The active ingredient in Tecfidera® is dimethyl fumerate, which works to reduce MS relapses and slow the progression of RRMS. Tecfidera reduces the inflammation in the brain caused by MS and helps to protect the cells that form the myelin against attacks which may damage it.
It is thought that Tecfidera does this by turning on an antioxidant mechanism in the body which deactivates and removes free radicals (generated by inflamation) that are damaging the myelin.
TECFIDERA cannot repair damage that has already been caused by MS. When you start Tecfidera you might not notice an improvement, but Tecfidera may still be working to help prevent your MS from becoming worse.
Tecfidera is proven to reinforce that early treatment with this drug can improve long-term clinical outcomes in patients. Studies have shown that half of newly diagnosed patients treated with Tecfidera did not relapse or progress for 6 years.
Tecfidera comes in a capsule that is taken twice a day; one capsule in the morning and the second (capsule) in the evening.
The starting dose is one 120mg capsule, twice a day for 7 days. After the first 7 days a regular dose of one 240mg capsule is taken twice a day. It is important to take as prescribed by your doctor, to take whole and with a glass of water. In no circumstances should you crush, divide or dissolve the capsule or its contents.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell. Side effects can include:
The above list includes the more common side effects of your medicine. If any of these persist or worsen, talk to your doctor as they may also be due to an infection or allergic reaction.
Special Authority must be approved by the Multiple Sclerosis Treatment Assessment Committee (MSTAC) before funding is approved. Applications will be considered by MSTAC at its regular meetings and approved subject to eligibility according to the Entry and Stopping criteria.
For details of the current criteria and how to apply for funded treatment see Disease Modifying Treatment Special Authority Criteria
It is often helpful to review how other people with MS have liked or tolerated a treatments and the benefits and side effects they have experienced.
Patients Like Me – Tecfidera
Three Phase 3 trials (DEFINE, CONFRIM, and ENDORSE) show Tecfidera’s efficacy in reducing relapse and disability measures in newly diagnosed relapsing remitting patients.
This was a 2-year, randomized, multi-centre, double-blind, placebo-controlled, dose-comparison phase 3 clinical trial. More than 1200 patients with remitting multiple sclerosis (RRMS) were evaluated. The main purpose of this study was to determine whether Tecfidera was effective in reducing relapses in patients after 2 years.
This was a 2-year, randomized, multi-centre, placebo-controlled, double-blind, dose-comparison phase 3 clinical trial. More than 1400 patients with RRMS were studied. The main purpose of this study was to determine whether Tecfidera was effective in reducing replaces in patients after two years.
This is an ongoing dose-blinded study that enrolled 1738 patients who completed either the DEFINE or CONFIRM studies.
A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes (PROTEC)
Reports from health professionals are preferred as doctors and other prescribers, pharmacists and nurses usually are able to provide more detailed information about the medications in use and other medical history from patient records that are helpful in evaluating the adverse reaction. However anyone may report a suspected adverse event or reaction to medication taken to the Centre for Adverse Reactions Monitoring (CARM).
For instructions and further information https://nzphvc.otago.ac.nz/reporting/