Lenalidomide

Generic Name: lenalidomide (LEN-a-LID-oh-mide)
Brand Name: Revlimid

Do not take lenalidomide if you are pregnant. It 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.

Women who are able to become pregnant and who take lenalidomide (including those who have started menopause within the last 24 months):

  • must not become pregnant;
  • must either avoid sexual contact with men or use at least 2 forms of effective birth control for at least 4 weeks before starting lenalidomide, while taking lenalidomide, during breaks in treatment, and for at least 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 taking 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.

Men who take lenalidomide must either:

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

Men who take lenalidomide and 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:

  • 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.
  • The risk of blood clots (eg, in the veins or lungs, heart attack, stroke) may be increased with lenalidomide in certain patients. The risk may be higher in people who have multiple myeloma and take lenalidomide with dexamethasone. Call your doctor right away if you experience shortness of breath; chest pain; coughing up blood; or pain, redness, tenderness, or swelling in the arms or legs. Call your doctor right away if you have symptoms of a heart attack (eg, chest pain that may spread to the arms, neck, jaw, back, or stomach; unusual sweating; feeling sick, or vomiting. Call your doctor right away if you have symptoms of a stroke (eg, numbness or weakness on 1 side of the body; severe headache or confusion; or vision, speech, or balance problems.
  • 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.
  • Complete blood counts will be done often while you are taking lenalidomide. Talk with your doctor. 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 can only be prescribed and dispensed through a special program called the Revlimid Risk Evaluation and Mitigation Strategy (REMS) 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.

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 multiple myeloma (MM) in certain patients. It is also used to treat mantle cell lymphoma (MCL) in certain patients. It may also be used for other conditions as determined by your doctor.

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 breast-feeding, or are pregnant, planning to become pregnant, or become pregnant during treatment with lenalidomide
  • you could become pregnant and are not using at least 2 forms of effective birth control or are not avoiding sexual contact with men
  • 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
  • you have chronic lymphocytic leukemia (CLL) unless directed by your doctor

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

Slideshow: Flashback: FDA Drug Approvals 2013

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 or liver problems, certain hereditary problems (glucose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption), or blood problems (eg, low white blood cell levels, low platelet counts), or if you receive dialysis
  • if you have an infection, blood electrolyte problems, high blood pressure, high blood cholesterol, or a history of blood clots or heart problems (eg, irregular heartbeat, heart attack)
  • if you are lactose intolerant or you smoke
  • if you are taking any medicines that may increase the risk of blood clots. There are many medicines that can do this. Ask your doctor or pharmacist if you are not sure

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
  • Medicines that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver

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.
  • Take lenalidomide by mouth with or without food.
  • Swallow lenalidomide whole with water. Do not break, crush, chew, or open before swallowing.
  • Take lenalidomide at about the same time each day to get the most benefit from it.
  • 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 a broken capsule or the medicine inside comes into contact with your eyes, flush thoroughly with 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 such as fever, sore throat, rash, or chills.
  • 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.
  • Severe and sometimes fatal liver problems have been reported in patients taking lenalidomide. Tell your doctor right away if you experience symptoms of liver problems (eg, dark urine; pale stools; severe or persistent nausea, loss of appetite, or stomach pain; unusual tiredness; yellowing of the skin or eyes).
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs such as red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Patients with chronic lymphocytic leukemia (CLL) who take lenalidomide have an increased risk of serious and sometimes fatal heart problems (eg, irregular heartbeat, heart attack, heart failure). Do not take lenalidomide if you have CLL unless directed by your doctor.
  • Patients with multiple myeloma (MM) who receive melphalan, a blood stem cell transplant, and lenalidomide may be at increased risk of developing new cancers (eg, acute myelogenous leukemia, Hodgkin lymphoma). Discuss the benefits and risks of lenalidomide, as well as any questions or concerns, with your doctor.
  • Do not donate semen, sperm, or blood while taking lenalidomide, during breaks in treatment, 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.
  • Tell your doctor or dentist you take lenalidomide before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including liver function, pregnancy tests, complete blood cell counts, and thyroid function, 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.
  • PREGNANCY and BREAST-FEEDING: Do not use lenalidomide if you are pregnant. It may cause severe birth defects or 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; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); black, tarry stools; blurred vision; burning, numbness, or tingling; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; joint pain; mental or mood problems (eg, depression); muscle pain, weakness, or cramps; pain, numbness, tingling, tenderness, redness, or swelling of the arms or legs; painful or difficult urination; reduced sense of touch; severe or persistent bone pain; severe or persistent headache, dizziness, or stomach pain; severe or persistent nosebleed; severe or persistent tiredness or weakness; sudden, unexplained weight changes; swelling of the hands, ankles, or feet; swollen glands; tremor; unusual bruising or bleeding; vomit that looks like coffee grounds.

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.

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 68 and 77 degrees F (20 and 25 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 should not be used to decide whether or not to take lenalidomide or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about lenalidomide. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to lenalidomide. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using lenalidomide.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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