GlobalRPh RX List - OPSUMIT
- Product / population
- Macitentan - OPSUMIT; selected renal source sections only, not a complete prescribing monograph.
- Renal measure
- Creatinine clearance (CrCl), mL/min; selected passage does not establish an estimating equation.
RX mirror: this is not independent corroboration of its underlying label. Check dated-label and formulation limitations.
Renal dosing, restrictions and evidence limits
At CrCl 15-29 mL/min, macitentan and active-metabolite exposure increased by 30% and 60%; the source considers these changes not clinically relevant. This pharmacokinetic statement alone does not establish a dialysis protocol. Do not transfer it to OPSYNVI, which also contains tadalafil and has additional renal restrictions.