When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to lenalidomide or if you are pregnant.

How to Use This Medicine:
Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Take this medicine the same way every day. Take it at the same time and take it consistently, either with or without food.
• Swallow the capsule whole with water. Do not crush, break, chew, or open it.
• Do not open the capsules or handle them any more than needed. If you accidentally touch the medicine in the capsule, wash your skin with soap and water right away.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose:
  
  • Less than 12 hours since your regular time: Take the missed dose as soon as you can. Take your next dose at the normal time.
  • More than 12 hours since your regular time: Skip the missed dose. Take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how lenalidomide works. Tell your doctor if you are using any of the following:
  
  • Darbepoetin alfa, epoetin alfa
  • Blood thinner (such as warfarin)
  • Digoxin
  • Medicine that contains estrogen

Warnings While Using This Medicine:

• This medicine will cause birth defects if either partner is using it during conception or pregnancy. Call your doctor for emergency contraception information if you think you or your sexual partner becomes pregnant.
• Women should begin using 2 forms of reliable birth control 4 weeks before starting therapy. Continue using birth control during therapy and for 4 weeks after the last dose. Routine pregnancy tests are necessary.
• Men, even those who have had a vasectomy, must prevent pregnancy in their sexual partners during therapy and for 4 weeks after the last dose. Do not donate sperm while using this medicine.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, lactose intolerance, high blood pressure, high cholesterol, or a history of heart attack or stroke. Tell your doctor if you smoke.
• Do not donate blood during therapy or for 1 month after the last dose.
• This medicine may cause the following problems:
  
  • Increased risk of blood clots, heart attack, or stroke
  • Increased risk of new cancer
  • Serious liver problems
  • Serious skin reactions
  • Tumor lysis syndrome
  • Worsening of your tumor (tumor flare reaction)
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Change in how often you urinate, uneven heartbeat, seizure
• Chest pain that may spread, trouble breathing, nausea, unusual sweating, fainting
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, sore throat, and body aches
• Numbness or weakness on one side of your body, sudden or severe headache, pain in your lower leg, problems with vision, speech, or walking
• Swollen lymph glands, low fever, pain, rash
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, constipation
• Dizziness, trouble sleeping, or tiredness
• Joint, back, or muscle pain
• Rapid weight gain, swelling in your hands, ankles, or feet

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088