GlobalRPh RX List - Golodirsen (Vyondys 53)
- Product / population
- VYONDYS 53 in Duchenne muscular dystrophy; low muscle mass limits creatinine-based estimates.
- Renal measure
- Cystatin C, urine protein testing and potential measured GFR; non-DMD MDRD studies are not a DMD renal dosing rule.
RX mirror: this is not independent corroboration of its underlying label. Check dated-label and formulation limitations.
Kidney-toxicity and assay-interference subsections also read (turn997795view5, turn948264view6).
Renal dosing, restrictions and evidence limits
Reduced muscle mass makes creatinine an unreliable kidney marker in DMD. Before therapy, obtain cystatin C, urine dipstick and urine protein/creatinine ratio, and consider measured GFR with an exogenous marker. Monitor urine dipstick monthly and cystatin C/protein-creatinine ratio every three months. Collect urine before infusion or at least 48 hours afterward; persistent abnormalities warrant pediatric nephrology assessment. No specific renal dose adjustment can be recommended from non-DMD adult eGFR studies. The drug can interfere with pyrogallol-red urine protein assays; use appropriate sampling or a noninterfering method. A creatinine-based estimate or isolated urine protein result must be interpreted in this disease and assay context.