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Amondys 45 Generic Name & Formulations
Legal Class
Rx
General Description
Casimersen 50mg/mL; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Antisense oligonucleotide.
How Supplied
Single-dose vial (2mL)—1
Manufacturer
Generic Availability
NO
Amondys 45 Indications
Indications
Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping.
Amondys 45 Dosage and Administration
Adults and Children
Give as IV infusion over 35–60mins. 30mg/kg once weekly.
Amondys 45 Contraindications
Not Applicable
Amondys 45 Boxed Warnings
Not Applicable
Amondys 45 Warnings/Precautions
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 Pharmacokinetics
See Literature
Amondys 45 Interactions
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.
Amondys 45 Adverse Reactions
Adverse Reactions
Upper RTI, cough, pyrexia, headache, arthralgia, oropharyngeal pain; renal toxicity.
Amondys 45 Clinical Trials
See Literature
Amondys 45 Note
Not Applicable
Amondys 45 Patient Counseling
See Literature
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