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Amondys 45 Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Amondys 45 Indications
Indications
Amondys 45 Dosage and Administration
Adults and Children
Administration
Amondys 45 Contraindications
Not Applicable
Amondys 45 Boxed Warnings
Not Applicable
Amondys 45 Warnings/Precautions
Warnings/Precautions
Consider slowing the infusion, interrupting, or discontinuing therapy if hypersensitivity reactions occur; treat appropriately and monitor until resolves. Monitor renal function. Measure serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio, and consider measuring GFR prior to initiation. During treatment, monitor urine dipstick monthly, and serum cystatin C and urine protein-to-creatinine ratio every 3 months. To test urine protein: may use urine samples obtained prior to infusion or at least 48hrs after the most recent infusion. Refer to pediatric nephrologist if a persistent increase in serum cystatin C or proteinuria is detected. Renal impairment: monitor closely. Pregnancy. Nursing mothers.
Amondys 45 Pharmacokinetics
Absorption
Cmax was reached at the end of infusion following a single IV dose of casimersen.
Casimersen exposure increased in a proportional manner with dose increment.
Distribution
Binding to human plasma protein was not concentration-dependent and ranged from 8.4% to 31.6%.
Mean apparent volume of distribution at steady state: 367 mL/kg (%CV = 28.9).
Elimination
Renal (>90%).
Half-life: 3.5 hours (SD 0.4 hours).
Amondys 45 Interactions
Interactions
Amondys 45 Adverse Reactions
Adverse Reactions
Upper RTI, cough, pyrexia, headache, arthralgia, oropharyngeal pain; hypersensitivity reactions, renal toxicity.
Amondys 45 Clinical Trials
See Literature
Amondys 45 Note
Not Applicable
Amondys 45 Patient Counseling
See Literature
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