LENALIDOMIDE

(LEN a LID oh mide) Brand: Revlimid

What is the most significant information I must know about lenalidomide?

• Lenalidomide can reason severe, life-threatening birth defects or death of a child if the mother or the father is taking this medicine at the time of conception or during pregnancy. Even one doze of lenalidomide can reason major birth defects of the baby's arms and legs, bones, ears, eyes, person, and heart. Never use lenalidomide if you are pregnant.

• For Women: You will be required to use two dependable forms of birth control beginning 4 weeks till you start taking lenalidomide 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 should agree in writing to use birth control till, during, and after taking lenalidomide. Even women with fertility problems are required to use birth control while taking this medicine. You should also have a negative pregnancy test at 10 to 14 days till treatment and again at 24 hours till. While you are taking lenalidomide, you will have a pregnancy test each 4 weeks.

• Stop using lenalidomide 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 should not reason a woman to become pregnant while you are taking lenalidomide because the medication may affect your sperm and reason birth defects in the child. You should 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.

• Lenalidomide is accessible only under a particular program called RevAssist. You should be registered in the program and sign documents stating that you understand the dangers of this medicine and that you agree to use birth control measures as required by the program.

• This medicine comes with patient instructions for safety and effective use. Follow these directions carefully. Never give lenalidomide to other face, even if he or she has the same mess for which you are being treated.

• Do not donate blood or sperm while you are using lenalidomide.

What is lenalidomide?

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

• Lenalidomide treats anemia (a lack of red blood cells in the body), multiple myeloma (cancer resulting from a progressive blood disease), and mantle cell lymphoma (a rare cancer of the lymph nodes). It is used in patients with myelodysplastic syndrome caused by an emergency chromosome. This mess is also called deletion 5q MDS, because part of chromosome 5 is missing. In people with this mess, the bone marrow does not manufacture satis healthy blood cells.

• Lenalidomide may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking lenalidomide?

• To create certain you can safely take lenalidomide, speak your doctor if you have any of these another conditions:

· kidney malady;

· a history of blood clots or stroke; or

· lactose intolerance.

• It is not known if lenalidomide passes into breast milk or if it could harm a nursing child. Do not use this medicine 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 till you start taking lenalidomide 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 should also have a negative pregnancy test at 10 to 14 days till treatment and again at 24 hours till. While you are taking lenalidomide, you will have a pregnancy test each 4 weeks.

• The birth control method you use should 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 should be a barrier method such as a latex condom, a diaphragm, or a cervical cap.

• Stop using lenalidomide 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.

• Lenalidomide is accessible only under a particular program called RevAssist. Under this program, only registered doctors and pharmacists can prescribe and dispense lenalidomide. You should be registered in the program and sign documents stating that you understand the dangers of this medicine 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 should read all written requirements for the RevAssist program and sign the agreements on behalf of the patient.

• Using lenalidomide may magnify your risk of developing another types of cancer, such as leukemia or lymphoma. Conversation with your doctor about your specific risk.

How must I take lenalidomide?

• While you are using lenalidomide, you will be required to be listed on a patient registry and participate in casual phone surveys. You will be limited to a 28-day supply of lenalidomide every 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 exactly as predesigned by your doctor. Do not take in larger or less amounts or for longer than recommended. Follow the directions on your prescription label.

• Your doctor may occasionally change your doze to create certain you get the excellent results.

• Take every doze with a full glass of water. Swallow the capsule intact, without breaking it open.

• To be certain lenalidomide is helping your condition and not causing deleterious effects, your blood will need to be tested each week for the first two months of treatment, and then each month after that. Visit your doctor regularly.

• Store at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

• An overdose of lenalidomide is not expected to manufacture life-threatening symptoms.

What must I avoid while taking lenalidomide?

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

• Body fluids must 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 lenalidomide.

What are the possible side effects of lenalidomide?

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.

• Call your doctor at once if you have any of these serious side effects:

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

· pain or swelling in your hand, thigh, or calf;

· light bruising, unusual bleeding or weakness;

· fever, chills, body aches, flu symptoms;

· lower back pain, blood in your urine;

· urinating smaller than normal or not at all;

· numbness or tingly feeling near your mouth;

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

· quick or slow heart course, 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.

• Smaller serious 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 message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect lenalidomide?

• There may be another drugs that can interact with lenalidomide. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about lenalidomide.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each 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 external 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 must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help 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.

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