title: Managing flushing and gastrointestinal events associated with delayed-release dimethyl fumarate: Experiences of an international panel.
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.
authors: Baylor Institute for Immunology Research, 3434 Live Oak Street, Dallas, TX 75204, USA. Electronic address: j.theod.phillips@gmail.com.
authors: J Theodore
authors: JT
authors: Phillips
authors: St. Vincent׳s University Hospital and University College Dublin, Elm Park, Dublin 4, Ireland. Electronic address: mhutchin2@mac.com.
authors: Michael
authors: M
authors: Hutchinson
authors: Mellen Center for Multiple Sclerosis, Cleveland Clinic, 9500 Euclid Avenue, U10, Cleveland, OH 44195, USA. Electronic address: rfox@ccf.org.
authors: Robert
authors: R
authors: Fox
authors: Ruhr-University Bochum, Gudrunstr. 56, 44791 Bochum, Germany. Electronic address: ralfgold@icloud.com.
authors: Ralf
authors: R
authors: Gold
authors: Charles University in Prague, Katerinska 30, 12808 Praha 2, Prague, Czech Republic. Electronic address: Eva.Havrdova@lf1.cuni.cz.
authors: Eva
authors: E
authors: Havrdova
keywords: Adverse events; Dimethyl fumarate; Flushing; Gastrointestinal adverse events; Multiple sclerosis; Tolerability