Pomalyst

Generic Name: pomalidomide (pom a LID oh mide)
Brand Names: Pomalyst

What is Pomalyst?

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). It 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 this medicine 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 Pomalyst can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medication at the time of conception or during pregnancy.

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. You must also have a negative pregnancy test at 10 to 14 days before treatment and again at 24 hours before.

Slideshow: Flashback: FDA Drug Approvals 2013

Pomalyst is available only under a special program called Pomalyst REMS. 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.

Pomalyst may cause blood clots. Stop using this medicine 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 medication at the time of conception or during pregnancy. Even one dose of Pomalyst 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:

  • liver disease;

  • kidney disease; or

  • if you smoke (smoking may make pomalidomide less effective).

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.

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 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.

Store at room temperature away from moisture and heat.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Pomalyst dosing information

Usual Adult Dose for Multiple Myeloma:

4 mg once daily orally on Days 1-21 of repeated 28-day cycles

Duration of therapy: Until disease progression occurs

Comments: Females of reproductive potential must have negative pregnancy testing and use contraception methods before initiating 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.

This medication 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 any of these 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:

  • fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

  • stabbing chest pain, wheezing, cough with yellow or green mucus;

  • numbness or tingly feeling;

  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

  • pain, swelling, warmth, or redness in one or both legs; or

  • swelling in your hands or feet.

Common Pomalyst side effects may include:

  • dizziness, confusion;

  • feeling weak or tired;

  • loss of appetite, nausea, diarrhea, constipation;

  • mild rash; or

  • back pain, joint pain, muscle pain or weakness.

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 pomalidomide with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Pomalyst, especially:

  • ciprofloxacin (Cipro); or

  • fluvoxamine (Luvox).

This list is not complete. Other drugs may interact with pomalidomide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Pomalyst.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Pomalyst only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2015 Cerner Multum, Inc. Version: 1.04. Revision Date: 2014-12-30, 10:16:43 AM.

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