FDA-approved PAH therapy indicated for pediatric patients
TRACLEER is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.
ed-pill-img ed-pill-img
Bisectable tablet designed for
more precise dosing.
Formulation is designed to help with administration in patients who have trouble swallowing pills
Formulation and dosage can help provide a more precise dose for pediatric patients
Fruit flavor with pediatric
patients in mind
TRACLEER® (bosentan): 32 mg Tablets Dosing and Administration1
Dosing recommendations in pediatric patients
indicate hcp ped spoon
Administering the dispersible formulation
TRACLEER film-coated tablets and tablets for oral suspension (dispersible tablets) should be administered orally twice daily. Disperse tablets for oral suspension, or dispersible tablet half, in a minimal amount of water immediately before administration. Store divided dispersible tablet pieces at 20°C – 25°C (68°F – 77°F) in the opened blister for up to 7 days.
TRACLEER® (bosentan) Has Been Studied in Pediatric Patients with PAH1
BREATHE-3 study design
TRACLEER® (bosentan) Demonstrated Efficacy in
Pediatric Patients1
Hemodynamic improvements
Hemodynamics were measured in 17 patients (see chart below). The mean decrease from baseline in pulmonary vascular resistance (PVR) was 389 dyn•sec•cm-5 at Week 12, which was similar to the effect seen in adults. Hemodynamic improvements from baseline were similar with or without coadministration of epoprostenol.
PVR (dyn•sec•cm-5)
1195 ± 755
Absolute Change
-389 ± 616
Safety Profile for TRACLEER® (bosentan) 32 mg Tablets for
Oral Suspension1
Safety of TRACLEER in pediatric patients similar to that in adults with PAH
TRACLEER was evaluated for safety in 119 pediatric patients in uncontrolled studies.
Risks of Hepatotoxicity
TRACLEER is available only through a restricted distribution program called the TRACLEER REMS Program because of risks of hepatotoxicity. Elevations of liver aminotransferases (ALT, AST) and liver failure have been reported
Dosage Adjustment and Monitoring in Patients Developing Aminotransferase Elevations > 3 x ULN
Adverse events* occurring in ≥3% of adult patients treated with TRACLEER 125-250 mg twice daily and more common on TRACLEER in placebo-controlled studies in pulmonary arterial hypertension
Note: only AEs with onset from start of treatment to 1 calendar day after end of treatment are included. All reported events (at least 3%) are included except those too general to be informative, and those not reasonably associated with the use of the drug because they were associated with the condition being treated or are very common in the treated population.
Respiratory Tract Infection combines the terms “Nasopharyngitis,” “Upper Respiratory Tract Infection,” and “Respiratory Tract Infection.” Combined data from Study 351, BREATHE-1, and EARLY.

Indication and Important Safety Information Including Boxed Warning

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