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Pomalyst

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Pomalyst

PATIENT INFORMATION

MEDICATION GUIDE

POMALYST
(POM-uh-list)
(pomalidomide) Capsules

Read the Medication Guide that comes with POMALYST before you start taking it and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

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

  • Before you begin taking POMALYST, you must read and agree to all of the instructions in the POMALYST REMS™ program.
  • POMALYST may cause serious side effects including:
    Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or who plan to become pregnant must not take POMALYST.
    POMALYST is similar to the medicine thalidomide (THALOMID). We know thalidomide can cause severe life-threatening birth defects. POMALYST has not been tested in pregnant women. POMALYST has harmed unborn animals in animal testing.
    Females must not get pregnant:
    • for at least 4 weeks before starting POMALYST
    • while taking POMALYST
    • during any breaks (interruptions) in your treatment with POMALYST
    • for at least 4 weeks after stopping POMALYST

If you become pregnant while taking POMALYST, stop taking it right away and call your healthcare provider. If your healthcare provider is not available, you can call 1-888-668-2528 for medical information. Healthcare providers and patients should report all cases of pregnancy to:

    • FDA MedWatch at 1-800-332-1088, and
    • Celgene Corporation at 1-888-423-5436

POMALYST can pass into human semen:

  • Males, including those who have had a vasectomy, must use a latex or synthetic condom during any sexual contact with a pregnant female or a female that can become pregnant while taking POMALYST, during any breaks (interruptions) in your treatment with POMALYST, and for 4 weeks after stopping POMALYST.
  • Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your healthcare provider if you do have unprotected sexual contact with a female who is or could become pregnant.
  • Do not donate sperm while taking POMALYST, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping POMALYST. If a female becomes pregnant with your sperm, the baby may be exposed to POMALYST and may be born with birth defects.

Men, if your female partner becomes pregnant, you should call your healthcare provider right away.

  • Blood clots in your veins and lungs. If you take POMALYST, you may have an increased risk for blood clots in your veins and lungs. Call your healthcare provider or get medical help right away if you get any of these signs or symptoms while taking POMALYST:
    • shortness of breath
    • chest pain
    • arm or leg swelling

What is POMALYST?

POMALYST is a prescription medicine used to treat people with multiple myeloma who:

  • have received at least two prior medicines to treat multiple myeloma, including bortezomib and lenalidomide, and
  • their disease has become worse during treatment or within 60 days of finishing the last treatment.

It is not known if POMALYST is safe and effective in people under 18 years of age.

Who should not take POMALYST?

Do not take POMALYST if you are pregnant, plan to become pregnant, or become pregnant during treatment with POMALYST. See “What is the most important information I should know about POMALYST?”

What should I tell my healthcare provider before taking POMALYST?

Before you take POMALYST, tell your healthcare provider if you:

  • have a history of serious allergic reactions to thalidomide (THALOMID) or lenalidomide (REVLIMID). You may be at risk if you take POMALYST if you have had serious allergic reactions to these medicines.
  • smoke cigarettes
  • have any other medical condition
  • are breastfeeding. POMALYST must not be used by women who are breastfeeding. It is not known if POMALYST passes into your breast milk and can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. POMALYST and other medicines may affect each other causing serious side effects.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist.

How should I take POMALYST?

Take POMALYST exactly as prescribed and follow all the instructions of the POMALYST REMS program.

Before prescribing POMALYST, your healthcare provider will:

    • explain the POMALYST REMS program to you
    • have you sign the Patient-Physician Agreement Form
  • Swallow POMALYST capsules whole with water 1 time a day. Do not break, chew, or open your capsules.
  • Take POMALYST at about the same time each day.
  • POMALYST should be taken without food, at least 2 hours before or 2 hours after a meal.
  • Do not open the POMALYST capsules or handle them any more than needed. If you touch a broken POMALYST capsule or the medicine in the capsule, wash the area of your body right away with soap and water.
  • If you miss a dose of POMALYST, and it has been less than 12 hours since your regular time, take it as soon as you remember. If it has been more than 12 hours, just skip your missed dose. Do not take 2 doses at the same time.
  • If you take too much POMALYST, call your healthcare provider right away.

Females who can become pregnant:

  • will have pregnancy tests weekly for 4 weeks, then every 4 weeks if your menstrual cycle is regular, or every 2 weeks if your menstrual cycle is irregular.
  • If you miss your period or have unusual bleeding, you will need to have a pregnancy test and receive counseling.
  • must agree to use 2 different forms of effective birth control at the same time, for at least 4 weeks before, while taking, during any breaks (interruptions) in your treatment, and for at least 4 weeks after stopping POMALYST.

Males who take POMALYST, even those who have had a vasectomy, must agree to use a latex or synthetic condom during sexual contact with a pregnant female or a female who can become pregnant.

What should I avoid while taking POMALYST?

  • See “What is the most important information I should know about POMALYST?”
  • Females: Do not get pregnant and do not breastfeed while taking POMALYST.
    Males: Do not donate sperm.
  • Do not share POMALYST with other people. It may cause birth defects and other serious problems.
  • Do not donate blood while you take POMALYST, during any breaks (interruptions) in your treatment, and for 4 weeks after stopping POMALYST. If someone who is pregnant gets your donated blood, her baby may be exposed to POMALYST and may be born with birth defects.
  • You should not smoke cigarettes while taking POMALYST. Smoking cigarettes during treatment with POMALYST may affect how well POMALYST works.

What are the possible side effects of POMALYST?

POMALYST may cause serious side effects, including:

  • See “What is the most important information I should know about POMALYST?”
  • Low white blood cells (neutropenia), low platelets (thrombocytopenia) and low red blood cells (anemia). POMALYST may cause low white blood cells, low platelets and low red blood cells. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your blood counts should be checked weekly for the first 8 weeks and monthly thereafter.

The most common side effects of POMALYST include:

  • tiredness and weakness
  • constipation
  • shortness of breath
  • diarrhea
  • fever
  • back pain
  • nausea

These are not all the possible side effects of POMALYST.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-332-1088.

How should I store POMALYST?

  • Store POMALYST at room temperature (68°F to 77°F [20°C to 25°C]) with excursions permitted to 59°F to 86°F (15°C to 30°C).
  • Return any unused POMALYST to Celgene or your healthcare provider.

Keep POMALYST and all medicines out of the reach of children.

General information about POMALYST

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take POMALYST for conditions for which it was not prescribed. Do not give POMALYST to other people, even if they have the same symptoms you have. It may harm them and may cause birth defects.

This Medication Guide provides a summary of the most important information about POMALYST. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about POMALYST that is written for health professionals.

For more information, call 1-888-423-5436 or go to www.celgeneriskmanagement.com.

What are the ingredients in POMALYST?

Active ingredient: pomalidomide

Inactive ingredients: mannitol, pregelatinized starch and sodium stearyl fumarate.

The 1 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, white ink and black ink.

The 2 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, FD&C red 3, and white ink.

The 3 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide and white ink.

The 4 mg capsule shell contains gelatin, titanium dioxide, FD&C blue 1, FD&C blue 2 and white ink.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued February 2013.

Last reviewed on RxList: 2/21/2013
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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