GlobalRPh RX List - EXONDYS 51
- Product / population
- Duchenne muscular dystrophy; renal PK was studied outside the DMD population. No patient-specific dose adjustment is established by this card.
- Renal measure
- Cockcroft-Gault CrCl in a non-DMD study; low muscle mass in DMD limits generalization.
RX mirror: this is not independent corroboration of its underlying label. Check dated-label and formulation limitations.
Renal dosing, restrictions and evidence limits
Exposure increased in non-DMD subjects with mild or moderate renal impairment. Because reduced muscle mass alters creatinine-based estimates in DMD, the study CrCl thresholds cannot be generalized to this population and a specific renal dosage adjustment cannot be recommended. Severe impairment and ESRD were not studied. This is an unresolved dosing-evidence gap, not an affirmative no-adjustment recommendation.