Version May 2024
Duchenne muscular dystrophy: IV: 80 mg/kg once weekly.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); monitor closely.
There are no dosage adjustments provided in the manufacturer's labeling; however, viltolarsen is not hepatically eliminated.
Refer to adult dosing.
(For additional information see "Viltolarsen: Pediatric drug information")
Duchenne muscular dystrophy (DMD): Children and Adolescents: IV: 80 mg/kg/dose once weekly. Note: DMD primarily affects males, and rarely females; therefore, clinical trial experience is limited to the male population.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Viltolarsen is mainly excreted unchanged in the urine and renal impairment may increase exposure. However, creatinine is not a reliable measurement of kidney function due to the reduced skeletal mass in patients with Duchenne muscular dystrophy (DMD) so no specific dosage adjustment can be recommended based on eGFR; closely monitor patients with known renal impairment.
There are no dosage adjustments provided in the manufacturer's labeling; however, viltolarsen is not hepatically eliminated.
Although not observed in clinical trials with viltolarsen, kidney toxicity was observed in animal studies (juvenile mice) at higher than recommended doses. The concern for a potential for renal toxicity with viltolarsen stems from cases of glomerulonephritis, including potentially fatal cases, observed with some antisense oligonucleotides, specifically inotersen. These cases of inotersen-induced glomerulonephritis were accompanied by nephrotic syndrome.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Cardiovascular: Reduced ejection fraction (13%)
Dermatologic: Urticaria (13%)
Gastrointestinal: Abdominal pain (13%), diarrhea (13%), vomiting (13%)
Hematologic & oncologic: Bruise (13%)
Local: Injection site reaction (25%; including bruising at injection site, erythema at injection site, swelling at injection site)
Neuromuscular & skeletal: Arthralgia (13%)
Respiratory: Cough (19%), upper respiratory tract infection (63%, including nasopharyngitis, rhinorrhea)
Miscellaneous: Fever (19%)
There are no contraindications listed in the manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Viltepso: 250 mg/5 mL (5 mL)
No
Solution (Viltepso Intravenous)
250 mg/5 mL (per mL): $338.40
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IV: Administer immediately, no more than 5 hours after preparation; complete infusion within 6 hours of preparation. Infuse via peripheral or central venous catheter. Do not mix with other medications or infuse other medications concomitantly via the same IV access line. Administer by IV infusion over 60 minutes. Flush IV access line with NS after infusion. Discard unused portion.
IV: Administer by IV infusion over 60 minutes via central or peripheral catheter. Administration should begin as soon as possible after preparation or within 5 hours of preparation; complete infusion within 6 hours of preparation. Do not mix with other medications or infuse other medications concomitantly via the same IV access line. Flush IV access line with NS after infusion. Discard unused portion.
Duchenne muscular dystrophy: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.
None known.
There are no known significant interactions.
Viltolarsen is approved for the treatment of Duchenne muscular dystrophy, a condition that primarily affects males. Animal reproduction studies have not been conducted and females were not included in the original studies (Clemens 2020).
It is not known if viltolarsen is present in breast milk.
Viltolarsen is approved for the treatment of Duchenne muscular dystrophy, a condition that primarily affects males; females were not included in the original studies (Clemens 2020). According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Urine dipstick (baseline and monthly), serum cystatin C (baseline and every 3 months), urine protein-to-creatinine ratio (baseline and every 3 months), GFR using exogenous filtration marker (baseline); signs and symptoms of kidney toxicity.
Binds to exon 53 of dystrophin premessenger RNA (mRNA), resulting in exclusion of this exon during mRNA processing. Exon 53 skipping allows for production of an internally truncated dystrophin protein in patients with genetic mutations that are amenable to exon 53 skipping.
Distribution: Vdss: 300 mL/kg.
Protein binding: ~40%.
Metabolism: Metabolically stable; no metabolites detected in plasma or urine.
Bioavailability: 100%.
Half-life elimination: 2.5 hours.
Time to peak: ~1 hour.
Excretion: Urine: Primarily as unchanged drug.
Altered kidney function: Renal impairment is expected to increase exposure.
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