GlobalRPh RX List - KALYDECO
- Product / population
- Oral ivacaftor single agent; not combination CFTR products.
- Renal measure
- CrCl <=30 mL/min for the severe-impairment caution, as printed.
RX mirror: this is not independent corroboration of its underlying label. Check dated-label and formulation limitations.
Renal dosing, restrictions and evidence limits
No adjustment is needed for mild or moderate renal impairment. Use cautiously in severe impairment, defined here as CrCl <=30, or ESRD; these populations were not studied. This caution does not provide a severe-impairment dose or dialysis schedule.