Amondys-45 (casimersen)
Duchenne Muscular Dystrophy-Exon Skipping Antisense Oligonuc Intravenous Vial (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Casimersen is an antisense oligonucleotide that binds to exon 45 of dystrophin pre-messenger RNA (pre-mRNA).
Casimersen is an antisense oligonucleotide of the phosphorodiamidate morpholino oligomer (PMO) subclass; the drug binds to exon 45 of dystrophin pre-mRNA. This binding promotes exon 45 exclusion during mRNA processing in patients with genetic mutations amenable to exon 45 skipping. By restoring the reading frame, casimersen enables the production of a truncated, yet partially functional, dystrophin protein.
Following IV administration of casimersen, peak plasma concentrations are reached at the end of the infusion. Exposure to casimersen increases in a dose-proportional manner, with minimal accumulation after once-weekly dosing. Casimersen plasma protein binding ranges from 8.4% to 31.6%, and is not concentration dependent.
Casimersen is not significantly metabolized by hepatic enzymes. The drug is primarily excreted unchanged through the urine with an elimination half-life of approximately 3.5 hours. Casimersen does not inhibit major cytochrome P-450 (CYP) enzymes and is not expected to cause clinically significant drug-drug interactions.
USES: Casimersen 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: casimersen
Pronunciation: (KAS-i-MER-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 Amondys-45
Indications
The following indications are listed for Amondys-45:
- Duchenne Muscular Dystrophy Due To Genetic Mutation Amenable To Exon 45 Skipping Therapy
Also known as: Dmd Amenable To Exon Skipping Therapy - Exon 45, Duchenne Muscular Dystrophy Amenable To Exon 45 Skipping, Duchenne Muscular Dystrophy Due To Genetic Mutation Amenable To Exon 45 Skipping.
Dosing
No dosing information is available for this tab.
No dosing information is available for this tab.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Amondys-45 100 Mg/2 Ml Vial | Maintenance | Infuse 30 mg/kg over 35-60 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
*Serious hypersensitivity to casimersen or any of its inactive ingredients.
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 (>20% and at least 5% more frequent than placebo) were upper respiratory tract infection, cough, pyrexia, headache, arthralgia, and oropharyngeal pain.
Rare or Very Rare
- Anaphylaxis
- Angioedema
More Frequent
- Arthralgia
- Cough
- Fever
- Headache disorder
- Pain in oropharynx
- Upper respiratory infection
Less Frequent
- Dizziness
- Earache
- Infection of ear
- Nausea
- Pain
Precautions
No enhanced messaging available.
Casimersen is indicated for the treatment of DMD in pediatric patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping.
In juvenile male rats, weekly IV administration of casimersen at the highest dose (900 mg/kg) caused renal tubular degeneration and necrosis. No effects were seen on the male reproductive system, neurobehavioral development, or immune function. At the no-effect dose (300 mg/kg), plasma exposure was 4 times that in humans at the recommended dose of 30 mg/kg once weekly.
Casimersen has not been studied in female patients. There is no human or animal data available to assess the use of casimersen during pregnancy.
There are no data on whether casimersen is present in human milk or has any effects on milk production or on the breastfed infant. Consider the benefits of breastfeeding along with the mother's need for casimersen and potential risks to the infant.
No specific dosage adjustment is recommended in geriatric patients.
Because DMD primarily affects children and young adults, there is no experience with casimersen in geriatric patients.
ICD codes
| Code | Type | Description |
|---|---|---|
| Duchenne muscular dystrophy due to genetic mutation amenable to exon 45 skipping therapy | ||
| G71.01 | ICD10CM | Duchenne or becker muscular dystrophy |
ICD code information from First Databank (FDB).
Formulary status
Search health-plan coverage for this drug by ZIP code.
Choose the first character of a health plan name.
Last reviewed · Source: First Databank (FDB) drug data
On this page
Actions
Sign in to save favorites
Saving this drug requires a free Physicians Office Resource account.