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|Lenalidomide

Lenalidomide

Lenalidomide 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.

Lenalidomide is an immunomodulatory medicine. Exactly how it works is not fully understood.

Do NOT use Lenalidomide if:

• you are allergic to any ingredient in Lenalidomide
• you are pregnant, planning to become pregnant, could become pregnant, or become pregnant during treatment with Lenalidomide

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

Before using Lenalidomide :

Some medical conditions may interact with Lenalidomide . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you 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 kidney problems

Some MEDICINES MAY INTERACT with Lenalidomide . However, no specific interactions with Lenalidomide are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lenalidomide 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 Lenalidomide :

Use Lenalidomide as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

• Lenalidomide comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Lenalidomide refilled.
• Lenalidomide can only be prescribed and dispensed through a special program. Make sure you understand all warnings and instructions for using Lenalidomide . Ask your doctor or pharmacist if you have any questions about this program or the use of Lenalidomide .
• Lenalidomide may be taken with or without food.
• Swallow Lenalidomide 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 Lenalidomide , unless they are not sexually active. These birth control methods must be used for at least 4 weeks before starting Lenalidomide , while taking Lenalidomide , during dose interruptions, and for 4 weeks after stopping Lenalidomide . Talk with your doctor about which methods of effective birth control may be appropriate for you.
• Men who take Lenalidomide must use a latex condom during any sexual contact with a woman who is pregnant or could become pregnant for as long as they are taking Lenalidomide and for 4 weeks after stopping Lenalidomide . This includes men who have had a vasectomy.
• If you miss a dose of Lenalidomide , take it as soon as you remember that day. If you do not remember until the next day, 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 Lenalidomide .

Important safety information:

• Lenalidomide may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Lenalidomide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Lenalidomide 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.
• Lenalidomide 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.
• Lenalidomide 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, tenderness, or swelling of an arm or leg.
• Do not donate semen, sperm, or blood while taking Lenalidomide or within 4 weeks after stopping Lenalidomide .
• Inform your doctor if you are taking an HIV-protease inhibitor (eg, ritonavir); griseofulvin, rifampin, rifabutin, penicillin, amoxicillin, ampicillin, or other antibiotic medicines; St. John"s wort; modafinil; phenytoin; or carbamazepine because these medicines may decrease the effectiveness of hormonal contraceptives (eg, birth control pills).
• Lab tests, including pregnancy tests and complete blood cell counts, may be performed while you use Lenalidomide . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Lenalidomide with caution in the ELDERLY; they may be more sensitive to its effects.
• Lenalidomide 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 Lenalidomide during pregnancy has resulted in 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 at once. If you become pregnant while using Lenalidomide , consult an obstetrician/gynecologist experienced in reproductive toxicity. It is unknown if Lenalidomide is found in breast milk. Do not breast-feed while taking Lenalidomide .

Possible side effects of Lenalidomide :

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; nausea; stuffy or runny nose; tiredness; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the stools or vomit; chest pain; dark urine; fast, slow, or irregular heartbeat; fever, chills, or sore throat; muscle cramps; muscle or joint pain; pain, numbness, tingling, tenderness, or swelling of the arms or legs; painful or difficult urination; severe tiredness or weakness; shortness of breath; stomach pain; unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Lenalidomide at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lenalidomide out of the reach of children and away from pets.

General information:

• If you have any questions about Lenalidomide , please talk with your doctor, pharmacist, or other health care provider.
• Lenalidomide 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.

This information is a summary only. It does not contain all information about Lenalidomide . 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.