HCP VILTEPSO Access Support

VILTEPSO Access Support

At NS Support Patient Access Solutions, we understand that prescribing treatment is just the beginning. We’re your dedicated partner in helping Duchenne muscular dystrophy families navigate access challenges and find the resources they need.

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.

Your Partners in Patient Care

Meet your NS Support Patient Access Solutions Team:

Case Manager 

A personal connection who provides ongoing support to help manage and expedite access and coordinate care for patients and their caregivers.

Patient Engagement Lead 

Provides a constant care connection throughout your patient’s treatment journey, helping to reduce delays in access to treatment.

Patient Access Professional 

A specialist who can help streamline coverage approvals and appeals and work closely with the entire access team to identify appropriate treatment providers and ensure continuation of coverage.

Identify Treatment Eligibility

Check if your patient’s mutation range is amenable to exon-skipping therapy.

Exon Skipping Tool

Supporting Patients and Practices

From the moment a patient is ready to start treatment, our NS Support Patient Access Solutions team is ready to support providers throughout the journey.

Contact the NS Support Patient Access Solutions team for referrals to patient foundations and advocacy groups, and for information about the following programs: