Because of the risks associated with treatment, the use of Tracleer requires participation in the Tracleer
Access Program (T.A.P.), a restricted distribution program. In order to receive Tracleer, prescribers and
patients must enroll in T.A.P. and agree to comply with the requirements of the program. Enrollment in
T.A.P. is accomplished by completing and submitting the Tracleer Enrollment and Renewal form to PAH
Pathways
®, which administers T.A.P. At PAH Pathways, our goal is to provide one point of access for your
patients taking Tracleer. Our team helps your patients get Tracleer quickly and provides them with answers
regarding shipment status.
What you need to prescribe Tracleer
Tracleer is not dispensed through retail pharmacies; rather, it is
dispensed through a network of specialty pharmacies that are certified by
Actelion to dispense Tracleer. Specialty pharmacies help ensure that required
monthly liver function and pregnancy testing has occurred. Specialty pharmacies
also arrange for Tracleer to be delivered conveniently and directly to patients
each month. If a patient does not confirm having the monthly tests or becomes
pregnant, the pharmacy will contact you.
In order to continue your patients on Tracleer, you need to renew their enrollment in T.A.P. annually.
You can reach PAH Pathways by calling, toll-free,
1-866-ACTELION (1-866-228-3546), or visit
www.PAHPathways.com for more information.
Tracleer is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in
patients with WHO Class II-IV symptoms, to improve exercise ability and decrease the rate of
clinical worsening. Patients with WHO Class II symptoms showed reduction in the rate of clinical
deterioration and a trend for improvement in walk distance. Physicians should consider whether
these potential benefits are sufficient to offset liver injury in WHO Class II patients, which may
preclude future use as their disease progresses.
Important safety information
Because of the associated risks, Tracleer may be prescribed only through the Tracleer Access Program.
Potential for serious liver injury (including, after prolonged treatment, rare cases of liver failure
and unexplained hepatic cirrhosis in a setting of close monitoring)—Liver monitoring of all patients
is essential prior to initiation of treatment and monthly thereafter.
High potential for major birth defects—Pregnancy must be excluded and prevented through the use of
reliable forms of birth control; monthly pregnancy tests should be obtained.
Contraindicated for use with cyclosporine A and glyburide.
Please see full prescribing information including BOXED WARNING.
