AMONDYS 45 50 mg/mL
casimersen · INJECTION · Sarepta Therapeutics, Inc.
AMONDYS 45 is a injection containing casimersen at 50 mg/mL, taken intravenous. Manufactured by Sarepta Therapeutics, Inc..
Key Facts
- Brand Name
- AMONDYS 45
- Generic Name
- casimersen
- NDC Code (Product)
60923-227- Manufacturer
- Sarepta Therapeutics, Inc.
- Strength
- 50 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA213026
- Drug Class
- Antisense Oligonucleotide [EPC]
- Marketing Start
- 02/25/2021
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE AMONDYS 45 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with AMONDYS 45 [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials. AMONDYS 45 is an antisense oligonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with AMONDYS 45 [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio should be measured before starting AMONDYS 45 ( 2.1 ) 30 milligrams per kilogram of body weight once weekly ( 2.2 ) Administer as an intravenous (IV) infusion over 35 to 60 minutes via an in-line 0.2 micron filter ( 2.2 , 2.4 ) Dilution required prior to administration ( 2.3 ) 2.1 Monitoring to Assess Safety Serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio (UPCR) should be measured before starting AMONDYS 45. Consider measurement of glomerular filtration rate prior to initiation of AMONDYS 45. Monitoring for kidney toxicity during treatment is recommended. Obtain the urine sample prior to infusion of AMONDYS 45 or at least 48 hours after infusion [see Warnings and Precautions ( 5.2 )] . 2.2 Dosing Information The recommended dosage of AMONDYS 45 is 30 milligrams per kilogram administered once weekly as a 35 to 60-minute intravenous infusion via an in-line 0.2 micron filter. If a dose of AMONDYS 45 is missed, it may be administered as soon as possible after the scheduled dose. 2.3 Preparation Instructions AMONDYS 45 is supplied in single-dose vials as a preserva…
Contraindications
4 CONTRAINDICATIONS AMONDYS 45 is contraindicated in patients with known serious hypersensitivity to casimersen or to any of the inactive ingredients in AMONDYS 45. Instances of hypersensitivity, including angioedema and anaphylaxis, have occurred in patients receiving AMONDYS 45 [see Warnings and Precautions ( 5.1 )] . AMONDYS 45 is contraindicated in patients with serious hypersensitivity to casimersen or to any of the inactive ingredients in AMONDYS 45. ( 4 , 5.1 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] The most common adverse reactions (incidence >20% and at least 5% higher than placebo) were upper respiratory tract infection, cough, pyrexia, headache, arthralgia, and oropharyngeal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sarepta Therapeutics, Inc. at 1-888-SAREPTA (1-888-727-3782) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the AMONDYS 45 clinical development program, 76 patients received at least one intravenous dose of AMONDYS 45 (30 mg/kg). All patients were male and had genetically confirmed Duchenne muscular dystrophy. Age at study entry was 7 to 20 years (mean 9.9 years). Most (88%) patients were White, and 9% were Asian. AMONDYS 45 was studied in a double-blind, placebo-controll…
Frequently Asked Questions
What is AMONDYS 45 used for?
AMONDYS 45 contains casimersen. It is a injection taken intravenous. Consult your doctor for specific uses.
Is AMONDYS 45 a controlled substance?
AMONDYS 45 is not classified as a controlled substance by the DEA.
What is the generic name for AMONDYS 45?
The generic name for AMONDYS 45 is casimersen. There are no other listed brand versions of casimersen.
What is the NDC code for AMONDYS 45 50 mg/mL?
The NDC (National Drug Code) for AMONDYS 45 50 mg/mL is 60923-227, listed by Sarepta Therapeutics, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)