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Viltepso Generic Name & Formulations
Legal Class
Rx
General Description
Viltolarsen 50mg/mL; soln for IV infusion; preservative-free.
Pharmacological Class
Antisense oligonucleotide.
How Supplied
Single-dose vial (5mL)—1
Manufacturer
Generic Availability
NO
Viltepso Indications
Indications
Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.
Viltepso Dosage and Administration
Adults and Children
Give as IV infusion over 60mins. 80mg/kg once weekly.
Viltepso Contraindications
Not Applicable
Viltepso Boxed Warnings
Not Applicable
Viltepso Warnings/Precautions
Warnings/Precautions
Monitor renal function. Measure baseline serum cystatin C, urine dipstick, urine protein-to-creatinine ratio, and consider measuring GFR prior to initiation. During treatment, monitor urine dipstick monthly, serum cystatin C and urine protein-to-creatinine ratio every 3 months. Refer to pediatric nephrologist if a persistent increase in serum cystatin C or proteinuria is detected. Renal impairment: monitor closely. Pregnancy. Nursing mothers.
Viltepso Pharmacokinetics
See Literature
Viltepso Interactions
Interactions
Do not mix or infuse with other drugs concomitantly via same IV access line. Avoid pyrogallol red reagent for lab testing; may cause false (+) result for urine protein.
Viltepso Adverse Reactions
Adverse Reactions
Upper RTI, inj site reaction, cough, pyrexia; renal toxicity.
Viltepso Clinical Trials
See Literature
Viltepso Note
Not Applicable
Viltepso Patient Counseling
See Literature
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