pronounced as (poe'' ma lid' oh mide)

Brand Name(s): Pomalyst®

Why is this medicine prescribed?

Pomalidomide is used in combination with dexamethasone to treat multiple myeloma (a type of cancer of the bone marrow) that has not improved during or within 60 days of treatment with at least two other medications, including lenalidomide (Revlimid) and a proteasome inhibitor such as bortezomib (Velcade) or carfilzomib (Kyprolis). It is also used to treat Kaposi's sarcoma (a type of cancer that causes abnormal tissue to grow on different parts of the body) related to acquired immunodeficiency syndrome (AIDS) after unsuccessful treatment with other medications or in people with Kaposi's sarcoma who are do not have human immunodeficiency virus (HIV) infection. Pomalidomide is in a class of medications called immunomodulatory agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow.

Are there other uses for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Pomalidomide comes as a capsule to take by mouth. It is usually taken once daily with or without food on days 1 to 21 of a 28-day cycle. This 28-day pattern may be repeated as recommended by your doctor. Take pomalidomide at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take pomalidomide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole with water; do not break or chew them. Do not open the capsules or handle them more than necessary. If your skin comes into contact with broken capsules or powder, wash the exposed area with soap and water. If any capsule contents get in your eyes, wash your eyes right away with water.

Your doctor may need to permanently or temporarily stop your treatment or reduce your dose if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with pomalidomide.

What special precautions should I follow?

Before taking pomalidomide,

  • tell your doctor and pharmacist if you are allergic to pomalidomide, any other medications, or any of the ingredients in pomalidomide capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: carbamazepine (Carbatrol, Tegretol, Teril, others); ciprofloxacin (Cipro); fluvoxamine (Luvox); and ketoconazole (Nizoral). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with pomalidomide, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
  • tell your doctor if you are receiving dialysis (medical treatment to clean the blood when the kidneys are not working properly) or have or have ever had liver disease.
  • do not breast-feed while you are taking pomalidomide.
  • you should know that pomalidomide may make you feel dizzy or confused. Do not drive a car, operate machinery, or do other activities that require you to be fully alert until you know how this medication affects you.
  • tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this medication.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget to take a dose?

Take the missed dose as soon as you remember it. However, if it is less than 12 hours until your next scheduled dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What should I do in case of overdose?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What side effects can this medicine cause?

Pomalidomide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • constipation
  • diarrhea
  • nausea
  • vomiting
  • loss of appetite
  • weight changes
  • uncontrollable shaking of a part of the body
  • unusual sweating or night sweats
  • anxiety
  • dry skin
  • swelling of the arms, hands, feet, ankles, or lower legs
  • joint, muscle, or back pain
  • trouble falling asleep or staying asleep

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, stop taking pomalidomide and call your doctor immediately:

  • rash
  • itching
  • hives
  • blistering and peeling skin
  • swelling of the eyes, face, tongue, throat, hands, arms, feet, ankles, or lower legs
  • difficulty breathing or swallowing
  • hoarseness
  • fever, sore throat, chills, cough, or other signs of infection
  • yellow eyes or skin
  • dark urine
  • pain or discomfort in the right upper stomach area
  • difficult, frequent, or painful urination
  • pale skin
  • unusual tiredness or weakness
  • unusual bleeding or bruising
  • nosebleed
  • numbness, burning, or tingling in the hands or feet
  • seizures

Pomalidomide may increase the risk that you will develop other cancers. Talk to your doctor about the risks of taking pomalidomide.

Pomalidomide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( http://www.fda.gov/Safety/MedWatch ) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Return any medication that is no longer needed to your pharmacy or the manufacturer. Ask your pharmacist if you have any questions about returning your medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to pomalidomide.

Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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