What is POMALYST® (pomalidomide)?POMALYST is a prescription medicine, taken along with the medicine dexamethasone, used to treat adults with multiple myeloma who have previously received at least 2 medicines to treat multiple myeloma, including a proteasome inhibitor and lenalidomide, and whose 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 children.
Serious side effects
These are not all the possible side effects of POMALYST. Your healthcare provider may adjust your dose or have you temporarily or permanently stop taking POMALYST if you develop certain serious side effects. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Before taking POMALYST, talk to your doctor about the serious side effects.
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 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 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 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 arteries, veins, and lungs; heart attack; and stroke
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, low platelets, and low red blood cells
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.
Severe liver problems, including liver failure and death
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
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
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
Dizziness and confusion
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.
Risk of 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 healthcare provider about your risk of developing new cancers if you take POMALYST.
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.
Talking with your doctor about POMALYST.
Your doctor or nurse is there to help you throughout your treatment. They are also there to answer any questions you may have about side effects that may happen with treatment. See what other questions you may want to ask with our customizable Conversation Starter.CONVERSATION STARTER