Tecfidera (Dimethyl Fumarate)
Tecfidera® (Dimethyl Fumarate) is a prescription medication approved by the Food and Drug Administration (FDA) for treating adults with relapsing forms of multiple sclerosis (MS). Approved by the Federal Drug Administration (FDA) in March 2013 he mechanism by which dimethyl fumarate exerts its therapeutic effect in MS is not fully understood. Tecfidera is thought to inhibit cells and molecules that may protect against damage to the brain and spinal cord nerves.
Tecfidera® is an oral therapy contained in capsules taken two times per day. The starting dose for Tecfidera is 120 mg twice daily orally for 7 days. After 7 days, the dose should be increased to the maintenance dose of 240 mg twice daily orally. Tecfidera (dimethyl fumarate) should be swallowed whole and intact, and should not be crushed or chewed. Tecfidera is a delayed-release (time release capsule) in both the 102mg and 240mg formats. The capsule contents of dimethyl fumarate should not be sprinkled on food.
The safety and efficacy of Tecfidera (dimethyl fumarate) were demonstrated in 2 studies which evaluated dimethyl fumarate taken 2 or 3 times daily in patients with Relapsing-Remitting Multiple Sclerosis. The starting dose for dimethyl fumarate was 120 mg 2 or 3 times daily for the first 7 days, followed by an increase to 240 mg twice or 3 times daily.
The safety and efficacy of dimethyl fumarate for the treatment of relapsing-remitting MS was confirmed in 2 phase III trials. Relative to placebo, twice-daily dimethyl fumarate was found to reduce the proportion of patients with relapses at 2 years by 34% to 49% and the annualized relapse rate by 44% to 53%. Although the incidence of serious adverse effects did not differ from that of placebo, intolerable flushing, and gastrointestinal adverse effects prompted discontinuation in 3% and 4% of patients, respectively.
In clinical studies the most common side effects were:
- Redness of skin
- Itching or Rash
- Stomach pain
They tended to happen earlier in treatment and usually decreased over time.
Taking Tecfidera with food, such as breakfast or dinner, may help with flushing. Ask your doctor if taking aspirin may also help with flushing.
It’s important to talk to your doctor if you’ve had an allergic reaction to Tecfidera or any of its ingredients. You should also discuss the serious side effects associated with Tecfidera, including:
- Allergic reactions (such as welts, hives, swelling of the face, lips, mouth, or tongue, or difficulty breathing)
- PML, a rare brain infection that usually leads to death or severe disability
- There have been 4 confirmed cases of PML with Tecfidera out of over 150,000 patients using the treatment.
- Decreases in your white blood cell count
Your doctor should do a blood test before you start treatment with TECFIDERA and while on therapy.
Some neurologists recommend monthly blood tests to check white blood cell counts.
Biogen is one of the world’s leading biotechnology companies, with a focus on developing therapies for neurodegenerative, hematologic and autoimmune disorders. Founded in 1978, our work in biologics and small-molecule drug discovery has led to the world’s most extensive portfolio of multiple sclerosis therapies and innovative new treatments for hemophilia patients. Our experience, capabilities and passion for innovation have enabled us to build a pipeline and develop advanced research programs that include exploration of potential candidates for serious and difficult-to-treat neurodegenerative diseases and fibrotic and nonmalignant blood disorders.
We are committed to research that uncovers the underlying biology of complex diseases. Our focus is on illnesses with few, if any, treatment options. Biogen’s success will always be measured by the answer to a simple question: Have we truly made a difference in the lives of patients?
Tecfidera Patient Information: