POMALYST® (pomalidomide) is a prescription medicine, taken along with the medicine dexamethasone, used to treat people with multiple myeloma who have received at least 2 prior medicines to treat multiple myeloma, including a type of medicine known as a proteasome inhibitor 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 if it works in people under 18 years of age.

Important Safety Information

WARNING: Risk to unborn babies, blood clots, heart attack, and stroke

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.

Women who can become pregnant must have 2 negative pregnancy tests before starting on POMALYST.

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 you take POMALYST, you may have an increased risk for blood clots in your arteries, veins (deep vein thrombosis) or lungs (pulmonary embolism), or a heart attack or stroke. Most people who take POMALYST will also take a blood thinner medicine to help prevent blood clots.

Risk to unborn babies

POMALYST may cause serious birth defects or death of an unborn baby. Do not take POMALYST if you are pregnant, plan to become pregnant, or become pregnant during treatment with POMALYST.

Females who can become pregnant

  • Must have 2 negative pregnancy tests before starting on POMALYST
  • 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
  • Females: Do not get pregnant and do not breastfeed while taking 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-FDA-1088, and Celgene Corporation at 1-888-423-5436

Males

  • 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 who can become pregnant. Males must do this while taking POMALYST, during any breaks (interruptions) in your treatment with POMALYST, and for 4 weeks after stopping POMALYST
  • 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

Females and Males

  • 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

Blood clots in the arteries, veins and lungs, heart attack, and stroke

  • If you take POMALYST, you may have an increased risk for blood clots in your arteries, veins and lungs, heart attack, and stroke. 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; leg swelling; chest pain that spreads to the arms, neck, jaw, back or stomach; feeling sweaty; feeling sick or vomiting; sudden numbness or weakness – especially on one side of the body; severe headache or confusion; or problems with vision, speech, or balance

Other serious side effects

POMALYST may cause serious side effects, including:

  • Low white blood cells (neutropenia), low platelets (thrombocytopenia), and low red blood cells (anemia): 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 of treatment and monthly thereafter
  • Severe liver problems, including liver failure or death: Tell your healthcare provider right away if you develop any of the following symptoms:
        • Yellowing of your skin or the white part of your eyes (jaundice)
        • Dark or brown (tea-colored) urine
        • Pain on the upper right side of your stomach area (abdomen)
        • Bleeding or bruising more easily than normal
        • Feeling very tired

    Your healthcare provider should do blood tests to check your liver function during your treatment with POMALYST

    • Severe allergic reactions and severe skin reactions: Severe allergic reactions and severe skin reactions can happen with POMALYST. Call your healthcare provider if you have any symptoms of a severe allergic reaction including: swelling of your lips, mouth, tongue, or throat; or if you develop trouble breathing; or if you develop a skin reaction
    • Dizziness and confusional state: POMALYST can cause dizziness and confusion. Avoid taking other medicines that may cause dizziness and confusion, and avoid situations that require you to be alert until you know how POMALYST affects you
    • Nerve damage: Stop taking POMALYST and call your healthcare provider if you develop symptoms of nerve damage including: numbness, tingling, pain, burning sensation in your hands, legs, or feet
    • New cancers: Cases of certain blood cancers (acute myelogenous leukemia or AML) have been reported in clinical trials with POMALYST outside of multiple myeloma
    • Tumor lysis syndrome (TLS): TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS

    Common side effects

    • The most common side effects of POMALYST include tiredness and weakness, constipation, shortness of breath, diarrhea, fever, back pain, and nausea
    • These are not all the possible side effects of POMALYST. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088

    Drug interactions

    • You should not smoke cigarettes while taking POMALYST. Smoking cigarettes during treatment with POMALYST may affect how well POMALYST works
    • POMALYST and other medicines may affect each other causing serious side effects

    Other important information about POMALYST

    • 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

    Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.