Find balance with BAFIERTAM

An efficacious treatment proven to reduce the risk and frequency of relapse, delay disability progression and the development of MRI lesions.2,3

A well-understood safety profile and good tolerability.1,4

Three fumarates, only one goes direct

BAFIERTAM belongs to the oral fumarate class of MS treatments, which are proven and effective at reducing the risk of disease progression.1,6

Within the fumarate class, Tecfidera® (dimethyl fumarate) delayed-release capsules and Vumerity® (diroximel fumarate) delayed-release capsules are prodrugs that require metabolic conversion to activate, and produce byproducts during conversion.6-9

Compared to BAFIERTAM, Tecfidera may come with more severe GI side effects,10 while Vumerity comes with lifestyle restrictions.8

The absorption of fumarates.1,7,8,11

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Not just another fumarate

BAFIERTAM is the only fumarate that delivers the active ingredient monomethyl fumarate (MMF) directly into the body,1,7,8 which means BAFIERTAM has a number of benefits over other fumarates. BAFIERTAM:

  • Does not generate metabolic byproducts1,7,8
  • Has reduced GI side effects and better tolerability than Tecfidera7
  • Does not have restrictions on food and alcohol, unlike Vumerity1,8
  • Is given at a lower dose, in smaller sized capsules than Tecfidera and Vumerity7,8,12
Find out more

The data

BAFIERTAM has proven efficacy against MS.2,3

BAFIERTAM has the same proven efficacy as Tecfidera, which was tested against placebo in a two-year DEFINE study and shown to reduce:

Annualized relapse rate (ARR) by

53%

Disability progression by

38%

T1 hypointense lesion development by

90%

T2 lesion development by

85%2

BAFIERTAM has no food or alcohol restrictions.1

On the other hand, for Vumerity, there is a limit of 700-calories and 30-g fat per meal, and Vumerity cannot be taken with alcohol.8 If these food and alcohol restrictions are not followed, your body may not be able to take up Vumerity effectively.6,9

Here are some examples of what the food restrictions may look like with Vumerity:

BAFIERTAM has a better GI tolerability profile.10

In a 5-week, head-to-head study comparing BAFIERTAM to Tecfidera, individuals taking BAFIERTAM had less severe and fewer GI events.10 Although the main analyses of the study did not reach statistical significance, based on the overall data, BAFIERTAM shows a trend for reduction of incidence, severity and duration of GI symptoms.10

BAFIERTAM may be the better option for maintaining absolute lymphocyte counts (ALC) when switching from Tecfidera or generic DMF.5

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.5

Results showed that patients switched to BAFIERTAM:

  • Were less likely to develop lymphopenia. 0% of BAFIERTAM patients had lymphopenia post-switch, compared to 56% of patients who switched to Vumerity.5
  • Had 1.8 times higher average ALC at follow-up, compared to patients who switched to Vumerity (p<0.001).5

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 Lymphopenia8 (14)6 (11)1 (7)0 (0)
Grade 2 Lymphopenia4 (7)20 (35)0 (0)0 (0)
Grade 3 Lymphopenia0 (0)6 (11)0 (0)0 (0)
Grade 4 Lymphopenia0 (0)0 (0)0 (0)0 (0)

IQR: interquartile range

Table 1. Lymphocyte changes and lymphopenia grade by fumarate switched to.

Switch to Vumerity(N = 57)

Baseline
(pre-switch)
ALC [ Median (IQR)]1.4 (1.1–1.7)
Any lymphopenia [n (%)]12 (21)
Grade 1 Lymphopenia8 (14)
Grade 2 Lymphopenia4 (7)
Grade 3 Lymphopenia0 (0)
Grade 4 Lymphopenia0 (0)
Follow up
(post-switch)
ALC [ Median (IQR)]0.9 (0.6–1.3)
Any lymphopenia [n (%)]32 (56)
Grade 1 Lymphopenia6 (11)
Grade 2 Lymphopenia20 (35)
Grade 3 Lymphopenia6 (11)
Grade 4 Lymphopenia0 (0)

Switch to BAFIERTAM(N = 15)

Baseline
(pre-switch)
ALC [ Median (IQR)]1.5 (1.4–2.3)
Any lymphopenia [n (%)]1 (7)
Grade 1 Lymphopenia1 (7)
Grade 2 Lymphopenia0 (0)
Grade 3 Lymphopenia0 (0)
Grade 4 Lymphopenia0 (0)
Follow up
(post-switch)
ALC [ Median (IQR)]1.9 (1.4–2.2)
Any lymphopenia [n (%)]0 (0)
Grade 1 Lymphopenia0 (0)
Grade 2 Lymphopenia0 (0)
Grade 3 Lymphopenia0 (0)
Grade 4 Lymphopenia0 (0)

IQR: interquartile range

References

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

2. 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/NEJMoa1114287.3.

3. 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.

4. 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.

5. 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.

6. 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].

7. TECFIDERA. Prescribing Information. Biogen Inc.

8. VUMERITY. Prescribing Information. Biogen Inc.

9. 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.

10. 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.

11. 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.

12. 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].

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.

Indications

BAFIERTAM® (monomethyl fumarate) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is not known if BAFIERTAM is safe and effective in children.

Important Safety Information

  • Do not take BAFIERTAM if you have had an allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing) to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or any of the ingredients in BAFIERTAM.
  • Do not take BAFIERTAM if you are taking dimethyl fumarate or diroximel fumarate.

Before taking and while you take BAFIERTAM, tell your Healthcare Provider about all your medical conditions, including if you:

  • have liver problems.
  • have or have had low white blood cell counts or an infection.
  • are pregnant or plan to become pregnant. It is not known if BAFIERTAM will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if BAFIERTAM passes into breast milk. Talk to your healthcare provider about the best way to feed your baby while using BAFIERTAM.

Tell your Healthcare Provider about all other medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Serious Adverse Reactions:

BAFIERTAM may cause serious side effects, including:

Allergic reactions (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing). Stop taking BAFIERTAM and get emergency medical help right away if you get any of these symptoms.

PML (progressive multifocal leukoencephalopathy) a rare brain infection that usually leads to death or severe disability over a period of weeks or months. Contact your Healthcare provider right away if you if you notice new or worsening symptoms such as weakness on one side of the body, vision problems, trouble thinking, or changes in memory or personality. Your healthcare provider may stop BAFIERTAM if PML is suspected. Increased risk of serious infections, including shingles (herpes zoster) and central nervous system infections.

Decrease in your white blood cell count Your healthcare provider will do a blood test to check your white blood cell count before you start treatment with BAFIERTAM and while you are on therapy. You should have blood tests after 6 months of treatment and every 6 to 12 months after that.

Liver problems. BAFIERTAM may cause serious liver problems that may lead to liver failure, a liver transplant, or death. Blood tests will be done before and during treatment to check your liver. Tell your healthcare provider right away if you have symptoms such as unusual tiredness, loss of appetite, dark urine, yellowing of your skin or eyes, or stomach pain. BAFIERTAM may be stopped if liver injury is suspected.

Flushing: BAFIERTAM may cause flushing, which can feel like warmth, redness, itching, or a burning sensation, usually on the face or upper body. Flushing often starts soon after beginning treatment and usually improves or goes away over time. Most flushing reactions are mild to moderate, but some people have stopped treatment because of flushing.

Tell your healthcare provider if flushing is bothersome or does not improve.

Serious Stomach and Intestinal Problems: Serious stomach and intestinal problems have been reported with medicines like BAFIERTAM. These problems can include severe stomach pain, ulcers, bleeding, blockage, or tears in the stomach or intestines, and in rare cases can be fatal. Serious stomach problems have occurred most often within the first 6 months of treatment.

Call your healthcare provider right away if you have new or worsening severe stomach pain, vomiting, blood in your stool, black stools, or other severe stomach symptoms. Your healthcare provider may stop BAFIERTAM if serious stomach problems occur.

Common Adverse Reactions:

The most common side effects of BAFIERTAM include:

  • Flushing, which may feel like warmth, redness, itching, or a burning sensation.
  • Stomach‑related problems, such as nausea, vomiting, diarrhea, stomach pain, and indigestion.
  • Skin reactions, including rash or itching.

These side effects were most common early in treatment and often became less frequent over time.

Other side effects reported after the medicine became available include hair thinning or hair loss. These are not all the possible side effects of BAFIERTAM. Call your healthcare provider for medical advice about side effects.

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

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

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