Active Ingredient: Bosentan
Bosentan is indicated for the treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III. Efficacy has been shown in:
Some improvements have also been shown in patients with PAH WHO functional class II.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 62.5 milligrams bosentan, 2 times daily, over the duration of 4 weeks. Afterwards, oral, 125 milligrams bosentan, 2 times daily.
In adult patients, bosentan treatment should be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily. The same recommendations apply to re-introduction of bosentan after treatment interruption.
In the event of clinical deterioration (e.g. decrease in 6-minute walk test distance by at least 10% compared with pre-treatment measurement) despite bosentan treatment for at least 8 weeks (target dose for at least 4 weeks), alternative therapies should be considered. However, some patients who show no response after 8 weeks of treatment with bosentan may respond favourably after an additional 4 to 8 weeks of treatment.
In the event of late clinical deterioration despite treatment with bosentan (i.e. after several months of treatment), the treatment should be re-assessed. Some patients not responding well to 125 mg twice daily of bosentan may slightly improve their exercise capacity when the dose is increased to 250 mg twice daily. A careful benefit/risk assessment should be made, taking into consideration that the liver toxicity is dose dependent.
There is limited experience with abrupt discontinuation of bosentan in patients with PAH. No evidence for acute rebound has been observed. However, to avoid the possible occurrence of harmful clinical deterioration due to potential rebound effect, gradual dose reduction (halving the dose for 3 to 7 days) should be considered. Intensified monitoring is recommended during the discontinuation period. If the decision to withdraw bosentan is taken, it should be done gradually while an alternative therapy is introduced.
It should be taken orally morning and evening, with or without food.
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