Amondys-45

Drug overview for AMONDYS-45 (casimersen):

Generic name: casimersen (KAS-i-MER-sen)
Drug class: Duchenne Muscular Dystrophy-Exon Skipping Antisense Oligonuc
Therapeutic class: Locomotor System

Casimersen is an antisense oligonucleotide that binds to exon 45 of dystrophin pre-messenger RNA (pre-mRNA).

No enhanced Uses information available for this drug.

DRUG IMAGES

AMONDYS-45 100 MG/2 ML VIAL

The following indications for AMONDYS-45 (casimersen) have been approved by the FDA:

Indications:
Duchenne muscular dystrophy due to genetic mutation amenable to exon 45 skipping therapy

Professional Synonyms:
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 information for AMONDYS-45
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
AMONDYS-45 100 MG/2 ML VIAL	Maintenance	Adults infuse 30 mg/kg over 35-60 minute(s) by intravenous route once weekly

Moderate List
No disease contraindications

The following adverse reaction information is available for AMONDYS-45 (casimersen):

Overview
Severe
Less Severe

Adverse reaction overview.

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.

There are 2 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Anaphylaxis Angioedema

There are 11 less severe adverse reactions.

More Frequent	Less Frequent
Arthralgia Cough Fever Headache disorder Pain in oropharynx Upper respiratory infection	Dizziness Earache Infection of ear Nausea Pain

Rare/Very Rare
None.

The following precautions are available for AMONDYS-45 (casimersen):

Pediatric
Pregnant
Lactation
Geriatric

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.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

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.

Because DMD primarily affects children and young adults, there is no experience with casimersen in geriatric patients.

Duchenne dystrophy amenable to exon 45 skipping therapy
G71.01	Duchenne or becker muscular dystrophy