Golodirsen Disease Interactions

Renal toxicity has been observed in animals receiving antisense oligonucleotides including golodirsen, casimersen, and viltolarsen. Renal toxicity has not been observed in clinical studies with these agents, but clinical experience is limited, and renal toxicity, including potentially fatal glomerulonephritis, has been observed after administration of some antisense oligonucleotides. Serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio should be measured prior to therapy with urine dipstick repeated monthly and serum cystatin C and UPCR repeated every 3 months during therapy. The glomerular filtration rate may be measured using an exogenous filtration marker prior to therapy. For patients with Duchenne muscular dystrophy (DMD), creatinine may not be a reliable measure of kidney function due to a reduced skeletal muscle mass. If persistent increases in serum cystatin C or proteinuria are detected, the patient should be referred to a nephrologist for further evaluation. Patients with known renal function impairment should be closely monitored during treatment.

Golodirsen has not been studied in patients with hepatic impairment. Caution is advised.