viltepso
Viltepso (Viltolarsen) is a medication used to treat Duchenne Muscular Dystrophy.
Viltolarsen · by Nippon Shinyaku
Key facts
- Active ingredient
- Viltolarsen
- Form
- Injectable
- Strength
- Viltolarsen 250MG/5ML (50MG/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- duchenne muscular dystrophy
- Manufacturer
- Nippon Shinyaku
- FDA application
- NDA212154
What is Viltepso?
From the FDA label:VILTEPSO (viltolarsen) injection is a sterile, preservative-free, aqueous solution for intravenous administration. VILTEPSO is a clear and colorless solution. VILTEPSO is supplied in single-dose vials containing 250 mg/5 mL viltolarsen (50 mg/mL) in 0.9% sodium chloride. Each milliliter of VILTEPSO contains 50 mg viltolarsen and 9 mg sodium chloride in water for injection. The final product is adjusted to a pH ranging between 7.0 and 7.5 using hydrochloric acid and/or sodium hydroxide. Viltolarsen is an antisense oligonucleotide of the phosphorodiamidate morpholino oligomer (PMO) subclass. PMOs are synthetic molecules in which the five-membered ribofuranosyl rings found in natural DNA and RNA are replaced by a six-membered morpholino ring. Each morpholino ring is linked through an uncharged phosphorodiamidate moiety rather than the negatively charged phosphate linkage that is present in natural DNA and RNA. Each phosphorodiamidate morpholino subunit contains one of the heterocyclic bases found in DNA (adenine, cytosine, guanine, or thymine). Viltolarsen contains 21 linked subunits. The molecular formula of viltolarsen is C 244 H 381 N 113 O 88 P 20 and the molecular weight is 6924.82 daltons. The structure and base sequence of viltolarsen are shown in Figure 1 . Figure 1: Structural Formula of Viltolarsen Figure
How to use
Serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio should be measured before starting VILTEPSO. ( 2.1 ) Recommended dosage is 80 milligrams per kilogram of body weight once weekly. ( 2.2 ) Administer as an intravenous infusion over 60 minutes. ( 2.2 , 2.4 ) If the volume of VILTEPSO required is less than 100 mL, dilution in 0.9% Sodium Chloride Injection, USP, is required. ( 2.3 ) 2.1 Monitoring to Assess Safety Serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio should be measured before starting VILTEPSO. Consider measurement of glomerular filtration rate prior to initiation of VILTEPSO. Monitoring for kidney toxicity during treatment is recommended. Obtain the urine samples prior to infusion of VILTEPSO or at least 48 hours after the most recent infusion [see Warnings and Precautions ( 5.1 )]. 2.2 Dosing Information The recommended dosage of VILTEPSO is 80 mg/kg administered once weekly as a 60-minute intravenous infusion. If a dose of VILTEPSO is missed, it should be administered as soon as possible after the scheduled dose time. 2.3 Preparation Instructions Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Prepare the VILTEPSO dose using aseptic technique. Calculate the total dose of VILTEPSO to be administered based on the…
Side effects
The most common adverse reactions (incidence ≥15% in patients treated with VILTEPSO) were upper respiratory tract infection, injection site reaction, cough, and pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact NS Pharma at 1-866 NSPHARM (1-866-677-4276) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials with VILTEPSO, 32 patients have been exposed to VILTEPSO once weekly, ranging between 40 mg/kg (0.5 times the recommended dosage) and 80 mg/kg (the recommended dosage), including 16 patients treated for greater than 12 months and 8 patients treated for greater than 24 months as part of an ongoing open-label extension study. All patients were male and had genetically confirmed DMD. Study 1 was a multicenter, 2-period, dose-finding study conducted in the United States and Canada in males 4 years to less than 10 years of age on a stable corticosteroid regimen for at least 3 months. During the initial period (first 4 weeks) of Study 1, patients were randomized (double-blind) to VILTEPSO or placebo. All patients then received 20 weeks of VILTEPSO 40 mg/kg once…
Warnings
Important safety information
Kidney Toxicity: Based on animal data, may cause kidney toxicity. Kidney function should be monitored; creatinine may not be a reliable measure of renal function in DMD patients. ( 5.1 , 13.2) 5.1 Kidney Toxicity Kidney toxicity was observed in animals who received viltolarsen [see Use in Specific Populations ( 8.4 )]. Although kidney toxicity was not observed in the clinical studies with VILTEPSO, the clinical experience with VILTEPSO is limited, and kidney toxicity, including potentially fatal glomerulonephritis, has been observed after administration of some antisense oligonucleotides. Kidney function should be monitored in patients taking VILTEPSO. Because of the effect of reduced skeletal muscle mass on creatinine measurements, serum creatinine may not be a reliable measure of kidney function in DMD patients. Serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio should be measured before starting VILTEPSO. Consider also measuring glomerular filtration rate using an exogenous filtration marker before starting VILTEPSO. During treatment, monitor urine dipstick every month, and serum cystatin C and urine protein-to-creatinine ratio every three months. Only urine expected to be free of excreted VILTEPSO should be used for monitoring of urine protein. Urine obtained on the day of VILTEPSO infusion prior to the infusion, or urine obtained at least 48 hours after the most recent infusion, may be used. Alternatively, use a laboratory test that does not use the reagent pyrogallol red, as this reagent has the potential to cross react with any VILTEPSO that is excreted in the urine and thus lead to a false positive result for urine protein. If a persistent increase in serum cystatin C or proteinuria is detected, refer to a pediatric nephrologist for further evaluation.
Who should not take Viltepso
None. None ( 4 )
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- What does Viltepso treat?
- Viltepso (Viltolarsen) may be used to treat duchenne muscular dystrophy, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Viltepso?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Viltepso. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Viltepso?
- Viltepso is marketed by Nippon Shinyaku. You can see Nippon Shinyaku's full profile, rating, and other products on pharmaranks.
- Is Viltepso a brand-name or generic drug?
- Viltepso is a brand-name product with the active ingredient Viltolarsen.
- Is Viltepso available over the counter?
- No. Viltepso is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Viltepso come in?
- Viltepso is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Viltepso FDA-registered?
- Viltepso is on record with the U.S. FDA under application number NDA212154. You can verify this on its official FDA label.
- Is Viltepso safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Viltepso. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Viltepso?
- Viltepso's side effects are taken directly from its FDA label. From the label: The most common adverse reactions (incidence ≥15% in patients treated with VILTEPSO) were upper respiratory tract infection, injection site reaction, cough, and pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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