Bafiertam
Bafiertam (monomethyl fumarate) is an oral medication that's FDA approved to treat multiple sclerosis (MS) in adults. It's a type of disease-modifying therapy for MS. This multiple sclerosis treatment is a capsule that's taken by mouth twice a day. Common side effects include flushing, stomach pain, and diarrhea. Bafiertam (monomethyl fumarate) is a brand-name medication only; there isn't a generic version yet.
What is Bafiertam (monomethyl fumarate)?
What is Bafiertam (monomethyl fumarate) used for?
How Bafiertam (monomethyl fumarate) works
Bafiertam (monomethyl fumarate) is a type of disease-modifying therapy (DMT) for multiple sclerosis. More specifically, it's a fumaric acid derivative that acts as an Nrf2 activator.
It's not exactly clear how Bafiertam (monomethyl fumarate) works to prevent MS flare-ups and symptoms. But it's thought to turn on Nrf2 pathways in the body. This helps protect your nerve cells from damage and lessen inflammation.
Drug facts
Side effects of Bafiertam (monomethyl fumarate)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
Note: Side effects were reported by people taking a similar medication called dimethyl fumarate (Tecfidera).
- Flushing (40%)
- Stomach pain (18%)
- Diarrhea (14%)
- Nausea (12%)
Less Common Side Effects
- Vomiting
- Indigestion
- Itchy skin
- Rash
- Skin redness
- Protein in your urine (foamy, frothy urine)
- Higher liver enzyme levels
- Low white blood cell count
Bafiertam (monomethyl fumarate) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious allergic reactions: hives, rash, swelling of the face and eyes, throat tightness, trouble breathing, wheezing, trouble swallowing, passing out
- Brain infection: weakness on one side of the body, clumsiness, changes in personality, confusion
- Serious infection: fever, chills, cough, runny nose
- Liver damage: yellow skin and eyes, tiredness, stomach pain, loss of appetite, nausea
- Serious stomach problems: severe stomach pain, diarrhea, or vomiting; constipation; bloody or black stool; bloating; can't pass gas
The following Bafiertam (monomethyl fumarate) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
- Bowel blockage—stomach cramping, unable to have a bowel movement or pass gas, loss of appetite, vomiting
- Dizziness, loss of balance or coordination, confusion or trouble speaking
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Stomach bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds
- Stomach pain that is severe, does not go away, or gets worse
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
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Pros and cons of Bafiertam (monomethyl fumarate)
Pros
- Taken by mouth, so it might be a good option for people who don't like needles
- Can take with or without food
- Might have less stomach-related side effects than dimethyl fumarate (Tecfidera)
- Okay for people with liver or kidney problems to take
Cons
- Need to take twice a day
- Flushing and stomach pain are common
- Raises the risk of serious infection
- Not known if it's safe to take during pregnancy
Pharmacist tips for Bafiertam (monomethyl fumarate)
- Keep unopened bottles of Bafiertam (monomethyl fumarate) in the refrigerator. Don't let them freeze because it can damage the medication.
- Once you open a bottle of Bafiertam (monomethyl fumarate), write down the date. The medication is good for 3 months from this date. Store opened bottles at room temperature in the original container, away from light. Don't let the medication get too warm because the capsules could melt.
- Take Bafiertam (monomethyl fumarate) with or without food. But taking it without food might lower the risk of stomach upset from the medication.
- Swallow Bafiertam (monomethyl fumarate) whole. Don't crush or chew the capsule. Also don't open the capsule to mix its contents with food. The capsule is made to help the medication get released into the body slowly over time.
- You'll first start Bafiertam (monomethyl fumarate) at a low dose. Then a week later, you'll continue treatment at a higher dose. Tell your prescriber if you have side effects like flushing, stomach pain, or nausea when your dose changes. You might have to go back to your starting dose for a short while until your body gets used to the medication.
- Flushing is a common side effect of Bafiertam (monomethyl fumarate). It can feel like warmth, redness, itching, or burning. Flushing usually gets better as you get used to the medication. To help with flushing, you can take up to 325 mg of aspirin 30 minutes before Bafiertam (monomethyl fumarate). Make sure the aspirin isn't enteric coated (a special coating that protects it from stomach acid).
- Stomach upset from Bafiertam (monomethyl fumarate) is common and might get better over time. But if you have severe stomach pain, vomiting, or bloody diarrhea, stop taking the medication and get medical help right away. The care team can check if there's something serious going on.
- You'll need lab tests to check your white blood cell count and liver before you start Bafiertam (monomethyl fumarate), and then regularly during treatment. These tests help make sure the medication is safe for you. Ask your care team if you're not sure whether you have lab work scheduled.
Common questions about Bafiertam (monomethyl fumarate)
No, Bafiertam (monomethyl fumarate) doesn't have a generic version yet. Right now, it's only a brand-name medication.
You need to refrigerate unopened bottles of Bafiertam (monomethyl fumarate). Then once you open a bottle, you can keep it at room temperature for 3 months.
Vumerity (diroximel fumarate) and Bafiertam (monomethyl fumarate) are both medications that treat multiple sclerosis (MS). They're both capsules that you take by mouth twice a day. The main difference is that Vumerity (diroximel fumarate) turns into into monomethyl fumarate in the body. That's the active form of the medication that works to treat MS. Bafiertam (monomethyl fumarate) was made later to skip that step. It gives your body the active form right away. Both medications have similar side effects. Talk to your prescriber to see which one might be best for you.
Bafiertam (monomethyl fumarate) is sometimes called an immunosuppressant. It works by lowering how active your immune system is. This helps reduce swelling and inflammation caused by MS.
Talk to your prescriber about whether you can take Bafiertam (monomethyl fumarate) if you're pregnant or planning to get pregnant. It's not known if this medication can harm a baby during pregnancy. Your prescriber can talk about the risks and benefits of taking this medication while pregnant. If you take Bafiertam (monomethyl fumarate) while pregnant, you can join a safety registry by calling 1-866-663-9564. This helps researchers learn more about how the medication affects people who are pregnant and their babies.
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Risks and warnings for Bafiertam (monomethyl fumarate)
Bafiertam (monomethyl fumarate) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Serious allergic reactions
Bafiertam (monomethyl fumarate) can cause serious allergic reactions. This can happen as early as after the first time you take the medication. Signs of an allergic reaction include hives, rash, swelling in your face or eyes, throat tightness, trouble breathing or swallowing, and nausea. Stop taking the medication and get medical help right away if you have any of these signs.
Risk of brain infection (progressive multifocal leukoencephalopathy)
- Risk factors: Other medical conditions that raise your risk of infections (e.g., cancer, HIV) | Taking medications that weaken your immune system
Bafiertam (monomethyl fumarate) can make it harder for your body to fight infections. It can raise your risk of getting progressive multifocal leukoencephalopathy (PML). This is a brain infection caused by the John Cummingham virus (JCV). This virus is common, though most people who get infected don't feel sick. But people with a weakened immune system (like those who take this medication) can get a serious form of PML that can be life-threatening or cause severe disability.
Stop Bafiertam (monomethyl fumarate) and call your care team right away if you have any early signs of PML. Watch for signs like weakness on one side of the body, clumsiness, mood or personality changes, and confusion. You might need to get testing or brain imaging done to confirm whether you have PML.
Risk of other serious infections
- Risk factors: Taking medications that lower your immune system | Other medical conditions that raise your risk of infections
Bafiertam (monomethyl fumarate) can raise your risk of serious opportunistic infections (OIs) because it can weaken your immune system. OIs usually don't cause serious problems. But they can lead to more severe illness for people with a weak immune system.
Some OIs include herpes zoster (which can cause shingles), yeast infections, and certain bacteria like the kind that causes tuberculosis (TB). These infections can happen at any time during treatment. They can affect any part of your body, like the brain, lungs, skin, and eyes.
Tell your prescriber about your medical history before you start Bafiertam (monomethyl fumarate). Call your care team if you feel sick. If you get a serious infection, you might need to stop the medication. This gives your immune system a chance to fight the infection.
Low white blood cell counts (lymphopenia)
Bafiertam (monomethyl fumarate) can lower your lymphocyte count. Lymphocytes are a type of white blood cell in your immune system. Having a low lymphocyte count puts you at risk for serious infections.
You'll need to get a blood test before starting Bafiertam (monomethyl fumarate) and then regularly while you're taking it. This checks that your blood cell counts aren't too low. If your lymphocyte count is too low and stays low, you might need to stop this medication until it goes back up. At that time, your prescriber will talk with you about either restarting Bafiertam (monomethyl fumarate) or switching to a different medication.
Let your prescriber know if you feel sick while taking Bafiertam (monomethyl fumarate). Look out for fever, chills, frequent cough, or runny nose. These can be signs of an infection.
Liver injury
Some people who take Bafiertam (monomethyl fumarate) might develop liver injury. This has happened as early as a few days after you start this medication but can also happen many months later. In serious cases, some people had to get hospitalized.
The first signs of liver problems might only show up in your blood test results. In studies, these signs appeared during the first 6 months of taking Bafiertam (monomethyl fumarate). You'll need lab work done before you start treatment and regularly while taking this medication. If your lab work shows liver injury, you might have to stop Bafiertam (monomethyl fumarate) so it doesn't get worse.
Call your prescriber if you notice yellow skin and eyes, stomach pain, tiredness, loss of appetite, and nausea. These can be signs of liver injury.
Serious stomach problems
Although it's rare, some people who took medications like Bafiertam (monomethyl fumarate) had serious stomach problems. This can include ulcers, bleeding, and blockages in the stomach. Most of the time, these stomach problems happened within 6 months of starting the medication. Call your prescriber if you have any stomach side effects that get worse or become severe.
Bafiertam (monomethyl fumarate) dosage
Capsule| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 95mg | 120 capsules | $6,899.20 | $57.49 |
Typical dosage for Bafiertam (monomethyl fumarate)
The typical starting dose is 95 mg by mouth twice a day for 7 days.
After 7 days, your dose will be raised to a maintenance dose of 190 mg (two 95 mg capsules) twice a day.
How much does Bafiertam (monomethyl fumarate) cost?
$6,899.20
Bafiertam (monomethyl fumarate) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Bafiertam (monomethyl fumarate) will not be safe for you to take.
- Take dimethyl fumarate (Tecfidera) or Vumerity (diroximel fumarate)
- Previous allergic reaction to dimethyl fumarate (Tecfidera) or Vumerity (diroximel fumarate)
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