Safebo Special Precautions

Bosentan is contra-indicated in patients with moderate to severe hepatic impairment (Child-Pugh Class B or C). Liver-aminotransferase concentrations should be measured before starting therapy, at monthly intervals during therapy, and 2 weeks after any increase in dose.
Bosentan therapy should not be started in patients with concentrations more than 3 times the upper limit of normal.
If concentrations increase to between 3 and 5 times the upper limit of normal during treatment, Bosentan should be stopped or the dose reduced and concentrations should be monitored every 2 weeks until they are below the pretreatment value; therapy may then be continued or reintro-duced, but aminotransferase concentrations should be checked after 3 days, after a further of 2 weeks, and then monthly.
If concentrations rise to more than 5 times the upper limit of normal, Bosentan should be stopped; reintroduction may be reconsidered when concentrations return to below the pretreat-ment value.