Dimethyl Fumarate Neuraxpharm
Disease-modifying therapy for relapsing-remitting multiple sclerosis (RRMS)
Dimethyl fumarate Neuraxpharm is a prescription oral medication used to treat adult patients with relapsing-remitting multiple sclerosis (RRMS). It belongs to a class of medications called immunomodulatory agents and works by reducing inflammation and protecting nerve cells in the brain and spinal cord. It is a generic version of the well-established branded product Tecfidera.
Quick Facts
Key Takeaways
- Dimethyl fumarate Neuraxpharm is approved for the treatment of relapsing-remitting multiple sclerosis in adults, reducing relapse rates by approximately 44-53% compared to placebo in clinical trials.
- The medication is started at 120 mg twice daily for 7 days, then increased to the maintenance dose of 240 mg twice daily, taken with food to reduce gastrointestinal side effects and flushing.
- Regular blood count monitoring is essential, as dimethyl fumarate can cause lymphopenia (low lymphocyte counts), which may increase the risk of infections including the rare but serious brain infection progressive multifocal leukoencephalopathy (PML).
- The most common side effects are flushing and gastrointestinal symptoms, which typically improve during the first 2-3 months of treatment.
- It is a generic equivalent of Tecfidera, offering the same clinical efficacy and safety profile with demonstrated bioequivalence.
What Is Dimethyl Fumarate Neuraxpharm and What Is It Used For?
Dimethyl fumarate Neuraxpharm is a gastro-resistant capsule formulation containing the active substance dimethyl fumarate, manufactured by Neuraxpharm as a generic alternative to the originator product Tecfidera (Biogen). It was approved by the European Medicines Agency (EMA) following demonstration of bioequivalence with the reference product, meaning it delivers the same therapeutic benefit with an identical safety and efficacy profile.
Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system in which the immune system attacks the myelin sheath surrounding nerve fibers. This demyelination disrupts nerve signal transmission, leading to a wide range of neurological symptoms. In relapsing-remitting MS, the most common form of the disease, patients experience periods of new or worsening symptoms (relapses) followed by periods of partial or complete recovery (remissions).
As a disease-modifying therapy, dimethyl fumarate does not cure MS, but it significantly alters the course of the disease. In the pivotal DEFINE and CONFIRM clinical trials, dimethyl fumarate 240 mg twice daily reduced the annualized relapse rate by approximately 44-53% compared to placebo. It also significantly reduced the proportion of patients who experienced a confirmed disability progression and decreased the number and volume of new or enlarging T2-hyperintense lesions and gadolinium-enhancing lesions on brain MRI.
The medication is indicated specifically for adults aged 18 years and older with relapsing-remitting multiple sclerosis. It is not approved for primary progressive MS or secondary progressive MS without active relapses. Treatment decisions should be made by a neurologist with experience in MS management, taking into account the individual patient's disease activity, risk factors, and treatment history.
Dimethyl fumarate belongs to the fumaric acid ester class of medications. While fumaric acid derivatives have been used for decades in dermatology for the treatment of psoriasis, the development of dimethyl fumarate as a delayed-release formulation specifically for MS represented a significant advance in oral disease-modifying therapy, offering patients an alternative to injectable treatments.
What Should You Know Before Taking Dimethyl Fumarate Neuraxpharm?
Before prescribing dimethyl fumarate Neuraxpharm, your neurologist will conduct a thorough evaluation to ensure the medication is appropriate for you. This includes reviewing your medical history, performing blood tests, and discussing the potential benefits and risks of treatment. Understanding the contraindications, warnings, and precautions is essential for safe and effective use.
Contraindications
Dimethyl fumarate Neuraxpharm must not be used in the following situations:
- Hypersensitivity to dimethyl fumarate or any of the excipients listed in the composition. Serious allergic reactions including anaphylaxis and angioedema have been reported with dimethyl fumarate products.
- Pregnancy – dimethyl fumarate should not be used during pregnancy unless clearly necessary and only if the potential benefit justifies the potential risk to the fetus.
- Severe gastrointestinal disease – patients with active gastric or duodenal ulcers or severe gastrointestinal conditions may not tolerate the medication.
- Severe renal impairment (estimated glomerular filtration rate below 30 mL/min/1.73 m²).
- Severe hepatic impairment (Child-Pugh Class C).
Warnings and Precautions
Cases of PML, a rare but potentially fatal brain infection caused by the JC virus, have been reported in patients treated with dimethyl fumarate, particularly in those with prolonged severe lymphopenia (lymphocyte counts below 0.5 × 10&sup9;/L for more than 6 months). Regular monitoring of lymphocyte counts is mandatory.
The following precautions apply during treatment with dimethyl fumarate:
- Lymphopenia and blood monitoring: Dimethyl fumarate can cause a decrease in lymphocyte counts. A complete blood count (CBC) including a differential white blood cell count must be obtained before starting treatment, then every 6 to 12 months during treatment. If the lymphocyte count falls below 0.5 × 10&sup9;/L and persists for more than 6 months, discontinuation should be strongly considered.
- Liver injury: Clinically significant cases of liver injury (elevated transaminases more than 5 times the upper limit of normal) have been reported. Liver function should be checked before starting treatment and during treatment as clinically indicated. Discontinue if significant liver injury is suspected.
- Flushing: Flushing is one of the most common adverse effects and can be distressing. It typically presents as warmth, redness, itching, or burning of the skin, and is most prevalent during the first month of treatment. Taking the medication with food and pre-treatment with aspirin (325 mg, 30 minutes before dosing) may help reduce flushing.
- Infections: Serious infections, including opportunistic infections and herpes zoster, have been reported more frequently in patients with lymphocyte counts below 0.8 × 10&sup9;/L. Consider withholding treatment in patients with serious infections until the infection has resolved.
- Renal effects: Cases of Fanconi syndrome and proteinuria have been reported in post-marketing experience. Renal function monitoring is recommended during treatment.
Pregnancy and Breastfeeding
Dimethyl fumarate should not be used during pregnancy unless the clinical condition of the woman requires treatment and the potential benefit to the mother justifies the potential risk to the fetus. Animal studies have demonstrated adverse developmental effects at doses approximately equivalent to human therapeutic doses. There are limited data from the use of dimethyl fumarate in pregnant women.
Women of childbearing potential should use effective contraception during treatment. If pregnancy is detected during treatment, dimethyl fumarate should be discontinued and the patient referred to a neurologist or obstetrician experienced in managing MS during pregnancy. 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. A risk to newborns and infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue dimethyl fumarate therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.
How Does Dimethyl Fumarate Neuraxpharm Interact with Other Drugs?
Dimethyl fumarate is rapidly converted to its active metabolite monomethyl fumarate (MMF), which is then metabolized through the tricarboxylic acid (TCA) cycle. Since it is not metabolized by cytochrome P450 (CYP) enzymes and does not inhibit or induce CYP enzymes, traditional pharmacokinetic drug-drug interactions are unlikely. However, several pharmacodynamic interactions must be considered.
Major Interactions
| Interacting Drug/Class | Effect | Clinical Advice |
|---|---|---|
| Other immunosuppressants (e.g., azathioprine, methotrexate, cyclosporine) | Additive immunosuppression; increased risk of infections including opportunistic infections and PML | Concurrent use is generally contraindicated. Allow adequate washout period when switching from other DMTs. |
| Live and live-attenuated vaccines | Risk of vaccine-related infection due to immunomodulatory effects; potentially reduced vaccine efficacy | Avoid live vaccines during treatment and for at least 4 weeks after discontinuation. Inactivated vaccines may be given but immune response may be reduced. |
| Other MS disease-modifying therapies (e.g., fingolimod, natalizumab, teriflunomide) | Overlapping immunomodulatory effects; increased risk of lymphopenia and infections | Do not use concomitantly. Observe appropriate washout periods when switching between DMTs. Consult your neurologist for specific guidance. |
| Nephrotoxic agents (e.g., aminoglycosides, NSAIDs, contrast media) | Potential additive renal effects given reports of Fanconi syndrome with dimethyl fumarate | Use with caution. Monitor renal function more frequently if concomitant use is necessary. |
Minor Interactions
| Interacting Drug/Class | Effect | Clinical Advice |
|---|---|---|
| Aspirin (acetylsalicylic acid) | Low-dose aspirin (325 mg) taken 30 minutes before dimethyl fumarate may reduce flushing | This is a beneficial interaction. Commonly recommended during the first month of treatment to manage flushing symptoms. |
| Antacids and proton pump inhibitors | May theoretically affect the gastro-resistant coating dissolution, but no clinically significant interaction has been demonstrated | No dose adjustment needed. Can be used concomitantly if needed for gastrointestinal symptom management. |
| Oral contraceptives | No pharmacokinetic interaction identified in studies | No dose adjustment needed. Oral contraceptives remain effective during dimethyl fumarate treatment. |
Before starting dimethyl fumarate, inform your neurologist about all medications you are currently taking, including prescription drugs, over-the-counter medications, herbal supplements, and vitamins. This is particularly important for any medications that affect the immune system or kidney function.
What Is the Correct Dosage of Dimethyl Fumarate Neuraxpharm?
Dimethyl fumarate Neuraxpharm is available as gastro-resistant hard capsules in two strengths: 120 mg (for the initial titration period) and 240 mg (for maintenance therapy). The gastro-resistant formulation is designed to dissolve in the small intestine rather than the stomach, which helps reduce gastrointestinal side effects. Capsules must be swallowed whole and must not be opened, crushed, dissolved, or chewed, as this would compromise the gastro-resistant coating.
Adults
Standard Adult Dosing
Titration (Days 1-7): 120 mg orally twice daily (morning and evening) with food.
Maintenance (Day 8 onward): 240 mg orally twice daily (morning and evening) with food.
The gradual dose increase during the first week helps the body adapt to the medication and reduces the incidence and severity of flushing and gastrointestinal symptoms. Some clinicians may recommend a slower titration over 4 weeks for patients particularly prone to these adverse effects.
Taking the capsules with a substantial meal (not just a snack) can significantly reduce flushing and gastrointestinal symptoms. Aspirin 325 mg taken 30 minutes before the dose may help with flushing during the first month. Avoid alcohol immediately before or after taking the capsule, as alcohol may worsen flushing.
Children and Adolescents
Pediatric Use
Dimethyl fumarate Neuraxpharm is not approved 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 pediatric population. While pediatric MS is an area of active research, treatment decisions for children with MS should be made by a pediatric neurologist experienced in managing MS in younger patients.
Elderly Patients
Dosing in Older Adults
Clinical trials of dimethyl fumarate did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger adults. In general, no dose adjustment is required for elderly patients, but caution should be exercised due to the greater frequency of decreased renal and hepatic function, and of concomitant medications in this population. MS diagnosed after age 65 is rare, and the use of dimethyl fumarate in elderly patients should be evaluated on a case-by-case basis.
Missed Dose
If you miss a dose of dimethyl fumarate Neuraxpharm, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses at the same time or take extra capsules to make up for a missed dose. If you miss several consecutive doses or are unsure about how to proceed, contact your neurologist or pharmacist for guidance.
Overdose
If you suspect an overdose of dimethyl fumarate Neuraxpharm, seek immediate medical attention by calling your local emergency services or contacting a poison control center. There is no specific antidote for dimethyl fumarate overdose. Treatment is supportive and symptomatic.
In clinical studies, overdose experience is limited. The most common symptoms in cases of excess dosing are expected to be an intensification of the known adverse effects: severe flushing, gastrointestinal disturbances (nausea, vomiting, diarrhea, abdominal pain), and potentially significant lymphopenia. Hemodialysis is not expected to be effective in removing dimethyl fumarate or its metabolites, as the active metabolite monomethyl fumarate is rapidly cleared through the TCA cycle.
What Are the Side Effects of Dimethyl Fumarate Neuraxpharm?
Like all medicines, dimethyl fumarate Neuraxpharm can cause side effects, although not everybody gets them. Most side effects are mild to moderate and tend to decrease with continued use. The safety profile of dimethyl fumarate has been well established through extensive clinical trials involving more than 2,600 patients and over a decade of post-marketing experience with the originator product. Understanding the frequency and nature of potential side effects can help you work with your healthcare team to manage them effectively.
Very Common Side Effects
- Flushing – warmth, redness, itching, or burning sensation of the skin, most commonly affecting the face, neck, chest, and upper body. Typically occurs within 30 minutes of taking the medication and lasts 30-60 minutes. Most frequent during the first month of treatment.
- Gastrointestinal events – diarrhea, nausea, abdominal pain (upper abdominal discomfort), and vomiting. These symptoms are most common during the first month and usually decrease significantly thereafter.
Common Side Effects
- Lymphopenia – decreased lymphocyte count, which may increase susceptibility to infections. Regular blood monitoring is required.
- Leukopenia – decreased white blood cell count overall.
- Feeling of warmth or hot flush – distinct from flushing, experienced as internal heat.
- Pruritus (itching) – generalized itching, sometimes associated with flushing episodes.
- Rash or erythema – skin redness or eruption.
- Proteinuria – protein in the urine, usually mild and reversible.
- Elevated liver enzymes (ALT, AST) – usually mild elevations that return to normal.
- Gastroenteritis – stomach or intestinal inflammation.
Uncommon Side Effects
- Severe lymphopenia – lymphocyte count below 0.5 × 10&sup9;/L, requiring consideration of treatment discontinuation.
- Herpes zoster (shingles) – reactivation of varicella-zoster virus, more common in patients with lymphopenia.
- Allergic reactions – including skin reactions, urticaria, and angioedema.
- Ketoacidosis – elevated ketone levels in blood, very rare.
Rare Side Effects
- Progressive multifocal leukoencephalopathy (PML) – a rare but potentially fatal brain infection caused by the JC virus. Cases have been reported predominantly in patients with prolonged moderate to severe lymphopenia. Early symptoms may include progressive weakness, visual disturbances, cognitive changes, and personality changes.
- Anaphylaxis – severe, life-threatening allergic reaction requiring immediate medical attention.
- Fanconi syndrome – a disorder of kidney tubular function causing loss of important substances through the urine.
- Severe liver injury – clinically significant hepatotoxicity with transaminases exceeding 5 times the upper limit of normal.
Contact your doctor immediately if you experience: signs of a serious infection (high fever, severe headache, stiff neck, confusion); signs of a severe allergic reaction (difficulty breathing, facial swelling, widespread hives); significant unexplained weakness or visual changes; or yellowing of the skin or eyes (jaundice). If you experience mild flushing or gastrointestinal symptoms, these are expected side effects that usually improve with time.
How Should You Store Dimethyl Fumarate Neuraxpharm?
Proper storage of dimethyl fumarate Neuraxpharm is important to maintain the stability and effectiveness of the medication. The gastro-resistant capsules are sensitive to moisture and light, so correct storage conditions help preserve the integrity of the capsule coating and active ingredient.
Store the capsules below 30°C (86°F). Do not store in the refrigerator or freezer. Keep the capsules in the original blister packaging to protect from light and moisture. Do not transfer capsules to other containers. If a capsule appears damaged, discolored, or if the blister seal is broken, do not take that capsule and consult your pharmacist.
Keep this medicine out of the sight and reach of children. Do not use dimethyl fumarate Neuraxpharm after the expiry date which is stated on the blister and carton after "EXP." The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Does Dimethyl Fumarate Neuraxpharm Contain?
The active substance in Dimethyl fumarate Neuraxpharm is dimethyl fumarate (also known as dimethyl (E)-butenedioate). Each gastro-resistant hard capsule is available in two strengths:
- 120 mg capsule: Each capsule contains 120 mg of dimethyl fumarate. These capsules are used during the initial 7-day titration period.
- 240 mg capsule: Each capsule contains 240 mg of dimethyl fumarate. These capsules are used for maintenance therapy.
The excipients (inactive ingredients) include substances used to form the capsule, enable the gastro-resistant coating, and ensure stability of the product. Typical excipients in gastro-resistant dimethyl fumarate formulations include:
- Capsule contents: Microcrystalline cellulose, croscarmellose sodium, talc, silica colloidal anhydrous, magnesium stearate, triethyl citrate, methacrylic acid-ethyl acrylate copolymer (gastro-resistant coating polymer).
- Capsule shell: Gelatin, titanium dioxide (E171), brilliant blue FCF (E133), and other coloring agents depending on capsule strength. May also contain iron oxide yellow (E172) and iron oxide red (E172).
The gastro-resistant (enteric) coating is a critical component of the formulation. It prevents the capsule from dissolving in the acidic environment of the stomach, allowing it to pass intact to the small intestine where the active substance is released and absorbed. This design reduces gastric irritation and improves tolerability. If you have a known allergy to any of the listed excipients, inform your doctor before starting treatment.
Frequently Asked Questions About Dimethyl Fumarate Neuraxpharm
Dimethyl fumarate Neuraxpharm is used to treat adult patients with relapsing-remitting multiple sclerosis (RRMS). It is a disease-modifying therapy that reduces the frequency and severity of relapses, slows disability progression, and decreases the number and volume of brain lesions. It is taken orally as gastro-resistant capsules twice daily, starting with a 7-day titration period at 120 mg twice daily before increasing to the 240 mg twice daily maintenance dose.
Dimethyl fumarate works through a dual mechanism. It activates the Nrf2 antioxidant pathway, protecting nerve cells from oxidative stress and damage. It also modulates the immune system by shifting immune responses from pro-inflammatory (Th1/Th17) to anti-inflammatory (Th2) pathways, and by reducing the number of activated immune cells that cross the blood-brain barrier to attack myelin. This combination of neuroprotective and immunomodulatory effects makes it effective in reducing MS disease activity.
The most common side effects are flushing (warmth, redness, itching of the skin) and gastrointestinal symptoms (diarrhea, nausea, abdominal pain, vomiting). These affect more than 1 in 10 people and are typically most troublesome during the first month of treatment. They usually improve significantly over the first 2-3 months. Taking the medication with food, using a slow dose titration, and taking aspirin 30 minutes before the dose can help reduce these effects.
Before starting treatment, you need a complete blood count (CBC) including lymphocyte count, liver function tests (ALT, AST), and renal function tests. During treatment, a CBC with differential should be repeated every 6-12 months and as clinically indicated. If your lymphocyte count drops below 0.5 × 10&sup9;/L for more than 6 months, your doctor will likely recommend stopping treatment due to the increased risk of PML. Liver and renal function should also be monitored periodically.
Dimethyl fumarate is not recommended during pregnancy. Animal studies have shown potential adverse effects on fetal development, and there are limited human data. Women of childbearing potential should use effective contraception during treatment and for at least 4 weeks after stopping. If you become pregnant while taking dimethyl fumarate, stop the medication and contact your neurologist immediately. Pregnancy registries exist to monitor outcomes, and your doctor can provide guidance on alternative MS treatment strategies during pregnancy.
Dimethyl fumarate Neuraxpharm is a generic version of Tecfidera (Biogen). Both contain the same active ingredient (dimethyl fumarate) in the same strengths (120 mg and 240 mg gastro-resistant capsules). The generic product has been approved based on bioequivalence studies demonstrating that it is absorbed and works in the body in the same way as the original product. The therapeutic efficacy, safety profile, and dosing regimen are identical. The main difference is typically the cost, with the generic version being more affordable.
References
This article is based on the following peer-reviewed sources and international guidelines:
- European Medicines Agency (EMA). Dimethyl fumarate – Summary of Product Characteristics. Last updated 2024. Available at: www.ema.europa.eu
- U.S. Food and Drug Administration (FDA). Tecfidera (dimethyl fumarate) – Prescribing Information. Last revised 2024. Available at: www.accessdata.fda.gov
- Gold R, Kappos L, Arnold DL, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis (DEFINE study). N Engl J Med. 2012;367(12):1098-1107. doi:10.1056/NEJMoa1114287
- Fox RJ, Miller DH, Phillips JT, et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis (CONFIRM study). N Engl J Med. 2012;367(12):1087-1097. doi:10.1056/NEJMoa1206328
- 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
- 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
- National Institute for Health and Care Excellence (NICE). Dimethyl fumarate for treating relapsing-remitting multiple sclerosis. Technology appraisal guidance [TA320]. Published 2014, last updated 2024.
- World Health Organization (WHO). Atlas of MS. 3rd Edition, 2020. Available at: www.who.int
- 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
- British National Formulary (BNF). Dimethyl fumarate. Last updated 2024. Available at: bnf.nice.org.uk
Editorial Team
This article has been written and medically reviewed by the iMedic Medical Editorial Team, which includes specialists in neurology and clinical pharmacology. All content follows international medical guidelines and the GRADE evidence framework.
iMedic Medical Editorial Team – specialists in neurology, neuroimmunology, and clinical pharmacology with experience in MS management and drug safety evaluation.
iMedic Medical Review Board – independent panel of board-certified physicians who verify accuracy against EMA SmPC, FDA labeling, and current clinical guidelines (AAN, ECTRIMS/EAN).
Editorial Standards: All medical content on iMedic is developed independently without pharmaceutical industry funding. We follow evidence-based medicine principles and the GRADE framework for evaluating the quality of evidence. Read more about our editorial standards and medical team.