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.
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
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.
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
with
TRACLEER:
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
