lenalidomide

This medication is used to treat anemia in patients with a certain blood/bone marrow disorders (myelodysplastic syndrome-MDS, multiple myeloma). These patients do not have enough properly working red blood cells. They often require blood transfusions to reverse their anemia. Lenalidomide may decrease the need for treatment with blood transfusions. Lenalidomide is a type of drug known as an immunomodulator. It is believed to work by decreasing the immune system's response, thereby lowering the number of working red blood cells that are destroyed naturally by the body

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

This medication must be used only within the RevAssist guidelines in order to avoid any possible exposure of an unborn baby to the drug. Consult your doctor or pharmacist. Read the Medication Guide provided by your pharmacist before you start using lenalidomide and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Before starting therapy, women of childbearing age should have two negative pregnancy tests before taking the drug. (See Warning section.) Take this medication by mouth with a full glass of water, usually once daily or as directed by your doctor. Swallow this medication whole. Do not break, chew, or open the capsules. Dosage is based on your medical condition, response to therapy, and laboratory test results. Be sure to follow your doctor's directions carefully. Use this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. Inform your doctor if your condition persists or worsens.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Do not share this medication with others. Laboratory and/or medical tests (e.g., complete blood counts, kidney function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. If you are a woman with regular periods, test for pregnancy before treatment, weekly during the first 4 weeks of treatment, then every 4 weeks thereafter. If you have irregular periods, test every 2 weeks.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

Before taking lenalidomide, tell your doctor or pharmacist if you are allergic to it; or to thalidomide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: multiple myeloma, kidney disease. This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at a greater risk for side effects while using lenalidomide. Because lenalidomide can cause severe birth defects or death to an unborn baby, several precautions are noted below. Do not donate blood while using lenalidomide and for 4 weeks after stopping this drug. It is unknown if this drug can be absorbed through the skin. Handle the capsules carefully. Caution is advised if you come in contact with the contents of a broken capsule. If this occurs, wash your hands thoroughly with soap and water. Males - Always use a latex condom when having sexual intercourse with a woman of childbearing age, even if you have had a vasectomy. You must not donate sperm while using lenalidomide and for 4 weeks after stopping this drug. Use two forms of effective birth control together for at least 4 weeks before beginning lenalidomide treatment, during lenalidomide treatment, and for 4 weeks after stopping lenalidomide, or avoid intercourse completely during this period. Reliable birth control is necessary even if you have been unable to get pregnant in the past. Consult your doctor for more information about the right forms of birth control to use during this therapy. Immediately tell your doctor if your period is late or if you have abnormal vaginal (menstrual) bleeding. Lenalidomide must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. Even a single dose of lenalidomide taken during pregnancy can cause severe birth defects. If pregnancy does occur during treatment, this drug must be stopped immediately. It is not known whether this drug passes into breast milk. Because of the potential for serious reactions in nursing infants, breast-feeding is not recommended while using lenalidomide.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

See also Warning section. Diarrhea, tiredness, dizziness, dry skin, constipation, stomach pain, vomiting, dry mouth, unpleasant taste, loss of appetite, headache, trouble sleeping, or painful urination may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes, pounding heartbeat. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Lenalidomide is a drug that is very similar to thalidomide, which is known to cause severe birth defects or death in unborn babies. If lenalidomide is taken during pregnancy, it may also cause severe birth defects or death in unborn babies. Therefore, this drug must never be used during pregnancy nor by women who could become pregnant while using this drug. Pregnancy must be ruled out before starting lenalidomide. Women must have two negative pregnancy tests before starting lenalidomide, the first 10-14 days before the first dose and the second within 24 hours before the first dose. Women must work with their doctors to check for and prevent pregnancy while using this medication. (See also Notes section.) For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the Revlimid Education and Prescribing Safety Program, also known as the RevAssist program, developed by the U.S. Food and Drug Administration. If the patient taking lenalidomide is between the ages 12-18, then a parent or legal guardian must also read the educational material and agree to carefully follow the requirements of the RevAssist program. Patients (male and female) who use this medication must use two reliable forms of birth control. For males, this means using a latex condom along with other effective birth control used by the female partner. If pregnancy does occur during treatment, stop this medication and contact your doctor immediately. (See also Precautions section.) Lenalidomide may benefit you by helping increase the number of functioning red blood cells. Unfortunately, it may also increase your risk of developing serious bone marrow problems such as low white blood cell counts or low platelet counts. Seek immediate medical attention if you develop the following symptoms: persistent fever, persistent sore throat, easy bleeding/bruising. Most patients will experience these effects, which will require your doctor to stop and restart lenalidomide or decrease your dose. Lenalidomide can cause serious (sometimes fatal) blood clots in veins and lungs. Seek immediate medical attention if you develop the following symptoms: calf pain/swelling, chest pain, trouble breathing.