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What is lenalidomide?

Lenalidomide affects the immune system. It helps promote immune responses to prevent inflammation in the body.

Lenalidomide treats anemia (a lack of red blood cells in the body) and multiple myeloma (cancer resulting from a progressive blood disease). It is used in patients with myelodysplastic syndrome caused by an abnormal chromosome. This disorder is also called deletion 5q MDS, because part of chromosome 5 is missing. In people with this disorder, the bone marrow does not produce enough healthy blood cells.

Lenalidomide may also be used for other purposes not listed in this medication guide.

Precautions

Instructions

Side Effects

Interactions

Precautions

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before taking lenalidomide, tell your doctor if you have:

• kidney disease; or
• a history of blood clots or stroke.

Lenalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medication at the time of conception or during pregnancy. Even one dose of lenalidomide can cause major birth defects of the baby’s arms and legs, bones, ears, eyes, face, and heart. Never use lenalidomide if you are pregnant. Tell your doctor right away if your period is late while using the medication.

It is not known if lenalidomide passes into breast milk or if it could harm a nursing baby. Do not use this medication 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 before 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 medication. You must also have a negative pregnancy test at 10 to 14 days before treatment and again at 24 hours before. While you are taking lenalidomide, you will have a pregnancy test every 4 weeks.

The birth control method you use must 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 must 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.

For Men: You must not cause a woman to become pregnant while you are taking lenalidomide because the medicine may affect your sperm and cause birth defects in the baby. You must 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. Contact your doctor if you have had unprotected sex, even once, or if you think your female sexual partner may be pregnant.

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

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

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine.

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

Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take extra medicine to make up the missed dose.

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Side Effects

Stop using lenalidomide and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, 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 arm, thigh, or calf;
• easy bruising, unusual bleeding or weakness;
• fever, chills, body aches, flu symptoms;
• lower back pain, blood in your urine;
• urinating less than usual or not at all;
• numbness or tingly feeling around your mouth;
• muscle weakness, tightness, or contraction, overactive reflexes;
• fast or slow heart rate, 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.

Less 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 report side effects to FDA at 1-800-FDA-1088.

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Interactions

There may be other drugs that can affect lenalidomide. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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