This is an oral medication in capsule form.
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. The FDA updated the prescribing information for Tecfidera in December, 2014.
This medication should not be taken by anyone with a known hypersensitivity to dimethyl fumarate or to any of the inactive substances used in this medication. Some people taking this medication have experienced severe reactions including anaphylaxis (an allergic reaction that occurs very quickly and may include itchy rash, difficulty breathing and swelling of the throat -- which may be life-threatening) and angioedema (a swelling similar to hives to occurs under the skin, typically in the throat and tongue).
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). If you are unable to tolerate the maintenance dose because of uncomfortable side effects, your healthcare provider may recommend a temporary dose reduction for a maximum of four weeks before resuming the maintenance dose. If you are unable to tolerate the maintenance dose in spite of temporary dose reductions, your healthcare provider may recommend stopping this medication.
The medication can be taken with or without food, but taking it with food may reduce the risk of flushing (see Possible Side Effects). The incidence of flushing may also be reduced by taking non-enteric coated aspirin (up to a dose of 325mg) 30 minutes before taking Tecfidera.
Prior to starting this medication, a recent (within 6 months) blood cell count (CBC - a simple blood test) is recommended to make sure that your lymphocyte (white blood cell) count is within the normal range. The CBC should be repeated 6 months after the start of treatment and then every 6-12 months thereafter, or more often if clinically indicated. The prescribing information also recommends that healthcare 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
Tefidera can cause severe allergic reactions that include anaphylaxis and angioedema (see Contraindications) after the first dose or at any time during treatment. A person who experiences any symptoms associated with anaphylaxis or angioedema should stop the medication and seek medical care immediately.
One person taking Tecfidera for four years while enrolled in a clinical trial developed progressive multifocal leukoencephalopathy (PML) and died. PML is an infection of the brain caused by the JC virus that typically occurs only in people whose ability to fight infection has been severaly reduced. This individual had very low amounts of white blood cells called lymphocytes (lymphopenia), but the role of the lymphopenia in this case of PML is not known. The person had no other known risk factors for PML, such as prior use of Tysabri or of immunosuppressive medications. Symptoms associated with PML progress over days to weeks and include progressive weakness on one side of the body, clumsiness, vision changes and changes in thinking, memory and orientation that lead to confusion and personality changes. Any changes of this kind should be reported immediately to one's healthcare provider.
Tecfidera may reduce blood lymphocyte (white blood cell) counts. In the controlled clinical trials, the mean lymphocyte counts decreased approximately 30% during the first year and then remained stable. Four weeks after stopping the medication, lymphocyte counts increased but did not return to the baseline level. A small percentage of people in the trials developed very low lymphocyte counts. Although no increase in serious infections was seen in the people with low lymphocyte counts, one person who had been in a controlled trial developed PML after the completion of the trial (see above). Before starting treatment with Tecfidera, a complete blood count (CBC), including lymphocyte count, should be done, followed by another CBC after six months of treatment, and every 6-12 months thereafter, or more often if clinically indicated. An interruption of treatment may be considered if a person's lymphocyte count drops very low and stays low for more than six months. People with a severe infection(s) should be be given Tecfidera until the infection(s) has gotten better.
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.®
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