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Bafiertam is commonly used to treat multiple sclerosis. Common side effects include flushing and stomach problems like stomach pain, nausea, and diarrhea. You can take Bafiertam with or without food. Swallow the capsules whole without crushing, chewing, or mixing the contents with food. 

Uses

What is Bafiertam used for?

Bafiertam (monomethyl fumarate) is commonly used to treat multiple sclerosis (MS). MS is a chronic condition where the immune system attacks and damages the protective coating around nerve cells, making it harder for the brain and body to work together. This can cause symptoms like trouble walking, fatigue, muscle weakness, numbness, and vision and memory problems. Bafiertam can treat the following relapsing forms of MS. 

  • Clinically isolated syndrome (CIS)
  • Relapsing-remitting MS (RRMS)
  • Active secondary progressive MS (SPMS)

Bafiertam may also be used for other conditions as determined by your health care provider.

How does Bafiertam work (mechanism of action)?

Bafiertam may work by helping to protect cells from damage caused by stress and supporting the body’s natural ability to repair and maintain itself.

How is Bafiertam supplied (dosage forms)?

Brands and other names

  • Bafiertam

Dosage forms and strengths

  • 95 mg delayed-release oral capsules

How should I store Bafiertam?

Store the unopened bottle in the refrigerator, between 35 F to 46 F (2 C to 8 C). Do not freeze. The medicine will expire on the date listed on the package.

Once opened, Bafiertam should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place in the original container and protect from light. Avoid high temperatures, which can damage the capsules. Throw away any remaining capsules if the bottle has been opened for more than three months.

Side Effects

What are the most common side effects of Bafiertam?

The most common side effects of Bafiertam are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Flushing, redness, rash, or itching
  • Stomach problems (see below)

There may be other side effects of Bafiertam that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Bafiertam?

While less common, the most serious side effects of Bafiertam are described below, along with what to do if they happen.

Severe Allergic Reactions. Bafiertam may cause allergic reactions, which can be serious. Stop taking Bafiertam and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Stomach Problems. Nausea, vomiting, diarrhea, stomach pain, and upset stomach (or indigestion) are common side effects of Bafiertam and may decrease over time. However, in some cases, serious stomach problems may also occur. These can include bleeding, ulcers (sores), blockage, and perforation (tears or holes) of the stomach or intestines. Call your health care provider right away if you have any of the following symptoms. 

  • Stomach pain that does not go away 
  • Bright red stools or black, tarry stools
  • Severe vomiting or diarrhea
  • Coughing up blood or blood clots
  • Vomiting blood or vomit that looks like coffee grounds

Progressive Multifocal Leukoencephalopathy(PML). People taking Bafiertam may develop a rare brain disease called PML. It is caused by a virus called the JC virus. PML is very serious and can lead to death. Stop taking Bafiertam and call your health care provider right away if you have any of the following symptoms of PML.

  • Clumsiness in the arms or legs or loss of coordination
  • Difficulty walking or speaking
  • Facial drooping
  • Vision problems
  • Confusion
  • Thinking, memory, or personality changes
  • Weakness on one side of your body that gets worse
  • Seizures

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Bafiertam. Your health care provider will order blood tests to check your liver before and during treatment with Bafiertam. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Low Lymphocyte Levels (Lymphopenia). Bafiertam may cause low lymphocyte levels, also called lymphopenia or lymphocytopenia. Lymphocytes are a type of white blood cell that help prevent infection. Having a low level of lymphocytes may increase your risk of infection. Your health care provider will order blood tests to check your lymphocyte levels before and during treatment with Bafiertam. Tell your health care provider if you have any of the following symptoms of low lymphocyte levels.

  • Fever, chills, or sweats
  • Tiredness
  • Sore throat, cough, or shortness of breath
  • Mouth or throat sores
  • Swollen lymph nodes

Herpes Zoster (Shingles). Bafiertam may cause serious cases of shingles, which may affect the eyes, brain, lungs, spinal cord, and other body systems. Call your health care provider right away if you have any of the following symptoms of shingles. 

  • Swollen lymph nodes
  • Fluid-filled blisters
  • Stabbing or shooting pain (with or without a rash)
  • Feeling like your skin is tingling or burning
  • Fever or chills
  • Headache
  • Tiredness
  • Upset stomach
  • Eye symptoms such as blurry vision, sensitivity to light, or eye pain, rash, redness, or oozing

Other Serious Infections. Bafiertam may also increase the risk of other serious infections, including viral, fungal, and bacterial infections. This can happen even if your bloodwork is normal. Talk to your health care provider about what kind of symptoms to look for and call your provider if you have any symptoms of infection.

Warnings & Precautions

Who should not use Bafiertam?

Allergies to Ingredients. People who are allergic to any of the following should not take Bafiertam.

  • Bafiertam
  • Monomethyl fumarate
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Bafiertam.

Drug Interactions. Bafiertam should not be taken while you are using certain other medicines. Before taking Bafiertam, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

What should I know about Bafiertam before using it?

Do not take Bafiertam unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Bafiertam with other people, even if they have the same condition as you. It may harm them.

Keep Bafiertam out of the reach of children. When this medicine is kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.

Your health care provider may order blood tests before and during treatment with Bafiertam. Keep all appointments for follow up and bloodwork.

Swallow the capsule whole. Do not crush or chew the capsule. Do not open the capsule and mix the contents with food.

Flushing is a common side effect of Bafiertam. You may feel warmth, redness, itching, and/or a burning feeling. If you have flushing that bothers you, ask your health care provider if you can take a non-enteric-coated aspirin 30 minutes before taking Bafiertam, which can help reduce flushing. 

What should I tell my health care provider before using Bafiertam?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Bafiertam is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Liver problems
  • Low white blood cells counts
  • Current or past infection

Pregnancy. It is not known if or how Bafiertam could affect pregnancy or harm an unborn baby. Tell your health care provider if you are or plan to become pregnant. If you become pregnant while taking Bafiertam, you can sign up for the pregnancy registry by calling 866-663-95MG (866-663-9564). This registry collects safety information about the use of certain multiple sclerosis drugs during pregnancy.

Breastfeeding. It is not known if Bafiertam passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will advise you if you should take Bafiertam while breastfeeding.

How can I get more information about Bafiertam?

For more information about Bafiertam, you can visit the drugmaker’s website at www.bafiertam.com or call them at 866-663-95MG (866-663-9564).

 

Interactions

Does Bafiertam interact with foods or drinks?

There are no known interactions between Bafiertam and foods or drinks.

It is unknown if drinking alcohol will affect Bafiertam, but both Bafiertam and alcohol can cause liver damage. It is likely best to limit the amount of alcohol you drink while taking Bafiertam.

Does Bafiertam interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. In particular, make sure that you discuss if you are taking dimethyl fumarate (Tecfidera) or diroximel fumarate (Vumerity), which are medicines used to treat multiple sclerosis.

This may not be a complete list of medicines that can interact with Bafiertam. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Bafiertam?

If you or someone else has used too much Bafiertam, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Bafiertam?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.