What is multiple sclerosis (MS)?

MS is an unpredictable disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body.1

Not actual patient

The exact cause of MS is unknown. Scientists believe it is triggered by several different factors and there is ongoing research to identify the exact cause.2

Nearly one million people are living with MS in the United States.3

No two MS patients are the same, and symptoms vary from person to person.4 Some of the main symptoms include problems with vision, fatigue, numbness, pain and bowel or bladder problems.4 Not everyone will experience all of these symptoms.

Diagnosis can be life altering and incredibly emotional for you and your family. There’s a lot to take in and think about, and every patient with MS has a different experience. That’s why we created Cycle Vita™, our dedicated patient support* program to support you throughout your treatment journey, for life.

Find resourcesLearn more about patient support
References

1. National Multiple Sclerosis Society (2024) What is MS? Available at: https://www.nationalmssociety.org/understanding-ms/what-is-ms. [Accessed: July 11 2025].

2. National Multiple Sclerosis Society (2024) What Causes MS? Available at: https://www.nationalmssociety.org/understanding-ms/what-is-ms/what-causes-ms. [Accessed: July 11 2025].

3. National Multiple Sclerosis Society (2024) Who gets Multiple Sclerosis? Available at: https://www.nationalmssociety.org/understanding-ms/what-is-ms/who-gets-ms. [Accessed: July 11 2025].

4. National Multiple Sclerosis Society (2024) MS Signs & Symptoms. Available at: https://www.nationalmssociety.org/understanding-ms/what-is-ms/ms-symptoms. [Accessed: July 11 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.

Indication and Important Safety Information
Indication and Important Safety Information
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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