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Multiple Sclerosis Centers of Excellence


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Dimethyl Fumarate (Tecfidera®)

Dimethyl Fumarate (Tecfidera®) is the third oral therapy approved for use in for relapsing-remitting MS (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 RRMS) and CONFIRM (Comparator and an Oral Fumarate in RRMS), 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 should contact their healthcare provider.

February 2016 Update

Progressive multifocal leukoencephalopathy (PML) has occurred in patients with MS treated with dimethyl fumarate. PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. A fatal case of PML occurred in a patient who received dimethyl fumarate for 4 years while enrolled in a clinical trial. During the clinical trial, the patient experienced prolonged lymphopenia (lymphocyte counts predominantly <0.5x109/L for 3.5 years) while taking dimethyl fumarate [see Warnings and Precautions (5.3)]. The patient had no other identified systemic medical conditions resulting in compromised immune system function and had not previously been treated with natalizumab, which has a known association with PML. The patient was also not taking any immunosuppressive or immunomodulatory medications concomitantly.

PML has also occurred in the postmarketing setting in the presence of lymphopenia (<0.8x109/L) persisting for more than 6 months. While the role of lymphopenia in these cases is uncertain, the majority of cases occurred in patients with lymphocyte counts <0.5x 109/L.

At the first sign or symptom suggestive of PML, withhold dimethyl fumarate and perform an appropriate diagnostic evaluation. MRI findings may be apparent before clinical signs or symptoms. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.

Summary of Major Updates for Dimethyl Fumarate

The FDA has updated the dimethyl fumarate 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 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 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 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

For More Information

Dimethyl Fumarate (Tecfidera®) Prescriber Information and Patient Label (December 2014)
Dimethyl Fumarate (Tecfidera®) Monograph
Dimethyl Fumarate (Tecfidera®) Criteria for Use
Tecfidera® (website for patients and professionals)