Tracleer Bosentan Tablets
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For patients with pulmonary arterial hypertension (PAH, WHO Group I)
WHO Class II, III, IV


Pulmonary arterial hypertension is a
serious cardiopulmonary condition


Pulmonary arterial hypertension is a rapidly progressing disease1


Presymptomatic Presymptomatic*
 Inflammation
Symptomatic Symptomatic*
 Inflammation Hypertrophy
 Vasoconstriction Fibrosis
Severely symptomatic
Severely symptomatic*
 Cell proliferation
 Plexiform lesions

*Statements are based on observations reported from in vitro, animal, and human trials. The clinical significance is unknown.

Pulmonary arterial hypertension is associated with diverse pathological events


Pulmonary vasoconstriction Fibrosis Hypertrophy In situ thrombosis Right ventricular strain and dysfunction Pulmonary vasoconstriction Fibrosis Hypertrophy In situ thrombosis Right ventricular strain and dysfunction

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.




  1. Gaine S. Pulmonary hypertension. JAMA. 2000;284:3160-3168.
  2. Rich S, McLaughlin VV. Pulmonary hypertension. In: Libby P, Bonow RO, Mann DL, Zipes DE, eds. Braunwald's Heart Disease. 2 vols. 8th ed. Philadelphia, PA: Saunders Elsevier; 2008:1883-1914.
  3. Morrell N. Pulmonary vascular disease. In: Dilworth JP, Baldwin DR, eds. Respiratory Medicine. Amsterdam: Overseas Publishers Association, Harcourt Academic; 2001:199-234.
  4. McCance KL, Huether SE. Pathophysiology: The Biologic Basis for Disease in Adults and Children. 4th ed. St. Louis, MO: Mosby; 2002.
  5. Miyauchi T, Masaki T. Pathophysiology of endothelin in the cardiovascular system. Annu Rev Physiol. 1999;61:391-415.
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