Selecting here opens the current stored cards. The pinned link below records their fingerprints. Do not enter patient information in links or searches.
Share or print this source review
1 local source card selected. Local card fingerprints checked where supplied. This is not an original-document hash, source-currency guarantee or clinical approval. Record-level cautions below are the current library's cautions, not a frozen prior version.
Copy is optional; the link can be selected and copied manually. No patient data or dose decision is collected.
Clinical context remains essential
Independent clinical review is pending. Confirm indication, exact formulation/route, population, renal measure and units, kidney-function stability, dialysis prescription, interacting drugs, monitoring and source revision. An RX mirror and its original label are not independent corroboration. Missing disagreement notes do not certify agreement.
Check source scope before reading a dose
Arimoclomol - MIPLYFFA official label
Product / population
Arimoclomol - MIPLYFFA official label; selected renal source sections only, not a complete prescribing monograph.
Renal method
Source prints eGFR in mL/min without a BSA denominator. Indexing is not established; do not silently convert or relabel.
Source revision
Prescribing information revised 3/2026.
Retrieved
2026-09-08
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.
MIPLYFFA: creatinine change may not equal a fall in GFR
The current label describes a creatinine change not attributable to glomerular function and recommends alternative kidney assessments. Its selected eGFR units omit an indexing denominator.
What to reconcile: Do not dismiss possible AKI. Review BUN, cystatin C or measured GFR in clinical context; do not silently convert the printed renal bands.
DailyMed / Acer Therapeutics Inc · Arimoclomol - MIPLYFFA official label; selected renal source sections only, not a complete prescribing monograph.
Renal method: Source prints eGFR in mL/min without a BSA denominator. Indexing is not established; do not silently convert or relabel. Source date: Prescribing information revised 3/2026. Retrieved: 2026-09-08
Dose or interval guidance. Use only the product, indication, renal metric and population described in this source.
Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.
Renal dosing, restrictions and evidence limits
For NPC neurologic manifestations at age >=2 years, use with miglustat. At eGFR 15 to <50 mL/min, doses are twice daily: actual weight 8-15 kg, 47 mg; >15-30 kg, 62 mg; >30-55 kg, 93 mg; >55 kg, 124 mg. At eGFR >=50, the same weight-based amounts are given three times daily. Below 15, pharmacokinetics are unstudied. Creatinine may rise without reduced glomerular function; the label recommends non-creatinine measures such as BUN, cystatin C or measured GFR. The source omits the eGFR indexing denominator; no conversion is inferred.
The RX mirror and official label are related evidence, not two independent validations. Do not assume every new creatinine rise is benign or dismiss another cause of kidney injury.
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.