Dimethyl Fumarate Medical Valley

Disease-modifying therapy for relapsing multiple sclerosis

Prescription Only (Rx) Immunomodulatory Agent
Active Ingredient
Dimethyl fumarate
Available Forms
Gastro-resistant hard capsules
Strengths
120 mg, 240 mg
Route
Oral
✓ Medically reviewed | Last reviewed: | Evidence level: 1A
Dimethyl fumarate Medical Valley is an oral disease-modifying therapy (DMT) used to treat relapsing forms of multiple sclerosis (MS) in adults. It contains the active substance dimethyl fumarate, which works by activating protective cellular pathways and modulating the immune response. Clinical trials have demonstrated its effectiveness in reducing relapse rates and slowing disability progression. It is available as gastro-resistant hard capsules in 120 mg and 240 mg strengths.
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✓ Written and reviewed by iMedic Medical Editorial Team | Specialists in neurology and clinical pharmacology

Quick Facts About Dimethyl Fumarate Medical Valley

Active Ingredient
Dimethyl fumarate
Drug Class
Immunomodulator
Common Uses
Relapsing MS
Available Forms
Capsules
120 mg & 240 mg
Prescription Status
Rx Only
Standard Dose
240 mg twice daily

Key Takeaways

  • Dimethyl fumarate Medical Valley is an oral disease-modifying therapy approved for relapsing forms of multiple sclerosis in adults.
  • The maintenance dose is 240 mg twice daily, taken with food. A 7-day titration period starting at 120 mg twice daily helps reduce side effects.
  • The most common side effects are flushing and gastrointestinal symptoms, which typically diminish after the first month of treatment.
  • Regular blood monitoring (complete blood count with lymphocytes) is required before starting and every 6–12 months during treatment.
  • It must not be used during pregnancy unless clearly necessary, and effective contraception is recommended for women of childbearing potential.

What Is Dimethyl Fumarate Medical Valley and What Is It Used For?

Quick Answer: Dimethyl fumarate Medical Valley is a prescription oral medication used to treat relapsing forms of multiple sclerosis (MS) in adults. It reduces the frequency of relapses and slows the progression of physical disability by modulating the immune system and protecting nerve cells from oxidative damage.

Dimethyl fumarate Medical Valley belongs to a class of medications known as disease-modifying therapies (DMTs) for multiple sclerosis. The active substance, dimethyl fumarate, was first approved for MS treatment by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) under the brand name Tecfidera. Dimethyl fumarate Medical Valley is a generic version that contains the same active ingredient and has been shown to be bioequivalent to the originator product.

Multiple sclerosis is a chronic autoimmune disease in which the immune system mistakenly attacks the protective myelin sheath surrounding 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. Relapsing forms of MS are characterised by episodes of new or worsening neurological symptoms (relapses) followed by periods of partial or complete recovery (remissions).

Dimethyl fumarate works through a dual mechanism of action. Its primary pathway involves the activation of the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) transcriptional pathway, which plays a crucial role in the cellular response to oxidative stress. By upregulating Nrf2, the drug enhances the production of antioxidant enzymes that protect neurons and other cells from damage caused by reactive oxygen species. Additionally, dimethyl fumarate has significant immunomodulatory properties, shifting the balance of immune cells away from pro-inflammatory responses and towards anti-inflammatory profiles.

Clinical evidence supporting the use of dimethyl fumarate in MS comes from two pivotal Phase III randomised controlled trials: DEFINE (Determination of the Efficacy and safety of oral Fumarate IN rElapsing-remitting MS) and CONFIRM (Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis). In the DEFINE trial, dimethyl fumarate 240 mg twice daily reduced the annualised relapse rate by 53% compared to placebo over two years. The CONFIRM trial demonstrated a 44% reduction in annualised relapse rate versus placebo. Both studies also showed significant reductions in new or enlarging T2-hyperintense lesions on MRI and a slower rate of disability progression.

Approved Indications

Dimethyl fumarate Medical Valley is specifically indicated for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS). This includes patients who have experienced at least one clinical relapse in the previous year or who have evidence of disease activity on brain MRI scans. In some countries, the indication also covers clinically isolated syndrome (CIS) and active secondary progressive MS with superimposed relapses, depending on local regulatory approvals.

It is important to understand that dimethyl fumarate is not a cure for multiple sclerosis. Rather, it is a long-term treatment designed to reduce the frequency and severity of relapses, slow the accumulation of disability, and decrease the formation of new inflammatory lesions in the central nervous system. The decision to initiate treatment should be made collaboratively between the patient and a neurologist experienced in MS management, taking into account the individual’s disease activity, risk profile, and treatment preferences.

What Should You Know Before Taking Dimethyl Fumarate Medical Valley?

Quick Answer: Before starting dimethyl fumarate, your doctor will perform blood tests (including a complete blood count and liver/kidney function tests), assess your infection history, and review your current medications. The drug is contraindicated in patients with known hypersensitivity to dimethyl fumarate and should be used with caution in those with low lymphocyte counts.

Contraindications

Dimethyl fumarate Medical Valley must not be used in patients who have a known hypersensitivity to dimethyl fumarate or to any of the excipients contained in the capsule formulation. Allergic reactions including anaphylaxis and angioedema have been reported, though rarely. If a serious allergic reaction occurs, treatment must be discontinued immediately and appropriate medical intervention provided.

Patients with confirmed severe active gastrointestinal disease, such as peptic ulcer disease or inflammatory bowel disease in its active phase, should exercise caution as the drug may exacerbate gastrointestinal symptoms. While not an absolute contraindication, careful clinical judgement is needed in these cases.

Warnings and Precautions

Important Safety Warning: Progressive Multifocal Leukoencephalopathy (PML) Cases of progressive multifocal leukoencephalopathy (PML) have been reported in patients treated with dimethyl fumarate, particularly in the context of prolonged moderate-to-severe lymphopenia. PML is a rare but serious brain infection caused by the JC virus that can lead to severe disability or death. If PML is suspected, treatment must be withheld immediately and diagnostic evaluation performed.

Lymphocyte monitoring: Dimethyl fumarate can cause a decrease in lymphocyte counts. A complete blood count (CBC) including lymphocyte count should be obtained before starting treatment, every 6 to 12 months thereafter, and as clinically indicated. In patients whose lymphocyte counts fall below 0.5 × 10⁹/L and persist at this level for more than 6 months, treatment discontinuation should be strongly considered due to the increased risk of opportunistic infections, including PML.

Hepatic injury: Clinically significant cases of liver injury have been reported with dimethyl fumarate. Elevations in serum aminotransferases (ALT and AST) and total bilirubin have occurred, in some cases without warning symptoms. Liver function tests, including serum aminotransferases and bilirubin levels, should be obtained before starting treatment and during treatment as clinically indicated. Patients should be advised to report symptoms suggestive of hepatic dysfunction, such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice.

Flushing: Flushing is one of the most commonly reported adverse reactions. The mechanism is thought to involve prostaglandin-mediated vasodilation. Taking aspirin (up to 325 mg) 30 minutes before dosing, taking the capsule with food, or using a temporary dose reduction may help manage flushing symptoms. Flushing tends to diminish over time with continued treatment.

Infections: Before initiating treatment, clinicians should evaluate patients for active or latent infections. A complete blood count, including differential white blood cell count, should be performed. Patients should be advised to report any signs or symptoms of infection to their healthcare provider. Treatment should be interrupted in patients who develop serious infections until the infection resolves.

Pregnancy and Breastfeeding

There are limited data on the use of dimethyl fumarate in pregnant women. Animal reproduction studies have shown adverse effects on foetal development at doses exceeding those used clinically. Dimethyl fumarate is not recommended during pregnancy unless the potential benefit to the mother justifies the potential risk to the foetus. Women of childbearing potential should use effective methods of contraception during treatment and for at least one month after the last dose.

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 should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the treatment to the mother. The European Medicines Agency recommends that breastfeeding should be discontinued during treatment with dimethyl fumarate.

Pre-treatment Assessment Checklist

  • Complete blood count (CBC) with differential and lymphocyte count
  • Liver function tests (ALT, AST, alkaline phosphatase, total bilirubin)
  • Renal function tests (serum creatinine, estimated GFR)
  • Infection screening including evaluation for active or latent infections
  • Pregnancy test for women of childbearing potential
  • Vaccination status review – live vaccines should be administered before starting treatment
  • Review of concomitant medications with particular attention to other immunosuppressive or immunomodulatory agents

How Does Dimethyl Fumarate Medical Valley Interact with Other Drugs?

Quick Answer: Dimethyl fumarate has a relatively low potential for drug-drug interactions because it is not metabolised through the cytochrome P450 enzyme system. However, concurrent use with other immunosuppressive or immunomodulatory agents is not recommended due to the risk of additive immunosuppression, including severe lymphopenia.

The pharmacokinetic profile of dimethyl fumarate makes it less likely to be involved in drug-drug interactions than many other disease-modifying therapies. After oral administration, dimethyl fumarate undergoes rapid presystemic hydrolysis by esterases in the gastrointestinal tract to its active metabolite, monomethyl fumarate (MMF). MMF is then further metabolised through the tricarboxylic acid (TCA) cycle, without involvement of the cytochrome P450 (CYP) enzyme system. This means that dimethyl fumarate is unlikely to affect the metabolism of drugs that are substrates of CYP enzymes.

In vitro studies have demonstrated that therapeutically relevant concentrations of dimethyl fumarate and MMF do not inhibit or induce CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4/5. Furthermore, dimethyl fumarate and MMF are not substrates or inhibitors of the major drug transporters P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) at clinically relevant concentrations.

Major Interactions

Major Drug Interactions with Dimethyl Fumarate Medical Valley
Interacting Drug/Class Type of Interaction Clinical Significance Recommendation
Other immunosuppressants (e.g., azathioprine, methotrexate, ciclosporin) Pharmacodynamic – additive immunosuppression Increased risk of severe lymphopenia and opportunistic infections including PML Concurrent use not recommended. Allow adequate washout before switching.
Other MS disease-modifying therapies (e.g., fingolimod, natalizumab, teriflunomide) Pharmacodynamic – additive immunomodulation Increased risk of infection and immune suppression Do not use concurrently. Follow recommended washout periods when switching therapies.
Live vaccines (e.g., MMR, varicella, yellow fever) Pharmacodynamic – reduced immune response Risk of vaccine-induced infection and reduced vaccine efficacy Avoid live vaccines during treatment. Complete vaccination before starting dimethyl fumarate.
Nephrotoxic drugs (e.g., aminoglycosides, NSAIDs at high doses) Pharmacodynamic – additive renal effects Potential for increased renal adverse effects, particularly proteinuria and elevated creatinine Monitor renal function more frequently when co-administered.

Minor Interactions

Aspirin (acetylsalicylic acid): Low-dose aspirin (325 mg or less) taken 30 minutes before the dimethyl fumarate dose may reduce the incidence and severity of flushing. This is considered a beneficial interaction and is recommended by prescribing information. However, patients should consult their healthcare provider before starting aspirin due to its own risk profile, including gastrointestinal bleeding.

Antacids and proton pump inhibitors: Since dimethyl fumarate is formulated as a gastro-resistant capsule designed to release the active substance in the small intestine, co-administration with drugs that significantly alter gastric pH could theoretically affect drug release. However, clinical studies have not demonstrated a significant pharmacokinetic interaction with commonly used antacids or proton pump inhibitors.

Oral contraceptives: No formal drug interaction studies have been conducted specifically with oral contraceptives. However, because dimethyl fumarate is not metabolised through the CYP system and does not affect drug transporters at therapeutic concentrations, it is not expected to reduce the efficacy of hormonal contraceptives. Women are generally advised to continue using their regular contraceptive method during treatment.

Switching from Other MS Therapies When switching from other disease-modifying therapies to dimethyl fumarate, appropriate washout periods should be observed. The required washout period varies by prior therapy. For example, after discontinuing fingolimod, a washout period of approximately 6 weeks is typically recommended to allow lymphocyte recovery. After natalizumab, a 6–8 week washout is commonly advised. Always follow your neurologist’s specific guidance regarding timing.

What Is the Correct Dosage of Dimethyl Fumarate Medical Valley?

Quick Answer: The starting dose is 120 mg twice daily for the first 7 days. After this titration period, the dose is increased to the recommended maintenance dose of 240 mg twice daily. Capsules should be swallowed whole with food to reduce gastrointestinal side effects and flushing.

Dimethyl fumarate Medical Valley should be initiated under the supervision of a neurologist experienced in the treatment of multiple sclerosis. The dose titration schedule is designed to reduce the incidence and severity of flushing and gastrointestinal adverse events that are most commonly experienced during the early weeks of treatment.

Adults

Starting Dose (Titration – Week 1)

120 mg twice daily (one 120 mg capsule in the morning and one 120 mg capsule in the evening) for the first 7 days. This initial lower dose allows the body to gradually adjust to the medication and helps minimise gastrointestinal side effects and flushing.

Maintenance Dose (From Week 2 onwards)

240 mg twice daily (one 240 mg capsule in the morning and one 240 mg capsule in the evening). This is the recommended long-term therapeutic dose. The total daily dose is 480 mg. Treatment should continue for as long as it remains clinically beneficial, as determined by the treating neurologist.

Dimethyl Fumarate Medical Valley Dosing Schedule
Treatment Phase Dose Frequency Duration
Titration (Week 1) 120 mg Twice daily (morning and evening) 7 days
Maintenance (Week 2+) 240 mg Twice daily (morning and evening) Ongoing / as prescribed
Temporary dose reduction (if needed) 120 mg Twice daily Up to 4 weeks, then resume 240 mg

Children

Dimethyl fumarate Medical Valley is not approved for use in children and adolescents under 18 years of age. The safety and efficacy of dimethyl fumarate have not been established in the paediatric population through adequately powered clinical trials. While some off-label use has been reported in the medical literature, particularly in adolescents aged 13–17 years, this should only be considered under the close supervision of a paediatric neurologist when the potential benefits clearly outweigh the risks and no approved alternative is suitable.

Elderly

Clinical trials of dimethyl fumarate did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. No dose adjustment is required based solely on age. However, elderly patients may have a greater frequency of decreased hepatic, renal, or cardiac function, and may be more susceptible to infections. Clinicians should consider the general health status and comorbidities of elderly patients when deciding whether to prescribe dimethyl fumarate, and monitoring may need to be more frequent in this population.

Renal and Hepatic Impairment

No formal studies have been conducted in patients with renal or hepatic impairment. Because dimethyl fumarate is metabolised primarily through the TCA cycle rather than the liver or kidneys, dose adjustments are not expected to be necessary in patients with mild-to-moderate hepatic or renal impairment. However, as a precautionary measure, liver and kidney function should be assessed before starting treatment. Dimethyl fumarate has not been studied in patients with severe renal or hepatic impairment, and use in these populations should be approached with caution.

Missed Dose

If a dose of dimethyl fumarate is missed, the patient should take it as soon as they remember, provided it is not close to the time of the next scheduled dose. A double dose should not be taken to make up for a missed dose. If the next dose is due within a few hours, the missed dose should be skipped, and the regular dosing schedule should be resumed. Patients should be counselled that consistent adherence to the prescribed dosing schedule is important for optimal therapeutic benefit.

Overdose

There is limited experience with overdose of dimethyl fumarate in clinical settings. Symptoms of overdose would be expected to include an exaggeration of the known adverse effects, particularly flushing, gastrointestinal disturbances (nausea, vomiting, diarrhoea, abdominal pain), and potentially headache. There is no specific antidote for dimethyl fumarate overdose. Management should be supportive and symptomatic. In the event of a significant overdose, general supportive measures should be initiated, including monitoring of clinical status and institution of supportive therapy as needed. Haemodialysis is unlikely to be effective given the rapid metabolism and high protein binding of the drug.

Administration Tips The capsules should be swallowed whole with water. They must not be crushed, chewed, or opened, as this would destroy the gastro-resistant coating and could lead to increased gastrointestinal side effects. Taking the capsule with food, particularly a meal containing some fat, can significantly reduce the incidence of flushing and gastrointestinal adverse events. Patients who experience persistent flushing may benefit from taking non-enteric-coated aspirin (325 mg or less) approximately 30 minutes before the dose.

What Are the Side Effects of Dimethyl Fumarate Medical Valley?

Quick Answer: The most common side effects are flushing (warmth, redness, itching, or burning sensation) and gastrointestinal symptoms (diarrhoea, nausea, abdominal pain). These are most pronounced during the first month of treatment and usually decrease over time. Serious but rare side effects include progressive multifocal leukoencephalopathy (PML) and severe, prolonged lymphopenia.

Like all medicines, dimethyl fumarate can cause side effects, although not everybody gets them. The safety profile of dimethyl fumarate has been characterised through extensive clinical trials involving over 2,500 patients treated for up to 12 years in the long-term extension studies. Understanding the frequency and nature of side effects can help patients and healthcare providers make informed treatment decisions and manage adverse reactions effectively.

The side effects listed below are categorised by frequency according to the standard medical convention: very common (affects more than 1 in 10 people), common (affects 1 in 10 to 1 in 100 people), uncommon (affects 1 in 100 to 1 in 1,000 people), and rare (affects fewer than 1 in 1,000 people).

Very Common (more than 1 in 10)

These side effects are experienced by more than 10% of patients
  • Flushing – warmth, redness, itching, or burning sensation of the skin, most commonly of the face, neck, and upper chest. Typically begins within 30 minutes of dosing and lasts 30–60 minutes. Most common in the first month and tends to diminish with continued use.
  • Diarrhoea – usually mild-to-moderate in severity and most common during the first weeks of treatment.
  • Nausea – often associated with the start of treatment and tends to improve with continued use and when taking the medication with food.
  • Abdominal pain – upper abdominal discomfort or cramping, typically mild and self-limiting.
  • Decreased lymphocyte count – a reduction in lymphocytes is expected with treatment and should be monitored regularly.

Common (1 in 10 to 1 in 100)

These side effects affect between 1% and 10% of patients
  • Vomiting – usually mild and often related to the gastrointestinal irritation seen early in treatment.
  • Dyspepsia (indigestion) – a sensation of discomfort in the upper abdomen.
  • Gastritis – inflammation of the stomach lining.
  • Gastrointestinal disorder – general GI disturbances including bloating and flatulence.
  • Pruritus (itching) – generalised itching not always associated with flushing.
  • Rash – various types of skin eruption.
  • Erythema (skin redness) – redness of the skin beyond typical flushing areas.
  • Proteinuria – presence of protein in the urine, usually transient.
  • Feeling hot – a sensation of body warmth without measurable fever.
  • Elevated liver enzymes (ALT, AST) – usually transient and asymptomatic.
  • Decreased white blood cell count (leucopenia).
  • Albumin in urine – usually mild and transient.

Uncommon (1 in 100 to 1 in 1,000)

These side effects affect between 0.1% and 1% of patients
  • Lymphopenia – severe and/or prolonged reduction in lymphocyte count below 0.5 × 10⁹/L.
  • Hypersensitivity reactions – allergic reactions including urticaria (hives) and angioedema.
  • Herpes zoster (shingles) – reactivation of varicella-zoster virus.

Rare (less than 1 in 1,000)

These side effects affect fewer than 0.1% of patients
  • Progressive multifocal leukoencephalopathy (PML) – a serious brain infection caused by the JC virus, primarily occurring in the context of prolonged lymphopenia. This can be fatal or cause severe permanent disability.
  • Anaphylaxis – severe, life-threatening allergic reaction requiring immediate medical intervention.
  • Severe hepatic injury – significant elevation of liver enzymes with potential clinical symptoms.
When to Seek Immediate Medical Attention Contact your healthcare provider or seek emergency care if you experience: signs of severe allergic reaction (difficulty breathing, swelling of face/throat, severe rash); signs of PML (progressive weakness on one side of the body, vision changes, confusion, memory problems, changes in thinking); signs of severe liver problems (unexplained nausea, vomiting, abdominal pain, fatigue, loss of appetite, yellowing of skin or eyes); or persistent severe infections.

It is important to note that the side effect profile of dimethyl fumarate tends to improve over time. In clinical trials, the incidence of flushing and gastrointestinal events was highest during the first month of treatment and declined substantially by the second and third months. Long-term extension studies of up to 12 years have confirmed that the safety profile remains consistent over time, without emergence of new or unexpected safety signals.

Patients should be encouraged to discuss any concerns about side effects with their neurologist or healthcare team. In many cases, practical management strategies (such as taking the medication with food, using low-dose aspirin for flushing, or temporary dose reduction) can help patients tolerate the medication and maintain adherence to their treatment plan.

How Should You Store Dimethyl Fumarate Medical Valley?

Quick Answer: Store dimethyl fumarate Medical Valley at room temperature below 30°C (86°F) in its original packaging to protect from light. Do not use the capsules after the expiry date printed on the carton. Keep out of reach of children.

Proper storage of dimethyl fumarate Medical Valley is essential to maintain the quality, efficacy, and safety of the medication throughout its shelf life. The gastro-resistant coating of the capsules is particularly sensitive to environmental conditions, and improper storage could compromise the integrity of the formulation.

  • Temperature: Store below 30°C (86°F). Do not refrigerate or freeze. Avoid exposing the capsules to excessive heat or direct sunlight.
  • Light protection: Keep the capsules in their original blister packaging or bottle until ready to use to protect from light exposure.
  • Moisture: Protect from moisture. Do not transfer capsules to pill organisers or other containers that do not provide adequate moisture protection, unless they will be used within a short time frame (24–48 hours).
  • Expiry date: Do not use the capsules after the expiry date stated on the blister/bottle and the outer carton. The expiry date refers to the last day of that month.
  • Children: Keep out of the sight and reach of children. Store in a secure location.
  • Disposal: Do not dispose of medications via household waste or wastewater. Ask your pharmacist how to dispose of medicines you no longer need. These measures help to protect the environment.

If you notice any visible changes to the capsules – such as discolouration, unusual odour, or damaged coating – do not take the medication and consult your pharmacist. Capsules that have been exposed to high temperatures or moisture for prolonged periods may have compromised gastro-resistant coatings, which could affect drug release and tolerability.

What Does Dimethyl Fumarate Medical Valley Contain?

Quick Answer: Each capsule contains dimethyl fumarate as the active substance, available in 120 mg and 240 mg strengths. The capsules also contain various excipients that form the gastro-resistant coating and capsule shell.

Dimethyl fumarate Medical Valley capsules are formulated as gastro-resistant (enteric-coated) hard capsules. The gastro-resistant design ensures that the active substance is released in the alkaline environment of the small intestine rather than the acidic environment of the stomach, which helps to reduce gastrointestinal side effects and optimise drug absorption.

Active Substance

  • Dimethyl fumarate 120 mg: Each gastro-resistant hard capsule contains 120 mg of dimethyl fumarate.
  • Dimethyl fumarate 240 mg: Each gastro-resistant hard capsule contains 240 mg of dimethyl fumarate.

Excipients

The excipients (inactive ingredients) in the formulation play important roles in drug stability, release characteristics, and manufacturability. Typical excipients found in dimethyl fumarate gastro-resistant capsule formulations include:

  • Capsule contents: Microcrystalline cellulose, croscarmellose sodium, talc, silica (colloidal anhydrous), magnesium stearate, triethyl citrate, methacrylic acid-ethyl acrylate copolymer (enteric coating polymer), simethicone.
  • Capsule shell: Gelatin, titanium dioxide (E171), brilliant blue FCF (E133), iron oxide yellow (E172) – the exact colourants may vary between the 120 mg and 240 mg capsules to enable visual differentiation of strengths.

Patients with known hypersensitivity to any of the excipients should inform their healthcare provider or pharmacist before starting treatment. The capsules do not contain lactose, gluten, or sucrose. For the most up-to-date and complete list of excipients specific to the Dimethyl fumarate Medical Valley formulation, patients should refer to the patient information leaflet included with their medication or consult their pharmacist.

Frequently Asked Questions About Dimethyl Fumarate Medical Valley

Medical References and Sources

All information presented in this article is based on international medical guidelines, peer-reviewed clinical research, and official regulatory documents. The following sources were used:

  1. European Medicines Agency (EMA). “Tecfidera (dimethyl fumarate) – Summary of Product Characteristics.” EMA, 2024. Available at: ema.europa.eu/en/medicines/human/EPAR/tecfidera
  2. Gold R, Kappos L, Arnold DL, et al. “Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis (DEFINE study).” New England Journal of Medicine. 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 (CONFIRM study).” New England Journal of Medicine. 2012;367(12):1087–1097. doi:10.1056/NEJMoa1206328
  4. U.S. Food and Drug Administration (FDA). “Tecfidera (dimethyl fumarate) Prescribing Information.” FDA, 2024.
  5. National Institute for Health and Care Excellence (NICE). “Dimethyl fumarate for treating relapsing-remitting multiple sclerosis.” Technology Appraisal Guidance TA320. NICE, 2014 (updated 2023).
  6. 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
  7. Gold R, Arnold DL, Bar-Or A, et al. “Long-term effects of delayed-release dimethyl fumarate in multiple sclerosis: Interim analysis of ENDORSE, a randomized extension study.” Multiple Sclerosis. 2017;23(2):253–265. doi:10.1177/1352458516649037
  8. World Health Organization (WHO). “WHO Model List of Essential Medicines.” 23rd edition, 2023. Available at: who.int/publications/i/item/WHO-MHP-HPS-EML-2023.02
  9. British National Formulary (BNF). “Dimethyl fumarate.” NICE/BNF, 2024. Available at: bnf.nice.org.uk/drugs/dimethyl-fumarate

Editorial Team

This article has been written and reviewed by our medical editorial team, consisting of licensed physicians and specialists in neurology and clinical pharmacology. Our content follows international medical guidelines and the GRADE evidence framework.

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