Tracleer Access Program (T.A.P.)
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 this 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.
You can reach PAH Pathways by calling toll-free at 1-866-ACTELION (1-866-228-3546).
What you need to prescribe Tracleer:
For more information, you can visit www.pahpathways.com.
Tracleer is indicated for the treatment of pulmonary arterial hypertension (PAH) 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 the risk of 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.
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Tracleer Access Program
