What should I watch for while using this medicine?

Visit your doctor for regular check ups. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. You will need to have important 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. Your prescription must be filled within 7 days of your doctor's office visit.

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 1 month after you stop taking this medicine. If you think that you might be pregnant talk to your doctor right away.

Men must use a latex condom during sexual contact with a woman while taking this medicine and for 30 days 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 30 days after you stop taking taking this medicine.

Do not give blood while taking the medicine and for 30 days after completion of treatment to avoid exposing pregnant women to the medicine through the donated blood.

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
• bloody or dark, tarry stools
• breathing problems
• chest pain
• dark urine
• fever, infection, runny nose, or sore throat
• pain in the legs
• swelling of your hands, ankles or leg
• unusual bleeding or bruising

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

• diarrhea
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.