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

Revlimid is used to treat multiple myeloma (bone marrow cancer), either in combination with another medicine or after stem cell transplant.

Revlimid is also used to treat anemia (a lack of red blood cells) 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 mantle cell lymphoma (a rare cancer of the lymph nodes), after other medications have been tried without success.

Revlimid should not be used for chronic lymphocytic leukemia (CLL) unless you are in a controlled medical study. Lenalidomide can increase the risk of death from serious heart problems in people with CLL.

This medicine is available only from a certified pharmacy under a special program called Revlimid REMS. Your doctor must be registered in the program in order to prescribe lenalidomide for you. 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.

Never use Revlimid if you are pregnant. Even one dose of lenalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medicine at the time of conception or during pregnancy.

Use birth control to prevent pregnancy, whether you are a man or a woman. For women: Use two forms of birth control beginning 4 weeks before you start taking Revlimid and ending 4 weeks after you stop taking it. For men: Use a condom to prevent pregnancy during your treatment, and for up to 4 weeks after your treatment ends.

Revlimid may cause blood clots. Stop using this medicine and call your doctor at once if you have symptoms such as sudden numbness, severe headache, problems with vision or speech, chest pain, shortness of breath, coughing up blood, or swelling in your arm or leg.

Revlimid can lower blood cells that help your body fight infections and help your blood to clot. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches). You will need frequent blood tests while you are taking Revlimid.

Take Revlimid exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Never share this medicine with another person, even if they have the same disorder you have.

Take the medicine at the same time each day. You may take Revlimid with or without food.

Take each dose with a full glass of water. Swallow the capsule whole, without breaking it open.

Lenalidomide can increase your risk of bleeding or infection. Your blood will need to be tested often.

The medicine from an open capsule can be dangerous if it gets on your skin. If this occurs, wash your skin with soap and water. Ask your doctor or pharmacist how to safely handle and dispose of a broken capsule.

Store Revlimid at room temperature away from moisture and heat.

Usual Adult Dose for Multiple Myeloma:

In combination with dexamethasone:
25 mg orally once a day on Days 1 to 21 of repeated 28-day cycles until disease progression or unacceptable toxicity

Maintenance therapy following auto-HSCT:
10 mg once a day continuously (Days 1 to 28 of repeated 28-day cycles) for 3 cycles, then increase to 15 mg once a day if tolerated until disease progression or unacceptable toxicity

Comments:
-For patients who are not eligible for auto-HSCT, therapy should continue until disease progression or unacceptable toxicity.
-For patients who are eligible for auto-HSCT, hematopoietic stem cell mobilization should occur within 4 cycles.
-Following auto-HSCT, initiate maintenance therapy after adequate hematologic recovery (ANC 1000/mcL or more AND/OR platelet count 75,000/mcL or more).
-Consult the manufacturer product information for dexamethasone dosing recommendations.

Uses:
-In combination with dexamethasone for multiple myeloma (MM)
-Maintenance therapy in patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT)

Usual Adult Dose for Myelodysplastic Disease:

10 mg orally once a day; therapy is continued or modified based upon clinical and laboratory findings until disease progression or unacceptable toxicity

Use: Treatment of transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities

Usual Adult Dose for Lymphoma:

FOLLICULAR LYMPHOMA OR MARGINAL ZONE LYMPHOMA:
20 mg orally once a day on Days 1 through 21 of repeated 28-day cycles for up to 12 cycles in combination with a rituximab-product

MANTLE CELL LYMPHOMA:
25 mg orally once a day on Days 1 to 21 of repeated 28-day cycles until disease progression or unacceptable toxicity; treatment is continued, modified, or discontinued based upon clinical and laboratory findings

Uses:
-For the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after 2 prior therapies, onw1 of which included bortezomib
Use: In combination with a rituximab product for the treatment of previously treated follicular lymphoma (FL)
-In combination with a rituximab product for the treatment of previously treated marginal zone lymphoma (MZL)

You should not use Revlimid if you are allergic to lenalidomide.

Revlimid can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medicine at the time of conception or during pregnancy. Even one dose of lenalidomide 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 taking Revlimid.

For Women: If you have not had a hysterectomy, 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. Even women with fertility problems are required to use birth control while taking this medicine. 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 2 to 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. Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.

For Men: If a man fathers a baby while using Revlimid, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment, and for up to 4 weeks after your treatment ends. 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.

To make sure Revlimid is safe for you, tell your doctor if you have ever had:

• an allergic reaction to thalidomide;

• kidney disease (or if you are on dialysis);

• liver disease;

• a blood clots or stroke;

• high blood pressure, high cholesterol or triglycerides;

• a thyroid disorder;

• lactose intolerance; or

• if you smoke.

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.

You should not breast-feed while using Revlimid.

Take the missed dose as soon as you remember. If you are more than 12 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.

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

You must not donate blood or sperm while you are using Revlimid, and for at least 4 weeks after your last dose. Avoid exposing another person to your blood or semen through casual or sexual contact.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's 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.

Get emergency medical help if you have signs of an allergic reaction to Revlimid: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• signs of a stroke or blood clot - sudden numbness or weakness, severe headache, problems with speech or vision, shortness of breath, swelling or redness in your arm or leg;

• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, sweating;

• liver problems - upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• low blood cell counts - fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, easy bruising, unusual bleeding;

• signs of a tumor getting worse - swollen glands, low fever, rash, or pain; or

• signs of tumor cell breakdown - lower back pain, blood in your urine, little or no urinating; numbness or tingly feeling around your mouth; muscle weakness or tightness; feeling short of breath; confusion, fainting.

Common Revlimid side effects may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;

• sleep problems, tiredness;

• weakness;

• headache;

• tremors;

• nosebleed;

• muscle cramps;

• joint pain;

• shortness of breath;

• fever, cough, tiredness;

• itching, rash, swelling; or

• stomach pain, nausea, vomiting, diarrhea, constipation.

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.

Tell your doctor if you also use pembrolizumab (Keytruda).

If you use hormonal birth control (pills, implants, injections) to prevent pregnancy: There are certain drugs that can make hormonal birth control less effective in your body. Tell your doctor about all other medicines you use. You may need to replace your hormonal birth control method with another effective form of contraception.

Other drugs may interact with lenalidomide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.