Product Information

Pomalyst capsules

What is pomalidomide?

Pomalidomide is used to treat multiple myeloma (cancer resulting from 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 did 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.

Warnings

Never use this medicine 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.

Before taking this medicine

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 pomalidomide 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 beginning 4 weeks before you start taking pomalidomide and ending 4 weeks after your last dose. Even women with fertility problems are required to use birth control while taking pomalidomide. 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 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, 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 pomalidomide 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 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 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.
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.

How should I take pomalidomide?

Never this medicine with another person.
Follow all directions 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.

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 should I avoid while taking pomalidomide?

Do not donate blood or sperm while you are using pomalidomide.
Avoid driving or hazardous activity until you know how pomalidomide will affect you. Your reactions could be impaired.

Pomalidomide side effects

Get emergency medical help if you have signs of an allergic reaction (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.
Pomalidomide may cause serious side effects. 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 side effects of pomalidomide 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.

What other drugs will affect pomalidomide?

Taking pomalidomide 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 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.