Dimethyl Fumarate Newbury
Disease-modifying therapy for relapsing multiple sclerosis
Quick Facts about Dimethyl Fumarate Newbury
Key Takeaways
- Proven MS therapy: Dimethyl fumarate significantly reduces relapse rates and MRI lesion activity in relapsing-remitting multiple sclerosis
- Gradual dose titration: Start with 120 mg twice daily for the first 7 days, then increase to the maintenance dose of 240 mg twice daily
- Regular blood monitoring required: Complete blood counts including lymphocyte counts must be checked before and every 6–12 months during treatment
- Common early side effects: Flushing and gastrointestinal symptoms are frequent initially but typically diminish within the first few months
- Take with food: Swallow capsules whole with food to help reduce flushing and stomach-related side effects
What Is Dimethyl Fumarate Newbury and What Is It Used For?
Dimethyl Fumarate Newbury is a disease-modifying oral therapy used to treat adults with relapsing forms of multiple sclerosis (MS). It contains the active substance dimethyl fumarate, which works by activating cellular defence pathways against oxidative stress and modulating the immune response to reduce inflammation in the central nervous system.
Multiple sclerosis is a chronic autoimmune disease in which the body's immune system mistakenly attacks the protective myelin sheath surrounding nerve fibres in the brain and spinal cord. This leads to inflammation, demyelination, and ultimately neurodegeneration, resulting in a wide range of neurological symptoms including fatigue, difficulty walking, numbness, visual disturbances, and cognitive impairment. Relapsing-remitting MS (RRMS) is the most common form, characterised by episodes of new or worsening symptoms (relapses) followed by periods of partial or complete recovery (remissions).
Dimethyl fumarate belongs to the class of fumaric acid esters and is classified as an immunomodulatory agent. After oral ingestion, it is rapidly converted in the body to its primary active metabolite, monomethyl fumarate (MMF). The therapeutic effects are primarily attributed to activation of the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) transcriptional pathway. This pathway plays a central role in protecting cells against oxidative stress and inflammation, which are key drivers of neurodegeneration in MS.
In major clinical trials (DEFINE and CONFIRM), dimethyl fumarate demonstrated significant reductions in annualised relapse rates compared with placebo, with reductions of approximately 44–53%. The medication also showed meaningful reductions in the number of new or enlarging T2-hyperintense lesions on MRI and reduced the proportion of patients who relapsed over a two-year period. Additionally, there was evidence of a reduction in disability progression as measured by the Expanded Disability Status Scale (EDSS).
Dimethyl fumarate activates the Nrf2 pathway, which upregulates antioxidant response genes. This provides neuroprotective effects by reducing oxidative damage to neurons and oligodendrocytes. The drug also has anti-inflammatory properties, shifting the immune response from pro-inflammatory Th1 and Th17 responses towards anti-inflammatory Th2 responses, reducing the migration of activated immune cells into the central nervous system.
Who can take Dimethyl Fumarate Newbury?
Dimethyl Fumarate Newbury is approved for the treatment of adult patients (18 years and older) with relapsing-remitting multiple sclerosis. It is considered a first-line disease-modifying therapy by many neurological guidelines, meaning it can be used as an initial treatment option for patients newly diagnosed with RRMS. It may also be used in patients who have not responded adequately to other treatments or who prefer an oral medication over injectable therapies.
The decision to prescribe dimethyl fumarate should be made by a specialist physician experienced in the management of multiple sclerosis, taking into account the individual patient's disease activity, previous treatment history, and any relevant comorbidities. Before initiating treatment, baseline blood tests including a complete blood count with differential, liver function tests, and renal function tests should be obtained.
What Should You Know Before Taking Dimethyl Fumarate Newbury?
Before starting Dimethyl Fumarate Newbury, you must have baseline blood tests including a complete blood count and lymphocyte count. The medicine is contraindicated in patients with known hypersensitivity to dimethyl fumarate or any excipients. Special caution is required in patients with pre-existing low lymphocyte counts, serious infections, or severe gastrointestinal disease.
Contraindications
Do not take Dimethyl Fumarate Newbury if you have a known hypersensitivity (allergy) to dimethyl fumarate or to any of the other ingredients in the capsule. Allergic reactions to dimethyl fumarate can include symptoms such as difficulty breathing, hives, or swelling of the face, lips, tongue, or throat. If you experience any signs of a serious allergic reaction, stop taking the medicine and seek immediate medical attention.
Patients with suspected or confirmed progressive multifocal leukoencephalopathy (PML) should not be started on dimethyl fumarate. PML is a rare but serious viral brain infection caused by the John Cunningham (JC) virus that occurs predominantly in immunocompromised individuals. Careful evaluation should be performed prior to initiation to rule out any signs or symptoms suggestive of PML.
Warnings and Precautions
There are several important precautions to consider before and during treatment with dimethyl fumarate. These relate primarily to the drug's effects on the immune system and its potential for causing gastrointestinal and hepatic adverse effects:
- Lymphopenia: Dimethyl fumarate can cause a significant reduction in lymphocyte counts. Before starting treatment, a complete blood count (CBC) with differential including lymphocyte count must be obtained. CBCs should then be repeated every 6 to 12 months during treatment. If the lymphocyte count falls below 0.5 × 109/L and persists at this level for more than 6 months, discontinuation should be strongly considered due to the increased risk of opportunistic infections including PML.
- Progressive Multifocal Leukoencephalopathy (PML): Cases of PML have been reported in patients treated with dimethyl fumarate, particularly in the setting of prolonged moderate to severe lymphopenia. PML is typically fatal or results in severe disability. Patients should be monitored for any new or worsening neurological symptoms and signs. If PML is suspected, treatment should be withheld and a diagnostic evaluation initiated.
- Infections: Before starting treatment, consider whether the patient has any active infections. Treatment initiation should be delayed until resolution of serious active infections. During treatment, patients who develop serious infections should be monitored closely, and temporary suspension of treatment may be considered.
- Hepatotoxicity: Cases of clinically significant liver injury, including elevated transaminases to more than five times the upper limit of normal, have been reported. Liver function should be checked before starting treatment and during treatment as clinically indicated. If significant liver injury is diagnosed, treatment should be discontinued.
- Flushing: Flushing is one of the most commonly reported side effects and is thought to be mediated through activation of prostaglandin pathways. Taking a non-enteric-coated aspirin (325 mg) 30 minutes before dosing may reduce the severity and incidence of flushing. Administering dimethyl fumarate with food may also help.
If your lymphocyte count drops below 0.5 × 109/L for more than 6 months, your doctor may consider stopping treatment due to the risk of progressive multifocal leukoencephalopathy (PML). Do not stop or change your dose without consulting your neurologist. Report any new or worsening neurological symptoms immediately.
Pregnancy and Breastfeeding
Dimethyl fumarate is not recommended during pregnancy unless clearly necessary and the potential benefit to the mother outweighs the potential risk to the foetus. Animal reproductive studies have shown adverse effects on embryo-foetal development at doses associated with clinically relevant plasma exposures. There are limited data from the use of dimethyl fumarate in pregnant women.
Women of childbearing potential should be informed about the potential risks and should use effective contraception during treatment. If a patient becomes pregnant or plans to become pregnant while taking dimethyl fumarate, the treating physician should discuss the risks and benefits of continuing therapy. Pregnancy registries exist to monitor outcomes in women exposed to dimethyl fumarate during pregnancy.
It is not known whether dimethyl fumarate or its metabolites are excreted in human breast milk. Because many drugs are excreted in human milk and the potential for serious adverse reactions in nursing infants is unknown, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the medicine to the mother. Your healthcare provider can help you weigh up the risks and benefits of breastfeeding while taking this medication.
How Does Dimethyl Fumarate Newbury Interact with Other Drugs?
Dimethyl fumarate may interact with other immunosuppressive or immunomodulatory therapies, increasing the risk of infection. Live vaccines should be avoided during and for a period after treatment. The drug has not shown significant interactions through cytochrome P450 enzyme pathways, but co-administration with nephrotoxic drugs requires caution.
Dimethyl fumarate undergoes rapid presystemic hydrolysis by esterases before reaching the systemic circulation and is metabolised primarily through the tricarboxylic acid (TCA) cycle rather than through cytochrome P450 (CYP) enzymes. This means that clinically significant drug interactions through CYP-mediated metabolism are not expected. However, there are several important interactions and considerations that patients and healthcare providers should be aware of.
The most clinically important interaction concern relates to the combined use of dimethyl fumarate with other immunosuppressive or immunomodulatory therapies. Because dimethyl fumarate can reduce lymphocyte counts, concurrent use with other drugs that also affect the immune system may lead to an additive immunosuppressive effect, increasing the risk of serious infections. When switching from other MS therapies, the half-life and mechanism of action of the previous treatment should be considered before starting dimethyl fumarate.
| Interacting Drug / Class | Interaction Type | Clinical Significance | Recommendation |
|---|---|---|---|
| Other immunosuppressants (e.g., azathioprine, methotrexate, ciclosporin) | Additive immunosuppression | Major | Concurrent use not recommended; increased risk of infections |
| Other MS disease-modifying therapies (e.g., fingolimod, natalizumab, teriflunomide) | Additive or synergistic immunosuppression | Major | Allow adequate washout period before switching; monitor blood counts |
| Live vaccines (e.g., MMR, varicella, BCG, yellow fever) | Risk of vaccine-related infection | Major | Avoid live vaccines during and for a period after treatment; inactivated vaccines may be given |
| Nephrotoxic drugs (e.g., aminoglycosides, NSAIDs at high doses) | Potential additive renal effects | Moderate | Monitor renal function more frequently if co-administered |
| Non-enteric-coated aspirin | Beneficial co-administration | Helpful | 325 mg taken 30 minutes before dimethyl fumarate may reduce flushing |
Major Interactions
The combination of dimethyl fumarate with other immunosuppressive or immunomodulatory agents is the most clinically relevant interaction. Drugs such as azathioprine, methotrexate, ciclosporin, or biologic therapies like natalizumab and rituximab can all affect immune function. When these agents are combined with dimethyl fumarate, the cumulative immune suppression can significantly increase the risk of opportunistic infections, including PML. Therefore, concomitant use of dimethyl fumarate with such agents is generally not recommended.
Live attenuated vaccines should not be administered to patients receiving dimethyl fumarate, as the immune response may be insufficient to prevent vaccine-related infection. This includes vaccines for measles, mumps, rubella (MMR), varicella (chickenpox), rotavirus, yellow fever, and BCG (tuberculosis). Inactivated vaccines are considered safe and can be administered during treatment, though the immune response may be somewhat reduced. Ideally, vaccinations should be completed before initiating dimethyl fumarate therapy.
Minor Interactions
Dimethyl fumarate has not demonstrated clinically significant interactions with commonly used medications such as oral contraceptives, interferon beta-1a, glatiramer acetate, or short courses of intravenous corticosteroids used to treat MS relapses. Food does not affect the overall bioavailability of dimethyl fumarate, although it may delay the peak plasma concentration. Taking the capsules with food is recommended as it can reduce gastrointestinal side effects and flushing.
There are no known significant interactions with common over-the-counter medications such as paracetamol (acetaminophen) or ibuprofen when used at standard doses. However, patients should always inform their healthcare provider about all medications, supplements, and herbal products they are taking, as individual circumstances may vary. Alcohol consumption has not been formally studied in combination with dimethyl fumarate, but moderation is generally advisable given the potential for liver effects.
What Is the Correct Dosage of Dimethyl Fumarate Newbury?
The starting dose is 120 mg twice daily for the first 7 days, then the maintenance dose is 240 mg twice daily. Capsules should be swallowed whole with food. A temporary dose reduction to 120 mg twice daily may be considered for managing side effects, but the target dose should be resumed within 4 weeks.
The dosing regimen for Dimethyl Fumarate Newbury is designed to minimise the gastrointestinal and flushing side effects that are particularly common during the initial weeks of treatment. A gradual dose titration approach is used, starting with a lower dose and increasing to the full maintenance dose after the first week. This allows the body to gradually adapt to the medication and can significantly improve tolerability.
Standard Dosing Schedule
Week 1 (titration): 120 mg orally, twice daily (morning and evening)
Week 2 onwards (maintenance): 240 mg orally, twice daily (morning and evening)
Total daily maintenance dose: 480 mg
| Patient Group | Starting Dose | Maintenance Dose | Notes |
|---|---|---|---|
| Adults (18+ years) | 120 mg twice daily for 7 days | 240 mg twice daily | Take with food; swallow capsules whole |
| Children (<18 years) | Not established | Not established | Safety and efficacy not established in paediatric patients |
| Elderly (65+ years) | 120 mg twice daily for 7 days | 240 mg twice daily | No dose adjustment required; limited clinical experience |
| Renal impairment | Standard dosing | Standard dosing | No dose adjustment needed; not studied in severe impairment |
| Hepatic impairment | Standard dosing | Standard dosing | No dose adjustment needed; not studied in severe impairment |
Adults
The recommended starting dose for adults is 120 mg taken orally twice daily (morning and evening) for 7 days. After this initial titration period, the dose is increased to the full maintenance dose of 240 mg twice daily. Capsules should be swallowed whole with food and should not be crushed, chewed, or opened, as the gastro-resistant coating is essential for ensuring that the drug is released in the small intestine rather than the stomach, which helps minimise gastrointestinal irritation.
If a patient experiences persistent and troublesome gastrointestinal side effects or flushing, a temporary dose reduction back to 120 mg twice daily may be considered. However, the target maintenance dose of 240 mg twice daily should be resumed within 4 weeks of the dose reduction. Doses lower than the recommended maintenance dose have not been shown to provide the full therapeutic benefit. Long-term use at the reduced dose is not recommended.
Children
The safety and efficacy of dimethyl fumarate have not been established in paediatric patients under 18 years of age. Clinical trials did not include a sufficient number of adolescent or younger patients to determine whether they respond differently from adult patients. Therefore, Dimethyl Fumarate Newbury is not recommended for use in children and adolescents. Ongoing studies are evaluating the use of dimethyl fumarate in paediatric MS populations, and prescribing information may be updated as new data becomes available.
Elderly
Clinical studies of dimethyl fumarate did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. No dose adjustment is required based solely on age, but closer monitoring may be prudent given the potentially higher risk of infections and reduced immune reserve in elderly patients.
Missed Dose
If you forget to take a dose of Dimethyl Fumarate Newbury, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and take the next dose at the regular time. Do not take a double dose to make up for a forgotten dose. Maintaining consistent timing of doses (approximately 12 hours apart) helps ensure steady drug levels and optimal therapeutic effect. If you frequently forget doses, consider setting reminders or using a pill organiser.
Overdose
There is limited clinical experience with overdose of dimethyl fumarate. In the event of an overdose, the symptoms are likely to be an exaggeration of the known adverse effects, particularly flushing and gastrointestinal disturbances such as nausea, vomiting, abdominal pain, and diarrhoea. There is no specific antidote for dimethyl fumarate overdose. Treatment should be symptomatic and supportive, with monitoring of vital signs and observation of the clinical status of the patient. Contact your local poison control centre or seek emergency medical attention if an overdose is suspected.
What Are the Side Effects of Dimethyl Fumarate Newbury?
The most common side effects of dimethyl fumarate are flushing (40%) and gastrointestinal events including diarrhoea, nausea, and abdominal pain (up to 18%). These side effects are most prominent during the first month and typically decrease over time. Serious but rare side effects include severe lymphopenia and progressive multifocal leukoencephalopathy (PML).
Like all medicines, Dimethyl Fumarate Newbury can cause side effects, although not everybody gets them. The most frequently reported adverse reactions in clinical trials were flushing and gastrointestinal events, which were the most common reasons for dose reduction or treatment discontinuation, particularly during the early months of therapy. Understanding these side effects and knowing how to manage them can help patients continue their treatment successfully.
The side effects are categorised below by their frequency of occurrence, based on data from large-scale clinical trials (DEFINE, CONFIRM, and ENDORSE) that included thousands of patients treated over multiple years. Many of the common side effects, particularly flushing and gastrointestinal symptoms, tend to diminish significantly after the first 2 to 3 months of treatment as the body adapts to the medication.
Very Common (affects more than 1 in 10 people)
- Flushing – warmth, redness, itching, or burning sensation of the skin, particularly of the face, neck, and upper chest. Typically occurs within 30 minutes of dosing and lasts 30–60 minutes
- Diarrhoea – loose or watery stools, usually mild to moderate in severity
- Nausea – feeling sick, particularly after taking the capsule
- Abdominal pain – upper abdominal discomfort or cramping
Common (affects 1 in 10 to 1 in 100 people)
- Vomiting – especially during the first month of treatment
- Dyspepsia – indigestion, heartburn, or stomach discomfort
- Gastritis – inflammation of the stomach lining
- Lymphopenia – decreased lymphocyte (white blood cell) counts
- Leukopenia – decreased overall white blood cell counts
- Hot flush – sensation of heat not related to skin flushing
- Pruritus – generalised itching
- Rash – skin eruptions of varying types
- Proteinuria – protein in the urine, usually mild
- Burning sensation – feeling of burning, particularly in the skin
- Elevated liver enzymes – increased ALT and AST levels
Uncommon (affects 1 in 100 to 1 in 1,000 people)
- Severe lymphopenia – lymphocyte counts below 0.5 × 109/L persisting for extended periods
- Hypersensitivity reactions – allergic reactions including anaphylaxis
- Angioedema – swelling beneath the skin, often affecting the face
Rare (affects fewer than 1 in 1,000 people)
- Progressive multifocal leukoencephalopathy (PML) – a rare, serious brain infection caused by the JC virus, typically associated with prolonged severe lymphopenia
- Severe hepatotoxicity – serious liver injury with marked elevation of liver enzymes
- Herpes zoster (shingles) – reactivation of the varicella-zoster virus
- Severe allergic reactions – including anaphylaxis requiring emergency treatment
Flushing and GI symptoms are most common during the first month of treatment and generally improve over time. Strategies to reduce these include: taking the capsules with food (particularly foods containing fat or protein), gradual dose titration during the first week, taking non-enteric-coated aspirin (325 mg) 30 minutes before dosing to reduce flushing, and taking an antihistamine before dosing if flushing is persistent. Avoid hot drinks, spicy foods, and alcohol close to dosing time, as these can worsen flushing.
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed above. You can also report side effects directly to your national pharmacovigilance authority (for example, the Medicines and Healthcare products Regulatory Agency [MHRA] in the United Kingdom, the European Medicines Agency [EMA] in Europe, or the Food and Drug Administration [FDA] MedWatch programme in the United States). By reporting side effects, you can help provide more information on the safety of this medicine.
How Should You Store Dimethyl Fumarate Newbury?
Store Dimethyl Fumarate Newbury below 30°C. Keep the capsules in the original packaging to protect them from light. Do not use after the expiry date printed on the packaging. Keep out of the sight and reach of children.
Proper storage of medications is important to ensure that they remain effective and safe to use. Dimethyl Fumarate Newbury capsules should be stored at a temperature not exceeding 30°C (86°F). The capsules should be kept in the original blister packaging until ready to use, as this protects them from light and moisture, which can degrade the active substance. Do not transfer capsules to pill organisers or other containers for extended periods.
Do not use Dimethyl Fumarate Newbury after the expiry date stated on the blister pack and the outer carton after “EXP.” The expiry date refers to the last day of that month. Do not store above the recommended temperature, and do not freeze the capsules. If capsules have been stored under conditions outside the recommended range, consult your pharmacist about whether they are still suitable for use.
Keep this medicine out of the sight and reach of children at all times. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment and ensure that medications do not accidentally end up in the hands of others.
What Does Dimethyl Fumarate Newbury Contain?
Each Dimethyl Fumarate Newbury 120 mg capsule contains 120 mg of dimethyl fumarate as the active substance. Each 240 mg capsule contains 240 mg of dimethyl fumarate. The capsules also contain inactive ingredients (excipients) needed for manufacturing the gastro-resistant formulation.
The active substance in Dimethyl Fumarate Newbury is dimethyl fumarate, a methyl ester of fumaric acid. The capsules are formulated with a gastro-resistant coating that prevents dissolution of the active substance in the stomach, ensuring that it is released in the upper small intestine. This delayed-release formulation is important for reducing gastrointestinal side effects and optimising drug absorption.
The inactive ingredients (excipients) typically include:
- Capsule contents: Microcrystalline cellulose, croscarmellose sodium, talc, silica colloidal anhydrous, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, and other excipients necessary for the gastro-resistant formulation
- Capsule shell: Gelatin, titanium dioxide (E171), iron oxide yellow (E172, for 120 mg capsules), brilliant blue FCF (E133, for 240 mg capsules), and other colourants depending on capsule strength
- Printing ink: Shellac, iron oxide black (E172), potassium hydroxide
The 120 mg capsules are typically identifiable by their green and white colouring, while the 240 mg capsules are typically green. Both strengths are hard gastro-resistant capsules designed to be swallowed whole. If you have any known allergies or intolerances to any of the excipients listed, inform your healthcare provider before starting treatment. Patients with rare hereditary problems of galactose intolerance should consult their doctor before taking this medicinal product if applicable excipients are present.
Frequently Asked Questions
Dimethyl Fumarate Newbury is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS). It is classified as a disease-modifying therapy and works by modulating the immune system and providing neuroprotective effects through activation of the Nrf2 pathway. It has been shown to significantly reduce the frequency of relapses and slow the progression of disability in clinical trials.
The most common side effects are flushing (warmth, redness, itching, or burning of the skin) and gastrointestinal events such as diarrhoea, nausea, abdominal pain, and vomiting. These typically occur during the first month of treatment and decrease over time. Taking the capsules with food and using non-enteric-coated aspirin 30 minutes before dosing can help manage these effects. Lymphopenia (low lymphocyte counts) is also common and requires regular monitoring.
Start with 120 mg twice daily for the first 7 days, then increase to the full maintenance dose of 240 mg twice daily. Always take the capsules with food and swallow them whole – do not crush, chew, or open them. Try to space doses approximately 12 hours apart (for example, morning and evening). Taking the medicine with food reduces gastrointestinal side effects and flushing.
Yes, regular blood tests are essential for safe treatment with dimethyl fumarate. A complete blood count including lymphocyte count should be obtained before starting treatment, then repeated every 6 to 12 months during treatment. Liver and kidney function tests should also be checked before starting treatment. If your lymphocyte count drops below 0.5 × 109/L for more than 6 months, your doctor may consider stopping treatment to reduce the risk of serious infections.
Dimethyl fumarate is not recommended during pregnancy unless clearly necessary. Animal studies have shown adverse effects on embryo-foetal development. Women of childbearing potential should use effective contraception during treatment. If you become pregnant or are planning to become pregnant, speak to your neurologist immediately to discuss the risks and benefits of continuing or stopping treatment.
Progressive multifocal leukoencephalopathy (PML) is a rare but serious brain infection that has been reported in patients taking dimethyl fumarate. The risk is primarily associated with prolonged severe lymphopenia (very low lymphocyte counts). The risk is minimised by regular blood count monitoring and by discontinuing treatment if lymphocyte counts remain critically low for more than 6 months. Report any new neurological symptoms to your doctor immediately.
References
- European Medicines Agency (EMA). Tecfidera (dimethyl fumarate) – Summary of Product Characteristics. Last updated 2024. Available at: ema.europa.eu
- Gold R, Kappos L, Arnold DL, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med. 2012;367(12):1098–1107. doi:10.1056/NEJMoa1114287 (DEFINE study)
- Fox RJ, Miller DH, Phillips JT, et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med. 2012;367(12):1087–1097. doi:10.1056/NEJMoa1206328 (CONFIRM study)
- Gold R, Arnold DL, Bar-Or A, et al. Long-term effects of delayed-release dimethyl fumarate in multiple sclerosis: Interim analysis of ENDORSE. Neurology. 2017;89(11):1135–1144. doi:10.1212/WNL.0000000000004364
- National Institute for Health and Care Excellence (NICE). Dimethyl fumarate for treating relapsing-remitting multiple sclerosis. Technology appraisal guidance [TA320]. Published August 2014.
- Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis. Neurology. 2018;90(17):777–788. doi:10.1212/WNL.0000000000005347 (AAN Guidelines)
- US Food and Drug Administration (FDA). Tecfidera (dimethyl fumarate) – Prescribing Information. Last revised 2024.
- Montalban X, Gold R, Thompson AJ, et al. ECTRIMS/EAN guideline on the pharmacological treatment of people with multiple sclerosis. Mult Scler. 2018;24(2):96–120. doi:10.1177/1352458517751049
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. 2023.
- Linker RA, Haghikia A. Dimethyl fumarate in multiple sclerosis: latest developments, evidence and place in therapy. Ther Adv Chronic Dis. 2016;7(4):198–207. doi:10.1177/2040622316653307
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed physicians specialising in neurology and clinical pharmacology.
Content reviewed according to EMA SmPC, FDA prescribing information, NICE guidelines, and AAN practice guidelines. Evidence level: 1A based on systematic reviews of randomised controlled trials.
All medical content follows the GRADE evidence framework. No commercial funding. Independent editorial process with no pharmaceutical industry influence. Read our editorial standards.
Last medical review: | Next scheduled review: June 2026