Amondys 45

— THERAPEUTIC DISORDERS TREATED —
  • Miscellaneous musculoskeletal disorders

Amondys 45 Generic Name & Formulations

General Description

Casimersen 50mg/mL; soln for IV infusion after dilution; preservative-free.

Pharmacological Class

Antisense oligonucleotide.

How Supplied

Single-dose vial (2mL)—1

Manufacturer

Generic Availability

NO

Amondys 45 Indications

Indications

Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping.

Amondys 45 Dosage and Administration

Adults and Children

Give as IV infusion over 35–60mins. 30mg/kg once weekly.

Amondys 45 Contraindications

Not Applicable

Amondys 45 Boxed Warnings

Not Applicable

Amondys 45 Warnings/Precautions

Warnings/Precautions

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

See Literature

Amondys 45 Interactions

Interactions

Do not mix or infuse with other drugs concomitantly via same IV access line. May cause false (+) results for urine protein with using pyrogallol red reagent.

Amondys 45 Adverse Reactions

Adverse Reactions

Upper RTI, cough, pyrexia, headache, arthralgia, oropharyngeal pain; renal toxicity.

Amondys 45 Clinical Trials

See Literature

Amondys 45 Note

Not Applicable

Amondys 45 Patient Counseling

See Literature

Images