Risk of severe life-threatening birth defects caused by lenalidomide:

For all patients:

Lenalidomide must not be taken by patients who are pregnant or who may become pregnant. There is a high risk that lenalidomide will cause severe birth defects (problems that are present at birth) or death of the unborn baby.

A program called REVLIMID REMS^TM has been set up to make sure that pregnant women do not take lenalidomide and that women do not become pregnant while taking lenalidomide. All patients, including women who cannot become pregnant and men, can get lenalidomide only if they are registered with REVLIMID REMS, have a prescription from a doctor who is registered with REVLIMID REMS, and fill the prescription at a pharmacy that is registered with REVLIMID REMS.

You will receive information about the risks of taking lenalidomide and must sign an informed consent sheet stating that you understand this information before you can receive the medication. If you are younger than 18 years of age, a parent or guardian must sign the consent sheet and agree to make sure you meet these requirements. You will need to see your doctor during your treatment to talk about your condition and the side effects you are experiencing or to have pregnancy tests as recommended by the program. You may need to complete a confidential survey at the beginning of your treatment and at certain times during your treatment to be sure that you have received and understand this information and that you can follow the instructions to prevent serious risks to unborn babies.

Tell your doctor if you do not understand everything you were told about lenalidomide and the REVLIMID REMS program and how to use the birth control methods discussed with your doctor, or if you do not think you will be able to keep appointments.

Do not donate blood while you are taking lenalidomide, during any breaks in your treatment, and for 4 weeks after your final dose.

Do not share lenalidomide with anyone else, even someone who has the same symptoms that you have.

For female patients:

If you can become pregnant, you will need to meet certain requirements during your treatment with lenalidomide. You must use two acceptable forms of birth control for 4 weeks before you begin taking lenalidomide, during your treatment, including at times when your doctor tells you to temporarily stop taking lenalidomide, and for 4 weeks after your final dose. Your doctor will tell you which forms of birth control are acceptable and will give you written information about birth control. You must use these two forms of birth control at all times unless you can guarantee that you will not have any sexual contact with a male for 4 weeks before your treatment, during your treatment, during any interruptions in your treatment, and for 4 weeks after your final dose.

If you choose to take lenalidomide, it is your responsibility to avoid pregnancy for 4 weeks before, during, and for 4 weeks after your final dose. You must understand that any form of birth control can fail. Therefore, it is very important to decrease the risk of accidental pregnancy by using two forms of birth control. Tell your doctor if you do not understand everything you were told about birth control or you do not think that you will be able to use two forms of birth control at all times.

You must have two negative pregnancy tests before you can begin to take lenalidomide. You will also need to be tested for pregnancy in a laboratory at certain times during your treatment. Your doctor will tell you when and where to have these tests.

Stop taking lenalidomide and call your doctor right away if you think you are pregnant, you miss a menstrual period, you have unusual menstrual bleeding, or you have sex without using two forms of birth control. If you become pregnant during your treatment or within 30 days after your treatment, your doctor will contact the REVLIMID REMS program, the manufacturer of lenalidomide, and the Food and Drug Administration (FDA). You will also talk with a doctor who specializes in problems during pregnancy who can help you make choices that are best for you and your baby. Information about your health and your baby’s health will be used to help doctors learn more about the effects of lenalidomide on unborn babies.

For male patients:

Lenalidomide is present in your semen when you take this medication. You must always use a latex condom, even if you have had a vasectomy (surgery that prevents a man from causing a pregnancy), every time you have sexual contact with a female who is pregnant or able to become pregnant while you are taking lenalidomide, during any breaks in your treatment, and for 4 weeks after your final dose. Tell your doctor if you have sexual contact with a female without using a condom or if your partner thinks she may be pregnant during your treatment with lenalidomide.

Do not donate sperm while you are taking lenalidomide, during any breaks in your treatment, and for 4 weeks after your final dose.

Other risks of taking lenalidomide:

Lenalidomide may cause a decrease in the number of certain types of blood cells in your body. Your doctor will order laboratory tests regularly during your treatment to see how much the number of blood cells has decreased. Your doctor may decrease your dose, interrupt your treatment, or treat you with other medications or treatments if the decrease in your blood cells is severe. If you experience any of the following symptoms, tell your doctor immediately: sore throat, fever, chills, and other signs of infection; easy bruising or bleeding; bleeding gums; or nosebleeds.

If you are taking lenalidomide with dexamethasone to treat multiple myeloma, there is an increased risk that you will develop a blood clot in your leg that may move through the bloodstream to your lungs, or have a heart attack or a stroke. Your doctor may prescribe other medication to be taken along with lenalidomide to decrease this risk. Tell your doctor if you smoke, if you have ever had a serious blood clot, and if you have or have ever had high blood pressure or a high level of fat in your blood.

Also tell your doctor about all the medications you are taking because certain medications may increase the risk that you will develop a blood clot while taking lenalidomide with dexamethasone including darbepoetin (Aranesp), epoetin alfa (Epogen, Procrit), and medications containing estrogen such as hormone replacement therapy or hormonal contraceptives (birth control pills, patches, rings, implants, or injections). If you experience any of the following symptoms, tell your doctor immediately: shortness of breath; chest pain that may spread to the arms, neck, back, jaw, or stomach; cough; redness or swelling in an arm or leg; sweating; nausea; vomiting; sudden weakness or numbness, especially on one side of the body; headache; confusion; or difficulty with vision, speech, or balance.