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Lenalidomide
Pronunciation: LEN-a-LID-oh-mide
Generic Name: Lenalidomide
Brand Name: Revlimid

Lenalidomide may cause severe birth defects or death of the fetus if used during pregnancy. Lenalidomide is similar to thalidomide, which causes life-threatening birth defects.

Females who are able to become pregnant and who take Lenalidomide:

  • must not become pregnant;
  • must avoid sexual contact with men or use at least 2 forms of effective birth control for 4 weeks before starting Lenalidomide, while taking Lenalidomide, during dose interruptions, and for 4 weeks after stopping Lenalidomide;
  • must have a negative pregnancy test 10 to 14 days before starting Lenalidomide and again within 24 hours before starting Lenalidomide; and
  • must have a pregnancy test every week for the first 4 weeks after starting Lenalidomide and then every 2 to 4 weeks thereafter while using Lenalidomide.

Women who experience abnormal menstrual bleeding, miss their menstrual period, become pregnant, or suspect for any reason they may be pregnant while taking Lenalidomide must stop taking it and contact their doctor immediately.

Males who take Lenalidomide must either:

  • avoid sexual contact with women who are pregnant or could become pregnant while taking Lenalidomide and for 4 weeks after stopping Lenalidomide; OR
  • use a latex condom during sexual contact with women who are pregnant or could become pregnant for as long as they are taking Lenalidomide and for 4 weeks after stopping Lenalidomide, even if they have had a successful vasectomy.

Men who have unprotected sexual contact with a woman who is pregnant or may become pregnant or who think for any reason that their sexual partner may be pregnant should contact their doctor immediately.

All patients who take Lenalidomide:

  • It is not known if Lenalidomide passes into semen. Female partners of men taking Lenalidomide should call their doctor if they become pregnant.
  • All patients must receive and understand all oral and written warnings about the risks of using Lenalidomide.
  • All patients must be able to follow the instructions for using Lenalidomide and for using effective birth control methods if they are sexually active.
  • Lenalidomide may cause an increased risk of blood clots in the veins and lungs. Call your doctor right away if you experience shortness of breath; chest pain; or pain, redness, tenderness, or swelling in the arms or legs.
  • Lenalidomide often lowers the number of white blood cells and platelets in the blood. Call your doctor right away if you experience unusual bleeding or bruising, fever, chills, or sore throat.
  • Blood counts should be checked each week for the first 8 weeks after starting Lenalidomide and at least once per month thereafter. If low blood counts develop, it may be necessary to lower the dose or stop treatment. Sometimes blood transfusions and treatment with other medicines may be necessary. Keep all doctor and lab appointments while using Lenalidomide.

Lenalidomide is used for:

Treating anemia in patients who have certain types of myelodysplastic syndrome (MDS). It is also used along with dexamethasone to treat a certain type of cancer (multiple myeloma) in certain patients.

Lenalidomide is an immunomodulatory medicine. Exactly how it works is not known.

Do NOT use Lenalidomide if:

  • you are allergic to any ingredient in Lenalidomide
  • you are pregnant, planning to become pregnant, could become pregnant, or become pregnant during treatment with Lenalidomide
  • you have had a severe allergic reaction (eg, rash; hives; hoarseness; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue) or a severe rash (eg, red, swollen, blistered, or peeling skin) from Lenalidomide or thalidomide in the past

Contact your doctor or health care provider right away if any of these apply to you.

Before using Lenalidomide:

Some medical conditions may interact with Lenalidomide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a tumor, cancer, kidney problems, certain hereditary problems (glucose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption), low white blood cell levels, or low platelet counts or if you receive dialysis
  • if you have an infection, blood electrolyte problems, high blood pressure, or a history of blood clots or heart problems (eg, irregular heartbeat, heart attack)

Some MEDICINES MAY INTERACT with Lenalidomide. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Erythropoietic agents (eg, erythropoietin), estrogens (eg, estrogen, estradiol), progestins (eg, medroxyprogesterone), or medicines that contain estrogens or progestins (eg, birth control pills) because the risk of developing blood clots may be increased
  • Digoxin because the risk of its side effects may be increased by Lenalidomide

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lenalidomide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Lenalidomide:

Use Lenalidomide as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Lenalidomide comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Lenalidomide refilled.
  • Lenalidomide can only be prescribed and dispensed through a special program. Make sure you understand all warnings and instructions for using Lenalidomide. Ask your doctor or pharmacist if you have any questions about this program or the use of Lenalidomide.
  • Take Lenalidomide by mouth with or without food.
  • Swallow Lenalidomide whole with water. Do not break, crush, or chew before swallowing.
  • Women who are able to become pregnant (including those who have started menopause within the last 24 months) must use at least 2 methods of effective birth control while taking Lenalidomide, unless they are not sexually active. These birth control methods must be used for at least 4 weeks before starting Lenalidomide, while taking Lenalidomide, during dose interruptions, and for 4 weeks after stopping Lenalidomide. Talk with your doctor about which methods of effective birth control may be appropriate for you.
  • Men who take Lenalidomide must always use a latex condom during any sexual contact with a woman who is pregnant or could become pregnant. Do this for as long as you are taking Lenalidomide and for 4 weeks after you stop taking it. This includes men who have had a vasectomy.
  • Do not open the capsules or handle them more than needed. If you touch a broken capsule or the medicine inside of the capsule, wash the area with soap and water.
  • If you miss a dose of Lenalidomide and it has been less than 12 hours since the missed dose, take it as soon as you remember. If it has been more than 12 hours since the missed dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Lenalidomide.

Important safety information:

  • Lenalidomide may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Lenalidomide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Lenalidomide may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Lenalidomide may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Lenalidomide may increase the risk of blood clots in certain patients. Tell your doctor at once if you notice shortness of breath; chest pain; or pain, redness, tenderness, or swelling of an arm or leg.
  • Patients with cancer who take Lenalidomide have a risk of developing a serious and possibly fatal condition called tumor lysis syndrome (TLS). Contact your doctor right away if you develop symptoms such as fast or irregular heartbeat; fainting; decreased urination; muscle weakness or cramps; nausea, vomiting, diarrhea, or loss of appetite; or sluggishness.
  • Do not donate semen, sperm, or blood while taking Lenalidomide or within 4 weeks after stopping Lenalidomide.
  • If you are using a hormonal contraceptive (eg, birth control pills) to prevent pregnancy, inform your doctor if you also take an HIV protease inhibitor (eg, ritonavir); griseofulvin, rifampin, rifabutin, penicillin, amoxicillin, ampicillin, or other antibiotic medicines; St. John's wort; modafinil; phenytoin; or carbamazepine. These medicines may decrease the effectiveness of hormonal contraceptives.
  • Lab tests, including pregnancy tests and complete blood cell counts, may be performed while you use Lenalidomide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Lenalidomide with caution in the ELDERLY; they may be more sensitive to its effects.
  • Lenalidomide should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Use of Lenalidomide during pregnancy may cause severe birth defects and death of the fetus. If you think you may be pregnant, miss your menstrual period, experience unusual menstrual bleeding, or stop using birth control, contact your doctor right away. If you become pregnant while using Lenalidomide, consult an obstetrician/gynecologist experienced in reproductive toxicity. It is not known if Lenalidomide is found in breast milk. Do not breast-feed while taking Lenalidomide.

Possible side effects of Lenalidomide:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; constipation; cough; diarrhea; dizziness; dry mouth or skin; headache; increased sweating or night sweats; loss of appetite; mild stomach pain; nausea; sluggishness; stuffy or runny nose; taste changes; tiredness; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; hoarseness; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the stools or vomit; burning, numbness, or tingling; chest pain; confusion; dark urine; depression; difficulty swallowing; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; joint pain; muscle pain, weakness, or cramps; one-sided weakness; pain, numbness, tingling, tenderness, redness, or swelling of the arms or legs; painful or difficult urination; red, swollen, blistered, or peeling skin; reduces senses of touch; severe or persistent headache, dizziness, or stomach pain; severe tiredness or weakness; shortness of breath; slurred speech; swelling of the hands, ankles, or feet; tremor; unusual bruising or bleeding; vision problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Lenalidomide side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Lenalidomide:

Store Lenalidomide at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lenalidomide out of the reach of children and away from pets.

General information:

  • If you have any questions about Lenalidomide, please talk with your doctor, pharmacist, or other health care provider.
  • Lenalidomide is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Lenalidomide. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012
Database Edition 12.1.1.002
Copyright 2012 Wolters Kluwer Health, Inc.

More Lenalidomide resources

  • Lenalidomide Side Effects (in more detail)
  • Lenalidomide Use in Pregnancy & Breastfeeding
  • Lenalidomide Drug Interactions
  • Lenalidomide Support Group
  • 1 Review for Lenalidomide - Add your own review/rating
  • Lenalidomide Professional Patient Advice (Wolters Kluwer)
  • Lenalidomide Monograph (AHFS DI)
  • lenalidomide Advanced Consumer (Micromedex) - Includes Dosage Information
  • Revlimid Prescribing Information (FDA)
  • Revlimid Consumer Overview

Compare Lenalidomide with other medications

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