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 thalidomide. This medicine can cause serious or life-threatening birth defects in unborn babies. Do not use this medicine if you are pregnant.

How to Use This Medicine:
Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take this medicine with water at least 1 hour after the evening meal, preferably at bedtime.
• Do not open the blister pack until you are ready to take the capsule. If you touch a broken capsule or 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: If it is more than 12 hours until your next regular dose, take the missed dose as soon as possible. If it is less than 12 hours, skip the missed dose and take your next dose at the regular 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. Return any unused capsules to your doctor or pharmacist.

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 medicines can affect how thalidomide works. Tell your doctor if you are using any of the following:
  
  • Amiodarone, bortezomib, carbamazepine, cimetidine, cisplatin, digoxin, disulfiram, docetaxel, famotidine, griseofulvin, lithium, metronidazole, modafinil, paclitaxel, phenytoin, rifabutin, rifampin, St John wort, vincristine
  • Birth control pills
  • Blood pressure medicine
  • Medicine to treat depression
  • Medicine to treat HIV infection
  • Penicillin antibiotics
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Women should use 2 forms of birth control starting 4 weeks before treatment begins, during treatment, and for at least 4 weeks after the last dose. Men should use a condom during sex while they are taking this medicine and for at least 4 weeks after the last dose, even if they had a vasectomy. Continue to use birth control even if the dose is stopped for a short time. Tell your doctor right away if you or your partner misses a period or may be pregnant.
• Do not donate blood or sperm while you are taking this medicine and for at least 4 weeks after your last dose.
• Tell your doctor if you are breastfeeding, or if you have bradycardia (slow heartbeat), HIV infection, or a history of seizures, heart attack, or stroke.
• This medicine may cause the following problems:
  
  • Increased risk for blood clots, heart attack, or stroke
  • Nerve damage, which may be permanent
  • Increased risk for bleeding or infections
  • Increased risk for serious skin reactions
  • Tumor lysis syndrome
• This medicine may cause you to feel dizzy, drowsy, or lightheaded. Do not drive or do anything that could be dangerous until you know how this medicine affects you. Stand or sit up slowly if you feel lightheaded.
• 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 much or how often you urinate, joint pain or swelling, lower back or side pain, swelling of the feet or lower legs
• Chest pain, trouble breathing, coughing up blood
• Chest pain that may spread, nausea, unusual sweating
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Lightheadedness, dizziness, fainting
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Seizures
• Slow, uneven, or fast, pounding heartbeat
• Unusual bleeding, bruising, or weakness

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

• Anxiety, agitation, confusion, tremors
• Constipation, loss of appetite, weight changes
• Mild skin rash or dry skin
• Tiredness, sleepiness

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