Managing flushing and gastrointestinal events associated with delayed-release dimethyl fumarate: Experiences of an international panel

J Theodore Phillips; Michael Hutchinson; Robert Fox; Ralf Gold; Eva Havrdova

doi:10.1016/j.msard.2014.03.003

Managing flushing and gastrointestinal events associated with delayed-release dimethyl fumarate: Experiences of an international panel

Mult Scler Relat Disord. 2014 Jul;3(4):513-9. doi: 10.1016/j.msard.2014.03.003. Epub 2014 Apr 1.

Authors

J Theodore Phillips¹, Michael Hutchinson², Robert Fox³, Ralf Gold⁴, Eva Havrdova⁵

Affiliations

¹ Baylor Institute for Immunology Research, 3434 Live Oak Street, Dallas, TX 75204, USA. Electronic address: j.theod.phillips@gmail.com.
² St. Vincent׳s University Hospital and University College Dublin, Elm Park, Dublin 4, Ireland. Electronic address: mhutchin2@mac.com.
³ Mellen Center for Multiple Sclerosis, Cleveland Clinic, 9500 Euclid Avenue, U10, Cleveland, OH 44195, USA. Electronic address: rfox@ccf.org.
⁴ Ruhr-University Bochum, Gudrunstr. 56, 44791 Bochum, Germany. Electronic address: ralfgold@icloud.com.
⁵ Charles University in Prague, Katerinska 30, 12808 Praha 2, Prague, Czech Republic. Electronic address: Eva.Havrdova@lf1.cuni.cz.

PMID: 25877064
DOI: 10.1016/j.msard.2014.03.003

Abstract

Strategies for monitoring and managing the known adverse event (AE) profile of therapies for relapsing-remitting multiple sclerosis have become key to the optimization of patient outcomes. Delayed-release dimethyl fumarate (DMF) was associated with an increased risk of flushing and gastrointestinal (GI) AEs in clinical trials. A survey of clinicians with significant research experience using delayed-release DMF was conducted to provide guidance to clinicians using delayed-release DMF in clinical practice on the management of flushing and GI tolerability AEs. Recommendations for prophylaxis included educating the patient about flushing and GI AEs associated with delayed-release DMF and recommending administration with food. A variety of symptomatic treatments were utilized during the delayed-release DMF clinical trials in patients presenting with delayed-release DMF-related flushing or GI AEs that were severe or bothersome enough to warrant pharmacological intervention.

Keywords: Adverse events; Dimethyl fumarate; Flushing; Gastrointestinal adverse events; Multiple sclerosis; Tolerability.