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Acute mycophenolate overdose: case series and systematic literature analysis
Alessandro Ceschi1, Claudia Gregoriano, Christine Rauber-Lüthy
1Swiss Toxicological Information Centre, Associated Institute of the University of Zurich , Freiestrasse 16, CH-8032 Zurich , Switzerland +41 44 634 1034 ; +41 44 252 8833 ; Alessandro.Ceschi@usz.ch.
Expert Opinion on Drug Safety
|March 25, 2014
Summary
Acute overdose of mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS) generally results in minor symptoms, with all cases showing favorable outcomes. Doses up to 2.5 times the usual amount did not cause symptoms in MMF overdose cases.
Area of Science:
- Pharmacology
- Toxicology
- Clinical Medicine
Background:
- Limited literature exists on the acute human toxicity of mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS).
- Understanding overdose scenarios is crucial for patient safety and clinical management.
Purpose of the Study:
- To describe overdose cases involving MMF or EC-MPS reported to the Swiss Toxicological Information Centre (STIC) and published literature.
- To determine the circumstances, magnitude, management, and outcomes of MMF and EC-MPS overdoses.
Main Methods:
- An observational case-series design was employed.
- A systematic literature search was conducted to identify relevant cases.
- Data from STIC reports and literature were analyzed.
Main Results:
- Fifteen cases of MMF (13) or EC-MPS (2) overdose were reported to STIC, with 7 pediatric cases. Three additional cases were found in the literature.
- Overdose magnitudes ranged from 1.2 to 16.7 times the usual dose (median 2.9).
- Thirty-three percent of MMF overdoses had minor attributable symptoms; severe outcomes like hypotension and leukopenia were rare. Doses ≤2.5 times the usual MMF dose did not cause symptoms.
Conclusions:
- Acute MMF and EC-MPS overdoses, based on reported cases, have a favorable outcome.
- Clinical vigilance is warranted for higher overdose magnitudes, though severe toxicity appears uncommon.
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