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Pomalyst

Generic Name: pomalidomide (POE-ma-LID-oh-mide)
Brand Name: Pomalyst

Do not take Pomalyst if you are pregnant. It may cause severe birth defects or death of the fetus if used during pregnancy. Pomalyst is similar to thalidomide, which causes life-threatening birth defects.

Women who are able to become pregnant and who take Pomalyst:

  • must not become pregnant by either avoiding sexual contact with men or using at least 2 forms of effective birth control for at least 4 weeks before starting Pomalyst, while taking Pomalyst, during breaks in treatment, and for at least 4 weeks after stopping Pomalyst;
  • must have a negative pregnancy test 10 to 14 days before starting Pomalyst and again within 24 hours before starting Pomalyst; and
  • must have a pregnancy test every week for the first 4 weeks after starting Pomalyst and then every 2 to 4 weeks thereafter while taking Pomalyst.

Women who experience abnormal menstrual bleeding, miss their menstrual period, become pregnant, or suspect for any reason they may be pregnant while taking Pomalyst must stop taking it and contact their doctor immediately.

Men who take Pomalyst must either:

  • avoid sexual contact with women who are pregnant or could become pregnant while taking Pomalyst and for at least 4 weeks after stopping Pomalyst; OR
  • use a latex or synthetic condom during sexual contact with women who are pregnant or could become pregnant for as long as they are taking Pomalyst, during breaks in treatment, and for at least 4 weeks after stopping Pomalyst, even if they have had a successful vasectomy.

Men who take Pomalyst and have unprotected sexual contact with a woman who is pregnant or may become pregnant, or who think for any reason that their sexual partner may be pregnant should contact their doctor immediately.

Pomalyst may cause an increased risk of blood clots in the veins and lungs. Call your doctor right away if you experience shortness of breath; chest pain; or pain, redness, tenderness, or swelling in the arms or legs.


Pomalyst is used for:

Treating a certain type of cancer (multiple myeloma). It may also be used for other conditions as determined by your doctor.

Pomalyst is an immunomodulatory medicine. Exactly how it works is not known.

Do NOT use Pomalyst if:

  • you are allergic to any ingredient in Pomalyst
  • you are pregnant, planning to become pregnant, or become pregnant during treatment with Pomalyst
  • you have severe kidney or liver problems
  • you are taking carbamazepine, ciprofloxacin, clarithromycin, cobicistat, enzalutamide, fluvoxamine, hydantoins (eg, phenytoin), itraconazole, ketoconazole, mifepristone, nefazodone, phenobarbital, primidone, protease inhibitors (eg, boceprevir, ritonavir), rifamycins (eg, rifampin), St. John's wort, telithromycin, or voriconazole

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Pomalyst:

Some medical conditions may interact with Pomalyst. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have had an allergic reaction to thalidomide or lenalidomide in the past
  • if you have kidney problems, liver problems, or blood problems (eg, low white blood cell levels, low platelet counts)
  • if you have a history of blood clots
  • if you smoke cigarettes

Some MEDICINES MAY INTERACT with Pomalyst. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Erythropoietic agents (eg, erythropoietin), estrogens (eg, estrogen, estradiol), progestins (eg, medroxyprogesterone), or medicines that contain estrogens or progestins (eg, birth control pills) because the risk of developing blood clots may be increased
  • Azole antifungals (eg, itraconazole, ketoconazole, voriconazole), ciprofloxacin, clarithromycin, cobicistat, fluvoxamine, mifepristone, nefazodone, protease inhibitors (eg, boceprevir, ritonavir), or telithromycin because they may increase the risk of Pomalyst's side effects
  • Carbamazepine, enzalutamide, hydantoins (eg, phenytoin), phenobarbital, primidone, rifamycins (eg, rifampin), or St. John's wort because they may decrease Pomalyst's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pomalyst may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pomalyst:

Use Pomalyst as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Pomalyst comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Pomalyst refilled.
  • Pomalyst can only be prescribed and dispensed through a special program. Make sure you understand all warnings and instructions for using Pomalyst. Ask your doctor or pharmacist if you have any questions about this program or the use of Pomalyst.
  • Take Pomalyst by mouth on an empty stomach at least 2 hours before or 2 hours after a meal.
  • Swallow Pomalyst whole with water. Do not break, crush, chew, or open before swallowing.
  • Take Pomalyst at about the same time each day to get the most benefit from it.
  • Do not open the capsules or handle them more than needed. If you touch a broken capsule or the medicine inside of the capsule, wash the area with soap and water. If a broken capsule or the medicine inside comes into contact with your eyes, flush thoroughly with water.
  • If you miss a dose of Pomalyst and it has been less than 12 hours since the missed dose, take it as soon as you remember. If it has been more than 12 hours since the missed dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pomalyst.

Important safety information:

  • Pomalyst may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Pomalyst with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Pomalyst may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Pomalyst may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Patients with multiple myeloma who use Pomalyst may be at increased risk of developing a second cancer. Discuss the benefits and risks of Pomalyst, as well as any questions or concerns, with your doctor.
  • Do not donate semen, sperm, or blood while taking Pomalyst, during breaks in treatment, or within 4 weeks after stopping Pomalyst.
  • Talk with your doctor about which methods of effective birth control may be appropriate for you.
  • If you are using a hormonal contraceptive (eg, birth control pills) to prevent pregnancy, inform your doctor if you also take an HIV protease inhibitor (eg, ritonavir); griseofulvin, rifampin, rifabutin, penicillin, amoxicillin, ampicillin, or other antibiotic medicines; St. John's wort; modafinil; phenytoin; or carbamazepine. These medicines may decrease the effectiveness of hormonal contraceptives.
  • Tell your doctor or dentist you take Pomalyst before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including pregnancy tests and complete blood cell counts, may be performed while you use Pomalyst. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Pomalyst with caution in the ELDERLY; they may be more sensitive to its effects.
  • Pomalyst should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use Pomalyst if you are pregnant. It may cause severe birth defects or death of the fetus. If you think you may be pregnant, miss your menstrual period, experience unusual menstrual bleeding, or stop using birth control, contact your doctor right away. If you become pregnant while using Pomalyst, consult an obstetrician/gynecologist experienced in reproductive toxicity. It is not known if Pomalyst is found in breast milk. Do not breast-feed while taking Pomalyst.

Possible side effects of Pomalyst:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; constipation; diarrhea; dizziness; dry mouth or skin; headache; increased sweating or night sweats; loss of appetite; mild cough; nausea; sluggishness; stuffy or runny nose; tiredness; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); black, tarry stools; bone pain; burning, numbness, or tingling; change in the amount of urine produced; chest pain; confusion; fainting; fever, chills, or persistent cough or sore throat; irregular heartbeat; joint pain; muscle pain, weakness, or cramps; pain, numbness, tingling, tenderness, redness, or swelling of the arms or legs; painful or difficult urination; severe or persistent headache, dizziness, or stomach pain; severe or persistent nosebleed; severe or persistent tiredness or weakness; shortness of breath; sudden, unexplained weight changes; swelling of the hands, ankles, or feet; tremor; unusual bruising or bleeding; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Pomalyst:

Store Pomalyst at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pomalyst out of the reach of children and away from pets.

General information:

  • If you have any questions about Pomalyst, please talk with your doctor, pharmacist, or other health care provider.
  • Pomalyst is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Pomalyst or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Pomalyst. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Pomalyst. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Pomalyst.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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