When This Medicine Should Not Be Used:
This medicine is not right for everyone. This medicine can cause serious or life-threatening birth defects. Do not use it if you are pregnant. Do not use this medicine if you had an allergic reaction to pomalidomide.

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 at the same time each day on an empty stomach, at least 2 hours before or 2 hours after a meal.
• Do not break, chew, or open the capsules. If you accidentally open the capsule or touch the medicine inside, 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 your dose as soon as you can, and then take your next dose at the normal time.
  • More than 12 hours since your regular time: Skip the missed dose, and then 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 drugs can affect how pomalidomide works. Tell your doctor if you also use ciprofloxacin, fluvoxamine, or ketoconazole.
• Do not smoke while you are using this medicine. This medicine may not work as well if you smoke.

Warnings While Using This Medicine:

• Women: Pregnancy tests are required before and during therapy. Use 2 forms of birth control together. Begin using birth control 4 weeks before you start therapy. Continue during therapy, even if the medicine is stopped for a short time, and for at least 4 weeks after your last dose. Talk to your doctor about the most effective forms of birth control for you and your partner.
• Men: You must protect your female partner from getting pregnant. Use a condom every time you have sex, even if you had a vasectomy. You must use a condom during therapy, even if the medicine is stopped for a short time, and for up to 28 days after your last dose. Do not donate sperm while you are being treated with this medicine.
• Tell your doctor right away if you or your partner becomes pregnant.
• Do not donate blood during therapy and for at least 1 month after your last dose.
• Tell your doctor if you are breastfeeding or if you have kidney disease, liver disease, high blood pressure, high cholesterol, or a history of blood clots.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may cause the following problems:
  
  • Blood clots, which can lead to heart attack or stroke
  • Liver problems
  • Tumor lysis syndrome (electrolyte and metabolic problems that can be life-threatening)
  • Peripheral neuropathy (nerve damage)
  • Possible risk of acute leukemia
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine may make you dizzy or confused. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• 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
• Chest pain, trouble breathing, coughing up blood
• Chest pain that may spread, nausea, unusual sweating, fainting
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Decrease in how much you urinate, uneven heartbeat, seizure
• Fever, chills, cough, sore throat, body aches
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Rapid weight gain, swelling in your hands, ankles, or feet
• Numbness, tingling, burning, or pain in your hands or feet
• Unusual bleeding, bruising, or weakness

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

• Back pain
• Constipation, diarrhea, nausea
• Tiredness

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