Bafiertam®
Quick Facts
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
Potential Benefit:
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.
Prescription Assistance:
For assistance finding additional resources that might help cover the costs of your prescription, contact MSAA.
DRUGMAKER
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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.
FDA-Approved
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).