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Vyondys 53 Generic Name & Formulations
Legal Class
Rx
General Description
Golodirsen 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
Vyondys 53 Indications
Indications
Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.
Vyondys 53 Dosage and Administration
Adults and Children
Give as IV infusion over 35–60mins. 30mg/kg once weekly.
Vyondys 53 Contraindications
Not Applicable
Vyondys 53 Boxed Warnings
Not Applicable
Vyondys 53 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 a pediatric nephrologist if a persistent increase in serum cystatin C or proteinuria is detected. Interrupt or slow infusion if hypersensitivity reaction occurs. Renal impairment: monitor closely. Pregnancy. Nursing mothers.
Vyondys 53 Pharmacokinetics
See Literature
Vyondys 53 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.
Vyondys 53 Adverse Reactions
Adverse Reactions
Headache, pyrexia, fall, abdominal pain, nasopharyngitis, cough, vomiting, nausea; renal toxicity, hypersensitivity reactions.
Vyondys 53 Clinical Trials
See Literature
Vyondys 53 Note
Not Applicable
Vyondys 53 Patient Counseling
See Literature
