Serious side effects

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 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
• For at least 4 weeks after stopping POMALYST

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 two acceptable forms of 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.
• Talk with your healthcare provider to find out about options for acceptable forms of birth control that you may use to prevent pregnancy before, during, and after treatment with 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 the REMS Call 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
• REMS Call Center 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 the REMS Call Center 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 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.

• 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 your arteries, veins, and lungs, heart attack, and stroke can happen if you take POMALYST. Most people who take POMALYST will also take a blood thinner medicine to help prevent blood clots.
Before taking POMALYST, tell your healthcare provider:

• If you have had a blood clot in the past
• If you have high blood pressure, smoke, or if you have been told you have a high level of fat in your blood (hyperlipidemia)
• About all the medicines you take. Certain other medicines can also increase your risk for blood clots

Call your healthcare provider or get medical help right away if you get any of the following during treatment with POMALYST:

• Signs or symptoms of a blood clot in the lung, arm, or leg may include: shortness of breath, chest pain, or arm or leg swelling
• Signs or symptoms of a heart attack may include: chest pain that may spread to the arms, neck, jaw, back, or stomach area (abdomen), feeling sweaty, shortness of breath, feeling sick or vomiting
• Signs or symptoms of stroke may include: sudden numbness or weakness, especially on one side of the body, severe headache or confusion, or problems with vision, speech, or balance.

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 weekly for the first 8 weeks of treatment and monthly after that.

Your healthcare provider should do blood tests to check your liver function during your treatment with POMALYST. Tell your healthcare provider right away if you develop any of the following symptoms of liver problems:

• 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

Severe allergic reactions and severe skin reactions can happen with POMALYST and may cause death.
Call your healthcare provider if you develop any of the following signs or symptoms during treatment with POMALYST:

• a red, itchy, skin rash
• peeling of your skin or blisters
• severe itching
• fever

Get emergency medical help right away if you develop any of the following signs or symptoms during treatment with POMALYST:

• swelling of your lips, mouth, tongue, or throat
• trouble breathing or swallowing
• raised red areas on your skin (hives)
• a very fast heartbeat
• you feel dizzy or faint

POMALYST can cause 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.

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, including certain blood cancers (acute myelogenous leukemia or AML) have been seen in people who received POMALYST. Talk with your healthcare provider about your risk.

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.