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:

Consider slowing the infusion, interrupting, or discontinuing therapy if hypersensitivity reactions occur; treat appropriately and monitor until resolves. 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; hypersensitivity reactions, renal toxicity.

Metabolism:

Casimersen is metabolically stable in human hepatic microsomal incubations.

Drug Elimination:

Renal (>90%). 

Half-life: 3.5 hours (SD 0.4 hours).

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (2mL)—1