Tracleer Bosentan Tablets

Step Forward with Tracleer

For patients with pulmonary arterial hypertension (PAH, WHO Group I) WHO Class II, III, IV
Patients at RiskIPAHPAH-Connective Tissue DiseaseSSc Screening and DiagnosisPAH-Congenital Heart Disease

Patients at Risk

Pulmonary arterial hypertension is associated with diverse background conditions1


Congenital heart disease Drug abuse/toxins Connective tissue disease HIV infection Unexplained dyspnea Congenital heart disease Drug abuse/toxins Connective tissue disease HIV infection Unexplained dyspnea

Risk factors and prevalence of pulmonary arterial hypertension


Idiopathic pulmonary arterial hypertension

 The overall prevalence of IPAH is estimated to be 6 per million.1

Congenital heart disease

 12% to 34% of patients with ASDs may also have PAH.2
 Approximately 50% of patients with large VSDs (>1.5 cm) may develop Eisenmenger syndrome.3


Drug abuse/toxins

 In a retrospective study of 340 PAH and PH patients at a single center, 29% of IPAH patients reported the use of stimulants, such as amphetamines and cocaine.4
 In an epidemiologic study of 579 PH patients, 13% reported the use of anorexigens.5

Connective tissue disease

 8% to 27% of patients with systemic sclerosis may also have PAH.1

HIV

 0.5% of patients with HIV may also have PAH.1

ASD atrial septal defect; HIV human immunodeficiency virus; IPAH idiopathic pulmonary hypertension;
PAH pulmonary arterial hypertension; PH pulmonary hypertension; VSD ventricular septal defect.

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.



Review idiopathic pulmonary arterial hypertension

  1. 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.
  2. 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.
  3. Simonneau G, Galiè N, Rubin LJ, et al. Clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2004;43(suppl S):5S-12S.
  4. Chin KM, Channick RN, Rubin LJ. Is methamphetamine use associated with idiopathic pulmonary arterial hypertension? Chest. 2006;130:1657-1663.
  5. Rich S, Rubin L, Walker AL, Schneeweiss S, Abenhaim L. Anorexigens and pulmonary hypertension in the United States: results from the Surveillance of North American Pulmonary Hypertension. Chest. 2000;117:870-874.