Viltepso (viltolarsen)
Duchenne Muscular Dystrophy-Exon Skipping Antisense Oligonuc Intravenous Vial (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Viltolarsen is an antisense oligonucleotide of the phosphorodiamidate morpholino oligomer subclass.
Viltolarsen is an antisense oligonucleotide of the phosphorodiamidate morpholino oligomer subclass; the drug binds to exon 53 of dystrophin pre-mRNA. In patients with Duchenne muscular dystrophy (DMD), frameshift mutations in the dystrophin gene disrupt the translational reading frame, resulting in the production of a nonfunctional dystrophin protein. Lack of dystrophin results in degeneration and necrosis of muscle fibers, inflammation, and ultimately replacement of muscle by fibrotic and adipose tissue.
By targeting a region in exon 53, viltolarsen restores the mRNA reading frame, inducing production of de novo truncated dystrophin protein.
Following IV infusions of viltolarsen, peak plasma concentrations are reached at the end of the infusion. Viltolarsen plasma protein binding ranges from 39% to 40% and is not concentration dependent. Viltolarsen is not metabolized by hepatic enzymes and no metabolites are detected in plasma or urine.
The drug is mainly excreted unchanged in the urine with an elimination half-life of 2.5 hours.
USES: Viltolarsen is used to treat a certain inherited muscle disorder (Duchenne muscular dystrophy-DMD). This disorder is caused by a lack of a certain muscle protein (dystrophin). This medication can increase the amount of dystrophin in your body.
Generic name: viltolarsen
Pronunciation: (VIL-toe-LAR-sen)
Drug class: Duchenne Muscular Dystrophy-Exon Skipping Antisense Oligonuc
Therapeutic class: Locomotor System
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Viltepso
Indications
The following indications are listed for Viltepso:
- Duchenne Muscular Dystrophy Due To Genetic Mutation Amenable To Exon 53 Skipping Therapy
Also known as: Dmd Amenable To Exon Skipping Therapy - Exon 53, Dmd Due To Genetic Mutation Amenable To Exon 53 Skipping, Duchenne Muscular Dystrophy Amenable To Exon 53 Skipping.
Dosing
No dosing information is available for this tab.
No dosing information is available for this tab.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Viltepso 250 Mg/5 Ml Vial | Maintenance | Infuse 80 mg/kg over 60 minute(s) by intravenous route once weekly. |
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*None.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- No disease contraindications
Adverse reactions
The most common adverse reactions (>=15%) reported with viltolarsen in clinical studies were upper respiratory tract infection, injection site reaction, cough, and pyrexia.
Rare or Very Rare
- Glomerulonephritis
More Frequent
- Cough
- Fever
- Injection site sequelae
- Upper respiratory infection
Less Frequent
- Acute abdominal pain
- Arthralgia
- Bruising
- Diarrhea
- Urticaria
- Vomiting
Precautions
No enhanced messaging available.
Viltolarsen is indicated for the treatment of DMD in pediatric patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. In juvenile male mice, weekly IV administration of viltolarsen at the highest dose (1200 mg/kg) resulted in deaths due to renal toxicity, reduced body weight gain, and delayed sexual maturity. At the no-effect dose (60 mg/kg), plasma exposure was similar to that in humans at the recommended dose of 80 mg/kg once weekly.
Viltolarsen has not been studied in female patients. It is not known whether the drug is associated with risk if used in pregnant women.
It is not known whether viltolarsen is distributed into human milk, or if the drug has any effects on the breastfed infant or on milk production. Consider the benefits of breastfeeding along with the mother's need for viltolarsen and potential risks to the infant.
No specific dosage adjustment is recommended in geriatric patients.
DMD is largely a disease of children and young adults. Safety and efficacy of viltolarsen have not been established in geriatric patients 65 years of age and older.
ICD codes
| Code | Type | Description |
|---|---|---|
| Duchenne muscular dystrophy due to genetic mutation amenable to exon 53 skipping therapy | ||
| G71.01 | ICD10CM | Duchenne or becker muscular dystrophy |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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