Lenalidomide Oral Capsules

What is this medicine?

LENALIDOMIDE (len a LID oh mide) is a chemotherapy drug that targets specific proteins within cancer cells and stops the cancer cell from growing. It is used to treat multiple myeloma, certain types of lymphoma, and some myelodysplastic syndromes that cause severe anemia requiring blood transfusions.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush, or chew this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A MedGuide will be given with each prescription and refill. Read this guide carefully each time. The MedGuide may change frequently.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chest pain or tightness

• fast, irregular heartbeat

• feeling faint

• fever with rash, swollen lymph nodes, or swelling of the face

• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.

• seizures

• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose

• signs and symptoms of a blood clot such as breathing problems; changes in vision; chest pain; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness or weakness of the face, arm or leg

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

• signs and symptoms of a stroke like changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination

• sweating

• vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation

• cough

• diarrhea

• joint pain

• muscle cramps

• swelling of the arms, legs, or skin

• tiredness

• trouble sleeping

What may interact with this medicine?

This medicine may interact with the following medications:

• digoxin

• medicines that increase the risk of thrombosis like estrogens or erythropoietic agents (e.g., epoetin alfa and darbepoetin alfa)

• warfarin

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 12 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• blood clots in the legs or the lungs

• high blood pressure

• high cholesterol

• infection

• irregular monthly periods or menstrual cycles

• kidney disease

• liver disease

• smoke tobacco

• thyroid disease

• an unusual or allergic reaction to lenalidomide, thalidomide, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

You may need blood work done while you are taking this medicine.

This medicine is available only through a special program. Doctors, pharmacies, and patients must meet all of the conditions of the program. Your health care provider will help you get signed up with the program if you need this medicine. Through the program you will only receive up to a 28 day supply of the medicine at one time. You will need a new prescription for each refill.

This medicine can cause birth defects. Do not get pregnant while taking this drug. Females with child-bearing potential will need to have 2 negative pregnancy tests before starting this medicine. Pregnancy testing must be done every 2 to 4 weeks as directed while taking this medicine. Use 2 reliable forms of birth control together while you are taking this medicine and for 4 weeks after you stop taking this medicine. If you think that you might be pregnant talk to your doctor right away. Do not breast-feed an infant while taking this medicine.

Men must use a latex condom during sexual contact with a woman while taking this medicine and for 4 weeks after you stop taking this medicine. A latex condom is needed even if you have had a vasectomy. Contact your doctor right away if your partner becomes pregnant. Do not donate sperm while taking this medicine and for 4 weeks after you stop taking this medicine.

Do not give blood while taking the medicine and for 4 weeks after completion of treatment to avoid exposing pregnant women to the medicine through the donated blood.

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.