Tecfidera® (dimethyl fumarate) is an immunomodulator with antioxidant properties.
Tablet taken orally
Twice daily after a first week titration
Relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.
Tecfidera® compared to placebo:
- Reduced annualized relapse rate by 53%
- Reduced number of gadolinium-enhancing lesions by 90% and number of T2 lesions by 85%
- Slowed disability progression by 38%
Common Potential Side Effects
Flushing, pruritus (chronic itching), erythema (skin redness or rash), gastrointestinal upset, diarrhea, and nausea
For assistance finding additional resources that might help cover the costs of your prescription, contact MSAA.
HOW Tecfidera® WORKS
Tecfidera® (dimethyl fumarate) is an immunomodulator with antioxidant properties that protects nerve damage in the brain and spinal cord. Tecfidera is the only disease-modifying therapy that works by activating the Nrf2 pathway, an important protective response mechanism in cellular defense.
Tecfidera® was FDA approved in 2013 for relapsing forms of MS. Tecfidera® is currently approved for clinically isolated syndrome, relapsing-remitting MS, and active secondary-progressive MS in adults.
Potential Side Effects
Most common adverse reactions are flushing, erythema (skin redness or rash), pruritus (itching), abdominal pain, diarrhea, and nausea. Other potential adverse events include upper respiratory and urinary tract infections, herpes zoster infection, and gastritis (stomach lining inflammation). Potential severe adverse events include reduced white blood cell (lymphocyte) counts, elevated liver enzymes, and rare risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection that usually leads to death or severe disability over a period of weeks or months, especially with prolonged lymphocytopenia.
OTHER KEY INFORMATION
Testing completed prior to starting Tecfidera® includes:
- Complete Blood Count (CBC) with differential
- Liver function tests
Periodic testing every 3-6 months for first year after starting Tecfidera® and then every 6-12 months thereafter, per the treating clinician, includes:
- CBC with differential
- Liver function tests
This treatment is also available in generic form (developed by Viatris). Given at the same dose, the warnings, side effects, and adverse events are similar to those listed for Tecfidera.
- If the absolute lymphocyte counts are 500-750, recheck CBC in 3 months then every 3 months until the count rises above 750.
- If the absolute lymphocyte count is under 500, recheck CBC monthly and obtain John Cunningham virus (JCV) serology to evaluate risk of PML.
- If the absolute lymphocyte count is persistently under 500 and you are JCV seropositive, alternative treatment is recommended.
When starting Tecfidera, please note there is a titration period (starting at a smaller dose and increasing over successive weeks). For Tecfidera, this would be 120 mg twice a day for the first 7 days, and then maintenance 240 mg twice a day thereafter.
Patient advocates talk about
their treatment experience
Kristie Salerno Kent“I have had situations where treatments aren’t approved at first. My doctors, nurses, they actually go to bat for me and made it happen.”
Azure Antoinette"I will be undergoing my first disease-modifying therapy to help treat multiple sclerosis in my body and while I’m very nervous, I am equally as excited and looking forward to the positive effects of how I will feel physically, and mentally, and emotionally."
Damian Washington“Nobody’s going to be looking out for your best interests better than you.”
Cathy Chester“I think it’s really important to talk about how to age with this illness.”
Lauren Hutton-Work“Just because you have this disease does not mean that your work life should be awkward or uncomfortable.”
Chernise Joseph“My first neurologist was a frontline neurologist, he wasn’t an MS specialist.”
Julian Gamboa“If you’re newly diagnosed with multiple sclerosis remember it’s always okay to get a second opinion.”
Lauren and Sam Alcorn“Our future is uncertain and we have to enjoy each other and love each other in the present.”
Shawn Feliciano“I want to know what medications might work best for someone who’s Hispanic.”
Darlene Feigen“The sooner you get on a therapy the better it is in the long run.”
Birgit Bauer“At the end of the appointment you should have an answer to the most important questions.”
Ellen Tutton“I looked up all the different disease-modifying therapies and compared them to my lifestyle.”
Victoria Marie Reese“I’m trying to show my daughter that taking care of yourself is cool.”