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Dimethyl Fumarate (Tecfidera®)

Dimethyl Fumarate (Tecfidera®) is the third oral therapy approved for use in for relapsing-remitting multiple sclerosis (RRMS). It is thought to cause an induction of helper cytokines which causes apoptosis (cell death) in activated T cells. Additionally, it affects adhesion molecules which results in decrease of lymphocytes movement into the central nervous system.  In two clinical trials—DEFINE (Determination of the Efficacy and Safety of Oral Fumarate in Relapsing–Remitting MS) and CONFIRM (Comparator and an Oral Fumarate in Relapsing–Remitting MS)—dimethyl fumarate reduced MS relapse rates by approximately 50% over placebo and reduced the progression of disability by about 30%. The recommended starting dose for dimethyl fumarate is 120 mg twice a day orally. After 7 days, the dose should be increased to the maintenance dose of 240 mg twice a day orally. The main side effects of dimethyl fumarate  include gastrointestinal symptoms (nausea, abdominal pain, vomiting, and diarrhea) and skin flushing.  Dimethyl fumarate can be taken with or without food. Administration with food may reduce the incidence of flushing These adverse effects decrease over time Recommended safety monitoring includes complete blood count prior to treatment and annually while on treatment. Dimethyl fumarate is an attractive option for first-line treatment, breakthrough disease activity, intolerance to other therapies, and possibly natalizumab-treated patients with positive JC virus serology (see bulletin and guidelines below). Individuals who have questions about Dimethyl Fumarate (Tecfidera) should contact their healthcare provider.

Bulletin: Dimethyl Fumarate Prescriber Information and Patient Label (December 2014)

Summary of major updates for dimethyl fumarate:

The FDA has updated the dimethyl fumarate (Tecfidera) Prescriber information. The label update is effective as of December 3, 2014. Summary of the major updates include:

1.       New contraindications for patients with known hypersensitivity to dimethyl fumarate (Tecfidera) or any of its excipients
2.       New warning for anaphylaxis and angioedema
3.       New warning for PML
4.       Revised lymphopenia warning and revised monitoring schedule
5.       Includes reference to the fatal case of PML in a patient taking dimethyl fumarate (Tecfidera) in a setting of prolonged lymphopenia
6.       Includes the incidence of patients who experienced lymphocyte counts of < 500cells/uL for at least 6 months in controlled and uncontrolled studies
7.       Recommends monitoring of lymphocyte counts at initiation, quarterly thereafter and as clinically indicated
8.       Dimethyl fumarate (Tecfidera) should be held if
        a.        WBC falls below 2000/mm3 or
        b.       Lymphocyte count is below 500/µL and
        c.        Permanently discontinued if the WBC did not increase to over 2000/mm3 or
        d.       Lymphocyte count increased to over 500/µL after 4 weeks of withholding therapy
9.       Patients with a lymphocyte count < 500/µL should not be initiated on therapy with
dimethyl fumarate (Tecfidera)

 For more information refer to the articles below:

Dimethyl Fumarate Monograph

Dimethyl Fumarate Criteria for Use

Dimethyl fumarate ordering information 

 

 

Updated: December  2014