Dimethyl Fumarate SUN

Immunomodulatory agent for relapsing-remitting multiple sclerosis

℞ Prescription Only ATC: L04AX07 Immunomodulators
Active Ingredient
Dimethyl fumarate
Available Forms
Gastro-resistant hard capsules
Strengths
120 mg, 240 mg
Known Brands
Dimethyl fumarate SUN, Tecfidera
Medically reviewed | Last reviewed: | Evidence level: 1A
Dimethyl fumarate SUN is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS) in adults. It contains the active ingredient dimethyl fumarate, which works by activating the Nrf2 antioxidant pathway and modulating the immune system. Available as 120 mg and 240 mg gastro-resistant hard capsules, it is a generic version of Tecfidera manufactured by Sun Pharmaceutical Industries.
📅 Published: | Updated:
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Written and reviewed by iMedic Medical Editorial Team | Specialists in neurology and clinical pharmacology

Quick facts about Dimethyl Fumarate SUN

Drug Class
Immunomodulator
Fumaric acid derivative
ATC Code
L04AX07
Other immunosuppressants
Standard Dose
240 mg x 2
twice daily with food
Indication
RRMS
Relapsing-remitting MS
Administration
Oral
Gastro-resistant capsule
Prescription
Rx Only
Requires medical prescription

Key takeaways about Dimethyl Fumarate SUN

  • Used for relapsing-remitting MS: Dimethyl fumarate SUN reduces relapse rates and slows disability progression in adults with relapsing-remitting multiple sclerosis
  • Gradual dose titration: Treatment starts at 120 mg twice daily for 7 days, then increases to 240 mg twice daily to reduce gastrointestinal side effects
  • Regular blood monitoring required: Complete blood counts including lymphocyte levels must be checked before starting and every 6-12 months during treatment
  • Common side effects improve over time: Flushing and gastrointestinal symptoms are most common in the first month and typically diminish with continued use
  • Not recommended in pregnancy: Women of childbearing potential must use effective contraception during treatment and for at least 4 weeks after stopping

What Is Dimethyl Fumarate SUN and What Is It Used For?

Dimethyl fumarate SUN is an immunomodulatory medicine containing dimethyl fumarate as its active substance. It is used to treat adult patients with relapsing-remitting multiple sclerosis (RRMS), the most common form of MS. It is a generic version of Tecfidera, approved by the European Medicines Agency (EMA) based on demonstrated bioequivalence.

Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system in which the body's immune system mistakenly attacks the protective myelin sheath that surrounds nerve fibres in the brain and spinal cord. This damage disrupts the normal flow of electrical impulses along the nerves, leading to a wide range of neurological symptoms including fatigue, numbness, weakness, vision problems, and difficulty with coordination and balance.

Relapsing-remitting MS (RRMS) is characterised by clearly defined episodes of new or worsening neurological symptoms (relapses or flare-ups), followed by periods of partial or complete recovery (remissions). Approximately 85% of people with MS are initially diagnosed with this form of the disease. Without effective disease-modifying therapy, many patients with RRMS will eventually transition to secondary progressive MS, where disability accumulates steadily over time.

Dimethyl fumarate works through multiple mechanisms of action. Its primary therapeutic effect is believed to involve activation of the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) antioxidant response pathway. When activated, the Nrf2 pathway upregulates a cascade of antioxidant and cytoprotective genes that help protect cells from oxidative stress and inflammation, both of which play critical roles in the pathophysiology of MS. The drug also exerts direct immunomodulatory effects by promoting a shift from pro-inflammatory Th1 and Th17 immune responses toward anti-inflammatory Th2 responses, and by reducing the overall number of circulating lymphocytes over time.

In the landmark DEFINE and CONFIRM clinical trials, dimethyl fumarate demonstrated significant efficacy in reducing the annualised relapse rate by approximately 44-53% compared with placebo. It also significantly reduced the risk of confirmed disability progression and the number of new or enlarging brain lesions visible on magnetic resonance imaging (MRI). These robust clinical data led to the approval of dimethyl fumarate (originally marketed as Tecfidera by Biogen) for the treatment of RRMS in the European Union in 2014 and in the United States in 2013.

Dimethyl fumarate SUN, manufactured by Sun Pharmaceutical Industries, is a generic version that contains the same active ingredient in the same pharmaceutical form and strengths. Generic medicines undergo rigorous bioequivalence testing to demonstrate that they deliver the same amount of active substance to the body at the same rate as the reference product. This ensures that patients can expect the same clinical efficacy and safety profile when using the generic version.

What Should You Know Before Taking Dimethyl Fumarate SUN?

Before starting treatment with dimethyl fumarate SUN, your doctor will perform blood tests and assess your medical history. There are specific situations where this medicine must not be used, and several precautions that require careful monitoring during treatment.

Contraindications

You must not take dimethyl fumarate SUN if you are allergic (hypersensitive) to dimethyl fumarate or any of the other ingredients listed in the composition section. Allergic reactions to dimethyl fumarate, although uncommon, can be serious and may include symptoms such as difficulty breathing, hives, swelling of the face or throat, and in rare cases, anaphylactic shock. If you experience any signs of a severe allergic reaction, seek emergency medical attention immediately.

You must also not take this medicine if you have suspected or confirmed progressive multifocal leukoencephalopathy (PML). PML is a rare but serious brain infection caused by the John Cunningham (JC) virus, which can occur in people with weakened immune systems. PML can cause severe disability or death and there is no effective treatment once it develops. The symptoms of PML can resemble those of an MS relapse, making early diagnosis critically important. Any new or worsening neurological symptoms should be investigated promptly to rule out PML before continuing treatment.

Do NOT take dimethyl fumarate SUN if:
  • You are allergic to dimethyl fumarate or any ingredient in the capsules
  • You have suspected or confirmed progressive multifocal leukoencephalopathy (PML)

Warnings and Precautions

Talk to your doctor before taking dimethyl fumarate SUN if you have severe kidney disease, severe liver disease, or severe active gastrointestinal disease (such as a stomach ulcer). Your doctor will carefully weigh the potential benefits against the risks before starting treatment in these situations, and more frequent monitoring may be required.

Before you start treatment, your doctor will order a complete blood count (CBC) including a differential white blood cell count with lymphocyte levels. This baseline blood test is essential because dimethyl fumarate can cause a reduction in lymphocyte counts (lymphopenia), which may increase your susceptibility to infections, including opportunistic infections. Blood tests should be repeated every 6 to 12 months during treatment and as clinically indicated. If the lymphocyte count falls below 0.5 x 109/L and persists at this level for more than 6 months, your doctor should consider discontinuing the treatment, as prolonged severe lymphopenia is the primary risk factor for the development of PML.

Your doctor will also assess your kidney and liver function before starting treatment. Dimethyl fumarate has been associated with elevated levels of liver enzymes (AST and ALT) and proteinuria (protein in the urine), so periodic monitoring of these parameters during treatment is recommended. Cases of clinically significant liver injury, including elevated liver enzymes greater than five times the upper limit of normal, have been reported in post-marketing surveillance, although these are rare.

Flushing (warmth, redness, itching, or burning sensation of the skin) is one of the most commonly reported side effects. While generally mild to moderate in intensity, flushing can occasionally be severe and may be accompanied by symptoms such as chest tightness, rapid heartbeat, or shortness of breath. Taking dimethyl fumarate with food and taking 325 mg of non-enteric-coated aspirin 30 minutes before dosing may reduce the incidence and severity of flushing, particularly during the first few months of treatment.

Blood monitoring schedule:

A complete blood count with lymphocyte count is required before starting treatment, then every 6-12 months during treatment. Kidney and liver function tests should also be performed at baseline and periodically thereafter. Report any new or worsening symptoms to your doctor promptly.

Pregnancy and Breastfeeding

Dimethyl fumarate is not recommended during pregnancy. Animal studies have demonstrated adverse effects on fertility and foetal development, including reduced foetal weight and delayed skeletal ossification. While there are limited data from the use of dimethyl fumarate in pregnant women, the potential risk to the developing foetus cannot be excluded based on the available preclinical evidence.

Women of childbearing potential should use effective contraception during treatment and for at least 4 weeks after the last dose. If you become pregnant while taking dimethyl fumarate SUN, you should discontinue treatment immediately and contact your neurologist or prescribing doctor. Your doctor will discuss alternative treatment options and the need for monitoring during the remainder of your 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 because of the potential for serious adverse reactions in nursing infants, a decision must be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother. Breastfeeding is therefore generally not recommended during treatment with dimethyl fumarate SUN.

How Does Dimethyl Fumarate SUN Interact with Other Drugs?

Dimethyl fumarate can interact with several types of medications, particularly those that affect the immune system. Always tell your doctor about all medicines you are taking, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

Although dimethyl fumarate is not primarily metabolised through the cytochrome P450 enzyme system and formal drug interaction studies have shown a low potential for pharmacokinetic interactions, there are important pharmacodynamic interactions that must be considered. Because dimethyl fumarate has immunomodulatory effects and can reduce lymphocyte counts, combining it with other immunosuppressive or immunomodulatory agents may significantly increase the risk of infections, including serious and opportunistic infections.

If you are switching from another MS disease-modifying therapy to dimethyl fumarate SUN, your doctor will take into account the duration of action and mechanism of the previous therapy to minimise the risk of additive immunosuppression while maintaining adequate disease control. A washout period may be necessary depending on the half-life and immunological effects of the prior treatment. In particular, switching from long-acting immunosuppressants such as alemtuzumab, cladribine, or mitoxantrone requires careful consideration of the recovery of immune function before initiating dimethyl fumarate.

Live and live-attenuated vaccines should generally be avoided during treatment with dimethyl fumarate, as the immune response to vaccination may be diminished, and there is a theoretical risk that live vaccines could cause infection in immunocompromised patients. If vaccination is necessary, inactivated vaccines are preferred. Your doctor may recommend completing any necessary vaccinations before starting treatment whenever possible.

Concurrent use of nephrotoxic drugs (medicines that can damage the kidneys) should be approached with caution, as dimethyl fumarate itself has been associated with proteinuria and, in rare cases, renal tubular damage. If concomitant use is unavoidable, more frequent monitoring of kidney function is recommended.

Drug Interactions with Dimethyl Fumarate SUN
Interacting Drug/Class Type of Interaction Clinical Significance Recommendation
Live vaccines (e.g., MMR, varicella, yellow fever) Pharmacodynamic Reduced vaccine efficacy; risk of vaccine-related infection Avoid during treatment; use inactivated alternatives
Other immunosuppressants (e.g., azathioprine, methotrexate, ciclosporin) Pharmacodynamic Increased risk of serious infections including PML Concomitant use not recommended
Other MS therapies (e.g., interferons, glatiramer, fingolimod, natalizumab) Pharmacodynamic Additive immunosuppression; increased infection risk Avoid concurrent use; washout period needed when switching
Nephrotoxic drugs (e.g., aminoglycosides, NSAIDs, contrast agents) Pharmacodynamic Increased risk of kidney damage Use with caution; monitor renal function closely
Non-enteric-coated aspirin (325 mg) Supportive co-administration May reduce flushing side effects Can be taken 30 min before dimethyl fumarate

What Is the Correct Dosage of Dimethyl Fumarate SUN?

The recommended maintenance dose of dimethyl fumarate SUN is 240 mg twice daily, taken orally with food. Treatment begins with a lower starting dose of 120 mg twice daily for the first 7 days to reduce the risk of gastrointestinal side effects and flushing.

Adults

For adult patients with relapsing-remitting multiple sclerosis, treatment with dimethyl fumarate SUN follows a stepwise titration schedule. During the first 7 days, the starting dose is one 120 mg capsule taken twice daily (morning and evening), providing a total daily dose of 240 mg. After this initial 7-day titration period, the dose is increased to the full maintenance dose of one 240 mg capsule taken twice daily (morning and evening), providing a total daily dose of 480 mg.

The capsules should be swallowed whole with liquid and should not be crushed, chewed, or opened. The enteric-resistant coating is specifically designed to protect the active ingredient from degradation in the acidic environment of the stomach and to release the drug in the small intestine, which helps reduce gastrointestinal side effects. Destroying the capsule coating by crushing or chewing can increase the risk of gastrointestinal adverse effects and may alter the drug's pharmacokinetic profile.

Taking dimethyl fumarate SUN with food is strongly recommended, particularly during the initial weeks of treatment. Clinical studies have shown that administration with food significantly reduces the incidence and severity of both flushing and gastrointestinal side effects. A meal that includes some fat content appears to be most effective at mitigating these adverse effects. The capsules can be taken with any meal, but maintaining a consistent schedule of morning and evening dosing with meals helps establish a routine and optimise tolerability.

Starting Dose (Days 1-7)

120 mg twice daily (one 120 mg capsule in the morning and one in the evening with food). Total daily dose: 240 mg.

Maintenance Dose (Day 8 onwards)

240 mg twice daily (one 240 mg capsule in the morning and one in the evening with food). Total daily dose: 480 mg.

Dimethyl Fumarate SUN Dosage Schedule
Treatment Phase Capsule Strength Frequency Total Daily Dose
Titration (Days 1-7) 120 mg Twice daily (morning and evening) 240 mg
Maintenance (Day 8+) 240 mg Twice daily (morning and evening) 480 mg

Dimethyl fumarate SUN is not recommended for use in children and adolescents under 18 years of age. There are insufficient data on the safety and efficacy of dimethyl fumarate in the paediatric population. Clinical trials have been conducted exclusively in adult patients, and dosing recommendations cannot be extrapolated to younger age groups without appropriate clinical evidence.

No dose adjustment is required in elderly patients, although clinical experience in patients over 55 years of age is limited. The decision to use dimethyl fumarate in older adults should consider the individual patient's overall health status, comorbidities, and concomitant medications. Similarly, no specific dose adjustment is necessary for patients with mild to moderate renal or hepatic impairment, but the drug has not been studied in patients with severe impairment of these organ systems.

Missed Dose

If you miss a dose of dimethyl fumarate SUN, take it as soon as you remember, provided it is not too close to the time of your next scheduled dose. If it is nearly time for the next dose, skip the missed dose and take the next one at the regular time. Do not take a double dose to make up for a missed one. Taking two doses at once or in close succession can increase the risk of side effects, particularly flushing and gastrointestinal symptoms.

Overdose

There is no specific antidote for dimethyl fumarate overdose. In the event of an overdose, seek medical attention immediately. Treatment should be supportive and symptomatic. General measures to manage an overdose may include monitoring of vital signs, observation for clinical symptoms, and supportive care as needed. Because dimethyl fumarate is rapidly metabolised and has a relatively short half-life, the duration of overdose symptoms may be limited, but medical supervision is nonetheless essential.

What Are the Side Effects of Dimethyl Fumarate SUN?

Like all medicines, dimethyl fumarate SUN can cause side effects, although not everybody gets them. The most frequently reported side effects are flushing and gastrointestinal events, which tend to occur early in treatment and diminish over time. Serious but rare side effects include progressive multifocal leukoencephalopathy (PML) and severe allergic reactions.

The side effect profile of dimethyl fumarate has been well characterised through extensive clinical trial data (including the DEFINE and CONFIRM pivotal studies involving over 2,600 patients) and post-marketing surveillance. Understanding the frequency, nature, and typical time course of these side effects can help patients and their healthcare providers manage them effectively and know when to seek medical attention.

Flushing is one of the most characteristic side effects and affects more than 1 in 10 patients. It typically manifests as a sensation of warmth, redness, itching, or burning of the skin, most commonly affecting the face, neck, chest, and upper arms. Flushing episodes usually begin within 30 minutes of taking a dose and can last from a few minutes to several hours. The frequency and intensity of flushing tend to decrease substantially after the first month of treatment. Taking the medicine with food, using the initial titration dose, and taking non-enteric-coated aspirin before dosing can all help reduce flushing.

Gastrointestinal side effects are also very common and include diarrhoea, nausea, abdominal pain or cramping, and upper abdominal discomfort. Like flushing, these symptoms are typically most pronounced during the early weeks of treatment and tend to improve with continued use. Eating a substantial meal before or with the capsule is the most effective strategy for minimising gastrointestinal discomfort. If symptoms are severe and persistent, a temporary return to the lower titration dose (120 mg twice daily) for up to 4 weeks may be considered, after which the dose can be re-escalated to the maintenance level.

Very Common (affects more than 1 in 10 people)

≥ 10% of patients
  • Flushing (warmth, redness, itching or burning of the skin)
  • Diarrhoea
  • Nausea
  • Abdominal pain or upper abdominal pain

Common (affects up to 1 in 10 people)

1% to 10% of patients
  • Gastroenteritis (stomach flu)
  • Lymphopenia (low lymphocyte count)
  • Leukopenia (low white blood cell count)
  • Burning sensation
  • Hot flush
  • Vomiting
  • Dyspepsia (indigestion)
  • Gastritis (inflammation of the stomach lining)
  • Pruritus (itching)
  • Proteinuria (protein in urine)
  • Feeling hot
  • Elevated AST/ALT (liver enzymes)
  • Elevated white blood cell count
  • Skin rash or erythema (redness)
  • Albumin in urine

Uncommon (affects up to 1 in 100 people)

0.1% to 1% of patients
  • Progressive multifocal leukoencephalopathy (PML)

Rare (affects up to 1 in 1,000 people)

< 0.1% of patients
  • Anaphylaxis (severe allergic reaction)
  • Angioedema (deep tissue swelling)

Lymphopenia is a pharmacologically expected effect of dimethyl fumarate and requires regular monitoring. In clinical trials, the mean lymphocyte count decreased by approximately 30% during the first year of treatment and then plateaued. While most patients maintain lymphocyte counts within the normal range, approximately 6% of patients experience severe lymphopenia (below 0.5 x 109/L). Prolonged severe lymphopenia is the key risk factor for PML, which is why regular blood monitoring is essential throughout the duration of treatment.

Seek immediate medical attention if you experience:
  • Signs of severe allergic reaction: difficulty breathing, hives, swelling of face/throat
  • New or worsening neurological symptoms that could indicate PML
  • Signs of serious infection: high fever, severe flu-like symptoms, persistent cough
  • Significant skin reactions: widespread rash, blistering, or peeling skin
  • Severe or persistent abdominal pain, blood in stool, or yellowing of eyes/skin

How Should You Store Dimethyl Fumarate SUN?

Store dimethyl fumarate SUN below 30°C in the original blister packaging to protect from light. Keep this medicine out of the sight and reach of children.

Proper storage of dimethyl fumarate SUN is important to ensure that the medicine remains effective and safe throughout its shelf life. The capsules should be stored at a temperature below 30°C (86°F). Do not refrigerate or freeze the capsules. Store them in the original blister packaging at all times until you are ready to take a dose, as the packaging is designed to protect the capsules from light and moisture, both of which can degrade the active ingredient.

Do not use this medicine after the expiry date which is stated on the blister and the carton after "EXP". The expiry date refers to the last day of that month. If you notice any change in the appearance of the capsules (such as discoloration, cracking, or an unusual smell), do not use them and consult your pharmacist for advice.

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 to protect the environment and ensure that unused medications are disposed of safely. Many pharmacies and local councils provide medicine take-back programmes for safe disposal.

What Does Dimethyl Fumarate SUN Contain?

Each capsule of dimethyl fumarate SUN contains either 120 mg or 240 mg of dimethyl fumarate as the active substance, together with several inactive ingredients (excipients) that form the capsule and its gastro-resistant coating.

The active substance is dimethyl fumarate. Each gastro-resistant hard capsule contains either 120 mg or 240 mg of dimethyl fumarate. The active ingredient is the component responsible for the therapeutic effect of the medicine.

The other ingredients (excipients) include:

  • Capsule contents: Microcrystalline cellulose, croscarmellose sodium, talc, colloidal anhydrous silica, magnesium stearate, methacrylic acid - ethyl acrylate copolymer (1:1), triethyl citrate, talc, simethicone emulsion
  • Capsule shell (120 mg): Gelatin, titanium dioxide (E171), brilliant blue FCF (E133), iron oxide yellow (E172) and other colourants
  • Capsule shell (240 mg): Gelatin, titanium dioxide (E171), brilliant blue FCF (E133), iron oxide yellow (E172), iron oxide red (E172) and other colourants
  • Printing ink: Shellac, iron oxide black (E172), propylene glycol, potassium hydroxide

The methacrylic acid copolymer is the enteric coating material that makes the capsule gastro-resistant. This polymer remains intact in the acidic environment of the stomach (pH below 5.5) and dissolves in the more alkaline environment of the small intestine (pH above 5.5), ensuring that the active ingredient is released in the intestine rather than the stomach. This design is crucial for reducing gastrointestinal irritation and optimising drug absorption.

Patients with known hypersensitivity to any of the excipients listed above should inform their doctor before starting treatment. If you are concerned about any of the inactive ingredients, discuss this with your pharmacist or prescribing physician.

Frequently Asked Questions About Dimethyl Fumarate SUN

Dimethyl fumarate SUN is a generic version of Tecfidera. Both medicines contain the same active ingredient (dimethyl fumarate) in the same strengths (120 mg and 240 mg) and the same pharmaceutical form (gastro-resistant hard capsules). Dimethyl fumarate SUN, manufactured by Sun Pharmaceutical Industries, was approved by the European Medicines Agency (EMA) after demonstrating bioequivalence to the reference product Tecfidera (Biogen). This means that the generic delivers the same amount of active substance to the body at the same rate, ensuring comparable efficacy and safety. The main difference is typically the price, with generic medicines generally being more affordable.

There is no specific contraindication against drinking alcohol while taking dimethyl fumarate. However, alcohol may worsen certain side effects such as flushing and gastrointestinal symptoms. Alcohol can also cause vasodilation (widening of blood vessels), which may intensify the flushing episodes that are common with dimethyl fumarate. Additionally, both alcohol and dimethyl fumarate can affect liver function, so moderation is advisable. Discuss your alcohol consumption with your doctor, particularly if you have pre-existing liver conditions.

Dimethyl fumarate begins to exert its pharmacological effects relatively quickly, with measurable changes in immune cell profiles detectable within weeks of starting treatment. However, the clinical benefits in terms of relapse reduction and slowing disability progression are assessed over longer periods. In clinical trials, significant reductions in MRI-detectable disease activity were observed as early as 12 weeks, while the full effect on relapse rates was typically evaluated over 1-2 years of treatment. It is important to continue taking the medicine as prescribed, even if you do not notice immediate changes in your symptoms, as the protective effects build up over time.

If you experience severe or persistent flushing, there are several strategies that can help. First, make sure you are always taking the capsules with a substantial meal, as food significantly reduces flushing. Taking non-enteric-coated aspirin (325 mg) approximately 30 minutes before each dose has been shown to reduce flushing in clinical studies. Your doctor may also consider temporarily reducing your dose back to 120 mg twice daily for up to 4 weeks before re-titrating to the maintenance dose. For most patients, flushing decreases substantially after the first month of treatment. If flushing remains intolerable despite these measures, contact your doctor to discuss alternative approaches.

While there is no strict requirement to take the medicine at exactly the same times each day, establishing a consistent dosing schedule is recommended. Taking the capsules with your morning and evening meals is a practical approach that helps you remember your doses and ensures you are taking the medicine with food, which reduces side effects. The two daily doses should be spaced approximately 12 hours apart when possible, although modest variations in timing are unlikely to affect the drug's efficacy. Consistency helps maintain steady blood levels of the medicine and makes it easier to incorporate into your daily routine.

Dimethyl fumarate does not cure multiple sclerosis. Currently, there is no cure for MS. However, dimethyl fumarate is an effective disease-modifying therapy that can significantly reduce the frequency and severity of relapses, slow the accumulation of disability, and reduce the formation of new brain lesions. By modifying the course of the disease, it can help patients maintain a better quality of life and preserve neurological function over the long term. Treatment with dimethyl fumarate is typically long-term, and the decision to continue, switch, or stop therapy should be made in close consultation with your neurologist based on your individual disease activity and treatment response.

References

  1. European Medicines Agency (EMA). Dimethyl fumarate SUN - Summary of Product Characteristics (SmPC). Available at: www.ema.europa.eu
  2. 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
  3. 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
  4. Linker RA, Lee DH, Ryan S, et al. Fumaric acid esters exert neuroprotective effects in neuroinflammation via activation of the Nrf2 antioxidant pathway. Brain. 2011;134(Pt 3):678-692.
  5. Filippi M, Bar-Or A, Piehl F, et al. Multiple sclerosis. Nat Rev Dis Primers. 2018;4(1):43.
  6. Mao-Draayer Y, Thiel S, Mills EA, et al. Neuromyelitis optica spectrum disorders and pregnancy: therapeutic considerations. Nat Rev Neurol. 2020;16(3):154-170.
  7. World Health Organization. WHO Model List of Essential Medicines - 23rd list, 2023. Geneva: WHO; 2023.
  8. European Medicines Agency (EMA). Assessment report: Tecfidera. Procedure No. EMEA/H/C/002601/0000. 2014.

About the Medical Editorial Team

This article has been written and reviewed by the iMedic Medical Editorial Team, which includes specialist physicians in neurology and clinical pharmacology. Our editorial process follows international medical standards and evidence-based guidelines from the EMA, FDA, and WHO.

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