Not just another fumarate

Not actual patient

Three oral fumarates, two are prodrugs, only one goes direct.1-3

BAFIERTAM® (monomethyl fumarate) delayed-release capsules are the only oral fumarate that delivers monomethyl fumarate (MMF) directly into the body, which enables systemic circulation at a lower dose.1

Tecfidera® (dimethyl fumarate) delayed-release capsules and Vumerity® (diroximel fumarate) delayed-release capsules are prodrugs, which require metabolic conversion into the pharmacologically active agent MMF generating byproducts methanol and hydroxyethyl succinimide (HES) respectively.2,3

Prodrug metabolic conversion
Graphic explaining prodrug metabolic conversion.
BAFIERTAM goes direct
A comparative view of the absorption of fumarates.1,4

Illustration demonstrates the effect of crossing the intestinal – blood barrier for each oral fumarate.

No dietary restrictions versus Vumerity

Vumerity has a food limit of 700-calories and 30-g fat, and cannot be taken with alcohol.3 A bioequivalence study has shown that the Cmax of MMF is significantly reduced by co-administration with a high-fat, high-calorie meal (44% decrease), and co-administration with alcohol (40% decrease).5

In the case of BAFIERTAM, a high-fat, high-calorie meal does not significantly affect the bioavailability of MMF.1 Therefore, BAFIERTAM has no alcohol restrictions and can be taken with or without food, while maintaining bioequivalence and efficacy to Tecfidera.1

Reduced GI side effects versus Tecfidera

In a head-to-head study, BAFIERTAM showed improved GI tolerability profile compared with Tecfidera, with fewer, less severe, and shorter GI events.6

For patients experiencing challenging GI side effects with Tecfidera, BAFIERTAM may be a better-tolerated option, without having to switch to an alternative class of disease-modifying therapies.

Maintained lymphocyte count when switching from Tecfidera

Retrospective data showed a lower rate of lymphopenia following dimethyl fumarate (DMF) switch to BAFIERTAM (0%), compared to DMF switch to Vumerity (56%).7

Patients switched to BAFIERTAM had a 1.8 times higher average absolute lymphocyte count (ALC) at follow-up compared to Vumerity (p<0.001).7

BAFIERTAM may be a better option for maintaining ALC above lymphopenia levels when switching from Tecfidera or generic DMF.

References

1. BAFIERTAM. Prescribing Information. Banner Life Sciences LLC.

2. TECFIDERA. Prescribing Information. Biogen Inc.

3. VUMERITY. Prescribing Information. Biogen Inc.

4. Hoogendoorn, A., Avery, T. D., Li, J., Bursill, C., Abell, A., & Grace, P. M. 2021. Emerging Therapeutic Applications for Fumarates. Trends in pharmacological sciences, 42(4), 239–254. doi: 10.1016/j.tips.2021.01.004.

5. CDER US FDA. Clinical pharmacology and biopharmaceutics review(s). Application Number 211855Orig1s000. Rev_211855(2)_package_Redacted.pdf. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211855Orig1s000ClinPharmR.pdf. [Accessed: July 17 2025].

6. Palte MJ, Wehr A, Tawa M, et al. Improving the gastrointestinal tolerability of fumaric acid esters: early findings on gastrointestinal events with diroximel fumarate in patients with relapsing-remitting multiple sclerosis from the phase 3, open-label EVOLVE-MS-1 study. Adv Ther. 2019;36(11):3154-3165.

7. Banks, A., et al. 2026. Retrospective review of lymphocyte changes when switching between fumarates in patients with multiple sclerosis. Mult Scler Relat Disord., 107, 106968. doi:10.1016/j.msard.2026.106968.

Tecfidera® and Vumerity® are registered trademarks of Biogen Inc.

Indication and Important Safety Information
Indication and Important Safety Information
Indications

BAFIERTAM® is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Contraindications

BAFIERTAM is contraindicated in patients

  • With known hypersensitivity to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or to any of the excipients of BAFIERTAM. Reactions may include anaphylaxis or angioedema.
  • Taking dimethyl fumarate or diroximel fumarate.

Important Safety Information

Warnings and Precautions

Anaphylaxis and Angioedema

  • BAFIERTAM can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms in patients taking dimethyl fumarate (the prodrug of BAFIERTAM) have included difficulty breathing, urticaria, and swelling of the throat and tongue. Patients should be instructed to discontinue BAFIERTAM and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema.

Progressive Multifocal Leukoencephalopathy (PML)

  • PML has occurred in patients with MS treated with dimethyl fumarate (the prodrug of BAFIERTAM). PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. A fatal case of PML occurred in a patient who received dimethyl fumarate (the prodrug of BAFIERTAM) for 4 years while enrolled in a clinical trial.
  • PML has also occurred in patients taking dimethyl fumarate in the postmarketing setting in the presence of lymphopenia (<0.9 x 10⁹/L). While the role of lymphopenia in these cases is uncertain, the PML cases have occurred predominantly in patients with lymphocyte counts <0.8 x 10⁹/L persisting for more than 6 months.
  • At the first sign or symptom suggestive of PML, withhold BAFIERTAM and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
  • Magnetic resonance imaging (MRI) findings may be apparent before clinical signs or symptoms. Monitoring with MRI for signs consistent with PML may be useful, and any suspicious findings should prompt further investigation for early diagnosis, if present.

Herpes Zoster and Other Serious Opportunistic Infections

  • Serious cases of herpes zoster have occurred with dimethyl fumarate (the prodrug of BAFIERTAM), including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster meningoencephalitis, and herpes zoster meningomyelitis. These events may occur at any time during treatment. Monitor patients on BAFIERTAM for signs and symptoms of herpes zoster. If herpes zoster occurs, appropriate treatment for herpes zoster should be administered.
  • Other serious opportunistic infections have occurred with dimethyl fumarate (the prodrug of BAFIERTAM), including cases of serious viral (herpes simplex virus, West Nile virus, cytomegalovirus), fungal (Candida and Aspergillus), and bacterial (Nocardia, Listeria monocytogenes, Mycobacterium tuberculosis) infections. These infections have been reported in patients with reduced absolute lymphocyte counts (ALC) as well as in patients with normal ALC. These infections have affected the brain, meninges, spinal cord, gastrointestinal tract, lungs, skin, eye, and ear. Patients with symptoms and signs consistent with any of these infections should undergo prompt diagnostic evaluation and receive appropriate treatment.
  • Consider withholding BAFIERTAM treatment in patients with herpes zoster or other serious infections until the infection has resolved.

Lymphopenia

  • BAFIERTAM may decrease lymphocyte counts. Prolonged, severe lymphopenia (lymphocyte counts <0.5 × 10⁹/L for ≥6 months) has been reported with dimethyl fumarate (the prodrug of BAFIERTAM), and recovery after discontinuation may be delayed.
  • Obtain a complete blood count (CBC), including lymphocyte count, before initiating treatment with BAFIERTAM, at 6 months after initiation, and then every 6 to 12 months thereafter, and as clinically indicated. Consider interruption of BAFIERTAM in patients with lymphocyte counts <0.5 × 10⁹/L persisting for more than 6 months. Continue to monitor lymphocyte counts until recovery if BAFIERTAM is discontinued or interrupted because of lymphopenia. Consider withholding treatment in patients with serious infections until resolution. Decisions to restart BAFIERTAM should be individualized.

Liver Injury

  • Clinically significant cases of liver injury have been reported in the postmarketing setting with dimethyl fumarate (the prodrug of BAFIERTAM), with onset ranging from a few days to several months after treatment initiation. Findings have included elevations of serum aminotransferases (>5× ULN) and total bilirubin (>2× ULN). Some cases required hospitalization, and abnormalities resolved following treatment discontinuation. The combination of new aminotransferase elevations with increased bilirubin levels is an important predictor of serious drug‑induced liver injury.
  • Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels before initiating BAFIERTAM and during treatment, as clinically indicated. Discontinue BAFIERTAM if clinically significant liver injury induced by BAFIERTAM is suspected.

Flushing

  • BAFIERTAM may cause flushing (e.g., warmth, redness, itching, and/or burning sensation). In clinical trials of dimethyl fumarate (the prodrug of BAFIERTAM), flushing was reported in approximately 40% of patients, generally occurring soon after treatment initiation and typically improving or resolving over time. In most patients, flushing was mild to moderate in severity. Administration of non-enteric coated aspirin (up to 325 mg) approximately 30 minutes prior to dosing may reduce the incidence or severity of flushing.

Serious Gastrointestinal Reactions

  • Serious gastrointestinal reactions, including perforation, ulceration, hemorrhage, and obstruction, some with fatal outcomes, have been reported in the postmarketing setting with the use of fumaric acid esters, including dimethyl fumarate, with or without concomitant aspirin use. The majority of these events have occurred within 6 months of fumaric acid ester treatment initiation. In controlled clinical trials, the incidence of serious gastrointestinal adverse events was 1% in patients treated with dimethyl fumarate; these events, none of which were fatal, included vomiting (0.3%) and abdominal pain (0.3%).
  • Monitor patients, promptly evaluate, and discontinue BAFIERTAM for new or worsening severe gastrointestinal signs and symptoms.

Adverse Reactions

  • The most common adverse reactions reported with dimethyl fumarate (the prodrug of BAFIERTAM) were flushing and gastrointestinal-related events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). Gastrointestinal events generally occurred early in treatment and often decreased over time.
  • A transient increase in mean eosinophil counts was observed during the first 2 months of treatment.

For more detailed information, please refer to the full Prescribing Information here.

To report SUSPECTED ADVERSE REACTIONS, contact Banner Life Sciences at toll free phone: 1-866-MMF-95MG or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

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US-MMF-2600136 | July 2026