Dimethyl Fumarate STADA Nordic
Oral disease-modifying therapy for relapsing-remitting multiple sclerosis
Quick Facts About Dimethyl Fumarate STADA Nordic
Key Takeaways
- Proven efficacy in RRMS: Clinical trials demonstrate approximately 44-53% reduction in annualised relapse rate compared to placebo in adults with relapsing-remitting multiple sclerosis
- Oral convenience: Taken as capsules twice daily with food, offering an alternative to injectable disease-modifying therapies for MS
- Regular blood monitoring required: Complete blood count including lymphocyte count must be checked before starting, at 6 months, and every 6-12 months thereafter
- Common initial side effects diminish: Flushing and gastrointestinal symptoms are most pronounced during the first month and typically decrease significantly over time
- Generic equivalent to Tecfidera: Contains the same active ingredient as the original branded product with identical efficacy and safety profile
What Is Dimethyl Fumarate STADA Nordic and What Is It Used For?
Dimethyl Fumarate STADA Nordic is an oral disease-modifying therapy (DMT) containing the active substance dimethyl fumarate. It is approved for the treatment of relapsing-remitting multiple sclerosis (RRMS) in adult patients and works by modulating the immune system and providing neuroprotective effects.
Multiple sclerosis (MS) 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 damage disrupts the normal flow of electrical impulses along the nerves, leading to a wide range of neurological symptoms. Relapsing-remitting MS, the most common form of the disease, is characterised by episodes of new or worsening symptoms (relapses) followed by periods of partial or complete recovery (remissions).
Dimethyl fumarate belongs to a class of medicines known as immunomodulatory agents. Unlike traditional immunosuppressants that broadly suppress the immune system, dimethyl fumarate has a more targeted mechanism of action. It primarily activates the Nuclear factor erythroid 2-related factor 2 (Nrf2) transcriptional pathway, a key cellular defence mechanism against oxidative stress. By activating this pathway, dimethyl fumarate enhances the production of antioxidant proteins that protect nerve cells (neurons) and the myelin-producing cells (oligodendrocytes) from inflammatory damage.
In addition to its neuroprotective effects, dimethyl fumarate modifies the immune response in several important ways. It shifts the balance of immune cells from pro-inflammatory T helper 1 (Th1) and T helper 17 (Th17) cells towards anti-inflammatory T helper 2 (Th2) cells. This immunological shift reduces the inflammatory processes that drive myelin destruction in MS. The medicine also promotes the programmed cell death (apoptosis) of activated immune cells that contribute to the autoimmune attack on the nervous system.
The clinical efficacy of dimethyl fumarate in RRMS was established in two large, randomised, double-blind, placebo-controlled Phase III clinical trials: DEFINE and CONFIRM. These studies involved over 2,600 patients with RRMS and demonstrated that dimethyl fumarate 240 mg twice daily significantly reduced the annualised relapse rate by approximately 44-53% compared to placebo over two years. The medicine also significantly reduced the proportion of patients who relapsed and slowed the progression of physical disability as measured by the Expanded Disability Status Scale (EDSS).
Dimethyl Fumarate STADA Nordic is a generic version of the original branded product Tecfidera (Biogen). It contains the same active ingredient in the same dose and has been approved by the European Medicines Agency (EMA) based on demonstrated bioequivalence. This means it has the same efficacy and safety profile as the original product but may be available at a lower cost.
What Should You Know Before Taking Dimethyl Fumarate STADA Nordic?
Before starting Dimethyl Fumarate STADA Nordic, your doctor will perform blood tests including a complete blood count and assess your kidney and liver function. The medicine is not recommended during pregnancy, and patients must not have severe active infections or significantly reduced lymphocyte counts before initiating treatment.
Contraindications
Dimethyl fumarate must not be used if you are allergic (hypersensitive) to dimethyl fumarate or any of the other ingredients in this medicine. You should also not take this medicine if you have been diagnosed with progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection caused by the John Cunningham (JC) virus. Patients with suspected or confirmed PML must not initiate treatment with dimethyl fumarate.
Treatment should not be started in patients with severe lymphopenia (low lymphocyte count), typically defined as a lymphocyte count below 0.5 x 109/L, as this significantly increases the risk of opportunistic infections including PML. Patients with severe active gastrointestinal disease, severe hepatic impairment (Child-Pugh class C), or severe renal impairment should also avoid this medicine due to the limited clinical data available in these populations.
Warnings and Precautions
One of the most important safety considerations with dimethyl fumarate is its effect on lymphocyte counts. The medicine can cause a sustained decrease in white blood cell (lymphocyte) counts, which may persist for the duration of treatment. On average, lymphocyte counts decrease by approximately 30% from baseline during the first year of treatment and then stabilise. However, in some patients, lymphocyte counts may fall below the lower limit of normal, and in rare cases, severe lymphopenia can develop.
Severe and prolonged lymphopenia has been associated with an increased risk of progressive multifocal leukoencephalopathy (PML), a potentially fatal opportunistic brain infection. Cases of PML have been reported in patients treated with dimethyl fumarate, primarily in those with lymphocyte counts persistently below 0.5 x 109/L for more than 6 months. If the lymphocyte count falls below 0.5 x 109/L and persists at this level for more than 6 months, your doctor should carefully reassess whether to continue treatment.
Before starting treatment, your doctor should also obtain a recent MRI scan (usually within 3 months) as a baseline reference. This can be compared with future MRI scans to monitor for any changes that might suggest PML. If PML is suspected, treatment must be stopped immediately and appropriate diagnostic investigations should be carried out.
Flushing (warmth, redness, itching or burning sensation of the skin) and gastrointestinal events (diarrhoea, nausea, abdominal pain, vomiting) are very common during the initial weeks of treatment. Taking the capsules with food and gradually titrating the dose during the first week can help minimise these effects. Aspirin (acetylsalicylic acid) 325 mg taken 30 minutes before the dose may also reduce the severity of flushing in some patients.
Contact your doctor immediately if you experience symptoms such as progressive weakness on one side of the body, clumsiness, visual disturbances, personality changes, or confusion that worsen over days to weeks. These could be signs of PML, which requires urgent medical evaluation. Do not stop taking the medicine without consulting your doctor first.
Pregnancy and Breastfeeding
Dimethyl fumarate is not recommended during pregnancy unless clearly necessary and the potential benefit to the mother justifies the potential risk to the foetus. Animal studies have shown adverse effects on foetal development at doses exceeding the human therapeutic dose. There are limited data from the use of dimethyl fumarate in pregnant women, and the potential risk to the human foetus is not fully known.
Women of childbearing potential should use effective contraception during treatment with dimethyl fumarate. If a woman becomes pregnant while taking this medicine, discontinuation should be considered after discussion with the treating neurologist, weighing the potential risks to the foetus against the risk of disease reactivation if treatment is stopped.
It is not known whether dimethyl fumarate or its metabolites are excreted in human breast milk. A risk to the newborn or infant cannot be excluded. A decision should be made whether to discontinue breastfeeding or discontinue therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
How Does Dimethyl Fumarate STADA Nordic Interact with Other Drugs?
Dimethyl fumarate may interact with other immunosuppressive or immunomodulatory medicines, live vaccines, and nephrotoxic drugs. Concurrent use of other MS treatments that suppress the immune system can increase the risk of infections. Always inform your doctor about all medicines you are currently taking.
The potential for drug interactions with dimethyl fumarate is an important consideration in clinical practice. Because dimethyl fumarate is rapidly converted to its active metabolite monomethyl fumarate (MMF) by esterases before reaching the systemic circulation, it does not interact significantly with the cytochrome P450 (CYP450) enzyme system. This means that many common drug-drug interactions seen with other medicines are unlikely to occur with dimethyl fumarate.
However, there are several clinically significant interactions that healthcare professionals and patients should be aware of. The most important relate to the combined immunosuppressive effects of dimethyl fumarate with other medicines that affect the immune system.
Major Interactions
| Interacting Drug | Effect | Recommendation |
|---|---|---|
| Other MS disease-modifying therapies (fingolimod, natalizumab, teriflunomide) | Additive immunosuppression; increased risk of severe infections including PML | Do not use concurrently. Allow adequate washout period when switching therapies. |
| Immunosuppressive agents (azathioprine, methotrexate, ciclosporin) | Increased risk of immunosuppression and opportunistic infections | Concomitant use not recommended. Monitor lymphocyte counts closely if unavoidable. |
| Live and live-attenuated vaccines | Risk of infection from the live vaccine due to immunomodulatory effect | Avoid live vaccines during treatment. Complete vaccinations before starting therapy. |
| Nephrotoxic drugs (aminoglycosides, NSAIDs at high doses) | Potential additive effect on kidney function; dimethyl fumarate may cause proteinuria | Monitor renal function regularly. Use with caution. |
Minor Interactions
Dimethyl fumarate has relatively few minor interactions due to its unique metabolic pathway. It is not significantly metabolised by the CYP450 enzyme system and does not inhibit or induce CYP450 enzymes at therapeutic concentrations. The active metabolite MMF is primarily eliminated through the tricarboxylic acid (TCA) cycle and exhalation as carbon dioxide, rather than through renal or hepatic elimination pathways.
Concomitant use of aspirin (acetylsalicylic acid) at a dose of 325 mg taken 30 minutes before the dimethyl fumarate dose may reduce the incidence and severity of flushing. This is considered a beneficial interaction and is commonly recommended during the initial titration period. However, long-term daily aspirin use solely for flushing management should be discussed with a healthcare professional due to the bleeding risks associated with aspirin.
Food does not significantly affect the total absorption (area under the curve) of dimethyl fumarate, although taking the capsules with food delays the time to peak plasma concentration by approximately 1 hour. Taking capsules with food is recommended as it can reduce the incidence of gastrointestinal adverse effects without meaningfully affecting drug efficacy.
What Is the Correct Dosage of Dimethyl Fumarate STADA Nordic?
The recommended starting dose is 120 mg twice daily for the first 7 days, followed by the maintenance dose of 240 mg twice daily. Capsules should be swallowed whole with food and not crushed or chewed. The gastro-resistant coating is essential for proper absorption and tolerability.
Adults
The treatment with Dimethyl Fumarate STADA Nordic follows a specific dose titration schedule to minimise the risk of adverse effects, particularly flushing and gastrointestinal symptoms. During the first 7 days (initial titration period), the dose is 120 mg twice daily (one 120 mg capsule in the morning and one in the evening). After this initial period, the dose is increased to the recommended maintenance dose of 240 mg twice daily (one 240 mg capsule in the morning and one in the evening).
Standard Adult Dosing Schedule
Week 1 (Days 1-7): 120 mg twice daily (morning and evening with food)
Week 2 onwards (maintenance): 240 mg twice daily (morning and evening with food)
Maximum daily dose: 480 mg (240 mg twice daily)
Capsules should be swallowed whole with liquid. They must not be crushed, divided, dissolved, sucked, or chewed, as the gastro-resistant coating is specifically designed to protect the active substance from degradation in the stomach and ensure release in the small intestine. Damaging this coating can lead to increased gastrointestinal irritation and reduced efficacy.
A temporary dose reduction to 120 mg twice daily may be considered for patients who experience persistent flushing or gastrointestinal adverse effects on the full maintenance dose. The full maintenance dose of 240 mg twice daily should be resumed within 4 weeks. If the patient cannot tolerate a return to the maintenance dose after this period, the treating physician should consider whether to discontinue treatment.
| Patient Group | Initial Dose | Maintenance Dose | Notes |
|---|---|---|---|
| Adults (18+ years) | 120 mg twice daily (7 days) | 240 mg twice daily | Standard dosing; take with food |
| Elderly (65+ years) | 120 mg twice daily (7 days) | 240 mg twice daily | No dose adjustment needed; limited data in over 65s |
| Renal impairment (mild-moderate) | 120 mg twice daily (7 days) | 240 mg twice daily | No dose adjustment; monitor renal function |
| Hepatic impairment (mild-moderate) | 120 mg twice daily (7 days) | 240 mg twice daily | No dose adjustment; monitor liver function |
Children and Adolescents
Dimethyl Fumarate STADA Nordic is not approved for use in children and adolescents below 18 years of age. The safety and efficacy of dimethyl fumarate in the paediatric population have not been established in adequate clinical trials. There are currently no data available from well-controlled studies in paediatric patients with multiple sclerosis.
Although paediatric MS is increasingly recognised as a clinical entity, the management of MS in children and adolescents should be guided by specialist paediatric neurologists experienced in managing this condition. Other disease-modifying therapies with established paediatric data may be more appropriate for this patient group.
Elderly Patients
Clinical trials of dimethyl fumarate did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently compared to younger adults. No dose adjustment is recommended for elderly patients. However, given the greater frequency of decreased hepatic, renal, and immune function in elderly individuals, caution should be exercised when prescribing dimethyl fumarate to older patients, and monitoring of laboratory parameters should be conducted diligently.
Missed Dose
If you miss a dose of Dimethyl Fumarate STADA Nordic, take it as soon as you remember on the same day. However, do not take a double dose to make up for a forgotten dose. If you have missed an entire day's doses, simply resume your normal dosing schedule the following day. Do not take more than two capsules of 240 mg (or the dose prescribed by your doctor) in any single day.
Occasional missed doses are unlikely to significantly affect the overall efficacy of your treatment. However, consistently missing doses can reduce the therapeutic benefit of dimethyl fumarate and may increase the risk of MS relapses. If you find it difficult to remember to take your medicine, consider setting a daily alarm or using a pill organiser to help establish a consistent routine.
Overdose
There is no specific antidote for an overdose of dimethyl fumarate. In the event of accidental or intentional overdose, seek immediate medical attention. Treatment should be symptomatic and supportive. Given the mechanism of action of dimethyl fumarate, an overdose might be expected to result in an exaggeration of its known adverse effects, particularly flushing, gastrointestinal disturbances, and potentially a more pronounced reduction in lymphocyte counts.
In clinical trials, doses up to 720 mg three times daily (total daily dose of 2,160 mg) were associated with a higher incidence and severity of flushing and gastrointestinal adverse effects but did not reveal any new or unexpected safety signals. Haemodialysis is not expected to be an effective method of removing dimethyl fumarate or its metabolite from the body.
What Are the Side Effects of Dimethyl Fumarate STADA Nordic?
The most common side effects of Dimethyl Fumarate STADA Nordic are flushing (warmth, redness, itching or burning sensation) and gastrointestinal events (diarrhoea, nausea, abdominal pain). These effects are typically most pronounced during the first month of treatment and tend to decrease significantly over time. Serious but rare side effects include severe lymphopenia and progressive multifocal leukoencephalopathy (PML).
Like all medicines, Dimethyl Fumarate STADA Nordic can cause side effects, although not everybody gets them. Understanding the frequency and nature of potential side effects can help you and your healthcare team manage your treatment effectively and recognise when medical attention may be needed.
The side effects reported in clinical trials and post-marketing surveillance are classified by frequency according to standard medical convention. It is important to note that many of the most common side effects, particularly flushing and gastrointestinal symptoms, tend to be most prominent during the first 2-4 weeks of treatment and typically diminish substantially with continued use. This pattern of early adverse events that improve over time is sometimes referred to as the "titration effect" and is one reason why the initial dose titration period is important.
Very Common (affects more than 1 in 10 patients)
Reported in >10% of patients in clinical trials
- Flushing (warmth, redness, itching or burning sensation of the skin) – reported in approximately 34% of patients; typically decreases after the first month
- Diarrhoea – usually mild to moderate and self-limiting
- Nausea – most common during the first few weeks of treatment
- Abdominal pain – upper abdominal discomfort; may be reduced by taking capsules with food
- Decreased lymphocyte count – average decrease of approximately 30% from baseline in the first year
Common (affects 1 to 10 in 100 patients)
Reported in 1-10% of patients in clinical trials
- Vomiting – more common during the early weeks of treatment
- Dyspepsia (indigestion) – burning or discomfort in the upper abdomen
- Gastritis (inflammation of the stomach lining)
- Gastrointestinal disorders – general digestive discomfort
- Pruritus (itching) – may occur with or without flushing
- Rash – typically mild and self-limiting
- Erythema (skin redness) – often associated with flushing episodes
- Hot flush – sensation of warmth without visible skin changes
- Proteinuria (protein in urine) – usually transient and mild
- Feeling of burning sensation – generalised burning feeling
- Elevated liver enzymes (ALT, AST) – usually transient
- Decreased white blood cell count (leukopenia)
Uncommon (affects 1 to 10 in 1,000 patients)
Reported in 0.1-1% of patients in clinical trials
- Lymphopenia (severely low lymphocyte count <0.5 x 109/L)
- Allergic reactions – hypersensitivity including angioedema and urticaria
Rare (affects fewer than 1 in 1,000 patients)
Reported in <0.1% of patients, including post-marketing reports
- Progressive multifocal leukoencephalopathy (PML) – rare but potentially fatal brain infection associated with severe, prolonged lymphopenia
- Anaphylaxis – severe, life-threatening allergic reaction
- Herpes zoster (shingles) – reactivation of varicella-zoster virus, particularly in patients with lymphopenia
- Severe hepatic injury – rare cases of clinically significant liver damage reported post-marketing
Taking the capsules with food (particularly a meal containing some fat) is the most effective strategy to reduce flushing and gastrointestinal effects. Your doctor may also recommend aspirin 325 mg taken 30 minutes before the dose, particularly during the first few weeks. A temporary dose reduction to 120 mg twice daily for up to 4 weeks may also help. Most patients find that these side effects diminish substantially after the first month of treatment.
How Should You Store Dimethyl Fumarate STADA Nordic?
Store Dimethyl Fumarate STADA Nordic below 30°C in the original packaging to protect from light. Keep out of reach and sight of children. Do not use this medicine after the expiry date stated on the packaging.
Proper storage of Dimethyl Fumarate STADA Nordic is essential to maintain the integrity and efficacy of the gastro-resistant capsules. Store the capsules at a temperature not exceeding 30°C (86°F). The capsules should be kept in the original blister packaging until the time of use to protect them from light and moisture. Do not transfer the capsules to other containers.
Do not store the capsules in a bathroom or other humid environment, as moisture can damage the gastro-resistant coating. If you travel with your medicine, ensure it is stored in appropriate conditions and avoid leaving it in a hot car or in direct sunlight. The capsules should not be frozen.
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. 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.
If you notice any visible changes in the appearance of the capsules, such as discolouration, cracking, or softening of the capsule shell, do not take them and consult your pharmacist for a replacement. Keep a record of when you started each blister pack to ensure you are using your medicine within the recommended timeframe.
What Does Dimethyl Fumarate STADA Nordic Contain?
Each gastro-resistant hard capsule contains either 120 mg or 240 mg of the active substance dimethyl fumarate. The capsules also contain several inactive ingredients (excipients) that are necessary for the manufacturing process and the gastro-resistant coating.
The active substance in Dimethyl Fumarate STADA Nordic is dimethyl fumarate, a methyl ester of fumaric acid. The 120 mg capsules and 240 mg capsules are designed to be visually distinguishable from each other to reduce the risk of dosing errors during the initial titration period when patients switch from the lower to the higher strength.
The excipients (inactive ingredients) in the capsule content include microcrystalline cellulose, croscarmellose sodium, talc, silica colloidal anhydrous, magnesium stearate, triethyl citrate, and methacrylic acid-methyl methacrylate copolymer (the gastro-resistant coating material). The capsule shell is made of hypromellose and may contain colouring agents such as titanium dioxide (E171), indigo carmine (E132), and iron oxide yellow (E172), depending on the capsule strength.
The gastro-resistant coating is a critical component of the formulation. It is designed to resist dissolution in the acidic environment of the stomach (pH 1-3) and dissolve in the more alkaline environment of the small intestine (pH 5.5 and above). This ensures that the active substance is released in the small intestine, which reduces direct gastric irritation and optimises absorption. For this reason, the capsules must always be swallowed whole and never crushed, chewed, or opened.
Patients with known allergies or intolerances to any of the listed excipients should discuss this with their doctor or pharmacist before starting treatment. The capsules do not contain lactose, gluten, or gelatin (the capsule shell is made from hypromellose, a plant-based material), making them suitable for patients with these specific dietary restrictions.
Frequently Asked Questions
Dimethyl Fumarate STADA Nordic is used for the treatment of relapsing-remitting multiple sclerosis (RRMS) in adults. It is a disease-modifying therapy that helps reduce the frequency of relapses and slows the progression of physical disability associated with MS. It is not a cure for MS but helps to control the disease and reduce the number and severity of flare-ups.
The starting dose is 120 mg twice daily for the first 7 days. After this initial period, the dose is increased to the recommended maintenance dose of 240 mg twice daily. Capsules should be swallowed whole with food and must not be crushed, dissolved, or chewed. Taking the capsules with food can help reduce flushing and gastrointestinal side effects.
The most common side effects include flushing (warmth, redness, itching or burning sensation), gastrointestinal events (diarrhoea, nausea, abdominal pain, vomiting), and decreased lymphocyte counts. Flushing and gastrointestinal effects tend to be most prominent during the first month of treatment and typically decrease over time. Taking capsules with food is the most effective way to reduce these effects.
Dimethyl fumarate is not recommended during pregnancy or in women of childbearing potential who are not using effective contraception. Animal studies have shown reproductive toxicity. If you become pregnant while taking this medicine, you should discuss discontinuation with your neurologist, weighing the risks to the foetus against the risk of disease reactivation if treatment is stopped.
Dimethyl Fumarate STADA Nordic contains the same active ingredient (dimethyl fumarate) as Tecfidera and has been approved as a generic equivalent based on demonstrated bioequivalence. It works in the same way and has the same efficacy and safety profile. The main difference is that it is manufactured by STADA rather than Biogen, and it may be available at a lower cost.
A complete blood count (CBC) including lymphocyte count should be obtained before starting treatment, at 6 months after starting, and then every 6 to 12 months thereafter. Kidney and liver function tests should also be performed before starting treatment and periodically during treatment. This monitoring is essential because dimethyl fumarate can reduce lymphocyte counts, which may increase the risk of serious infections.
References
- European Medicines Agency (EMA). Dimethyl fumarate – Summary of Product Characteristics. Available at: www.ema.europa.eu. Accessed January 2026.
- 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
- National Institute for Health and Care Excellence (NICE). Dimethyl fumarate for treating relapsing-remitting multiple sclerosis. Technology appraisal guidance [TA320]. Published August 2014. Updated 2024.
- 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. doi:10.1093/brain/awq386
- World Health Organization (WHO). Model List of Essential Medicines – 23rd List, 2023. Geneva: WHO; 2023.
- Kita M, Fox RJ, Phillips JT, et al. Effects of BG-12 (dimethyl fumarate) on health-related quality of life in patients with relapsing-remitting multiple sclerosis: findings from the CONFIRM study. Mult Scler. 2014;20(2):253-257.
- European Medicines Agency (EMA). Assessment report for dimethyl fumarate generic medicinal products. EMEA/H/C/005765. 2024.
- Berkovich R, Weiner LP. Effects of dimethyl fumarate on lymphocyte subsets. Mult Scler Relat Disord. 2015;4(4):339-341.
- Prosperini L, Pontecorvo S. Dimethyl fumarate in the management of multiple sclerosis: appropriate patient selection and special considerations. Ther Clin Risk Manag. 2016;12:339-350.
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