Miscellaneous musculoskeletal disorders:
Indications for: AMONDYS 45
Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping.
Adults and Children:
Give as IV infusion over 35–60mins. 30mg/kg once weekly.
AMONDYS 45 Warnings/Precautions:
Monitor renal function. Measure serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio, and consider measuring GFR prior to initiation. During treatment, monitor urine dipstick monthly, and serum cystatin C and urine protein-to-creatinine ratio every 3 months. To test urine protein: may use urine samples obtained prior to infusion or at least 48hrs after the most recent infusion. Refer to pediatric nephrologist if a persistent increase in serum cystatin C or proteinuria is detected. Renal impairment: monitor closely. Pregnancy. Nursing mothers.
AMONDYS 45 Classification:
Antisense oligonucleotide.
AMONDYS 45 Interactions:
Do not mix or infuse with other drugs concomitantly via same IV access line. May cause false (+) results for urine protein with using pyrogallol red reagent.
Adverse Reactions:
Upper RTI, cough, pyrexia, headache, arthralgia, oropharyngeal pain; renal toxicity.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial (2mL)—1
