pomalidomide

What is the most important information I should know about pomalidomide?

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 during your treatment, and for up to 28 days after your treatment ends.

What is pomalidomide?

Pomalidomide affects the immune system. It promotes immune responses to help slow tumor growth.

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 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.

Pomalidomide may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking pomalidomide?

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 pomalidomide 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 pomalidomide, 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.

For Men: If a man fathers a baby while using pomalidomide, 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 pomalidomide is safe for you, tell your doctor if you have:

• liver disease (especially hepatitis B);
• kidney disease (or if you are on dialysis);
• 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
• 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 pomalidomide may increase your risk of developing other types of cancer, such as leukemia or lymphoma. Talk with your doctor about your specific risk.

How should I take pomalidomide?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Pomalidomide 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 pomalidomide.

Never give pomalidomide to another person, even if he or she has the same disorder for which you are being treated.

While using pomalidomide, 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.

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?

What should I avoid while taking pomalidomide?

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's 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.

What are the possible side effects of pomalidomide?

• blistering and peeling of your skin;
• 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;
• liver problems --nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• 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;
• 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;
• 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 --pain, swelling, warmth, or redness in one or both legs; or
• 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 side effects may include:

• fever, weakness or feeling tired;
• dizziness, confusion;
• nausea, diarrhea, constipation;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• back pain; or
• 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.

What other drugs will affect pomalidomide?

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.

Where can I get more information?

Your pharmacist can provide more information about pomalidomide.