Liver function | Treatment and monitoring recommendations |
Before treatment | Liver ALT/AST levels must be measured prior to initiation of treatment and subsequently at monthly intervals. In addition, levels must be measured 2 weeks after any dose increase |
ALT/AST levels | |
>3–≤5×ULN | Confirm by another liver test; if confirmed, reduce daily dose or stop treatment and monitor ALT/AST levels at least every 2 weeks. If ALT/AST levels return to pre-treatment values, consider continuing or re-introducing bosentan according to re-introduction conditions¶ |
5–≤8×ULN | Confirm by another liver test; if confirmed, stop treatment and monitor ALT/AST levels at least every 2 weeks. If ALT/AST levels return to pre-treatment values, consider continuing or re-introducing bosentan according to re-introduction conditions¶ |
>8×ULN | Treatment must be stopped and re-introduction of bosentan is not to be considered |
Associated clinical symptoms of injury# | Treatment must be stopped and re-introduction of bosentan is not to be considered |