Viltepso

Last updated on RxList: 3/22/2021
Viltepso Side Effects Center

What Is Viltepso?

Viltepso (viltolarsen) is an antisense oligonucleotide used to treat Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.

What Are Side Effects of Viltepso?

Side effects of Viltepso include:

  • upper respiratory tract infection,
  • injection site reactions (bruising, redness, swelling),
  • cough,
  • fever,
  • bruising,
  • joint pain,
  • diarrhea,
  • vomiting,
  • abdominal pain,
  • ejection fraction decreased, and
  • hives

Dosage for Viltepso

The recommended dosage of Viltepso is 80 milligrams per kilogram of body weight once weekly.

Viltepso In Children

Viltepso is indicated for the treatment of DMD in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping, including pediatric patients.

What Drugs, Substances, or Supplements Interact with Viltepso?

Viltepso may interact with other medicines.

Tell your doctor all medications and supplements you use.

Viltepso During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Viltepso; it is unknown how it would affect a fetus. It is unknown if Viltepso passes into breast milk or how it might affect a breastfeeding infant. Consult your doctor before breastfeeding.

Additional Information

Our Viltepso (viltolarsen) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Viltepso Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, itching, rash, blistering or peeling; fever; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • pink, brown, or red urine;
  • foamy urine; or
  • swelling in your face, hands, feet, or stomach.

Common side effects may include:

  • redness, bruising, or swelling where an injection was given;
  • fever;
  • cough; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Viltepso (Viltolarsen Injection)

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Viltepso Professional Information

SIDE EFFECTS

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 weekly (0.5 times the recommended dose) (N=8), or 80 mg/kg once weekly (N=8) [see Clinical Studies].

Study 2 was a multicenter, parallel-group, open-label, dose-finding study conducted in Japan. Eligible patients included ambulatory and non-ambulatory males 5 years to less than 18 years of age who were assigned to receive intravenous VILTEPSO 40 mg/kg once weekly (0.5 times the recommended dose) (N=8) or 80 mg/kg once weekly (N=8) for 24 weeks.

Adverse reactions reported in ≥10% of patients treated with VILTEPSO 80 mg/kg/wk in pooled Studies 1 and 2 are displayed in Table 1. The most common adverse reactions (incidence ≥15% in patients treated with VILTEPSO) were upper respiratory tract infection, injection site reaction, cough, and pyrexia. Patients in the pooled analysis were treated with VILTEPSO for 20 to 24 weeks.

Table 1: Adverse Reactions Reported in ≥10% of DMD Patients Treated with VILTEPSO 80 mg/kg Once Weekly (Pooled Studies 1 and 2)

Adverse Reaction VILTEPSO 80 mg/kg Once Weekly
(n=16) %
Upper respiratory tract infection* 63
Injection site reaction** 25
Cough 19
Pyrexia 19
Contusion 13
Arthralgia 13
Diarrhea 13
Vomiting 13
Abdominal pain 13
Ejection fraction decreased 13
Urticaria 13
* Upper respiratory tract infection includes the following terms: upper respiratory tract infection, nasopharyngitis, and rhinorrhea.
**Injection site reaction includes the following terms: injection site bruising, injection site erythema, injection site reaction, and injection site swelling.

Immunogenicity

As with all oligonucleotides, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies may be misleading.

For Study 1, samples collected from all 16 patients at Day 1 (pre-dose), Week 5, Week 13, and Week 24 were assessed for anti-viltolarsen antibodies. All samples were determined to be antibody negative. For the same study, serum samples collected from all 16 patients at Day 1 (pre-dose), Week 13, and Week 24 were analyzed for anti-dystrophin antibodies. Anti-dystrophin antibodies were detected in 1 out of 16 patients (6.25%) at Weeks 13 and 24; however, at Weeks 37, 49, 73, and 97, no anti-dystrophin antibodies were detected in the same patient. Further, this patient achieved a change from baseline in dystrophin levels that was comparable to the mean change in his dosage group (80 mg/kg/week) and there were no adverse events reported with this antibody production. For Study 2, all samples collected from the 16 patients were determined to be both anti-viltolarsen antibody and anti-dystrophin antibody negative. Overall, there was a lack of observed immunogenicity, which indicates that viltolarsen is not highly immunogenic.

DRUG INTERACTIONS

No Information provided

Read the entire FDA prescribing information for Viltepso (Viltolarsen Injection)

© Viltepso Patient Information is supplied by Cerner Multum, Inc. and Viltepso Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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