Revlimid

Pronunciation

Generic Name: lenalidomide (LEN a LID o mide)
Brand Names: Revlimid

What is Revlimid?

Revlimid affects the immune system. It promotes immune responses to help slow tumor growth.

Revlimid treats anemia (a lack of red blood cells in the body) and multiple myeloma (cancer resulting from a progressive blood disease). Revlimid is used in patients with myelodysplastic syndrome caused by an abnormal chromosome. This disorder is also called deletion 5q MDS, because part of chromosome 5 is missing. In people with this disorder, the bone marrow does not produce enough healthy blood cells.

Revlimid is also used to treat patients with mantle cell lymphoma (a rare cancer of the lymph nodes) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (Velcade).

Revlimid may be used for other purposes not listed in this medication guide.

Important information

Revlimid can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medication at the time of conception or during pregnancy. Even one dose of Revlimid can cause major birth defects of the baby's arms and legs, bones, ears, eyes, face, and heart. Never use Revlimid if you are pregnant.

For Women: You will be required to use two reliable forms of birth control beginning 4 weeks before you start taking Revlimid and ending 4 weeks after you stop taking it. Any woman who has not had a hysterectomy or has not been in menopause for at least 24 months in a row must agree in writing to use birth control before, during, and after taking Revlimid. Even women with fertility problems are required to use birth control while taking this medication. You must also have a negative pregnancy test at 10 to 14 days before treatment and again at 24 hours before. While you are taking Revlimid, you will have a pregnancy test every 4 weeks.

Slideshow: Flashback: FDA Drug Approvals 2013

Stop using Revlimid and call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.

For Men: You must not cause a woman to become pregnant while you are taking Revlimid because the medicine may affect your sperm and cause birth defects in the baby. You must agree in writing to always use latex condoms when having sex with a woman who is able to get pregnant, even if you have had a vasectomy.

Revlimid is available only under a special program called RevAssist. You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control measures as required by the program.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Never give Revlimid to another person, even if he or she has the same disorder for which you are being treated.

Do not donate blood or sperm while you are using Revlimid.

Before taking this medicine

To make sure you can safely take Revlimid tell your doctor if you have any of these other conditions:

  • kidney disease;

  • a history of blood clots or stroke; or

  • lactose intolerance.

Revlimid can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medication at the time of conception or during pregnancy. Even one dose of Revlimid can cause major birth defects of the baby's arms and legs, bones, ears, eyes, face, and heart. Never use Revlimid if you are pregnant. Tell your doctor right away if your period is late while using the medication. It is not known if lenalidomide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

For Women: If you have not had a hysterectomy or have not been in menopause for at least 24 months in a row, you will be required to use two forms of birth control beginning 4 weeks before you start taking Revlimid and ending 4 weeks after you stop taking it. Even women with fertility problems are required to use birth control while taking this medication. You must also have a negative pregnancy test at 10 to 14 days before treatment and again at 24 hours before. While you are taking Revlimid, you will have a pregnancy test every 4 weeks.

The birth control method you use must be proven highly effective, such as birth control pills, an intrauterine device (IUD), a tubal ligation, or a sexual partner's vasectomy. The extra form of birth control you use must be a barrier method such as a latex condom, a diaphragm, or a cervical cap.

Stop using Revlimid and call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.

For Men: You must not cause a woman to become pregnant while you are taking Revlimid because the medicine may affect your sperm and cause birth defects in the baby. You must agree in writing to always use latex condoms when having sex with a woman who is able to get pregnant, even if you have had a vasectomy. Contact your doctor if you have had unprotected sex, even once, or if you think your female sexual partner may be pregnant.

Revlimid is available only under a special program called RevAssist. Under this program, only registered doctors and pharmacists can prescribe and dispense Revlimid. You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control measures as required by the program.

For patients between 12 and 18 years, a parent or legal guardian must read all written requirements for the RevAssist program and sign the agreements on behalf of the patient.

Using Revlimid may increase your risk of developing other types of cancer, such as leukemia or lymphoma. Talk with your doctor about your specific risk.

How should I take Revlimid?

While you are using Revlimid, you will be required to be listed on a patient registry and participate in occasional telephone surveys. You will be limited to a 28-day supply of Revlimid each time your prescription is refilled. You may continue getting refills only if you participate fully in the RevAssist program and commit to all agreements.

Take Revlimid exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Never give Revlimid to another person, even if he or she has the same disorder for which you are being treated.

Your doctor may occasionally change your dose to make sure you get the best results.

Take each dose with a full glass of water.

Swallow the capsule whole, without breaking it open.

To be sure Revlimid is helping your condition and not causing harmful effects, your blood will need to be tested every week for the first two months of treatment, and then every month after that. Visit your doctor regularly.

Store Revlimid at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of Revlimid is not expected to produce life-threatening symptoms.

What should I avoid?

Lenalidomide can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Do not donate blood or sperm while you are using Revlimid.

Revlimid side effects

Stop using Revlimid and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • chest pain, sudden shortness of breath, coughing up blood;

  • pain or swelling in your arm, thigh, or calf;

  • easy bruising, unusual bleeding or weakness;

  • fever, chills, body aches, flu symptoms;

  • lower back pain, blood in your urine;

  • urinating less than usual or not at all;

  • numbness or tingly feeling around your mouth;

  • muscle weakness, tightness, or contraction, overactive reflexes;

  • fast or slow heart rate, weak pulse, feeling short of breath, confusion, fainting;

  • severe blistering, peeling, and red skin rash; or

  • the first sign of any skin rash, no matter how mild.

Less serious Revlimid side effects may include:

  • nausea, diarrhea, constipation;

  • dry or itchy skin;

  • runny or stuffy nose;

  • muscle or joint pain;

  • headache; or

  • tiredness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Revlimid?

There may be other drugs that can interact with Revlimid. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about Revlimid.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 6.03 Revision Date: 2013-07-15, 2:46:45 PM.

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