Lenalidomide capsule

What is this medicine?

LENALIDOMIDE affects the immune system. It promotes immune responses to help slow tumor growth.

Lenalidomide treats anemia (a lack of red blood cells in the body), multiple myeloma (cancer resulting from a progressive blood disease), and mantle cell lymphoma (a rare cancer of the lymph nodes). 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 should not be used for chronic lymphocytic leukemia (CLL) unless you are in a controlled medical study. Lenalidomide can increase the risk of death from serious heart problems in people with CLL.

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

Important information

Never use this medicine if you are pregnant. Lenalidomide can cause severe, life-threatening birth defects. You will need to have a negative pregnancy test before starting this treatment. You will also be required to use two reliable forms of birth control to prevent pregnancy during treatment.

Lenalidomide is available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks of taking this medicine.

Lenalidomide can lower blood cells that help your body fight infections and help your blood to clot. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches). You will need frequent blood tests while you are taking Lenalidomide.

Lenalidomide may increase your risk of developing a blood clot, especially if you also take dexamethasone (a steroid). Get emergency medical help if you have any of these signs of a blood clot: chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; pain, swelling, warmth, or redness in your arm or leg.

Before taking this medicine

You should not use Lenalidomide if you are allergic to lenalidomide.

Lenalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medicine 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 taking Lenalidomide.

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 reliable 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 medicine. 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. This 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 from a certified pharmacy under a special program called Lenalidomide REMS. You must be registered in the program and sign documents stating that you understand the dangers of this medicine and that you agree to use birth control measures as required by the program. You will be limited to a 28-day supply of Lenalidomide each time your prescription is refilled.

For patients between 12 and 18 years, a parent or legal guardian must read all written requirements for the Lenalidomide REMS program and sign the agreements on behalf of the patient.

To make sure Lenalidomide is safe for you, tell your doctor if you have:

• kidney disease;

• liver disease;

• a history of blood clots or stroke;

• lactose intolerance; or

• a history of allergic reaction to thalidomide.

Using Lenalidomide ay increase your risk of developing other types of cancer, such as leukemia or lymphoma. Talk with your doctor about your specific risk.

It is not known whether lenalidomide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take Lenalidomide?

Take Lenalidomide exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Never give Lenalidomide to another person, even if he or she has the same disorder for which you are being treated.

You may take Lenalidomide with or without food, but take it the same way each time.

Take each dose with a full glass of water. Swallow the capsule whole, without breaking it open.

Lenalidomide can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood will need to be tested often. Visit your doctor regularly.

The medicine from an open capsule can be dangerous if it gets on your skin. If this occurs, wash your skin with soap and water. Ask your doctor or pharmacist how to safely handle and dispose of a broken capsule.

Store at room temperature away from moisture and heat.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Lenalidomide dosing information

Usual Adult Dose for Myelodysplastic Diseases:

10 mg orally once daily

Approved indication: Treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Usual Adult Dose for Multiple Myeloma:

25 mg/day of Lenalidomide with water orally as a single 25 mg capsule on days 1 through 21 of repeated 28 day cycles.

(The recommended dose of dexamethasone is 40 mg/day on days 1 through 4, 9 through 12, and 17 through 20 of each 28 day cycle for the first 4 cycles of therapy and then 40 mg/day orally on days 1 through 4 every 28 days.)

The effects of substituting lesser strengths of Lenalidomide to equal a 25 mg capsule dose is unknown.

Usual Adult Dose for Lymphoma:

25 mg orally once a day on Days 1 to 21 of repeated 28 day cycles.

Duration of therapy: Treatment should be continued until disease progression or unacceptable toxicity.

Approved indication: Treatment of mantle cell lymphoma (MCL) in patients whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If you are more than 12 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Lenalidomide?

Do not donate blood or sperm while you are using Lenalidomide, and for 4 weeks after you stop taking it.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Lenalidomide side effects

Get emergency medical help if you have any signs of an allergic reaction to Lenalidomide: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• signs of a blood clot--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; pain, swelling, warmth, or redness in your arm or leg;

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• signs of tumor cell breakdown--lower back pain, blood in your urine, little or no urinating; numbness or tingly feeling around your mouth; muscle weakness or tightness; fast or slow heart rate, weak pulse, feeling short of breath; confusion, fainting; or

• signs of a tumor getting worse--swollen glands, low fever, rash, or pain.

Common Lenalidomide side effects may include:

• itching or rash;

• diarrhea; or

• tired feeling.

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.

What other drugs will affect Lenalidomide?

Other drugs may interact with lenalidomide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.