Amondys 45
(Casimersen)Dosage & Administration
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Amondys 45 Prescribing Information
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 ] .AMONDYS 45 is contraindicated in patients with serious hypersensitivity to casimersen or to any of the inactive ingredients in AMONDYS 45. | 7/2024 |
Warnings and Precautions (Hypersensitivity reactions, including angioedema and anaphylaxis, have occurred in patients who were treated with AMONDYS 45. If a hypersensitivity reaction occurs, institute appropriate medical treatment, and consider slowing the infusion [see Dosage and Administration ] , interrupting, or discontinuing the AMONDYS 45 infusion and monitor until the condition resolves. AMONDYS 45 is contraindicated in patients with known serious hypersensitivity to casimersen or to any of the inactive ingredients in AMONDYS 45[see Contraindications ] . | 7/2024 |
AMONDYS 45 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the
The effect of AMONDYS 45 on dystrophin production was evaluated in one study in male DMD patients who have a confirmed mutation of the
Study 1 is an ongoing, double-blind, placebo-controlled, multicenter study designed to evaluate the safety and efficacy of AMONDYS 45 in ambulatory patients. The study is planned to enroll a total of 111 patients, age 7 to 13 years, randomized to AMONDYS 45 or placebo in a 2 to 1 ratio. Patients were required to have been on a stable dose of oral corticosteroids for at least 24 weeks prior to dosing with AMONDYS 45 or placebo. Following the 96-week double-blind period, all patients began or are to begin an additional 48 week open-label treatment period. Interim efficacy was assessed based on change from baseline in the dystrophin protein level (measured as % of the dystrophin level in healthy subjects, i.e., % of normal) at Week 48 of Study 1. Interim results from 43 evaluable patients (n = 27, AMONDYS 45; n = 16, placebo) who had a muscle biopsy at Week 48 of the double-blind period are presented in Table 2. Patients who provided muscle biopsy data had a median age of 9 years and were 86% White.
| Placebo | AMONDYS 45 30 mg/kg/week IV | |
| Dystrophin by Sarepta Western blot | n=16 | n=27 |
| Baseline Mean (SD) | 0.54 (0.79) | 0.93 (1.67) |
| Week 48 Mean (SD) | 0.76 (1.15) | 1.74 (1.97) |
| Change from Baseline Mean (SD) | 0.22 (0.49) | 0.81 (0.70) |
| p-value Change from Baseline to Week 48 | 0.09 | <0.001 |
| Between group mean difference | 0.59 | |
| p-value between groups | p=0.004 | |
- Serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio should be measured before starting AMONDYS 45 ()
2.1 Monitoring to Assess SafetySerum 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 ]. - 30 milligrams per kilogram of body weight once weekly ()
2.2 Dosing InformationThe 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.
- Administer as an intravenous (IV) infusion over 35 to 60 minutes via an in-line 0.2 micron filter (,
2.2 Dosing InformationThe 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.
)2.4 Administration InstructionsApplication of a topical anesthetic cream to the infusion site prior to administration of AMONDYS 45 may be considered.
AMONDYS 45 is administered via intravenous infusion. Flush the intravenous access line with 0.9% Sodium Chloride Injection, USP, prior to and after infusion.
Infuse the diluted AMONDYS 45 over 35 to 60 minutes via an in-line 0.2 micron filter. Do not mix other medication with AMONDYS 45 or infuse other medications concomitantly via the same intravenous access with AMONDYS 45.
If a hypersensitivity reaction occurs, consider slowing the infusion, interrupting or discontinuing the AMONDYS 45 therapy
[see Contraindications , Warning and Precautions and Adverse Reactions ]. - Dilution required prior to administration ()
2.3 Preparation InstructionsAMONDYS 45 is supplied in single-dose vials as a preservative-free concentrated solution that requires dilution prior to administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Use aseptic technique.
- Calculate the total dose of AMONDYS 45 to be administered based on the patient's weight and the recommended dose of 30 milligrams per kilogram. Determine the volume of AMONDYS 45 needed and the correct number of vials to supply the full calculated dose.
- Allow the vials to warm to room temperature. Mix the contents of each vial by gently inverting 2 or 3 times. Do not shake.
- Visually inspect each vial of AMONDYS 45. The solution is a clear to slightly opalescent, colorless liquid, and may contain trace amounts of small, white to off-white amorphous particles. Do not use if the solution in the vials is cloudy, discolored or contains extraneous particulate matter other than trace amounts of small, white to off-white amorphous particles.
- With a syringe fitted with a 21-gauge or smaller bore non-coring needle, withdraw the calculated volume of AMONDYS 45 from the appropriate number of vials. To avoid dulling the needle and fragmenting the stoppers, replace the needle periodically during preparation.
- Dilute the withdrawn AMONDYS 45 in 0.9% Sodium Chloride Injection, USP, to make a total volume of 100 to 150 mL. Gently invert 2 to 3 times to mix. Do not shake. Visually inspect the diluted solution. Do not use if the solution is cloudy, discolored or contains extraneous particulate matter other than trace amounts of small, white to off-white amorphous particles.
- Administer the diluted solution via an in-line 0.2 micron filter.
- AMONDYS 45 contains no preservatives and should be administered immediately after dilution. Complete infusion of diluted AMONDYS 45 within 4 hours of dilution. If immediate use is not possible the diluted product may be stored for up to 24 hours at 2 °C to 8 °C (36 °F to 46 °F). Do not freeze. Discard unused AMONDYS 45.
AMONDYS 45 is a clear to slightly opalescent, colorless liquid and may contain trace amounts of small, white to off-white amorphous particles and is available as:
- Injection: 100 mg/2 mL (50 mg/ mL) solution in a single-dose vial
There are no human or animal data available to assess the use of AMONDYS 45 during pregnancy. In the U.S. general population, major birth defects occur in 2% to 4% and miscarriage occurs in 15% to 20% of clinically recognized pregnancies.