Alternate Name(s):
AMONDYS-45
Classification:
Antisense Oglionucleotide
Original Date:
June 2024
Indications:
- Duchenne Muscular Dystrophy (DMD)
Reconstitution and Stability:
- Available as a 50mg/mL - 2mL vial single dose vial
- Refrigerate vials and protect from light
- Solution is a clear to slightly opalescent, colourless liquid. It may contain trace amounts of small, white to off-white amorphous particles
- Allow vials to warm to room temperature. Mix the contents of each vial by gently inverting 2-3 times. Do not shake
- Casimersen should be diluted to a volume to 100 to 150 mL of 0.9% sodium chloride USP
- Diluted solution should be administered using an in-line 0.2 micron filter
- Diluted infusion should be administered within 4 hours. If not possible, diluted product can be stored for up to 24 hours at 2-8 degrees Celsius. Do not freeze.
Compatibility:
- Compatible: 0.9% NaCl
- Incompatible: Do not mix other medication or infuse other medications concomitantly via the same intravenous access with AMONDYS-45
Administration:
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
| SC | NO |
| IM | NO |
| IV direct | NO |
| IV intermittent infusion |
Yes Dilution - in 100-150mL of 0.9%NaCl Infusion time: over 35-60 minutes using a 0.2 micron in-line filter |
Dosage:
(For neonatal dosages, refer to Neonatal IV Drug Manual.)
- 30 mg/kg IV once weekly
Potential hazards of parenteral administration:
- Cough, oropharyngeal pain
- Fever
- Nausea, dizziness, headache
- Arthralgia
Notes:
- Kidney toxicity observed in animals who received casimersen
- Serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio should be measured before starting treatment
- Monitor urine dipstick every month
- Monitor serum cystatin C and urine protein-to-creatinine ratio every 3 months
- Limited to Health Canada’s Special Access Program (SAP)