Bafiertam® (monomethyl fumarate) is a selective immunosuppressant with neuroprotective and immunomodulatory effects.
Capsule taken orally
Half-dose (95 mgs) taken twice daily for the first 7 days; then full maintenance dose (190 mgs) taken twice daily
Relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting MS, and active secondary-progressive MS
The 190 mg dose of Bafiertam® (monomethyl fumarate) is similar to the 240 mg dose of Tecfidera® (dimethyl fumarate). Because of their similarities, results from the Tecfidera® clinical trials are used for Bafiertam®.
Clinical trial results for Tecfidera® compared to placebo:
- Reduced annual relapse rate by 53%
- MRI showed a 90% reduction of detectable brain lesions (Gd+ lesions) and 85% and T2 lesions
- Slowed disability progression by 38%
Common Potential Side Effects
Flushing and stomach problems (especially at the start of therapy, and may decrease over time), redness, itching, rash, diarrhea.
For assistance finding additional resources that might help cover the costs of your prescription, contact MSAA.
HOW Bafiertam® WORKS
Bafiertam® acts similarly to the oral treatment Tecfidera (dimethyl fumarate), also known as DMF. DMF gets absorbed in the gastrointestinal (GI) tract, where it’s converted and becomes the active agent monomethyl fumarate (MMF). MMF has been shown to have neuroprotective and immunomodulatory effects.
Bafiertam® was FDA-approved in 2020 to treat relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary-progressive disease, in adults.
Potential Side Effects
Flushing and stomach problems are common, especially at the start of therapy, and may decrease over time; redness, itching, rash, or diarrhea may also occur.
Warnings, side effects, and adverse events are similar to those listed for Tecfidera®. Allergic reactions, progressive multifocal leukoencephalopathy (PML) – a rare brain infection that usually leads to death or severe disability over a period of weeks or months – serious infections, and liver injury, are among the potential adverse events.
OTHER KEY INFORMATION
Testing completed prior to starting Bafiertam® includes:
- A complete blood count (CBC), including lymphocyte count.
- Liver tests, including serum aminotransferase, alkaline phosphatase, and total bilirubin levels.
Testing completed after starting Bafiertam® includes:
- CBC, including lymphocyte count, 6 months after initiation, and then every 6 to 12 months thereafter as directed by your physician.
- Liver tests (serum aminotransferase, alkaline phosphatase, and total bilirubin levels) during treatment as directed by your physician.
When starting Bafiertam, please note there is a titration period (starting at a half dose and increasing to the full dose after the first 7 days).
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.”