The information in this medication sheet has been adapted from the FDA-approved prescribing information for Tecfidera (dymethyl fumarate ).
Tecfidera™ is an oral therapy contained in capsules taken two times per day. Tecfidera, formerly known as BG-12, is dimethyl fumarate, a formulation that was developed specifically for use by people with multiple sclerosis. A chemically related compound, called Fumaderm (dimethyl fumarate and fumaric acid esters), has been used at higher doses for decades in Germany to treat acute flare-ups of psoriasis. Although its 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.
- In the DEFINE trial, there was a significant reduction in the proportion of people on Tecfidera who experienced relapses at 2 years, compared with those on inactive placebo. For those on the approved twice-daily dose, 27% experienced relapses, versus 46% of those on placebo – a 49% reduction in the risk of relapse. All secondary outcomes were also met in the Tecfidera groups, including significant impact on disease activity detected with MRI, and reduction in the risk of confirmed progression of disability (detected by the EDSS, a standard scale that measures disability). The proportion of those who progressed over two years was 16% for twice-daily Tecfidera compared with 27% for placebo – a 38% reduction in the risk of disability.
- In the CONFIRM trial, there was a significant reduction in the average annual number of MS relapses (annualized relapse rate, or ARR) in the Tecfidera groups compared with the placebo group. For those on the approved twice-daily dose, ARR was reduced by 44% compared with placebo. Results for secondary endpoints included significant reductions in disease activity on MRI and in the proportion of patients experiencing relapses in the Tecfidera groups compared with those in the placebo group. Disability progression was not reduced significantly in the Tecfidera groups compared with the placebo group in this trial.
- Tecfidera has not been studied in people under the age of 18.
Approval by the U.S. Food and Drug Administration (FDA)
Tecfidera was approved by the U.S. Food and Drug Administration (FDA) in 2013 as a first-line therapy for adults with relapsing forms of MS, which means that the FDA does not require that any other medication(s) be tried before Tecfidera is prescribed.
- Tecfidera capsules are taken orally twice per day. When treatment with Tecfidera is started, you will be given a one-week reduced starter dose (120mg twice a day), and thereafter a maintenance dose (240mg twice a day).
- The medication can be taken with or without food, but taking it with food may reduce the risk of flushing (see Possible Side Effects).
- Prior to starting this medication, the prescribing information for Tecfidera recommends that your doctor check a recent (within 6 months) blood cell count (a simple blood test to make sure that your lymphocyte (white blood cell) count is within the normal range. Thereafter, the FDA recommends annual blood cell counts and more frequent ones if clinically indicated. The prescribing information also recommends that health care providers consider withholding treatment for any person with a serious infection until the infection has resolved.
- Do not crush or chew the capsules or sprinkle the contents on food.
- Store the medication in a dry place at room temperature.
Warnings and Precautions
- Tecfidera reduced blood lymphocyte (white blood cell) 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.
Possible Side Effects
- The most common side effects in the clinical trials of Tecfidera 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). The incidence of these events during clinical trials was highest in the first month of treatment, decreasing thereafter. Taking Tecfidera with food may reduce flushing. Tecfidera reduced blood lymphocyte (white blood cell) counts but no significant or severe infections were reported.