FDA Approves Oral Treatment for Multiple Sclerosis

Written by: Vanessa Smith Ohio Northern University, PharmD Candidate
As of March 2013, the FDA approved Tecfidera (dimethyl fumarate) as a first-line therapy for relapsing forms of multiple sclerosis (MS). Tecfidera is an immunomodulator that is thought to produce its therapeutic effects from its anti-inflammatory and cytoprotective properties.  Tecfidera is one of three oral medications approved for this specific indication.  It is taken twice daily and comes in two strengths as 120mg and 240mg.  As it is a delayed release capsule, it should be taken whole or sprinkled on food.
Monitoring parameters for Tecfidera include obtaining a complete blood count within six months of initiating treatment, then at least every year once treatment has begun.  Specifically, white blood cell levels should be closely monitored as Tecfidera can cause leukopenia.  Furthermore, due to its therapeutic immunosuppressive properties, it is recommended that treatment with Tecfidera be withheld if serious infection is suspected, and resumed only when the infection resolves. 
Currently, there are no known major drug interactions and no dosing adjustments necessary in the case of renal or hepatic impairment.  However, some adverse reactions associated with Tecfidera in clinical trials include nausea, vomiting, diarrhea, along with mild-moderate flushing (redness with a burning sensation).  The incidence of both the gastrointestinal effects and the flushing tend to decrease with use, and may also be decreased with the administration of food.
While taking Tecfidera, patients may look for an improvement of MS symptoms, lessening of relapses, and a slowing of disability progression.  Patients considering this treatment should be made aware that there is currently no cure for MS, but medications such as Tecfidera can help reduce the amount and severity of MS symptoms and greatly improve quality of life.

U.S. Food and Drug Administration. FDA Approves New Multiple Sclerosis Treatment: Tecfidera. 28 March 2013. [Cited 23 July 2013]. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm345528.htm
Lexicomp [database on the Internet]. Hudson (OH): Lexi Comp Online. 2013. [cited 22 July 2013]. Available from: http://0-online.lexi.com.polar.onu.edu/crlsql/servlet/crlonline

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