Lenalidomide, Oral

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KEY POINTS

• This medicine is taken by mouth to treat multiple myeloma, myelodysplastic syndromes, or mantle cell lymphoma. Take it exactly as directed.
• DO NOT take this medicine if you are pregnant. The baby may die or be born with serious birth defects.
• You may bleed or get infections more easily while taking this medicine. This medicine may cause a second type of cancer, increase your risk for blood clots, or cause other serious side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: immunomodulator

Generic and brand names: lenalidomide, oral; Revlimid

What is this medicine used for?

This medicine is taken by mouth to treat the type of myelodysplastic syndrome where part of chromosome 5 is missing. People with this disorder need blood transfusions because the bone marrow does not make enough normal blood cells. This medicine is also used to treat multiple myeloma and mantle cell lymphoma when other medicines have not worked or when the disease comes back.

This medicine causes severe birth defects. Only a few healthcare providers are allowed to prescribe this medicine. Also, only a few pharmacies are allowed to sell it. You must be enrolled in a special program before you can receive this medicine. Talk with your healthcare provider about this. For more information call 1-888-423-5436.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• Bleeding problems or blood clots
• Chronic lymphocytic leukemia (CLL)
• Heart disease
• High blood pressure
• Kidney or liver disease
• Lactose intolerance (this medicine contains lactose)

Also tell your healthcare provider if you smoke cigarettes.

Females of childbearing age: DO NOT take this medicine if you are pregnant. The baby may die or be born with serious birth defects. You should have two pregnancy tests that are negative before you start taking this medicine. You must use two reliable methods of birth control such as birth control pills and condoms or a diaphragm. Start using these birth control methods 1 month before you start taking this medicine. Use them while you are taking this medicine, during any dose interruptions, and for 1 month after you stop taking it. Discuss birth control with your healthcare provider. Pregnancy tests will be repeated weekly during the first month while taking this medicine, then every month if you have regular menstrual cycles or every 2 weeks if you have irregular menstrual cycles. Stop taking this medicine at the first sign you may be pregnant and contact your healthcare provider right away. Do not breast-feed while taking this medicine.

Males: Use condoms during sexual intercourse with females of childbearing age while you are taking this medicine and for 1 month after you stop taking it, even if you have had a successful vasectomy. Do not donate sperm while receiving this medicine and for 1 month after you stop taking it.

How do I take it?

You must sign a consent form after your healthcare provider explains the risks of taking this medicine. You will need a copy of the consent form and the prescription to give to the pharmacist at a pre-registered pharmacy. You cannot get more than one 28-day supply of this medicine at a time. See your healthcare provider every 28 days for an exam and a new prescription, if needed.

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Swallow the capsules whole. Do not break, chew, or crush the capsules. Take this medicine with water. You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach.

Check with your healthcare provider before using this medicine in children under age 18.

If you accidentally open or touch the medicine inside of the capsule, wash your hands with soap and water right away, and contact your healthcare provider.

If you have any unused or outdated medicine, talk with your healthcare provider or pharmacist about how to safely dispose of the medicine.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is within 12 hours of the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine may increase the chance for blood clots in veins and in the lungs. Call your healthcare provider right away if you have arm or leg swelling, trouble breathing, or chest pain.

This medicine lowers the number of certain types of blood cells in your body. As a result, you may bleed or get infections more easily. Stay away from people with colds, flu, or other infections. Contact your healthcare provider right away if you have any signs of infection, or any unusual bruising or bleeding. You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

Do not give blood while you take this medicine and for 1 month after you stop taking it.

This medicine may cause a second type of cancer. Talk with your provider about this.

This medicine may cause drowsiness or dizziness. Do not drive or operate machinery unless you are fully alert.

This medicine can cause liver problems. Contact your healthcare provider right away if you have severe tiredness, vomiting, loss of appetite, dark urine, fever, headache, muscle or joint pain, or yellowing of your eyes and skin.

If you develop hives, an itchy rash, or peeling skin, stop taking the medicine and contact your provider right away.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Numbness, pain, or swelling in your arms or legs; chest pain; unexplained fever, sore throat, cough, or mouth sores; unusual bruising or bleeding; unusual tiredness or weakness; trouble breathing; coughing up blood; swelling; redness or pain in calf; increased thirst; increased urination; fast or irregular heart beat; severe skin redness, blistering or peeling; dark urine; light-colored bowel movements; unexplained loss of appetite; yellowing of the skin or eyes; severe stomach pain, nausea, or vomiting; tender, swollen lymph nodes.

Other: Diarrhea, constipation, mild nausea or vomiting, decreased appetite, joint or muscle pain, dry skin, blurred vision, tiredness, trouble sleeping, mild dizziness, tremor, headache, change in sense of taste.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Canakinumab (Ilaris)
• Clozapine (Clozaril, FazaClo)
• Digoxin (Lanoxin)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings, and hormones such as conjugated estrogens (Premarin), estradiol (Climara, Estrace, Estraderm, Vivelle), and estrogens such as Cenestin, Estinyl, Estrace, Estraderm, Estratab, FemPatch, Premarin, and Vivelle
• Immunosuppressants such as azathioprine (Azasan, Imuran), basiliximab (Simulect), cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (CellCept, Myfortic), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Medicines to treat low red blood cell counts such as darbepoetin alfa (Aranesp) and epoetin alfa (Epogen, Procrit)
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as abatacept (Orencia), adalimumab (Humira), anakinra (Kineret), certolizumab pegol (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), leflunomide (Arava), tocilizumab (Actemra), tofacitinib (Xeljanz), and ustekinumab (Stelara)
• Natalizumab (Tysabri)
• Natural remedies such as cat's claw, echinacea, and garlic
• Vaccines

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.