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|Lenalidomide

LENALIDOMIDE (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Revlimid

† Not commercially available in Canada.

Category

• Antianemic
• antiangiogenesis agent
• immunomodulator

Description

Lenalidomide ((le-na-LID-oh-mide ))is a medicine used to treat anemia in patients with a certain type of myelodysplastic syndrome (MDS) called 5q MDS. Patients with this type of MDS may have low red blood cell counts that require blood transfusions.

This medicine is available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Capsules (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For lenalidomide, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to lenalidomide. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Lenalidomide must not be used during pregnancy. It has been shown to cause serious birth defects in humans. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether lenalidomide passes into breast milk. However, lenalidomide is not recommended during breast-feeding, because it may cause unwanted effects in nursing infants.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of lenalidomide in children with use in other age groups.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of lenalidomide. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—May increase the amount of lenalidomide in your body and increase the risk of side effects.

• Liver disease—Caution, studies have not been done.

• Multiple myeloma—May increase your risk for serious side effects.

Proper Use of This Medicine

The importance of becoming educated and counseled on the requirements of the RevAssist program, and familiar with the RevAssist educational materials, Patient Medication Guide, and directing any questions to a physician or pharmacist prior to starting lenalidomide therapy.

Taking the necessary precautions to avoid pregnancy while taking lenalidomide. Using one highly effective form of birth control plus an additional effective form of birth control at the same time, if abstinence is not the chosen method. Starting 4 weeks before starting lenalidomide and for 4 weeks after stopping the medication.

Participation in a telephone survey and patient registry while taking lenalidomide.

Swallow whole, do not break, chew, or open the capsule.

The importance of having laboratory test on blood.

The importance of pregnancy tests at regular intervals.

Male patients, even those who have had a vasectomy must use a latex condom during sexual contact with a female patient.

The importance of not donating blood while taking lenalidomide.

The importance of not sharing this medication with anyone, even someone with similar symptoms.

For male patients not donating semen or sperm while taking lenalidomide.

Dosing—The dose of lenalidomide will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of lenalidomide. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules that you take depends on the strength of the medicine.

• For oral dosage form (capsules):
  • For treating anemia in patients with myelodysplastic syndrome:
    • Adults—Oral, 10 milligrams daily, taken with water . Dosing is continued or modified based upon clinical and laboratory findings.
    • Children—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Regular visits to the physician every 4 weeks for pregnancy testing for women with regular menstrual cycles and every 2 weeks for women with irregular cycles.

Calling your doctor or 1-888-688-2528 for emergency contraception information if you for any reason think you are pregnant or, for males, your sexual partner may be pregnant.

Seeking medical attention if you develop any shortness of breath, chest pain, or arm or leg swelling.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 02/17/2006

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