BAFIERTAM® (monomethyl fumarate) delayed-release capsules

95 mg

What is BAFIERTAM?

BAFIERTAM is a unique agent in the fumarates class of disease modifying therapies (DMTs), requiring no dietary restrictions and no metabolic conversion.

It 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.1

At Cycle, we know that life-changing treatments need life-improving support to match. That’s why we created Cycle Vita™, delivering individualized product support every step of the way with BAFIERTAM.

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Support available to you with BAFIERTAM

Start your BAFIERTAM enrollment here

Download and print the enrollment form, share it with your doctor and discuss why you think BAFIERTAM may be suited to your needs.

The first steps

Your Cycle Vita team will quickly get to work with your insurance provider to help you understand your coverage.

We will coordinate seamlessly between different parties, such as insurance companies, doctors, and pharmacists to help you with your Prior Authorization and document requirements.

We will route your BAFIERTAM therapy to the appropriate specialty pharmacy and follow-up to ensure swift shipment of your medication.

Additional assistance, when required, thoughout your journey

If you have commercial insurance, you may be eligible for the Cycle Vita Co-Pay Assistance Program. Commercially insured eligible patients may pay as little as $0. Please contact us to find out more about this and other programs that may be available to you (such as the Bridge Program).

A free supply of BAFIERTAM is available while we secure appropriate Benefit Verification and assist with Prior Authorization activities, as necessary. It may also be requested if you experience a temporary disruption in therapy due to insurance coverage. Bridge duration is driven by insurance coverage and the active collaboration of your clinic.

Our Clinical Support team can provide you with training to help you keep on top of your medication schedule.

Translation services are available on request.

In some cases, an appeal may be needed. Where this is the case, our experienced team will work with your insurer and doctor to understand the requirements and help you with any BAFIERTAM reimbursement gaps.

If you agree, our proactive team will remind your doctor when your BAFIERTAM prescription needs to be renewed, in a timely manner, to ensure an uninterrupted supply of your therapy.

What is multiple sclerosis (MS)?

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

No two MS patients are the same, and symptoms vary from person to person.3 Some of the main symptoms include problems with vision, fatigue, numbness, pain and bowel or bladder problems.3 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. At Cycle Vita, we are here to support you, for life.

Resources

Footnote
*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.

BAFIERTAM® is a registered trademark of Banner Life Sciences, LLC, a Cycle Pharmaceuticals company.

References

  1. BAFIERTAM. Prescribing Information. Banner Life Sciences LLC.
  2. National Multiple Sclerosis Society (2024) What Causes MS? Available at: https://www.nationalmssociety.org/understanding-ms/what-is-ms/what-causes-ms [Accessed: March 6 2025].
  3. National Multiple Sclerosis Society (2024) Multiple Sclerosis Symptoms. Available at: https://www.nationalmssociety.org/understanding-ms/what-is-ms/ms-symptoms [Accessed: March 6 2025].

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INDICATION AND IMPORTANT SAFETY INFORMATION

WHAT IS BAFIERTAM® (MONOMETHYL FUMARATE)?

  • BAFIERTAM 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.

WHO SHOULD NOT TAKE BAFIERTAM?

  • 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 doctor about all of 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 your breast milk. Talk to your healthcare provider about the best way to feed your baby while using BAFIERTAM.

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

WHAT ARE THE POSSIBLE SIDE EFFECTS OF BAFIERTAM?

BAFIERTAM may cause serious side effects, including:

  • allergic reaction (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.
    • Tell your doctor right away if you get any of these symptoms of PML:
      • weakness on one side of the body that gets worse
      • clumsiness in your arms or legs
      • vision problems
      • changes in thinking and memory
      • confusion
      • personality changes
  • herpes zoster infections (shingles), including central nervous system infections
  • other serious infections
  • decreases in your white blood cell count. Your doctor should 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. Your doctor should do blood tests to check your liver function before you start taking BAFIERTAM and during treatment if needed.
    • Tell your doctor right away if you get any of these symptoms of a liver problem during treatment:
      • severe tiredness
      • loss of appetite
      • pain on the right side of your stomach
      • have dark or brown (tea color) urine
      • yellowing of your skin or the white part of your eyes
  • serious gastrointestinal problems, including bleeding, ulcers, blockage, and tears (perforation) of the stomach or intestines.
    • Tell your healthcare provider right away if you have any of these symptoms during treatment:
      • Stomach-area pain that does not go away
      • Bright red or black stools (that look like tar)
      • Severe vomiting
      • Severe diarrhea
      • Coughing up blood or blood clots
      • Vomiting blood or your vomit looks like “coffee grounds”

THE MOST COMMON SIDE EFFECTS OF BAFIERTAM INCLUDE:

  • flushing, redness, itching, or rash
  • nausea, vomiting, diarrhea, stomach pain, or indigestion
  • Flushing and stomach problems are the most common reactions, especially at the start of treatment, and may decrease over time. Call your doctor if you have any of these symptoms and they bother you or do not go away. Ask your doctor if taking aspirin before taking BAFIERTAM may reduce flushing.

These are not all the possible side effects of BAFIERTAM. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
For more information go to dailymed.nlm.nih.gov.

Please see the full Prescribing Information and Patient Information.

This information does not take the place of talking with your doctor about your medical condition or your treatment.