This summary has been prepared by
the Multiple Sclerosis Society of Canada and reviewed for accuracy
by the national medical advisor.
FAQ - TecfideraTM
Tecfidera is an oral medication for the treatment of
relapsing-remitting multiple sclerosis (MS). It is the only compound
for the treatment of MS known to activate the Nrf2 pathway, a central
mechanism of cellular defense.
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. Health
Canada's approval was based largely on results of two large-scale phase III
studies of Tecfidera, called DEFINE and CONFIRM,
which were conducted in people
with relapsing-remitting MS.
INDICATIONS AND USE
Tecfidera is indicated as monotherapy for the treatment of relapsing-remitting MS to reduce the frequency of relapses 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.
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.
The recommended dose of Tecfidera is two 120 mg capsules taken twice daily for a total of 480 mg per day.
Tecfidera comes in capsules. Two capsules are taken orally, twice a day with or without food.
The most common adverse events experienced by people taking Tecfidera during the trials were flushing
(which can create a sensation of heat or itching and a red blush on the skin) and gastrointestinal events
(such as diarrhea, nausea, and upper abdominal pain.) During the clinical trials, up to 40% of participants
experienced flushing, and some experienced gastrointestinal events. The incidence of these events was highest
in the first month of treatment, decreasing thereafter.
Tecfidera reduced blood lymphocyte (white blood cells) counts but no significant or severe infections were reported. Liver enzyme tests were elevated, but there were no reports of significant liver injury or liver failure.
Tecfidera may reduce the effectiveness of oral contraceptives and another method should be used if on this medication.
This is not a comprehensive list of all possible side effects of Tecfidera. For more information, ask your physician or pharmacist.
DRUG IDENTIFICATION NUMBER (DIN)
Biogen Idec has initiated the process to make Tecfidera accessible to Canadians through private health insurers and through the provincial and federal drug plans.
The Common Drug Review (CDR) at the Canadian Agency for Drugs and Technologies in Health (CADTH) is a pan-Canadian process for conducting objective, rigorous reviews of the clinical, cost-effectiveness, and patient evidence for drugs. Provincial drug programs then use this information in making their decisions. Depending on the province, this can take anywhere from 8-24 months from initial submission to final recommendation. It should be noted that Quebec conducts its own review, independent of the CDR.
UPDATE: On September 25, 2013, the CDR issued the following recommendations:
- Tecfidera to treat people with relapsing-remitting MS who have a contraindication to, or who have failed to respond adequately to at least one interferon formulation and glatiramer acetate and;
- the individual being treated with Tecfidera is under the care of a neurologist who specializes in MS diagnosis and disease management.
Please call 1-800-268-7582 for additional information on reimbursement in your province.
CLINICAL TRIAL RESULTS
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).
[Gold et al. N Engl J Med. 2012 Sep 20;367(12):1098-107.]
- 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)
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]
Biogen Idec Canada
3 Robert Speck Parkway
Mississauga, Ontario L4Z 2G5
Further information for persons with MS is available from Biogen Idec ONETM program at 1-855-MSONE-00 or 1-855-676-6300.
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- Gold R, Kappos L, Arnold DL, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med. 2012 Sep 20;367(12):1098-107.
- Fox RJ, Miller DH, Phillips JT, et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis.N Engl J Med. 2012 Sep 20;367(12):1087-97.
The drug information contained in this publication
has been obtained from the manufacturers’ product monographs.
Consult the package insert for more
detailed information about the product’s indications, contraindications,
medical use and side effects. If you are taking any of the medications
listed above, do not change the dose or stop taking your medication
without consulting your physician first.
Avonex® is a registered trademark of Biogen Idec Canada Inc.
Betaplus® is a registered trademark of Bayer HealthCare Pharmaceuticals
Betaseron® is a registered trademark of Bayer HealthCare Pharmaceuticals
Biogen Idec ONETM Program is a registered trademark of Biogen Idec Canada Inc.
Copaxone® is a registered trademark of Teva Neuroscience
Extavia® is a registered trademark of Novartis Pharmaceuticals
Gilenya® is a registered trademark of Novartis Pharmaceuticals
Gilenya GO Program® is a registered trademark of Novartis Pharmaceuticals
Rebif® is a registered trademark of EMD Serono Canada Inc.
Multiple Support Program® is a registered trademark of EMD Serono
Shared Solutions® is a registered trademark of Teva Neuroscience
TecfideraTM is a registered trademark of Biogen Idec Canada Inc.
Tysabri® is a registered trademark of Biogen Idec Canada Inc.
and Elan Pharmaceuticals
© 2010, National Multiple Sclerosis Society (updated 2013)
This resource has been adapted by the Multiple Sclerosis Society of Canada with
permission of the National Multiple Sclerosis Society (USA).
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