Lenalidomide (Revlimid) is an oral anti-cancer medication. Lenalidomide is similar to thalidomide (Thalomid), an older cancer medicine that, although effective, was associated with serious side effects. The exact mechanism through which lenalidomide stops the growth of cancer cells is not understood. Lenalidomide stimulates or regulates the body's immune system to attack and kill cancer cells, reduces the formation of new blood vessels that supply nutrients to the cancer cells, and prevents or stops growth of the cancer. Laboratory studies have shown that lenalidomide inhibits cancer growth and causes programmed cell death in certain types of cancers, including multiple myeloma, mantle cell lymphoma, and del (5q) myelodysplastic syndromes. Lenalidomide was approved by the FDA Dec. 27, 2005.

Revlimid

GENERIC AVAILABLE: No

Yes

Common side effects of lenalidomide are:

• diarrhea,
• itching,
• rash,
• tiredness,
• fatigue,
• neutropenia (a drop in white blood cell count),
• constipation,
• diarrhea,
• muscle cramp,
• anemia,
• fever,
• peripheral edema (swelling in the ankles, feet, or legs),
• nausea,
• back pain,
• upper respiratory tract infection,
• shortness of breath,
• dizziness,
• thrombocytopenia ( a drop in the platelet count),
• tremor, and
• rash.

Lenalidomide may cause some other rare but serious side effects. These include:

• increase risk of death in patients who have chronic lymphocytic leukemia (CLL);
• risk of new cancers;
• severe liver problems;
• serious skin reactions;
• tumor lysis syndrome, or TLS (caused by the fast breakdown of cancer cells);
• formation of blood clots in the arteries, veins, and lungs;
• serious birth defects or death of an unborn baby;
• and worsening of tumors.

Lenalidomide capsules should be swallowed whole with water around the same time each day.

Multiple myeloma (MM): the recommended starting dose of lenalidomide is 25 mg by mouth once a day on day 1-21 of repeated 28-day cycles. The recommended dose of dexamethasone is 40 mg once daily on day 1-4, 9-12, and 17-20 of each 28-day cycle for the first 4 cycles of therapy, followed by 40 mg once daily on day 1-4 every 28 days thereafter.

Myelodysplastic syndrome (MDS): the recommended starting dose of lenalidomide is 10 mg by mouth once a day.

Mantle cell lymphoma (MCL): the recommended starting dose of lenalidomide is 25 mg by mouth once a day on days 1-21 of repeated 28 cycles.

As lenalidomide is primarily cleared from the body via the kidneys, dose adjustments are recommended in patients with moderate or severe kidney disease and in patients on dialysis.

When multiple doses of lenalidomide were administered with digoxin, the blood levels of digoxin were increased. Patients receiving both medications should be closely monitored to minimize the occurrence of unwanted side effects.

Due to the increased risk of forming blood clots in the arteries, veins, or lungs, lenalidomide should be used cautiously in patients using erythropoietin-stimulating agents and estrogen-containing therapies.

Lenalidomide is similar to thalidomide which is a known human teratogen that causes life-threatening human birth defects or embryo-fetal death. It should not be used during pregnancy. Lenalidomide is classified as FDA pregnancy risk category X (animal and human studies have demonstrated harm to the fetus). A program called Revlimid REMS was developed to prevent fetal exposure to lenalidomide. Patients, prescribers, and pharmacies must be registered in the Revlimid REMS programs to receive, prescribe, and dispense lenalidomide.

Females must not get pregnant for 4 weeks before starting lenalidomide, while taking lenalidomide, during any breaks in treatment, and for 4 weeks after stopping lenalidomide.

As lenalidomide may pass into human semen, all males taking lenalidomide must use a latex or synthetic condom during any sexual contact with a pregnant female or a female who can become pregnant. Male patients should not donate sperm while taking lenalidomide, during any breaks in treatment, and for 4 weeks after stopping lenalidomide.

Lenalidomide should not be used by females who are breastfeeding. It is not known whether lenalidomide is excreted in breast milk and its effect on the nursing infant.

What preparations of lenalidomide Revlimid are available?

Oral capsules: 2.5, 5, 10, 15, 20, and 25 mg.

How should I keep lenalidomide Revlimid stored?

Capsules should be stored at room temperature, between 15 C and 30 C (59 F to 86 F). It is extremely important to keep this medication away from children, pets, and pregnant females due to the high risk of serious side effects associated with accidental exposure.