dimethyl fumarate
Dimethyl fumarate (Tecfidera) is used to treat adults with certain types of multiple sclerosis (MS), a condition that affects your nervous system. This medication is a disease-modifying therapy (DMT) that belongs to the drug class called fumaric acid derivatives. Dimethyl fumarate (Tecfidera) is available as a brand-name medication and a lower-cost generic. The capsules are taken by mouth twice per day. The most common side effects are stomach upset and flushing (e.g., facial warmth, redness, burning sensation).
What is Dimethyl fumarate (Tecfidera)?
What is Dimethyl fumarate (Tecfidera) used for?
Relapsing forms of multiple sclerosis (MS)
How Dimethyl fumarate (Tecfidera) works
Dimethyl fumarate (Tecfidera) is a type of disease-modifying therapy (DMT). More specifically, it belongs to the drug class called fumaric acid derivatives.
It's not entirely clear how dimethyl fumarate (Tecfidera) works to treat multiple sclerosis. But it's thought to help defend against the toxins that your body makes when there's a lot of inflammation. The medication appears to work through many different signaling pathways in the body to protect your cells from stress.
Drug Facts
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What are the side effects of Dimethyl fumarate (Tecfidera)?
Common Side Effects
- Flushing (40%)
- Stomach pain (18%)
- Diarrhea (14%)
- Nausea (12%)
- Vomiting (9%)
- Itchiness (8%)
- Rash (8%)
Other Side Effects
- Redness of the skin
- Upset stomach or indigestion
- Higher liver enzyme levels on blood test results
- Low white blood cell count
Serious Side Effects
- Liver damage: fever, feeling tired, nausea, vomiting, yellowing of the skin or whites of the eyes, clay-colored stool, dark urine
- Serious infection: fever, cough, weakness, difficulty speaking or thinking, muscle pain, changes in personality, confusion
- Stomach or gut issues: rectal bleeding, bloody diarrhea, severe vomiting or diarrhea, severe stomach pain
- Serious allergic reaction: difficulty breathing, rash, swelling of lips or tongue
Source: DailyMed
The following side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Chills
feeling of warmth
hoarseness
lower back or side pain
painful or difficult urination
redness of the face, neck, arms, and occasionally, upper chest
Incidence not known
Black, tarry stools
difficulty with swallowing
dizziness
fast heartbeat
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
painful blisters on the trunk of the body
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
sores, ulcers, or white spots on the lips or in the mouth
swollen glands
tightness in the chest
trouble breathing
unusual bleeding or bruising
unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Dimethyl fumarate (Tecfidera)
Pros
Works well to lessen MS relapses
Can take with or without food
Available as a lower-cost generic medication
No known interactions with other medications or supplements
Cons
Need to take twice a day
Might need MRI scans to see whether the medication is working for you
Might need to have regular blood work done to make sure the medication isn't causing any liver problems
Pharmacist tips for Dimethyl fumarate (Tecfidera)
Be sure to get MRI scans when your prescriber recommends you to. These MRI scans check for brain damage from MS and helps your prescriber see how well dimethyl fumarate (Tecfidera) is working for you.
Make sure to mark your appointments on your calendar to keep up with scheduled tests while you're taking dimethyl fumarate (Tecfidera). You'll need to get blood tests before you start the medication and periodically during treatment. These blood tests check the health of your liver and your blood cell counts) to make sure dimethyl fumarate (Tecfidera) is safe for you.
You can take dimethyl fumarate (Tecfidera) with or without food. If you experience upset stomach or flushing from the medication, taking it with high-fat, high-protein foods, like yogurt or peanut butter, might help you tolerate the medication better.
Swallow dimethyl fumarate (Tecfidera) capsules whole. The medication is meant to be slowly released into the body over time. Don't crush or chew the capsule. Also don't open the capsule and sprinkle its contents onto food. Otherwise, the medication might get absorbed into the body too quickly.
One of the common side effects of dimethyl fumarate (Tecfidera) is stomach upset and stomach pain. Ask your prescriber or pharmacist about safe over-the-counter antacids for you to take to help manage stomach problems while you're taking dimethyl fumarate (Tecfidera).
Contact your prescriber right away if you experience symptoms of infection, like fever, rash, muscle pain, or confusion, during your treatment with dimethyl fumarate (Tecfidera). You might need to take a break from the medication so that your body can fight the infection.
Let your prescriber know if you experience stomach pain, nausea, vomiting, or yellowing of your skin or whites of your eyes while you're taking dimethyl fumarate (Tecfidera). These can signs of liver damage.
Frequently asked questions about Dimethyl fumarate (Tecfidera)
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What are the risks and warnings for Dimethyl fumarate (Tecfidera)?
Dimethyl fumarate (Tecfidera) 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.
Severe allergic reactions
Severe allergic reactions to dimethyl fumarate (Tecfidera) are possible, including life-threatening reactions like facial or neck swelling and anaphylaxis (e.g., closing of the throat). Get medical help right away if you experience symptoms of an allergic reaction, such as difficulty breathing, hives, or swelling of the throat or tongue.
Serious infections
Risk factors: Taking medications that weaken your immune system | Having other medical conditions that raise your risk of infections
Dimethyl fumarate (Tecfidera) can weaken your immune system. This can put you at higher risk for serious opportunistic infections (OIs). OIs are infections that typically don't cause serious problems for healthy people but can cause more frequent or more severe illness for people with a weakened immune system.
In general, OIs can be caused by bacteria, viruses, or fungi. OIs can affect many parts of the body, including the brain, lungs, skin, and eyes. During clinical studies, some OIs that people who took dimethyl fumarate (Tecfidera) had included herpes zoster (shingles), progressive multifocal leukoencephalopathy (PML), and Mycobacterium tuberculosis (the bacteria that causes tuberculosis), among others.
Make sure your care team knows about your past medical history before you start dimethyl fumarate (Tecfidera). Tell your care team if you feel sick or have symptoms like fever, cough, tiredness, muscle pain, weakness on one side of the body, changes in personality, or confusion. You might have to stop dimethyl fumarate (Tecfidera) to give your immune system the chance to fight the infection if you get a serious infection during treatment.
Low white blood cell counts (lymphopenia)
Dimethyl fumarate (Tecfidera) can lower the amount of lymphocytes (a type of white blood cell) in your body. This can put you at risk for serious infections. You'll need to get blood draws before you start treatment and then regularly while you're taking dimethyl fumarate (Tecfidera). This helps your prescriber check that your blood cell levels aren't too low.
If your lymphocyte count gets too low during treatment, you might need to stop taking dimethyl fumarate (Tecfidera) until it goes back up. Discuss with your prescriber about whether you can restart dimethyl fumarate (Tecfidera) or whether you need to change to a different medication when your lymphocyte count recovers. Let your prescriber know if you have symptoms of infection, such as fever, cough, feeling tired, or muscle pain.
Liver damage
Risk factors: History of liver problems | Taking medications that affect your liver
Some people who took dimethyl fumarate (Tecfidera) had liver damage that sometimes required hospitalization. Liver damage has happened as early as a few days after the start of treatment, and the risk appears to be highest during the first several months of treatment. In addition, the risk is higher in people who already have liver problems or in people who take other medications that can harm the liver. Typically, the liver damage goes away once treatment is stopped.
Because of the risk for liver damage, your prescriber will ask you to get lab work done to check the health of your liver before you start treatment and regularly while you're taking dimethyl fumarate (Tecfidera). Your prescriber might ask you to stop the medication if your lab work shows that you have liver injury to prevent it from getting worse. Get medical help right away if you have signs of liver injury, including yellow skin and whites of your eyes, stomach pain, loss of appetite, nausea, and tiredness.
Flushing
Dimethyl fumarate (Tecfidera) can cause flushing that gets better over time. Symptoms of flushing include warmth, redness, itching, or a burning sensation on your skin. In most cases, flushing is bothersome but won't cause any serious harm. To lower the chance of flushing, you can take aspirin (up to 325 mg) half an hour before your dimethyl fumarate (Tecfidera) dose if your prescriber tells you it's safe to do so. It's also helpful to take dimethyl fumarate (Tecfidera) with food to lower your risk of flushing.
Serious stomach and intestine problems
Although very rare, some people who took dimethyl fumarate (Tecfidera) and other similar medications reported having serious stomach problems. These problems included ulcers, perforation (holes), bleeding, and bowel obstruction (a blockage in the stomach or gut). Most of these reports happened within 6 months of starting the medication. Let your care team know right away if you have any new or worsening stomach pain, acid reflux, nausea, vomiting, or stomach bloating.
Dimethyl fumarate (Tecfidera) dosage forms
Typical dosing for Dimethyl fumarate (Tecfidera)
The typical starting dose is 120 mg by mouth twice a day for 7 days. Then, your prescriber will raise your dose to 240 mg by mouth twice a day.
Interactions between Dimethyl fumarate (Tecfidera) and other drugs
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Diroximel Fumarate
How much does Dimethyl fumarate (Tecfidera) cost?
What are alternatives to Dimethyl fumarate (Tecfidera)?
Relapsing forms of multiple sclerosis (MS)
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References
Best studies we foundBiogen Inc. (2024). Tecfidera- dimethyl fumarate kit; Tecfidera- dimethyl fumarate capsule [package insert]. DailyMed.
Gold, R., et al. (2022). Long-term safety and efficacy of dimethyl fumarate for up to 13 years in patients with relapsing-remitting multiple sclerosis: Final ENDORSE study results. Multiple Sclerosis.
Iyer, P., et al. (2023). Multiple sclerosis in pregnancy: A commentary on disease modification and symptomatic drug therapies. Neurology and Therapy.
Khatri, B. O., et al. (2015). The effect of dimethyl fumarate (Tecfidera™) on lymphocyte counts: A potential contributor to progressive multifocal leukoencephalopathy risk. Multiple Sclerosis and Related Disorders.
Lategan, T. W., et al. (2021). Pharmacokinetics and bioavailability of monomethyl fumarate following a single oral dose of Bafiertam™ (monomethyl fumarate) or Tecfidera® (dimethyl fumarate). Central Nervous System Drugs.
Mills, E. A., et al. (2018). Emerging understanding of the mechanism of action for dimethyl fumarate in the treatment of multiple sclerosis. Frontiers in Neurology.
National Institute of Neurological Disorders and Stroke. (2024). Progressive multifocal leukoencephalopathy.
Porwal, M. H., et al. (2022). Alopecia in multiple sclerosis patients treated with disease modifying therapies. Journal of Central Nervous System Disease.
Theodore Phillips, J., et al. (2014). Managing flushing and gastrointestinal events associated with delayed-release dimethyl fumarate: Experiences of an international panel. Multiple Sclerosis and Related Disorders.
Theodore Phillips, J., et al. (2015). Consensus management of gastrointestinal events associated with delayed-release dimethyl fumarate: A Delphi study. Neurology and Therapy.
Wundes, A., et al. (2021). Improved gastrointestinal profile with diroximel fumarate is associated with a positive impact on quality of life compared with dimethyl fumarate: Results from the randomized, double-blind, phase III EVOLVE-MS-2 study. Therapeutic Advances in Neurological Disorders.
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