[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 lenalidomide 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: [Web] and [Web].
REMS:
FDA approved a REMS for lenalidomide to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of lenalidomide and consists of the following: medication guide, elements to assure safe use, and implementation system. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush, or chew this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.
A MedGuide will be given with each prescription and refill. Read this guide carefully each time. The MedGuide may change frequently.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor for regular check ups. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. You will need to have important blood work done while you are taking this medicine.
This medicine is available only through a special program. Doctors, pharmacies, and patients must meet all of the conditions of the program. Your health care provider will help you get signed up with the program if you need this medicine. Through the program you will only receive up to a 28 day supply of the medicine at one time. You will need a new prescription for each refill. Your prescription must be filled within 7 days of your doctor's office visit.
This medicine can cause birth defects. Do not get pregnant while taking this drug. Females with child-bearing potential will need to have 2 negative pregnancy tests before starting this medicine. Pregnancy testing must be done every 2 to 4 weeks as directed while taking this medicine. Use 2 reliable forms of birth control together while you are taking this medicine and for 1 month after you stop taking this medicine. If you think that you might be pregnant talk to your doctor right away.
Men must use a latex condom during sexual contact with a woman while taking this medicine and for 30 days after you stop taking this medicine. A latex condom is needed even if you have had a vasectomy. Contact your doctor right away if your partner becomes pregnant. Do not donate sperm while taking this medicine and for 30 days after you stop taking taking this medicine.
Do not give blood while taking the medicine and for 30 days after completion of treatment to avoid exposing pregnant women to the medicine through the donated blood.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
diarrhea
tiredness
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
