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.