Revlimid

Pronunciation

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

Do not take Revlimid if you are pregnant. It may cause severe birth defects or death of the fetus if used during pregnancy. Revlimid is similar to thalidomide, which causes life-threatening birth defects.

Women who are able to become pregnant and who take Revlimid:

  • 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 Revlimid, while taking Revlimid, during breaks in treatment, and for at least 4 weeks after stopping Revlimid;
  • must have a negative pregnancy test 10 to 14 days before starting Revlimid and again within 24 hours before starting Revlimid; and
  • must have a pregnancy test every week for the first 4 weeks after starting Revlimid and then every 2 to 4 weeks thereafter while taking Revlimid.

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

Men who take Revlimid must either:

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

Men who take Revlimid 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 Revlimid:

  • Revlimid passes into semen. Female partners of men taking Revlimid should call their doctor if they become pregnant.
  • All patients must receive and understand all oral and written warnings about the risks of using Revlimid.
  • All patients must be able to follow the instructions for using Revlimid and for using effective birth control methods if they are sexually active.
  • Revlimid 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.
  • Revlimid 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 Revlimid. 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 Revlimid.
  • Revlimid 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 Revlimid. Ask your doctor or pharmacist if you have any questions about this program or the use of Revlimid.

Revlimid 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.

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

Do NOT use Revlimid if:

  • you are allergic to any ingredient in Revlimid
  • you are breast-feeding, or are pregnant, planning to become pregnant, or become pregnant during treatment with Revlimid
  • 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 Revlimid 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 Revlimid:

Some medical conditions may interact with Revlimid. 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, or a history of blood clots or heart problems (eg, irregular heartbeat, heart attack)
  • if you are lactose intolerant

Some MEDICINES MAY INTERACT with Revlimid. 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 Revlimid
  • 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 Revlimid 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 Revlimid:

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

  • Revlimid comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Revlimid refilled.
  • Take Revlimid by mouth with or without food.
  • Swallow Revlimid whole with water. Do not break, crush, chew, or open before swallowing.
  • Take Revlimid at about the same time each day to get the most benefit from it.
  • 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 Revlimid, unless they are not sexually active. These birth control methods must be used for at least 4 weeks before starting Revlimid, while taking Revlimid, during dose interruptions, and for at least 4 weeks after stopping Revlimid. Talk with your doctor about which methods of effective birth control may be appropriate for you.
  • Men who take Revlimid must always use a latex or synthetic condom during any sexual contact with a woman who is pregnant or could become pregnant. Do this for as long as you are taking Revlimid, during breaks in treatment, and for at least 4 weeks after you stop taking it. This includes men who have had a vasectomy. If you or your partner are allergic to latex, check with your health care provider.
  • 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 Revlimid 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 Revlimid.

Important safety information:

  • Revlimid may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Revlimid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Revlimid 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.
  • Revlimid 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.
  • Revlimid 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 Revlimid 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 Revlimid. 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 Revlimid have an increased risk of serious and sometimes fatal heart problems (eg, irregular heartbeat, heart attack, heart failure). Do not take Revlimid if you have CLL unless directed by your doctor.
  • Patients with multiple myeloma (MM) who receive melphalan, a blood stem cell transplant, and Revlimid may be at increased risk of developing new cancers (eg, acute myelogenous leukemia, Hodgkin lymphoma). Discuss the benefits and risks of Revlimid, as well as any questions or concerns, with your doctor.
  • Do not donate semen, sperm, or blood while taking Revlimid, during breaks in treatment, or within 4 weeks after stopping Revlimid.
  • 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 Revlimid 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 Revlimid. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Revlimid with caution in the ELDERLY; they may be more sensitive to its effects.
  • Revlimid 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: Do not use Revlimid 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 Revlimid, consult an obstetrician/gynecologist experienced in reproductive toxicity. It is not known if Revlimid is found in breast milk. Do not breast-feed while taking Revlimid.

Possible side effects of Revlimid:

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; burning, numbness, or tingling; chest pain; confusion; dark urine; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; joint pain; mental or mood problems (eg, depression); 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; 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; shortness of breath; slurred speech; sudden, unexplained weight changes; swelling of the hands, ankles, or feet; swollen glands; tremor; unusual bruising or bleeding; vision problems (eg, blurred vision); 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 Revlimid:

Store Revlimid 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 Revlimid out of the reach of children and away from pets.

General information:

  • If you have any questions about Revlimid, please talk with your doctor, pharmacist, or other health care provider.
  • Revlimid 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 Revlimid 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 Revlimid. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Revlimid. 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 Revlimid.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
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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