Pomalyst (pomalidomide) 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). Pomalidomide is usually given after at least two other medications have been tried without success.
Pomalyst is available only from a certified pharmacy under a special program called Pomalyst REMS. Your doctor must be registered in the program in order to prescribe pomalidomide for you. You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control measures as required by the program.
Important information
Never use Pomalyst 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 Pomalyst and ending 4 weeks after you stop taking it. For men: Use a condom to prevent pregnancy during your treatment, and for up to 28 days after your treatment ends.
Pomalyst may cause blood clots. Stop using Pomalyst and call your doctor at once if you have symptoms such as chest pain, wheezing, coughing up blood, or if you have pain, swelling, warmth, or redness in one or both legs.
Before taking this medicine
Pomalyst 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. Even one dose of pomalidomide can cause major birth defects of the baby"s arms and legs, bones, ears, eyes, face, and heart. Never use Pomalyst if you are pregnant. Tell your doctor right away if your period is late while using the medication.
For Women: If you have not had a hysterectomy, you will be required to use two forms of birth control beginning 4 weeks before you start taking Pomalyst and ending 4 weeks after you stop taking it. Even women with fertility problems are required to use birth control while taking this medication. 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 4 weeks.
The birth control method you use must be proven highly effective, such as birth control pills, an intrauterine device (IUD), a tubal ligation, or a sexual partner"s vasectomy. The extra form of birth control you use 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.
For Men: If a man fathers a baby while using Pomalyst, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment, and for up to 28 days after your treatment ends. 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 you think your female sexual partner may be pregnant.
To make sure Pomalyst is safe for you, tell your doctor if you have:
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liver disease;
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kidney disease;
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risk factors for coronary artery disease (such as diabetes, menopause, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy); or
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if you smoke (smoking may make pomalidomide less effective and may increase your risk of a stroke or blood clot while taking this medicine).
Using Pomalyst may increase your risk of developing other types of cancer, such as leukemia or lymphoma. Talk with your doctor about your specific risk.
It is not known whether pomalidomide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
How should I take Pomalyst?
Pomalyst is usually taken once per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Pomalyst is given in a 28-day treatment cycle. You may only need to use the medicine during the first 3 weeks of each cycle. Your doctor will determine how long to treat you with Pomalyst.
Take Pomalyst on an empty stomach, at least 2 hours before or 2 hours after a meal.
Take the medicine at the same time each day.
Take each dose with a full glass of water. Swallow the capsule whole.
Do not open the Pomalyst capsule. The medicine from inside the capsule can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken capsule.
Never give Pomalyst to another person, even if he or she has the same disorder for which you are being treated.
While using Pomalyst, you may need frequent blood tests.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Store at room temperature away from moisture and heat. Return any unused Pomalyst to your doctor, or as directed by the Pomalyst REMS program.
Pomalyst dosing information
Usual Adult Dose for Multiple Myeloma:
-4 mg orally once a day on Days 1 to 21 of repeated 28-day cycles until disease progression
-Comments: This drug should be given in combination with dexamethasone; consult the manufacturer product information for dexamethasone dosing when used in combination with Pomalyst.
-Use: Treatment of 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.
What happens if I miss a dose?
Take the missed dose as soon as you remember. If you are more than 12 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Pomalyst?
Do not donate blood or sperm while you are using Pomalyst.
Pomalyst may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.
Pomalyst side effects
Get emergency medical help if you have signs of an allergic reaction to Pomalyst: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
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blistering and peeling of your skin;
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numbness, tingling, or burning pain in your hands or feet;
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heart attack symptoms-chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
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liver problems-nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
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low blood cell counts-fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed;
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signs of a stroke-sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
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signs of a blood clot in the lung-chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
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signs of a blood clot in your leg-pain, swelling, warmth, or redness in one or both legs; or
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signs of tumor cell breakdown-lower back pain, blood in your urine, little or no urinating; numbness or tingly feeling around your mouth; muscle weakness or tightness; fast or slow heart rate, weak pulse, feeling short of breath; confusion, fainting.
Common Pomalyst side effects may include:
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fever, weakness or feeling tired;
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nausea, diarrhea, constipation;
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back pain; or
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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.
See also: Side effects (in more detail)
What other drugs will affect Pomalyst?
Taking Pomalyst with other drugs that cause dizziness or confusion can worsen these effects. Ask your doctor before taking Pomalyst with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.
Other drugs may interact with pomalidomide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
