Tecfidera

Indications and Use

Tecfidera is indicated as monotherapy for the treatment of relapsing-remitting MS to reduce the frequency of clinical exacerbations and to delay the progression of disability.

Tecfidera should only be prescribed by clinicians who are experienced in the diagnosis and management of multiple sclerosis.

Tecfidera should not be taken by individuals who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.

It is not known if Tecfidera is safe and effective in children under age 18 or adults over 65.

There are no adequate and well-controlled studies of Tecfidera in pregnant or nursing women. It is not known whether dimethyl fumarate or its metabolites are excreted in human milk.

Tecfidera is not approved for people with CIS or progressive MS. For information on CIS approved treatment options and treatments for progressive MS, please speak with your physician or contact the MS Society of Canada at 1-800-268-7582.

Mechanism of action (MOA)

Although the 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. Tecfidera may work by changing the way the body’s immune system works, to help keep it from further damaging the brain and spinal cord.

Administration and dose

Tecfidera is taken orally, with or without food. The initial recommended dose of Tecfidera is 120 mg twice a day for a total of 240 mg per day for seven days. The usual dose of Tecfidera after seven days is two 240 mg capsules taken daily, for a total of 480 mg per day.

Side effects*

The most common side effects are flushing and stomach upset. People are more likely to have these side effects when they first start taking Tecfidera (mostly during the first month). Most people have mild to moderate symptoms and they tend to go away over time. Signs of stomach upset may include: diarrhea, nausea, stomach pain or stomach cramps, vomiting and indigestion.

If you become flushed and get swelling of the face, lips, mouth or tongue, wheezing, difficulty breathing or shortness of breath, stop taking Tecfidera and seek emergency medical assistance.

In October 2014 a case of progressive multifocal leukoencephalopathy (PML) was reported in an individual enrolled in a clinical trial evaluating the long-term effects of treatment with Tecfidera. The individual had been taking Tecfidera for four and a half years when they exhibited reduced blood cell counts – known as lymphopenia, a known adverse effect of this treatment. The patient was diagnosed with PML and later died from complications associated with pneumonia.

Healthcare professionals must monitor people on Tecfidera for any new sign or symptom that may be suggestive of PML. Complete blood counts, including lymphocyte counts, should be obtained prior to treatment with TECFIDERA, then every 6 to 12 months and as clinically indicated.

This is not a comprehensive list of all possible side effects of Tecfidera. Please see the Tecfidera product monograph for a list of other potentially serious side effects. It is important that those with MS discuss side effects about any medication they are considering with their physician. (*Health Canada, product monograph for Tecfidera.)

Clinical trials

DEFINE Study Group

DEFINE (Determination of the Efficacy and Safety of Oral Fumarate in Relapsing-Remitting MS)

The DEFINE trial was designed to determine if treatment with BG-12 would decrease the proportion of participants experiencing relapses compared to placebo, while also noting factors of safety and tolerability. The secondary outcomes included disability progression, frequency of relapses and, disease activity as detected by MRI. A significant reduction in the number of participants who experienced relapses at two years, compared to the placebo group was identified. Secondary objectives were also met, which included reductions in the annualized relapse rate and reduction in risk of confirmed progression of disability as detected by EDSS (Expanded Disability Status Scale, a standard scale used to measure disability progression).

Significantly reduced annual relapse rate (by 53 per cent) Significantly reduce MRI detection of brain lesions (Gd+ lesions by 90 per cent, T2 Lesions by 85 per cent) Slow disability progression as measured by the Expanded Disability Status Scale (EDSS) (by 38 per cent) [Gold et al. N Engl J Med. 2012 Sep 20; 367(12):1098-107.]

CONFIRM Study Group

The CONFIRM trial assessed whether treatment with BG-12 could decrease the average annual rate of MS relapses at two years. Secondary objectives included disability progression, assessing effects on the proportion of people who experienced relapses, as well as disease activity as identified by MRI. Safety and tolerability were also considered.

Results from the CONFIRM trial showed that the average annual relapse rate for those in the BG-12 group reduced compared to the placebo. Significant reductions were also observed within the secondary objectives which involved a decrease in disease activity as seen on MRI as well as a fewer number of patients experiencing relapses in the BG-12 group compared to the placebo. Disability progression however, was not reduced significantly in the BG-12 groups compared to placebo. [Fox et al. N Engl J Med. 2012 Sep 20; 367(12):1087-97]

Cost reimbursement

The price of Tecfidera is approximately $23,000 per year. Much of the cost can be reimbursed through private and group health plans for people who meet the prescribing criteria and through provincial drug programs for individuals who meet the prescribing criteria.

Drug support program

Further information for persons with MS is available from Biogen's ONE™ program at 1-855-MSONE-00 or 1-855-676-6300.