Bafiertam (Monomethyl Fumarate) for Multiple Sclerosis

Bafiertam (monomethyl fumarate) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for treating adults with relapsing forms of multiple sclerosis (MS).

How Bafiertam Works and How It’s Taken

Bafiertam works by changing certain cell pathways linked to oxidative stress, which is damage caused by unstable molecules in the body. The exact way it helps in relapsing forms of multiple sclerosis is not fully known. It has been shown to turn on the Nrf2 pathway, which helps cells respond to stress. This may help protect cells and lower harmful activity that can play a role in multiple sclerosis.

Bafiertam is used to treat adults with relapsing forms of multiple sclerosis. It comes as a capsule taken by mouth two times a day. The starting dose is 95 milligrams two times a day for seven days. After that, the usual dose is 190 milligrams two times a day, taken as two capsules of 95 milligrams each time.

Bafiertam Side Effects

In clinical studies of adults with relapsing forms of MS, the most common side effects of Bafiertam occurred in between 12 percent and 40 percent of people. These side effects include:

Flushing (warmth, redness or skin darkening, itching, or a burning feeling)
Abdominal pain
Diarrhea
Nausea

Serious Side Effects and Warnings

Bafiertam can cause serious side effects that require immediate medical attention. These include:

Anaphylaxis and angioedema — These severe allergic reactions can cause trouble breathing, hives, or swelling of the throat or tongue.
Progressive multifocal leukoencephalopathy — PML is a rare, serious brain infection that can lead to severe disability or death.
Serious infections — Herpes zoster and other opportunistic infections may affect the brain, eyes, lungs, skin, or other organs.
Lymphopenia — Low white blood cell counts can raise infection risk.
Liver injury — Liver damage may cause tiredness, loss of appetite, right-sided upper belly pain, dark urine, or yellowing of the skin or eyes.
Serious gastrointestinal problems — These include bleeding, ulcers, blockage, and tears in the stomach or intestines.

Get medical help right away if you think you are having a serious reaction.

How To Save on Bafiertam

Cycle Pharmaceuticals Limited, the manufacturer of Bafiertam, offers Cycle Vita, a dedicated patient support program. Eligible people with commercial insurance may pay as little as $0 with copay assistance.

Cycle Vita also offers a bridge program (a free supply of Bafiertam while waiting for benefit verification and assistance with prior authorization) and reimbursement research support. To learn more, visit the Bafiertam site or call 888-360-8482.

What To Know Before Taking Bafiertam

Before starting Bafiertam, your doctor will order blood tests, including liver blood tests (serum aminotransferase, alkaline phosphatase, and total bilirubin).

Do not take Bafiertam if you have a known hypersensitivity to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or any of the ingredients in Bafiertam, or if you are currently taking dimethyl fumarate or diroximel fumarate.

Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, and supplements. Also tell your doctor about all of your medical conditions, including if you have liver problems or if you have or have had an infection.

If you are pregnant, planning to become pregnant, or breastfeeding while taking Bafiertam, talk with your doctor about the risks and benefits.

Community FAQs

How effective is Bafiertam?
In studies of people with relapsing-remitting multiple sclerosis, the dimethyl fumarate regimen lowered the annualized relapse rate (average number of relapses experienced by a person in a year) by 53 percent and 44 percent at two years compared with placebo (an inactive treatment). MRI scan results also improved; people on treatment had fewer new or enlarging brain lesions.

Can Bafiertam cause flushing or stomach problems in people with multiple sclerosis?
Yes. Flushing, stomach pain, diarrhea, and nausea are among the most common side effects. These side effects are often more common when treatment starts and may decrease over time.

In studies with the dimethyl fumarate regimen, flushing happened in 40 percent of people, stomach pain in 18 percent, diarrhea in 14 percent, and nausea in 12 percent. Tell your healthcare provider if flushing is severe or does not go away. Severe stomach or bowel symptoms need prompt medical attention.

What tests are needed before and during treatment with Bafiertam for multiple sclerosis?
Before starting Bafiertam, blood tests are needed. These include a complete blood count (CBC) with a lymphocyte count, and liver tests such as serum aminotransferase, alkaline phosphatase, and total bilirubin. Another CBC, including lymphocyte count, is recommended six months after starting treatment and then every six to 12 months after that, as needed. Liver tests should also be checked during treatment when needed.