Active Ingredient: Ambrisentan
Ambrisentan is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
5 - 10 mg
From 5 To 10 mg once every day
Ambrisentan is to be taken orally to begin at a dose of 5 mg once daily and may be increased to 10 mg daily depending upon clinical response and tolerability.
When used in combination with tadalafil, ambrisentan should be titrated to 10 mg once daily.
In the AMBITION study, patients received 5 mg ambrisentan daily for the first 8 weeks before up titrating to 10 mg, dependent on tolerability. When used in combination with tadalafil, patients were initiated with 5 mg ambrisentan and 20 mg tadalafil. Dependent on tolerability the dose of tadalafil was increased to 40 mg after 4 weeks and the dose of ambrisentan was increased to 10 mg after 8 weeks. More than 90% of patients achieved this. Doses could also be decreased
depending on tolerability.
Limited data suggest that the abrupt discontinuation of ambrisentan is not associated with rebound worsening of PAH.
When co-administered with cyclosporine A, the dose of ambrisentan should be limited to 5 mg once daily and the patient should be carefully monitored.
It can be taken with or without food.
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