Lenalidomide is used to treat multiple myeloma (bone marrow cancer), either in combination with another medicine or after stem cell transplant.

Lenalidomide is also used to treat anemia (a lack of red blood cells) in patients with myelodysplastic syndrome caused by an abnormal chromosome. This disorder is also called deletion 5q MDS, because part of chromosome 5 is missing. In people with this disorder, the bone marrow does not produce enough healthy blood cells.

Lenalidomide is also used to treat mantle cell lymphoma, follicular lymphoma, or marginal zone lymphoma, after other medications have been tried without success.

Lenalidomide is available only under a special program. You must be registered in the program and understand the risks and benefits of lenalidomide. You must also agree to use birth control measures as required by the program.

Lenalidomide may also be used for purposes not listed in this medication guide.

Never use lenalidomide if you are pregnant. Even one dose of lenalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medicine at the time of conception or during pregnancy.

Use birth control to prevent pregnancy, whether you are a man or a woman. For women: Use two forms of birth control beginning 4 weeks before you start taking lenalidomide and ending 4 weeks after you stop taking it. For men: Use a condom to prevent pregnancy during your treatment, and for up to 4 weeks after your treatment ends.

Lenalidomide may cause blood clots. Stop using this medicine and call your doctor at once if you have symptoms such as sudden numbness, severe headache, problems with vision or speech, chest pain, shortness of breath, coughing up blood, or swelling in your arm or leg.

Lenalidomide comes as a capsule to take by mouth. When lenalidomide is used to treat myelodysplastic syndrome, it is usually taken with or without food once daily. When lenalidomide is used to treat multiple myeloma or mantle cell lymphoma, it is usually taken with or without food once daily for the first 21 days of a 28-day cycle. When lenalidomide is used to treat multiple myeloma after HSCT, it is usually taken with or without food once daily for 28 days of a 28-day cycle. The 28-day cycle regimen may be repeated as recommended by your doctor based on your body's response to this medication. Take lenalidomide at around the same time of day every day that you take it. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lenalidomide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole with plenty of water; do not break, chew, or open them. Handle the capsules as little as possible. If you touch a broken lenalidomide capsule or the medicine in the capsule, wash that area of your body with soap and water. If the medicine in the capsule gets into your mouth, nose, or eyes, wash it away with plenty of water.

Your doctor may need to interrupt your treatment or reduce your dose if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with lenalidomide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Never share lenalidomide with another person, even if they have the same disorder you have.

Take the medicine at the same time each day, with or without food.

Take each dose with a full glass of water. Swallow the capsule whole, without breaking it open.

Lenalidomide can increase your risk of bleeding or infection. You will need frequent medical tests.

The medicine from an open capsule can be dangerous if it gets on your skin. If this occurs, wash your skin with soap and water. Ask your doctor or pharmacist how to safely handle and dispose of a broken capsule.

Store at room temperature away from moisture and heat.

You should not use lenalidomide if you are allergic to it.

Lenalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medicine at the time of conception or during pregnancy. Even one dose of lenalidomide can cause major birth defects of the baby's arms and legs, bones, ears, eyes, face, and heart. Never use lenalidomide if you are pregnant. Tell your doctor right away if your period is late while taking lenalidomide.

For Women: If you have not had a hysterectomy, you will be required to use two reliable forms of birth control beginning 4 weeks before you start taking lenalidomide and ending 4 weeks after you stop taking it. Even women with fertility problems are required to use birth control while taking this medicine. You must also have a negative pregnancy test at 10 to 14 days before treatment and again at 24 hours before. While you are taking lenalidomide, you will have a pregnancy test every 2 to 4 weeks.

The birth control method you use must be proven highly effective, such as birth control pills, an intrauterine device (IUD), a tubal ligation, or a sexual partner's vasectomy. The extra form of birth control you use must be a barrier method such as a latex condom, a diaphragm, or a cervical cap.

Stop using lenalidomide and call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant. Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.

For Men: If a man fathers a baby while using lenalidomide, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment, and for up to 4 weeks after your treatment ends. You must agree in writing to always use latex condoms when having sex with a woman who is able to get pregnant, even if you have had a vasectomy. Contact your doctor if you have had unprotected sex, even once, or if you think your female sexual partner may be pregnant.

Tell your doctor if you have ever had:

• an allergic reaction to thalidomide;

• kidney disease (or if you are on dialysis);

• liver disease;

• a blood clot or stroke;

• high blood pressure, high cholesterol or triglycerides;

• a thyroid disorder;

• lactose intolerance; or

• if you smoke

Using lenalidomide may increase your risk of developing other types of cancer, such as leukemia or lymphoma. Talk with your doctor about your specific risk.

You should not breastfeed while using lenalidomide.

Take the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Return any medication that is outdated or no longer needed to your doctor, the pharmacy that gave you the medication, or the manufacturer.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

You must not donate blood or sperm while you are using lenalidomide, and for at least 4 weeks after your last dose. Avoid exposing another person to your blood or semen through casual or sexual contact.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Lenalidomide may cause serious side effects. Call your doctor at once if you have:

• signs of a stroke or blood clot--sudden numbness or weakness, severe headache, problems with speech or vision, shortness of breath, swelling or redness in your arm or leg;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, sweating;

• liver problems--upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• low blood cell counts--fever, chills, swollen gums, mouth sores, skin sores, easy bruising, unusual bleeding;

• signs of a tumor getting worse--swollen glands, low fever, rash, or pain; or

• signs of tumor cell breakdown--lower back pain, blood in your urine, little or no urinating; numbness or tingly feeling around your mouth; muscle weakness or tightness; feeling short of breath; confusion, fainting.

Common side effects of lenalidomide may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;

• sleep problems, tiredness;

• weakness;

• headache;

• tremors;

• nosebleed;

• muscle cramps;

• joint pain;

• shortness of breath;

• fever, cough, tiredness;

• itching, rash, swelling; or

• stomach pain, nausea, vomiting, diarrhea, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor if you also use pembrolizumab (Keytruda).

Other drugs may affect lenalidomide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor. Your doctor may order certain tests before and during your treatment to check your body's response to lenalidomide.

Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.