Tracleer

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.

Tracleer 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 and Medication Guide.

Ventavis

For full Prescribing Information for Ventavis, click here.