AMONDYS 45
- Brand Name: Amondys 45
- Active Ingredient: Casimersen
- Strength: 100mg/2mL injection
- Originator Name/ Marketing-authorisation Holder: Sarepta Therapeutics
What is Amondys 45, and what it is used for:?
Amondys 45 (casimersen injection) is a sterile, aqueous, preservative-free, concentrated solution for dilution prior to intravenous administration. It is a clear-slightly opalescent, colorless liquid and may contain trace amounts of small, white to off-white amorphous particles. Amondys 45 is supplied in single-dose vials containing Casimersen 100 mg (50 mg/mL). Each milliliter of Amondys 45 contains: casimersen 50 mg; potassium chloride 0.2 mg; potassium phosphate monobasic 0.2 mg; sodium chloride 8 mg; and sodium phosphate dibasic 1.14 mg, anhydrous, in water for injection. This medicinal product may contain sodium hydroxide or hydrochloric acid to adjust pH.
The medicine Amondys 45 is used for the treatment of patients with Duchenne muscular dystrophy (DMD) who have a confirmed mutation of the dystrophin gene that can be treated by skipping exon 45.
Dosage and Administration
The recommended dosage of
Amondys 45
is 30 milligrams per kilogram administered once weekly as a 35-60 minute intravenous infusion via an in-line 0.2 micron filter. If any dose of this medication is skipped/missed, it may be administered as quickly as possible after the scheduled dose.
Application of a topical anesthetic cream to the infusion site before administration of Amondys 45 (Casimersen) may be considered.
Dosage is administered via intravenous infusion. Flush the intravenous access line with 0.9 percent Sodium Chloride Injection, prior to and following the infusion. Infuse the diluted medicine over 35-60 minutes via an in-line 0.2 micron filter. It is not advisable to mix other medication with Amondys 45 or infuse other drugs concomitantly via the same intravenous access with Amondys 45.
Side effects
The most commonly reported side effects with Amondys 45 (incidence >20% and at least 5% higher than placebo) are cough, pyrexia, upper respiratory tract infection, headache, arthralgia, and oropharyngeal pain.
In rare instances, Amondys 45 injection can cause more severe side effects. These can include: Kidney toxicity.
Precautions and Warnings
urine protein-to-creatinine ratio (UPCR), serum cystatin C, and urine dipstick needs to be measured prior to starting Amondys 45. Consider measurement of glomerular filtration rate prior to initiation of this therapy.
Monitoring for kidney toxicity throughout the therapy is recommended. Obtain the urine sample before the infusion of Amondys 45 Injection or at least 48 hours following infusion.
Due to the effect of reduced skeletal muscle mass on creatinine measurements in those with DMD, no specific dosage adjustment is needed for DMD patients with renal impairment depending on estimated glomerular filtration rate. Patients with known renal function impairment need to be precisely monitored throughout Amondys 45 treatment.
If you want to continue taking your other medicinal products while on Amondys 45, kindly interact with your health specialist about all the medications you are taking. Your specialist is the best person to advise you about your medicines.
Handling and storage
Injection Amondys 45 is supplied in single dose vials. The solution is a clear to a bit opalescent, colorless liquid, and may be a composition of trace quantities of tiny, white to off-white amorphous particles. Single-dose vials contain Casimersen 100 mg/2 mL (50 mg/mL).
Store vials of Amondys 45 at 2°C to 8°C (36°F to 46°F). Do not freeze. Store in the original carton until ready for use in order to protect from light.
Frequently asked questions (FAQs)
To receive this medicine, patients must have a mutation in the dystrophin gene that can be treated by skipping exon 45. Mutations are confirmed by a genetic test, which must be interpreted by a health specialist.
The active ingredient of Amondys 45 injection is Casimersen, an antisense oligonucleotide of the phosphorodiamidate morpholino oligomer (PMO) subclass.
Amondys 45 is supplied in a 2 mL single-dose vial that contains casimersen 100 mg (50 mg/mL). The solution is a clear to a bit opalescent, colorless liquid, and may be a composition of trace quantities of white to off-white amorphous particles.
Amondys 45 is given by IV infusion once weekly via an in-line 0.2 micron filter. An IV infusion is a method of delivering drugs directly into a patient’s bloodstream through a vein. Infusions of Amondys 45 are always given and monitored by a health specialist. Some patients may have a device named a port installed under their skin for repeat infusions.
For medicine Amondys 45, Sarepta Therapeutics is the innovator, and Ikris Pharma Network is an authorized partner who can help access this medicine in India for the patient through legal procedures. To know more, contact IKRIS Pharma Network (IPN) at TOLL-FREE Number: 18008891064 or Write at: [email protected].
The Amondys 45 cost is reasonable. To authenticate this medicinal product, you can Call/WhatsApp: +91 8130290915, Or dial TOLL-FREE: 18008891064, Or E-mail: [email protected].
In India, you can buy Amondys 45 online with the help of Ikris Pharma Network (IPN), an authorized partner of “Sarepta Therapeutics” for this medicine.
