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

Pricing for AMONDYS 45

2ml of 50mg/ml vial (Qty: 1)
Appx. price $1642
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