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AMONDYS 45 - casimersen injection
Product / population
AMONDYS 45 intravenous casimersen in Duchenne muscular dystrophy with an exon-45-skipping-amenable mutation; renal monitoring is not a creatinine-only dose table.
Renal method
DMD monitoring: cystatin C, urine protein and optional measured GFR; no validated eGFR-based adjustment
Source revision
1/2026
Retrieved
2026-09-10
Local review status
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.
Documented differences and cautions on this drug
All record notes are retained here, including notes about sources not selected in this review.
A creatinine-only dosing shortcut is inappropriate for this evidence
The product requires DMD-specific renal surveillance rather than a validated creatinine-based reduction table.
What to reconcile: Use the dated monitoring card, including urine-collection timing and assay interference precautions; do not infer a renal dose.
DailyMed / Sarepta Therapeutics, Inc. · AMONDYS 45 intravenous casimersen in Duchenne muscular dystrophy with an exon-45-skipping-amenable mutation; renal monitoring is not a creatinine-only dose table.
Renal method: DMD monitoring: cystatin C, urine protein and optional measured GFR; no validated eGFR-based adjustment Source date: 1/2026 Retrieved: 2026-09-10
Monitoring or renal-toxicity guidance. This finding concerns risk or surveillance; it may not establish a dose adjustment.
Dialysis evidence: No dialysis regimen established in selected content
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.
Renal dosing, restrictions and evidence limits
Before treatment measure cystatin C, urine dipstick and urine protein-to-creatinine ratio; consider measured GFR using an exogenous filtration marker. Reduced muscle mass makes creatinine unreliable in DMD.
Check urine dipstick monthly and cystatin C/protein-to-creatinine ratio every three months. Collect urine before an infusion or at least 48 hours afterward; alternatively use a protein assay without pyrogallol red to avoid drug-related false positivity. Persistent cystatin C elevation or proteinuria warrants pediatric-nephrology evaluation.
The renal study in non-DMD adults cannot establish an eGFR-based adjustment for DMD. Section 8.6 provides no specific adjustment recommendation and calls for closer monitoring in known impairment.
RDM58-official-casimersen-amondys45-148a680973-C1 · Source locator: Sections 2.2, 5.2 and 8.6
Source-specific limits
Selected sections only; not a complete prescribing monograph or independent clinician approval.
Exact DailyMed HTML identity and named sections read. Raw SPL XML, original document hash and complete revision history were not obtained. Availability is not established by label retrieval.
This reference does not select a regimen. Complete the indication, measured/estimated renal function and trend, dialysis setting, source rationale, monitoring and reassessment plan in your institution's approved documentation system. Confirm the complete current source before adopting its regimen.
GlobalRPh v6.6 | RDM66-DIRECT-PHP-20260911 | Local library date 2026-09-11. Selected-card identity does not imply clinical verification.