Bosentan

NDICATIONS AND USAGE

LuciBose is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):

In adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-toright shunts 18%

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.

DOSAGE AND ADMINISTRATION

• Patients older than 12 years of age: initiate at 62.5 mg orally twice daily; for patients weighing greater than 40 kg, increase to 125 mg orally twice daily after 4 weeks.

• Patients 12 years of age and younger: dosage is based on weight, full prescribing information.
• Reduce the dose and closely monitor patients developing aminotransferase elevations more than 3x Upper Limit of Normal (ULN) .

DOSAGE FORMS AND STRENGTHS

Tablets: 125 mgx56 tablets