidomide will affect you. Your reactions may be affected.

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

Other drugs may affect 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.