Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or who plan to become pregnant must not take REVLIMID.
REVLIMID is similar to the medicine thalidomide which is known to cause severe life-threatening birth defects. REVLIMID has not been tested in pregnant females. REVLIMID has harmed unborn animals in animal testing.

Females must not get pregnant:

• For at least 4 weeks before starting REVLIMID
• While taking REVLIMID
• During any breaks (interruptions) in your treatment with REVLIMID
• For at least 4 weeks after stopping REVLIMID

Females who can become pregnant:

• Must 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 REVLIMID.
• Talk with your healthcare provider to find out about options for effective forms of birth control that you may use to prevent pregnancy before, during, and after treatment with REVLIMID.
• If you had unprotected sex or if you think your birth control has failed, stop taking REVLIMID immediately and call your healthcare provider right away.

If you become pregnant while taking REVLIMID, 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
• Celgene Corporation, a Bristol-Myers Squibb Company, at 1-888-423-5436.

There is a pregnancy exposure registry that monitors the outcomes of females who take REVLIMID during pregnancy, or if their male partner takes REVLIMID and they are exposed during pregnancy. You can enroll in this registry by calling Celgene Corporation, a Bristol-Myers Squibb Company, at the phone number listed above.

REVLIMID 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 REVLIMID, during any breaks (interruptions) in your treatment with REVLIMID, and for up to 4 weeks after stopping REVLIMID.
• 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 REVLIMID, during any breaks (interruptions) in your treatment, and for up to 4 weeks after stopping REVLIMID. If a female becomes pregnant with your sperm, the baby may be exposed to REVLIMID and may be born with birth defects.

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

Low white blood cells (neutropenia) and low platelets (thrombocytopenia). REVLIMID causes low white blood cells and low platelets in most people. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your healthcare provider should check your blood counts often, especially during the first several months of treatment with REVLIMID, and then at least monthly. Tell your healthcare provider if you develop any bleeding or bruising during treatment with REVLIMID.

Blood clots. Blood clots in the arteries, veins, and lungs happen more often in people who take REVLIMID. This risk is even higher for people with multiple myeloma who take the medicine dexamethasone with REVLIMID. Heart attacks and strokes also happen more often in people who take REVLIMID with dexamethasone. To reduce this increased risk, most people who take REVLIMID will also take a blood thinner medicine.

Before taking REVLIMID, 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); and
• 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 REVLIMID:

• 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

• your skin, wash the skin right away with soap and water.
• inside of your eyes, nose, or mouth, flush well with water.

See “What is the most important information I should know about REVLIMID?”

Increased risk of death in people who have chronic lymphocytic leukemia (CLL). People with CLL who take REVLIMID have an increased risk of death compared with people who take the medicine chlorambucil. REVLIMID may cause you to have serious heart problems that can lead to death, including atrial fibrillation, heart attack, or heart failure. You should not take REVLIMID if you have CLL unless you are participating in a controlled clinical trial.

Risk of new cancers (malignancies). An increase in new (second) cancers has happened in patients who received REVLIMID and melphalan, or a blood stem cell transplant, including certain blood cancers, such as acute myelogenous leukemia (AML), myelodysplastic syndromes (MDS), and certain other types of cancers of the skin and other organs. Talk with your healthcare provider about your risk of developing new cancers if you take REVLIMID. Your healthcare provider will check you for new cancers during your treatment with REVLIMID.

Severe liver problems, including liver failure and death. Your healthcare provider should do blood tests to check your liver function during your treatment with REVLIMID. 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 skin reactions and severe allergic reactions can happen with REVLIMID and may cause death. Call your healthcare provider right away if you develop any of the following signs or symptoms during treatment with REVLIMID:

• 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 REVLIMID:

• 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

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.

Worsening of your tumor (tumor flare reaction) can happen with REVLIMID and may cause death. Tell your healthcare provider if you get any of these symptoms of tumor flare reaction while taking REVLIMID: tender, swollen lymph nodes; low-grade fever, pain, or rash.

Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or who plan to become pregnant must not take REVLIMID.
REVLIMID is similar to the medicine thalidomide which is known to cause severe life-threatening birth defects. REVLIMID has not been tested in pregnant females. REVLIMID has harmed unborn animals in animal testing.

Females must not get pregnant:

• For at least 4 weeks before starting REVLIMID
• While taking REVLIMID
• During any breaks (interruptions) in your treatment with REVLIMID
• For at least 4 weeks after stopping REVLIMID

Females who can become pregnant:

• Must 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 REVLIMID.
• Talk with your healthcare provider to find out about options for effective forms of birth control that you may use to prevent pregnancy before, during, and after treatment with REVLIMID.
• If you had unprotected sex or if you think your birth control has failed, stop taking REVLIMID immediately and call your healthcare provider right away.

If you become pregnant while taking REVLIMID, 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
• Celgene Corporation, a Bristol-Myers Squibb Company, at 1-888-423-5436.

There is a pregnancy exposure registry that monitors the outcomes of females who take REVLIMID during pregnancy, or if their male partner takes REVLIMID and they are exposed during pregnancy. You can enroll in this registry by calling Celgene Corporation, a Bristol-Myers Squibb Company, at the phone number listed above.

REVLIMID 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 REVLIMID, during any breaks (interruptions) in your treatment with REVLIMID, and for up to 4 weeks after stopping REVLIMID.
• 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 REVLIMID, during any breaks (interruptions) in your treatment, and for up to 4 weeks after stopping REVLIMID. If a female becomes pregnant with your sperm, the baby may be exposed to REVLIMID and may be born with birth defects.

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

Low white blood cells (neutropenia) and low platelets (thrombocytopenia). REVLIMID causes low white blood cells and low platelets in most people. You may need a blood transfusion or certain medicines if your blood counts drop too low. Your healthcare provider should check your blood counts often, especially during the first several months of treatment with REVLIMID, and then at least monthly. Tell your healthcare provider if you develop any bleeding or bruising during treatment with REVLIMID.

Blood clots. Blood clots in the arteries, veins, and lungs happen more often in people who take REVLIMID. This risk is even higher for people with multiple myeloma who take the medicine dexamethasone with REVLIMID. Heart attacks and strokes also happen more often in people who take REVLIMID with dexamethasone. To reduce this increased risk, most people who take REVLIMID will also take a blood thinner medicine.

Before taking REVLIMID, 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); and
• 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 REVLIMID:

• 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

• your skin, wash the skin right away with soap and water.
• inside of your eyes, nose, or mouth, flush well with water.

See “What is the most important information I should know about REVLIMID?”

Increased risk of death in people who have chronic lymphocytic leukemia (CLL). People with CLL who take REVLIMID have an increased risk of death compared with people who take the medicine chlorambucil. REVLIMID may cause you to have serious heart problems that can lead to death, including atrial fibrillation, heart attack, or heart failure. You should not take REVLIMID if you have CLL unless you are participating in a controlled clinical trial.

Risk of new cancers (malignancies). An increase in new (second) cancers has happened in patients who received REVLIMID and melphalan, or a blood stem cell transplant, including certain blood cancers, such as acute myelogenous leukemia (AML), myelodysplastic syndromes (MDS), and certain other types of cancers of the skin and other organs. Talk with your healthcare provider about your risk of developing new cancers if you take REVLIMID. Your healthcare provider will check you for new cancers during your treatment with REVLIMID.

Severe liver problems, including liver failure and death. Your healthcare provider should do blood tests to check your liver function during your treatment with REVLIMID. 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 skin reactions and severe allergic reactions can happen with REVLIMID and may cause death. Call your healthcare provider right away if you develop any of the following signs or symptoms during treatment with REVLIMID:

• 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 REVLIMID:

• 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

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.

Worsening of your tumor (tumor flare reaction) can happen with REVLIMID and may cause death. Tell your healthcare provider if you get any of these symptoms of tumor flare reaction while taking REVLIMID: tender, swollen lymph nodes; low-grade fever, pain, or rash.