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


Suspect pulmonary arterial hypertension
in at-risk and symptomatic patients


Adapted from the updated clinical classification of WHO Group I PAH (JACC 2009)1 Prevalence rates2
1.1. Idiopathic6 per million2
1.2. Heritable
1.2.1. BMPR2
1.2.2. ALK1, endoglin*
1.2.3. Unknown
BMPR2 mutations detected in 11% to 40% of IPAH cases with no family history1
1.3. Drug- and toxin-induced 29% of IPAH patients reported stimulant use in a retrospective study of 340 PAH and PH patients in a single center3

In an epidemiologic study of 579 PH patients, 13% reported anorexigen use4
1.4. Associated with:
1.4.1. Connective tissue disease
1.4.2. HIV infection
1.4.3. Portal hypertension
1.4.4. Congenital heart disease
1.4.5. Schistosomiasis
1.4.6. Chronic hemolytic anemia
8% to 27% of systemic sclerosis patients may develop PAH2

0.5% of HIV patients may develop PAH2

12% to 34% of congenital heart disease patients may develop PAH5
*With or without hereditary hemorrhagic telangiectasia.
Read about the signs and symptoms of PAH




ALK1 activin receptor–like kinase 1; BMPR2 bone morphogenetic protein receptor type 2; HIV human immunodeficiency virus; IPAH idiopathic pulmonary arterial hypertension; WHO World Health Organization.

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. Simonneau G, Robbins IM, Beghetti M, et al. Updated clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2009;54(suppl 1):S43-S54.
  2. McLaughlin VV, Archer SL, Badesch DB, et al. ACCF/AHA 2009 expert consensus document on pulmonary hypertension. J Am Coll Cardiol. 2009;53:1573-1619.
  3. Chin KM, Channick RN, Rubin LJ. Is methamphetamine use associated with idiopathic pulmonary arterial hypertension? Chest. 2006;130:1657-1663.
  4. Rich S, Rubin L, Walker AL, et al. Anorexigens and pulmonary hypertension in the United States: results from the Surveillance of North American Pulmonary Hypertension. Chest. 2000;117:870-874.
  5. Engelfriet PM, Duffels MGJ, Möller T, et al. Pulmonary arterial hypertension in adults born with a heart septal defect: the Euro Heart Survey on adult congenital heart disease. Heart. 2007;93:682-687.
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