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.
Ambrisentan is indicated for treatment of PAH in adolescents and children (aged 8 to less than 18 years) of WHO Functional Class (FC) II to III including use in combination treatment. Efficacy has been shown in IPAH, familial, corrected congenital and in PAH associated with connective tissue disease.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 5 milligrams ambrisentan, once daily. Afterwards, oral, between 5 milligrams ambrisentan and 10 milligrams ambrisentan, once daily.
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.
In adults, 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.
For:
Regimen A, in case that patient age in years is ≥ 8 and patient weight is ≥ 50 kg
Oral, 5 milligrams ambrisentan, once daily. Afterwards, oral, 10 milligrams ambrisentan, once daily.
Regimen B, in case that patient age in years is ≥ 8 and patient weight is ≥ 35 kg and patient weight is < 50 kg
Oral, 5 milligrams ambrisentan, once daily. Afterwards, oral, 7.5 milligrams ambrisentan, once daily.
Regimen C, in case that patient age in years is ≥ 8 and patient weight is ≥ 20 kg and patient weight is < 35 kg
Oral, 2.5 milligrams ambrisentan, once daily. Afterwards, oral, 5 milligrams ambrisentan, once daily.
Ambrisentan is to be taken orally based on the dose regimen described below:
| Body weight (kg) | Initial once daily dose (mg) | Subsequent once daily dose titration (mg)a |
|---|---|---|
| ≥50 | 5 | 10 |
| ≥35 to <50 | 5 | 7.5 |
| ≥20 to <35 | 2.5 | 5 |
a = dependent on clinical response and tolerability
Ambrisentan in combination with cyclosporine A In paediatric patients, when co-administered with cyclosporine A, the dose of ambrisentan for patients ≥50 kg should be limited to 5 mg once daily, or for patients ≥20 to <50 kg should be limited to 2.5 mg once daily. The patient should be carefully monitored.
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