Important Safety Information

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. Before prescribing POMALYST, your healthcare provider (HCP) will explain the POMALYST REMS program to you and have you sign the Patient-Physician Agreement Form.

POMALYST can cause serious side effects, including:

• Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or plan to become pregnant must not take POMALYST.
  • POMALYST is similar to the medicine thalidomide (THALOMID^®), which is known to cause severe life-threatening birth defects. POMALYST has not been tested in pregnant females. 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, and for at least 4 weeks after stopping POMALYST.
  • Females who can become pregnant:
    • Must have pregnancy tests weekly for 4 weeks once treatment has started, 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 treatment, and for at least 4 weeks after stopping POMALYST. Talk with your HCP to find out about options for acceptable forms of birth control that you may use to prevent pregnancy.
  • If you become pregnant while taking POMALYST, stop taking it right away and call your HCP. If your HCP is not available, you can call Celgene Customer Care Center at 1-888-423-5436. 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. There is a pregnancy exposure registry that monitors the outcomes of females who take POMALYST during pregnancy, or if their male partner takes POMALYST and they are exposed during pregnancy. You can enroll in this registry by calling Celgene Corporation at the phone number listed above.
  • POMALYST can pass into human semen. Males, including those who have had a vasectomy, must always 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 at least 4 weeks after stopping POMALYST.
    • If a female becomes pregnant with your sperm, you should call your HCP right away. The baby may be exposed to POMALYST and may be born with birth defects.
    • Do not have unprotected sexual contact with a female who is or could become pregnant. Tell your HCP if you 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 at least 4 weeks after stopping POMALYST.
  • Do not donate blood while you take POMALYST, during any breaks (interruptions) in your treatment, and for at least 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 your arteries, veins, and lungs; heart attack; and stroke. Most people who take POMALYST will also take a blood thinner medicine to help prevent blood clots.
  • Before taking POMALYST, tell your HCP if you have had a blood clot in the past, if you have high blood pressure or hyperlipidemia (high level of fat in your blood), or if you smoke. Tell your HCP about all the medicines you take because certain other medicines can also increase your risk for blood clots.
  • Call your HCP or get medical help right away if you get any of the following during treatment with POMALYST: (1) signs or symptoms of a blood clot in the lung, arm, or leg, including shortness of breath, chest pain, or arm or leg swelling; (2) signs or symptoms of a heart attack, including chest pain that may spread to the arms, neck, jaw, back, or stomach area (abdomen); feeling sweaty; shortness of breath; feeling sick; or vomiting; or (3) signs or symptoms of stroke, including sudden numbness or weakness, especially on one side of the body; severe headache or confusion; or problems with vision, speech, or balance.

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 (HCP) before taking POMALYST?

• If you smoke cigarettes (POMALYST may not work as well in people who smoke), have any other medical conditions, or are breastfeeding. Do not breastfeed during treatment with POMALYST—it is not known if POMALYST passes into breast milk and can harm the baby.
• Tell your HCP 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. Talk with your HCP before taking any new medicines.

How should I take POMALYST?

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

• Swallow POMALYST capsules whole with water 1 time a day. Do not break, chew, or open capsules.
• Take POMALYST at the same time each day with or without food.
• If you are on hemodialysis, take POMALYST after hemodialysis on hemodialysis days.
• Do not open 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 POMALYST 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 (HCP) right away.
• Do not share POMALYST with other people. It may cause birth defects and other serious problems.

What are the possible side effects of POMALYST?

• See "What is the most important information I should know about POMALYST?"
• POMALYST can cause serious side effects, including:
  • Low white blood cells (neutropenia), low platelets (thrombocytopenia), and low red blood cells (anemia) are common with POMALYST, but can also be serious. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your blood counts should be checked by your healthcare provider (HCP) weekly for the first 8 weeks of treatment and monthly after that.
  • Severe liver problems, including liver failure or death. Your HCP should do blood tests to check your liver function during your treatment with POMALYST. Tell your HCP right away if you develop any of the following symptoms: yellowing of your skin or the white parts 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, or feeling very tired.
  • Severe allergic and skin reactions. Call your HCP if you have any symptoms of an allergic reaction, including: swelling of your lips, mouth, tongue, or throat; trouble breathing; or skin reaction.
  • Dizziness and confusion. Avoid taking other medicines that may cause dizziness and confusion during treatment with POMALYST. Avoid situations that require you to be alert until you know how POMALYST affects you.
  • Nerve damage. Stop taking POMALYST and call your HCP if you develop numbness, tingling, pain, or a burning sensation in your hands, legs, or feet.
  • New cancers (malignancies). New cancers, including certain blood cancers (acute myelogenous leukemia or AML) have been seen in people who received POMALYST. Talk with your HCP about your risk.
  • 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 HCP may do blood tests to check you for TLS.
• The most common side effects of POMALYST include tiredness, weakness, constipation, nausea, diarrhea, shortness of breath, upper respiratory tract infection, back pain, and fever.
• These are not all the possible side effects of POMALYST. Your HCP may tell you to stop taking POMALYST if you develop certain serious side effects during treatment. Call your HCP for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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