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Lenalidomide Oral capsule

It is used to treat certain types of cancer, including multiple myeloma and mantle cell lymphoma

Generic Name: lenalidomide

Brand Names: Revlimid

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[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]).

What is this medicine?

LENALIDOMIDE (len a LID oh mide) is used to treat certain types of cancer, including multiple myeloma and mantle cell lymphoma. It is also used to treat some myelodysplastic syndromes that cause severe anemia requiring blood transfusions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

-blood clots in the legs or the lungs
-infection
-irregular monthly periods or menstrual cycles
-kidney disease
-liver disease
-an unusual or allergic reaction to lenalidomide, other medicines, foods, dyes, or preservatives
-pregnant or trying to get pregnant
-breast-feeding

How should I use this medicine?

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.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 12 hours, then do not take

the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medicine?

  • vaccines

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.

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 28 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 28 days after you stop taking this medicine.

Do not give blood while taking the medicine and for 1 month after completion of treatment to avoid exposing pregnant women to the medicine through the donated blood.

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

You may need blood work done while you are taking this medicine.


Last Updated: June 11, 2013
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