|What is the Scientific Name||Dimethyl fumarate|
|What is it?||A disease-modifying oral agent that is indicated to reduce the frequency of MS relapses and to slow the worsening of physical disability in patients with relapsing forms of MS.|
|What does it do?||Dimethyl fumarate is a disease-modifying drug used as monotherapy to reduce exacerbations and accumulation of disability in relapsing forms of MS.|
|Clinical Results and FDA approval||FDA approval for Tecfidera® was on March 27, 2013. There were two major trials to assess the safety and efficacy of the drug.
1. Placebo-Controlled Phase 3 Study of Oral BG-12 or Glatiramer in Multiple Sclerosis - Robert J. Fox, M.D., David H. Miller, M.D., J. Theodore Phillips, M.D., Ph.D., Michael Hutchinson, F.R.C.P., et al., for the CONFIRM Study Investigators*
N Engl J Med 2012; 367:1087-1097
2. Placebo-Controlled Phase 3 Study of Oral BG-12 for Relapsing Multiple Sclerosis -Ralf Gold, M.D., Ludwig Kappos, M.D., Douglas L. Arnold, M.D., Amit Bar-Or, M.D., Gavin Giovannoni, M.D., et al. for the DEFINE Study Investigators*
N Engl J Med 2012; 367:1098-1107
|How does it work?||Although its exact mechanism of action is not known, Tecfidera is thought to inhibit immune cells and molecules, and may have anti-oxidant properties that could be protective against damage to the brain and spinal cord. The proposed mechanism is that it reduces cellular stress in the body. By reducing this stress, dimethyl fumarate may lessen the inflammatory response that occurs in MS.|
|How is it taken?||Take Tecfidera® exactly as your doctor tells you to take it|
|What are the side effects ?||Common side effects include:
-flushing, redness, itching, or rash
-nausea, vomiting, diarrhea, stomach pain, or indigestion
-Flushing and stomach problems are the most common reactions, especially at the start of therapy, and may decrease over time.
In order to minimize gastrointestinal discomfort and flushing, you should always take the medication with food.
Serious side effects: