Treats anemia caused by myelodysplastic syndrome (MDS), a disease in which the bone marrow does not function normally and the body does not make enough normal blood cells. When taken together with dexamethasone, this medicine also treats multiple myeloma (plasma cell cancer) in patients who have received at least one prior therapy.
There may be other brand names for this medicine.
When This Medicine Should Not Be Used
This medicine can cause serious or life-threatening birth defects in unborn babies. You should not use this medicine if you are pregnant or breastfeeding, or if you may become pregnant during treatment. You should not use this medicine if you have had an allergic reaction to lenalidomide.
How to Use This Medicine
- Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
- Swallow the capsule whole. Do not crush, break, or chew it. Drink a full glass of water (about 8 ounces) when you take this medicine.
- You may take this medicine with or without food.
- This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.
If a dose is missed:
- If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.
How to Store and Dispose of This Medicine
- Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
- Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
- Keep all medicine away from children and never share your medicine with anyone.
Drugs and Foods to Avoid
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- Make sure your doctor knows about ALL other medicines you are using. This is especially important if you are a woman taking birth control pills while you are using lenalidomide. Some medicines can cause birth control pills to not work as well in preventing pregnancy, and you should not take lenalidomide if you are able to get pregnant.
- Tell your doctor if you are also using digoxin (such as Digitek® or Lanoxin®).
Warnings While Using This Medicine
- Using this medicine while you are pregnant can harm your unborn baby. The medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are using this medicine, tell your doctor right away.
- You will be asked to sign a consent and agreement form before you take this medicine. This form tells you about the risks of using this medicine and the guidelines for safe use. Make sure you understand what is on the form before you sign it. You will also be asked to take part in a telephone survey and have your name placed on a patient registry list. If you have any questions ask your doctor.
- Use two forms of effective birth control to avoid pregnancy for 4 weeks before you start using lenalidomide, during your treatment (even during times when treatment is temporarily stopped), and for at least 4 weeks after your treatment ends. This is very important whether you are a man or a woman. The most effective forms of birth control include birth control pills or implants, a diaphragm or cervical cap, an IUD, tubal ligation (for women), or vasectomy and a condom (for men).
- If you are a woman who can get pregnant, your doctor will do tests to make sure you are not pregnant before starting lenalidomide therapy. These tests may be done weekly for the first month, and then every month if you have regular menses or every 2 weeks if you have irregular menses. If you are a man, you should use a latex condom every time you have sexual intercourse with a woman who could possibly get pregnant. You must use a latex condom even if you have had a vasectomy.
- Do not breastfeed while you are using this medicine.
- Make sure your doctor knows if you have kidney disease or any other blood disease.
- This medicine may increase your risk of having blood clots in veins and in the lungs. Tell your doctor right away if you start having shortness of breath, chest pain, or swelling of the arms or legs.
- You must not share this medicine with anyone, even someone who has similar symptoms.
- You should not donate blood or sperm while taking this medicine.
- This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
- Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.
- This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.
- Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.
Possible Side Effects While Using This Medicine
Call your doctor right away if you notice any of these side effects:
- Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.
- Change in how much or how often you urinate.
- Chest pain, shortness of breath, or coughing up blood.
- Dizziness, drowsiness, or trouble concentrating.
- Dry mouth, muscle cramps, nausea or vomiting.
- Fast, pounding, or irregular heartbeat.
- Fever, chills, cough, sore throat, or body aches.
- Increased hunger or thirst.
- Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
- Numbness or weakness in your arm, leg, or on one side of your body.
- Pain in your lower leg (calf).
- Pale skin, including decreased pinkness of the lips, gums, lining of the eyelids, nail beds, and palms.
- Red or black stools.
- Red or dark brown urine.
- Sudden or severe headache, problem with vision, speech, or walking.
- Swelling of the arms, legs, hands, or feet.
- Unusual bleeding or bruising.
- Yellowing of your skin or the whites of your eyes.
If you notice these less serious side effects, talk with your doctor:
- Decreased weight.
- Dry skin, rash, or itching.
- Headache, nosebleeds, or runny or stuffy nose.
- Joint, back, or muscle pain.
- Loss of appetite.
- Loss of taste or change in taste.
- Painful or difficulty in urination.
- Stomach pain, upset stomach, constipation, or diarrhea.
- Tiredness, weakness, restlessness, or irritability.
- Trouble sleeping or night sweats.
If you notice other side effects that you think are caused by this medicine, tell your doctor
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
Review Date: 2011-02-04