Revlimid

Disclaimer

Revlimid

Revlimid Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

LENALIDOMIDE - ORAL

(len-a-LID-o-mide)

WARNING: Lenalidomide is a drug that is very similar to thalidomide, which is known to cause severe birth defects or death in unborn babies. If lenalidomide is taken during pregnancy, it may also cause severe birth defects or death in unborn babies. Therefore, this drug must never be used during pregnancy nor by women who could become pregnant while using this drug. Pregnancy must be ruled out before starting lenalidomide. Women must have two negative pregnancy tests before starting lenalidomide, the first 10-14 days before the first dose and the second within 24 hours before the first dose. Women must work with their doctors to check for and prevent pregnancy while using this medication. (See also Notes section.)

For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the Revlimid Education and Prescribing Safety Program, also known as the RevAssist program, developed by the U.S. Food and Drug Administration.

If the patient taking lenalidomide is between the ages 12-18, then a parent or legal guardian must also read the educational material and agree to carefully follow the requirements of the RevAssist program.

Patients (male and female) who use this medication must use two reliable forms of birth control. For males, this means using a latex condom along with other effective birth control used by the female partner. If pregnancy does occur during treatment, stop this medication and contact your doctor immediately. (See also Precautions section.)

Lenalidomide may benefit you by helping increase the number of functioning red blood cells. Unfortunately, it may also increase your risk of developing serious bone marrow problems such as low white blood cell counts or low platelet counts. Seek immediate medical attention if you develop the following symptoms: persistent fever, persistent sore throat, easy bleeding/bruising. Most patients will experience these effects, which will require your doctor to stop and restart lenalidomide or decrease your dose.

Lenalidomide can cause serious (sometimes fatal) blood clots in veins and lungs. Seek immediate medical attention if you develop the following symptoms: calf pain/swelling, chest pain, trouble breathing.

USES: This medication is used to treat anemia in patients with certain blood/bone marrow disorders (myelodysplastic syndromes-MDS). These patients do not have enough properly working red blood cells. They often require blood transfusions to reverse their anemia. Lenalidomide may decrease the need for treatment with blood transfusions. This medication may also be used to treat a certain type of cancer (multiple myeloma).

Lenalidomide is a type of drug known as an immunomodulator. It is believed to work by decreasing the immune system's response, thereby lowering the number of working red blood cells that are destroyed naturally by the body.

HOW TO USE: This medication must be used only within the RevAssist guidelines in order to avoid any possible exposure of an unborn baby to the drug. Consult your doctor or pharmacist.

Read the Medication Guide provided by your pharmacist before you start using lenalidomide and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Before starting therapy, women of childbearing age should have two negative pregnancy tests before taking the drug. (See Warning section.)

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow this medication whole with water. Dosage is based on your medical condition, response to therapy, and laboratory test results. Be sure to follow your doctor's directions carefully.

Do not open, chew, or break the capsules, or handle them any more than needed. If any of the powder from the capsule gets on your skin, wash the area with soap and water.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from broken capsules. All people should wash their hands thoroughly after handling this drug.

Use this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day.

Inform your doctor if your condition persists or worsens.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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