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Trade/other name(s): Revlimid (formerly Revimid), CC-5013

Why would this drug be used?

This drug is used to people with a disease of the bone marrow called myelodysplastic syndrome. It is also sometimes used to treat multiple myeloma and some types of non-Hodgkin lymphoma and is being studied for use against other cancers.

How does this drug work?

The exact way this drug works against cancer cells is not clear. Lenalidomide is known to be an immunomodulating agent – it affects some of the ways the immune system functions. It also appears to work in part by slowing or stopping the growth of new blood vessels (angiogenesis), which tumors need to grow and survive. It may also have direct effects on cancer cells themselves.

Before taking this medicine

Tell your doctor…

  • If you are allergic to anything, including medicines, dyes, additives, or foods.
  • If you have any kidney problems. This drug is cleared from the body mainly by the kidneys. Reduced kidney function may result in more drug than expected staying in the body, which could lead to unwanted side effects. Your doctor may need to adjust your dose accordingly.
  • If you have ever had major blood clots or bleeding problems. This drug may increase your risk of blood clots and bleeding (see “Precautions”).
  • If you have any other medical conditions such as liver disease (including hepatitis), heart disease, diabetes, high blood pressure, gout, or infections. These conditions may require that your medicine dose, regimen, or timing be changed.
  • If you are pregnant, trying to get pregnant, or if there is any chance of pregnancy. Lenalidomide, which is related to thalidomide, has the potential to cause severe birth defects (see “Precautions”).
  • If you are breast-feeding. This drug may pass into breast milk and affect the baby. Women who are taking this drug should not breast-feed.
  • If you think you might want to have children in the future. It is not known if this drug may affect fertility. Talk with your doctor about the possible risk with this drug and the options that may preserve your ability to have children.
  • About any other prescription or over-the-counter medicines you are taking, including vitamins and herbs. In fact, keeping a written list of each of these medicines (including the doses of each and when you take them) with you in case of emergency may help prevent complications if you get sick.

Interactions with other drugs

If you are taking birth control pills while on lenalidomide, they may not work if you take HIV treatment drugs, certain antibiotics, anti-seizure drugs, or St. John’s wort. If you must take one of these drugs, you will need 2 other forms of contraception while taking lenalidomide. Talk with your pharmacist or doctor.

No serious interactions between lenalidomide and other drugs are known at this time. But this does not necessarily mean that none exist. Check with your doctor, nurse, or pharmacist about your other medicines, herbs, and supplements, and whether alcohol can cause problems with this medicine.

Interactions with foods

No serious interactions with food are known at this time. Check with your doctor, nurse, or pharmacist about whether some foods may be a problem.

Tell all the doctors, dentists, nurses, and pharmacists you visit that you are taking this drug.

How is this drug taken or given?

Lenalidomide is usually taken as a 10 milligram (mg) capsule once a day with water. You should not break, chew, or open the capsules. If you experience severe side effects, your dose may need to be interrupted or lowered.

Note that, because of restrictions on the use of thalidomide due to the risk of serious birth defects, this drug is only available through a special program with the drug company that you and your doctor must sign up for. A program of special requirements is in place, which may include pregnancy tests, informed consent, and written agreements before you start this drug.

Store the medicine in a tightly closed container away from heat and moisture and out of the reach of children and pets.


This drug may increase your risk of abnormal blood clots, such as blood clots in the veins of the legs (deep venous thrombosis) or arteries of the lungs (pulmonary embolus). Your doctor may give you blood thinners or tell you to take aspirin to help lower this risk. Tell your doctor right away if you notice chest pain, shortness of breath, or swelling, pain, redness, or warmth in an arm or leg.

Heart disease, heart attacks, and strokes also occur at a higher rate in people taking this drug. Get emergency help for any symptoms of a heart attack or stroke, such as pain or pressure in the chest; shortness of breath; numbness, weakness, or trouble moving one side of the body; confusion; or trouble speaking.

This drug may cause serious diarrhea. If left unchecked, this could lead to dehydration and chemical imbalances in the body. Your doctor may advise you to drink plenty of fluids and may prescribe medicine to help prevent or control this side effect. It is very important that you take this medicine as prescribed. Make sure you get the medicine right away, so that you will have it at home when you need it.

This drug can cause the rapid killing of large numbers of tumor cells, which then break open and release their contents into the bloodstream. This, called tumor lysis syndrome, can lead to kidney failure and might also affect the heart and nervous system. It’s most common at the beginning of treatment. If your doctor thinks you’re at risk for it, you’ll get medicines and be encouraged to drink lots of fluids during the first days of treatment to help the body get rid of these substances. Tell your doctor or nurse if you have nausea, vomiting, diarrhea, or tiredness or if you feel weak or faint, have trouble breathing, or notice swelling in the first few days of taking it.

This drug can also cause tumor flare reaction in people with lymphoma, in which lymph nodes grow tender and larger, along with fever, pain and rash. These symptoms are temporary but can make it look like your lymphoma is getting worse. Tell your doctor if this happens to you. You may need extra treatment for some of these symptoms.

Allergic reactions with swelling of the mouth, tongue, face, or throat can cause trouble breathing or swallowing. Get emergency help right away, and let your doctor know what happened.

Your doctor will likely test your blood each week for the first 2 months of your treatment and frequently thereafter, looking for possible effects of the drug on blood counts or on blood chemistry levels. Based on the test results, you may be given medicines to help treat any effects. Your doctor may also need to reduce or delay your next dose of this drug, or even stop it altogether.

This drug can lower your white blood cell count, especially in the weeks after the drug is given. This can increase your chance of getting an infection. Be sure to let your doctor or nurse know right away if you have any signs of infection, such as fever (100.5º or higher), chills, pain when passing urine, a new cough, or bringing up sputum.

This drug may lower your platelet count in the weeks after it is given, which can increase your risk of bleeding. Speak with your doctor before taking any drugs or supplements that might affect your body’s ability to stop bleeding, such as aspirin or aspirin-containing medicines, warfarin (Coumadin), or vitamin E. Tell your doctor right away if you have unusual bruising, or bleeding such as nosebleeds, bleeding gums when you brush your teeth, or black, tarry stools.

While taking this medicine, and for a few days afterward, there is a slight chance of a serious skin reaction. Symptoms often start as a skin rash with redness or blistering in the mouth, nose, or eyes, along with fever and body aches. If this happens, stop the drug and call your doctor right away.

This drug can cause severe liver damage in a few people. Your doctor will likely check your blood so that if this happens, it can be found early. Call your doctor right away if you notice nausea, vomiting, fatigue, poor appetite, dark urine, yellowing skin or eyes, or tenderness under the right side of the rib cage.

Do not get any immunizations (vaccines), either during or after treatment with this drug, without your doctor’s OK. This drug may affect your immune system, which could make vaccinations ineffective, or could even lead to serious infections. Try to avoid contact with people who have recently received a live virus vaccine, such as the oral polio vaccine or smallpox vaccine. Check with your doctor about this.

Do not donate blood or sperm while taking this drug and for 4 weeks after stopping it, as this drug may still be in your system and could enter these body fluids. During and for a month after treatment, men should use condoms when having sex with a partner who might get pregnant.

Avoid pregnancy while taking this drug; it is related to thalidomide and can cause serious birth defects. Women of child-bearing age must use 2 forms of reliable birth control at the same time during treatment with lenalidomide, as well as for 4 weeks before starting and 4 weeks after stopping the drug. Women who could become pregnant should take 2 pregnancy tests before starting the drug, and again every 2 to 4 weeks throughout treatment. Notify your doctor if you stop using birth control, miss a menstrual period, have irregular menstrual periods, or if pregnancy is suspected for any reason. Men who have sex with women of child-bearing age must use a condom during treatment and for the first 4 weeks after treatment is stopped.

Lenalidomide can increase your risk of having a second type of cancer in the future.

Possible side effects

You will probably not have most of the following side effects, but if you have any talk to your doctor or nurse. They can help you understand the side effects and cope with them.


  • Low white blood cell counts with increased risk for infection*
  • Low platelet count with increased risk of bleeding*
  • Diarrhea*
  • Itching
  • Rash
  • Tiredness

Less common

  • Dizziness
  • Headache
  • Constipation
  • Nausea/vomiting
  • Fever
  • Weakness
  • Cough
  • Shortness of breath
  • Blood clot in the deep veins of the legs or in the lungs*
  • Joint or muscle pain
  • Abnormal blood tests which suggest that the drug is affecting the liver (Your doctor will discuss the importance of this finding, if any.)*
  • Tumor flare reaction (symptoms get worse) in people with lymphoma*
  • Low red blood cell count (anemia) with tiredness, pale lips or skin, shortness of breath*
  • Swelling in hands or feet
  • Pain or numbness in hands or feet
  • Tremor


  • Change in the sense of taste
  • Allergic reaction with swelling in the throat, trouble breathing
  • Serious skin rash that may progress to blistering*
  • Weight loss
  • Changes in blood chemistry (low potassium, calcium, or phosphate)*
  • Fast or irregular heartbeat
  • Liver failure*
  • Depression
  • Stroke*
  • Heart attack or heart disease*
  • Second cancer such as acute leukemia or Hodgkin lymphoma*
  • Death due to allergic reaction, tumor lysis syndrome, liver failure, or other cause

*See “Precautions” section for more detailed information.

There are some other side effects not listed above that can also occur in some patients. Tell your doctor or nurse if you develop these or any other problems.

FDA approval

Yes – first approved in 2005.

Disclaimer: This information does not cover all possible uses, actions, precautions, side effects, or interactions. It is not intended as medical advice, and should not be relied upon as a substitute for talking with your doctor, who is familiar with your medical needs.

Last Medical Review: 12/02/2014
Last Revised: 12/02/2014