Information for US healthcare providers
Not actual patient
Three fumarates, only one goes direct
BAFIERTAM® (monomethyl fumarate) delayed-release capsules belong to the fumarate class of DMTs; a class proven and effective at reducing the risk of disease progression.1
Other fumarates, Tecfidera® (dimethyl fumarate) delayed-release capsules and Vumerity® (diroximel fumarate) delayed-release capsules, are prodrugs that require metabolic conversion, produce metabolic byproducts, and may come with more severe GI side effects or lifestyle restrictions, respectively.2-4
A comparative view of the absorption of fumarates.2,3,5,6
Illustration demonstrates the effect of crossing the intestinal – blood barrier for each oral fumarate.
BAFIERTAM is not just another fumarate
BAFIERTAM is the only fumarate that delivers the active molecule monomethyl fumarate (MMF) directly into the body,2,3,5 which means BAFIERTAM has a number of benefits over other fumarates. BAFIERTAM:
-
- Does not generate metabolic byproducts2,3,5
- Has reduced GI side effects and better tolerability than Tecfidera®4
- Does not have restrictions on food and alcohol, unlike Vumerity®3,5
- May be a better alternative than Vumerity® for maintaining lymphocyte count when switching from Tecfidera® or generic DMF7
- Is given at a lower dose, in smaller sized capsules than Tecfidera® and Vumerity®2,3,8
BAFIERTAM benefits
Established efficacy
BAFIERTAM has been shown to reduce the number of relapses, delay disability progression, and slow the development of brain lesions.9,10
No dietary restrictions
BAFIERTAM has no alcohol restrictions and can be taken with or without food.5
Reduced GI side effects
Better GI tolerability profile than Tecfidera® (dimethyl fumarate) delayed-release capsules.4
Maintained lymphocyte count
When switching from dimethyl fumarate (DMF), BAFIERTAM may be the better option for maintaining a healthy lymphocyte count.7
Quick elimination in 24 hours
BAFIERTAM has a plasma half-life of 0.5 hours,5 which makes it easier for dose adjustments and discontinuation, when needed.
Comprehensive patient support*
Cycle Vita™ is here to offer your BAFIERTAM patients the clinical, educational, and financial support they need to navigate their treatment.
The data
BAFIERTAM has proven efficacy against MS.9,10
BAFIERTAM is bioequivalent to dimethyl fumarate (DMF). In the two-year, placebo-controlled DEFINE study, DMF was proven to:
Reduce annualized relapse rate (ARR) by
53%
Reduce disability progression by
38%
Reduce T1 hypointense lesion development by
90%
Reduce T2 lesion development by
85%9
BAFIERTAM has no alcohol restrictions and can be taken with or without food, while maintaining bioequivalence to DMF.5
On the other hand, for Vumerity® to remain bioequivalent to DMF with food, there is a limit of 700-calories and 30-g fat per meal, and Vumerity® cannot be taken with alcohol.3,7,11,12
BAFIERTAM has a better GI tolerability profile compared to Tecfidera®.4
In a 5-week, head-to-head study comparing BAFIERTAM to Tecfidera®, individuals taking BAFIERTAM had less severe and fewer GI events.4 Although the main analyses of the study did not reach statistical significance, based on the totality of data from this study and previous single dose studies comparing BAFIERTAM and Tecfidera®, BAFIERTAM seems to show improved GI tolerability in terms of incidence, severity and duration.4
BAFIERTAM may be the better option for maintaining absolute lymphocyte counts (ALC) when switching from Tecfidera® or generic DMF.7
A single-center, retrospective study conducted at Vanderbilt University Medical Center examined the effects of fumarate switching on ALC and lymphopenia in 72 patients. Patients either switched from DMF to Vumerity® or to BAFIERTAM, mostly due to insurance and financial reasons.7
Results showed that patients switched to BAFIERTAM:
- Were less likely to develop lymphopenia. 0% of BAIFERTAM patients had lymphopenia post-switch, compared to 56% of patients who switched to Vumerity®.7
- Had 1.8 times higher average ALC at follow-up, compared to patients who switched to Vumerity® (p<0.001).7
Table 1. Lymphocyte changes and lymphopenia grade by fumarate switched to.
| Switch to Vumerity® (N = 57) | Switch to BAFIERTAM (N = 15) |
|||
|---|---|---|---|---|
| Baseline (pre-switch) | Follow up (post-switch) | Baseline (pre-switch) | Follow up (post-switch) |
|
| ALC [ Median (IQR)] | 1.4 (1.1–1.7) | 0.9 (0.6–1.3) | 1.5 (1.4–2.3) | 1.9 (1.4–2.2) |
| Any lymphopenia [n (%)] | 12 (21) | 32 (56) | 1 (7) | 0 (0) |
| Grade 1 Lymphopenia | 8 (14) | 6 (11) | 1 (7) | 0 (0) |
| Grade 2 Lymphopenia | 4 (7) | 20 (35) | 0 (0) | 0 (0) |
| Grade 3 Lymphopenia | 0 (0) | 6 (11) | 0 (0) | 0 (0) |
| Grade 4 Lymphopenia | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
IQR: interquartile range
1. Dighriri IM, Aldalbahi AA, Albeladi F, et al. (2023). An Overview of the History, Pathophysiology, and Pharmacological Interventions of Multiple Sclerosis. Cureus, 15(1):e33242. doi:10.7759/cureus.33242.
2. TECFIDERA. Prescribing Information. Biogen Inc.
3. VUMERITY. Prescribing Information. Biogen Inc.
4. Wynn, D., et al. 2020. Monomethyl fumarate has better gastrointestinal tolerability profile compared with dimethyl fumarate. Mult Scler Relat Disord. 45:102335. doi:10.1016/j.msard.2020.102335.
5. BAFIERTAM. Prescribing Information. Banner Life Sciences LLC.
6. Palte MJ, Wehr A, Tawa M, et al. (2019). 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, 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.
8. Drugs.com. (2025). 95 Pill – white capsule/oblong, 13mm. Available at: https://www.drugs.com/imprints/95-30363.html#:~:text=95%20Pill%20%2D%20white%20capsule%2Foblong%2C%2013mm&text=Pill%20with%20imprint%2095%20is,identified%20as%20Bafiertam%2095%20mg. [Accessed: November 26 2025].
9. Gold R, Kappos L, Arnold DL, et al. (2012). Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med. 367(12):1098-1107. doi:10.1056/NEJMoa1114287.
10. Lategan, T. W., Wang, L., Sprague, T. N., & Rousseau, F. S. (2021). Pharmacokinetics and Bioavailability of Monomethyl Fumarate Following a Single Oral Dose of Bafiertam™ (Monomethyl Fumarate) or Tecfidera® (Dimethyl Fumarate). CNS drugs, 35(5), 567–574. doi:10.1007/s40263-021-00799-9.
11. Rousseau, F. S., Wang, L., Sprague, T. N., Lategan, T. W., & Berkovich, R. R. (2023). Comparative pharmacokinetics and bioavailability of monomethyl fumarate following a single oral dose of Bafiertam® (monomethyl fumarate) versus Vumerity® (diroximel fumarate). Mult Scler Relat Disord. 70:104500. doi:10.1016/j.msard.2023.104500.
12. CDER US FDA. (2018). 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: November 26 2025].
13. CalorieKing. 2019. Food Nutrition Facts and Free Calorie Counter | CalorieKing. [online] Calorieking.com. Available at: https://www.calorieking.com/us/en/. [Accessed: October 10 2025].
14. Subway. 2024. Subway Order. [online] Subway.com. Available at: https://www.subway.com/en-us/-/media/northamerica/usa/nutrition/nutritiondocuments/us_nutrition_1. [Accessed: October 10 2025].
*Some areas of support may not be accessible to all patients. Eligibility criteria may apply to ensure compliance with all applicable federal and state requirements, and benefits may be limited to commercially insured patients only. For more detailed information about eligibility, terms and conditions, please contact the Cycle Vita team at 888-360-8482.
Tecfidera® and Vumerity® are registered trademarks of Biogen Inc.
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.
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.
BAFIERTAM® is a registered trademark of Banner Life Sciences, LLC, a Cycle Pharmaceuticals company.
Cycle Vita™ is a trademark of Cycle Pharmaceuticals Limited in the United States.
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