Dosing and administration

VILTEPSO is given by intravenous infusion, at treatment centers or in the comfort of the patient’s home

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DOSING

VILTEPSO is a weight-based infusion medication for amenable Duchenne patients

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VILTEPSO is given as an 80-mg/kg weekly intravenous infusion

Outlined icon of a weight scale in blue, typically used for tracking body weight.

The appropriate dose of VILTEPSO is calculated based upon the patient’s weight

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VILTEPSO is infused for 60 minutes by a healthcare professional, either at the patient’s home or at a treatment center

LETTER OF MEDICAL NECESSITY TOOL

Ready to prescribe VILTEPSO? Our Letter of Medical Necessity tool can help.

HOW TO DOSE AND ADMINISTER A VILTEPSO INFUSION

Determining dosing for VILTEPSO infusion

VILTEPSO is available as single-dose vials containing 250 mg/5 mL (50 mg/mL) solution. The appropriate dose is based on patient’s body weight, with the recommended dosage of VILTEPSO 80 mg/kg administered once weekly as a 60-minute intravenous infusion. There are no age restrictions for VILTEPSO.

Weekly dosing chart

Odd-numbered body weights (in kg) are shown for illustrative purposes only.

Desktop graphic of weekly dosing schedule for Viltepso.
Arrow icon used to expand or collapse weekly dosing data table. Table showing secondary endpoints from a clinical trial evaluating exon 53 skipping efficiency, dystrophin production, and localization with Viltepso… Mobile graphic showing weekly dosing intervals.

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If volume of VILTEPSO required is <100 mL, dilution in 0.9% sodium chloride for injection, USP, is required such that the total volume in the infusion bag is 100 mL. If the volume of VILTEPSO to be infused is ≥100 mL, dilution is not required.

The actual number of theoretical vials required is 15.04.

When less than 100 mL of VILTEPSO is required:

1.

Withdraw from the 100‑mL infusion bag a volume of 0.9% sodium chloride for injection, USP, equivalent to the calculated volume of VILTEPSO solution that will be added.

2.

Withdraw the calculated volume of VILTEPSO solution from the appropriate number of vials, and inject into the infusion bag, such that the total volume in the bag is 100 mL.

When 100 mL or more of VILTEPSO is required:

Withdraw the calculated volume of VILTEPSO solution from the appropriate number of vials, and inject into an empty infusion bag. Further dilution is not required if the volume of VILTEPSO is 100 mL or more.

After preparation, VILTEPSO infusion
should begin as soon as possible

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Infusion should begin no more than 5 hours after preparation of VILTEPSO and be completed within 6 hours of preparation (allowing for 1 hour of infusion time) if diluted solution is stored at 20°C to 26°C (68°F to 79°F).

Icon of an IV infusion pole, commonly used to indicate intravenous treatment or hospital care.

VILTEPSO is administered via intravenous infusion using a peripheral or central venous catheter. Flush the intravenous access line with 0.9% sodium chloride for injection, USP, after infusion. Filtration of VILTEPSO is not required.

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Do not mix other medications with VILTEPSO or infuse other medications concomitantly via the same intravenous access line.

VILTEPSO Pocket Dosing Guide

This guide serves as a quick reference for information on appropriate VILTEPSO dose and number of corresponding VILTEPSO vials, as well as corresponding volumes of saline, VILTEPSO, and total volume of VILTEPSO solution, for select patient body weights.

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Product Order Form

Complete this form and fax or mail it to NS Support to order VILTEPSO for your appropriate patients with Duchenne muscular dystrophy (DMD) who are amenable to exon 53 skipping.

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NS Pharma Goodwill Replacement Policy

Provides guidance on how to submit a request for replacement credit due to user error or technical malfunctions during the administration of VILTEPSO.

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NS Pharma Return Goods Policy

Explains the requirements for initiating a VILTEPSO product return and describes which products are eligible for credit.

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    Indication

    VILTEPSO is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VILTEPSO. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

    Important Safety Information

    • Warnings and Precautions: Kidney toxicity was observed in animals who received viltolarsen. 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. 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 before starting VILTEPSO. During treatment, monitor urine dipstick every month, and serum cystatin C and urine protein-to-creatinine ratio every three months.
    • Urine should be free of excreted VILTEPSO for monitoring of urine protein. Obtain urine either prior to VILTEPSO infusion, or at least 48 hours after the most recent infusion. Alternatively, use a laboratory test that does not use the reagent pyrogallol red, which has the potential to generate a false positive result due to cross reaction with any VILTEPSO in the urine. If a persistent increase in serum cystatin C or proteinuria is detected, refer to a pediatric nephrologist for further evaluation.
    • Adverse Reactions: The most common adverse reactions include upper respiratory tract infection, injection site reaction, cough, and pyrexia.
    • To report an adverse event, or for general inquiries, please call NS Pharma Medical Information at 1-866-NSPHARM (1-866-677-4276).

    For more information about VILTEPSO, see full Prescribing Information.

    For more information about VILTEPSO, see full Prescribing Information.