Revlimid

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

Revlimid 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.

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

• 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 Revlimid, while taking Revlimid, during dose interruptions, and for 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 using 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.

Males who take Revlimid must either:

• avoid sexual contact with women who are pregnant or could become pregnant while taking Revlimid and for 4 weeks after stopping Revlimid; OR


• use a latex condom during sexual contact with women who are pregnant or could become pregnant for as long as they are taking Revlimid and for 4 weeks after stopping Revlimid, 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 Revlimid:

• It is not known if 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.


• Blood counts should be checked each week for the first 8 weeks after starting Revlimid 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 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 a certain type of cancer (multiple myeloma) in certain patients.

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 pregnant, planning to become pregnant, could become pregnant, or become pregnant during treatment with Revlimid


• 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

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

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 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 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

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.


• Revlimid can only be prescribed and dispensed through a special 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.


• Take Revlimid by mouth with or without food.


• Swallow Revlimid 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 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 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 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 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 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 like 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.


• Do not donate semen, sperm, or blood while taking Revlimid 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.


• Lab tests, including pregnancy tests and complete blood cell counts, 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: Use of Revlimid 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 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; 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: Revlimid 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 Revlimid:

Store Revlimid 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 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 is a summary only. It does not contain all information about Revlimid. 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 Revlimid resources

• Revlimid Side Effects (in more detail)
• Revlimid Use in Pregnancy & Breastfeeding
• Revlimid Drug Interactions
• Revlimid Support Group
• 1 Review for Revlimid - Add your own review/rating

• Revlimid Prescribing Information (FDA)


• Revlimid Consumer Overview


• Revlimid Monograph (AHFS DI)


• Revlimid Advanced Consumer (Micromedex) - Includes Dosage Information


• Lenalidomide Professional Patient Advice (Wolters Kluwer)

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