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[Posted 04/08/2011] ISSUE: FDA is informing the public that we are aware of results from clinical trials conducted inside and outside the United States that found that patients treated with lenalidomide (Revlimid) may be at an increased risk of developing new types of cancer compared to patients who did not take the drug. FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review.

BACKGROUND: Lenalidomide is used to treat a type of blood disorder known as myelodysplastic syndrome. Lenalidomide is also used along with other drugs to treat people with the cancer known as multiple myeloma.

RECOMMENDATION: At this time, there is no recommendation to delay, modify or restrict the use of enalidomide for patients being treated according to the FDA-approved indications. FDA is currently reviewing all available information on this potential risks and will communicate any new recommendations once it has completed its review. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.

Risk of 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 loss of the pregnancy or will cause the baby to be born with birth defects (problems that are present at birth).

A program called RevAssist^® 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 RevAssist, have a prescription from a doctor who is registered with RevAssist, and fill the prescription at a pharmacy that is registered with RevAssist.

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 less 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.

Tell your doctor if you do not understand everything you were told about lenalidomide and the RevAssist 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 and for 4 weeks after your treatment.

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

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with lenalidomide and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs), the manufacturer's website, or the RevAssist program website (http://www.revlimid.com/hcp/hcp-revassist.aspx) to obtain the Medication Guide.

Talk to your doctor about the risks of taking lenalidomide.

For female patients:

If you can become pregnant, you will need to meet certain requirements during your treatment with lenalidomide. You need to meet these requirements even if you have had a tubal ligation ('tubes tied,' surgery to prevent pregnancy). You may be excused from meeting these requirements only if you have not menstruated for 24 months in a row and your doctor says you have passed menopause ('change of life') or you have had surgery to remove your uterus and/or both ovaries. If none of these are true for you, then you must meet the requirements below.

You must use 2 acceptable forms of birth control for 4 weeks before you begin to take lenalidomide, during your treatment, including at times when your doctor tells you to temporarily stop taking lenalidomide, and for 4 weeks after your treatment. 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 2 forms of birth control at all times unless you can promise 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 treatment.

If you choose to take lenalidomide, it is your responsibility to avoid pregnancy for 4 weeks before, during, and for 4 weeks after your treatment. 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 2 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 2 forms of birth control at all times.

You must have 2 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, or you have sex without using 2 forms of birth control. If you become pregnant during your treatment or within 30 days after your treatment, your doctor will contact the RevAssist 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:

It is not know if lenalidomide is present in your semen when you take prescribed doses of this medication. You must 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 and for 4 weeks after your treatment. 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 and for 4 weeks after your treatment.

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 to treat multiple myeloma, there is a risk that you will develop a blood clot in your leg that may move through the bloodstream to your lungs. Your doctor may prescribe other medication to be taken along with lenalidomide to decrease this risk. If you experience any of the following symptoms, tell your doctor immediately: shortness of breath, chest pain, cough, or redness or swelling in an arm or leg.

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Page last updated: 27 September 2012