IMPORTANT SAFETY INFORMATION

Because of the risks associated with Tracleer, this medication may be prescribed only by your doctor through the Tracleer Access Program. Liver damage: Tracleer can cause serious liver damage, including in rare cases liver failure and, in situations with regular liver testing, unexplained liver cirrhosis. So you must have a blood test to check your liver function before you start Tracleer and each month after that. Call your doctor right away if you have any of these symptoms of liver problems: nausea, vomiting, fever, unusual tiredness, abdominal (stomach area) pain, or yellowing of the skin or the whites of your eyes (jaundice). Serious birth defects: Tracleer is very likely to cause serious birth defects. It is important not to be or to become pregnant while taking Tracleer and to have a pregnancy test before you start the drug and each month thereafter. It is very important for you to use reliable forms of birth control while taking Tracleer. Hormonal contraceptives should not be used alone because they may not be effective in patients taking Tracleer.
Do not take Tracleer with glyburide because it may increase your chance of liver damage. Do not take Tracleer with cyclosporine A, lopinavir/ritonavir, or ritonavir-containing HIV regimens because they may increase your chance of side effects.