Downloadable Patient Materials With
Information About PAH and Tracleer
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Tracleer Educational Materials
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Tracleer Patient Brochure-to help you understand your disease and how treatment with Tracleer can help treat Functional Class II, III, and IV PAH.
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Tracleer Roadmap-explains who may contact you and reasons you may want to contact them.
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Liver Function Test (LFT) Flashcard-explains the importance of getting your LFT each month to help your healthcare team better manage your treatment with Tracleer.
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Tracleer Access Program (T.A.P.®) Materials
To start treatment with Tracleer, you must review essential safety information with your healthcare provider, complete a
Tracleer Enrollment and Renewal form, and agree to have important monthly tests. Your first step is reviewing the Tracleer
Medication Guide (found in the Patient Essentials Guide) with your healthcare provider.
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Patient Essentials Guide-A guide to starting, taking, and renewing Tracleer.
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Tracleer Enrollment and Renewal form and HIPAA form.
To be enrolled in the Tracleer Access Program you and your healthcare team need to
complete the Enrollment and Renewal form. You can also enroll in voluntary patient
education and support programs by completing the HIPAA form.
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IMPORTANT SAFETY INFORMATION
Because of the risks associated with Tracleer, this medication may be prescribed by your doctor only
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 or one month after stopping treatment
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 injury. Do
not take Tracleer with cyclosporine-A because it may increase your chance of side effects.
Please see
Additional Safety Information.
Please see full
Prescribing Information, including
BOXED WARNING and
Medication Guide.
