Dimethyl fumarate Teva: Uses, Dosage & Side Effects
An oral immunomodulatory therapy for the treatment of relapsing-remitting multiple sclerosis (RRMS) in adults
Dimethyl fumarate Teva is a prescription oral disease-modifying therapy (DMT) used for the treatment of relapsing-remitting multiple sclerosis (RRMS) in adults. It contains the active substance dimethyl fumarate, which is rapidly converted in the body to its active metabolite monomethyl fumarate. This medication works through a dual mechanism: it activates the Nrf2 antioxidant pathway to protect nerve cells from oxidative damage, and it modulates the immune response by shifting inflammatory activity away from the destructive processes that characterize MS. Clinical trials have shown that dimethyl fumarate significantly reduces the annualized relapse rate, the number of new or enlarging brain lesions on MRI, and the progression of disability in patients with RRMS. Available as gastro-resistant capsules in 120 mg and 240 mg strengths, it is taken twice daily by mouth. Dimethyl fumarate Teva is a generic version that has been approved based on bioequivalence to the original product.
Quick Facts: Dimethyl fumarate Teva
Key Takeaways
- Dimethyl fumarate Teva is an oral disease-modifying therapy for relapsing-remitting multiple sclerosis (RRMS) in adults, taken as gastro-resistant capsules twice daily with food.
- It works through a dual mechanism: activation of the Nrf2 antioxidant pathway to protect nerve cells and immunomodulation to reduce inflammatory damage to the myelin sheath.
- Clinical trials (DEFINE and CONFIRM) demonstrated a significant reduction in relapse rate (approximately 44–53%), new brain lesions, and disability progression compared with placebo.
- The most common side effects are flushing and gastrointestinal symptoms (nausea, diarrhea, abdominal pain), which typically improve after the first month of treatment; regular blood monitoring for lymphocyte counts is required.
- Treatment starts with a 120 mg twice daily dose for 7 days, then increases to the maintenance dose of 240 mg twice daily; capsules should be swallowed whole with food, not crushed or chewed.
What Is Dimethyl fumarate Teva and What Is It Used For?
Dimethyl fumarate Teva contains the active substance dimethyl fumarate (DMF), a fumaric acid ester that has been developed as a disease-modifying therapy for multiple sclerosis. Multiple sclerosis 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 fibers in the brain and spinal cord. This process, known as demyelination, disrupts the ability of nerves to conduct electrical signals efficiently, leading to a wide range of neurological symptoms including visual disturbances, muscle weakness, numbness, fatigue, cognitive difficulties, and problems with coordination and balance.
In relapsing-remitting MS (RRMS), which is the most common form of the disease and affects approximately 85% of people initially diagnosed with MS, patients experience episodes of new or worsening symptoms (relapses) followed by periods of partial or complete recovery (remissions). Over time, however, incomplete recovery from relapses can lead to progressive accumulation of disability. Disease-modifying therapies like dimethyl fumarate are designed to reduce the frequency and severity of relapses and to slow the long-term progression of disability.
After oral administration, dimethyl fumarate is rapidly metabolized by esterases in the gastrointestinal tract to its primary active metabolite, monomethyl fumarate (MMF). The precise mechanism of action in MS is not fully elucidated, but current scientific understanding points to a dual mechanism involving both neuroprotective and immunomodulatory effects. The neuroprotective component involves activation of the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) transcription factor pathway. When activated, Nrf2 translocates to the cell nucleus and upregulates the expression of a broad range of antioxidant and cytoprotective genes, including heme oxygenase-1, NAD(P)H quinone dehydrogenase 1, and glutathione S-transferase. These enzymes help neutralize reactive oxygen species and other toxic byproducts of inflammation, thereby protecting oligodendrocytes (the cells that produce myelin) and neurons from oxidative stress-induced damage.
The immunomodulatory effects of dimethyl fumarate involve a shift in the immune response from pro-inflammatory T-helper 1 (Th1) and Th17 pathways toward anti-inflammatory T-helper 2 (Th2) and regulatory T-cell responses. Specifically, dimethyl fumarate has been shown to reduce the absolute numbers of CD4+ and CD8+ T lymphocytes in the circulation, with a preferential reduction in memory T cells and relative preservation of naive T cells. It also affects dendritic cell maturation and function, reduces the production of pro-inflammatory cytokines such as interleukin-6, interleukin-12, interferon-gamma, and tumor necrosis factor-alpha, and increases the production of anti-inflammatory cytokines like interleukin-10. These combined effects result in a reduction of the inflammatory immune cells that are thought to cross the blood-brain barrier and drive the demyelination and neurodegeneration characteristic of MS.
The clinical efficacy of dimethyl fumarate was established in two pivotal phase III randomized, double-blind, placebo-controlled trials:
- DEFINE (Determination of the Efficacy and Safety of Oral Fumarate in Relapsing-Remitting MS): This trial enrolled 1,234 patients with RRMS and compared dimethyl fumarate 240 mg twice daily and 240 mg three times daily with placebo over 2 years. The twice-daily regimen (the approved dose) reduced the annualized relapse rate by 53% compared with placebo (0.17 vs 0.36, p < 0.001). The proportion of patients who relapsed over 2 years was also significantly reduced (27% vs 46%). Furthermore, dimethyl fumarate reduced the risk of confirmed disability progression sustained for 12 weeks by 38% and the number of new or newly enlarging T2 lesions on MRI by 85%.
- CONFIRM (Comparator and an Oral Fumarate in Relapsing-Remitting MS): This trial enrolled 1,417 patients and included a glatiramer acetate arm as a reference comparator. Dimethyl fumarate 240 mg twice daily reduced the annualized relapse rate by 44% compared with placebo (0.22 vs 0.40, p < 0.001). The reduction in new or newly enlarging T2 lesions on MRI was 71%. These results were broadly consistent with those of the DEFINE trial and confirmed the efficacy of dimethyl fumarate as a disease-modifying therapy for RRMS.
Long-term extension studies (ENDORSE) have demonstrated sustained efficacy over up to 13 years of continuous treatment, with maintained low relapse rates and stable or improving disability scores in a substantial proportion of patients. The overall safety profile remained consistent with that observed in the pivotal trials, with no new safety signals emerging during long-term follow-up.
Dimethyl fumarate was first approved by the FDA (as Tecfidera) in March 2013 and by the EMA in January 2014. Dimethyl fumarate Teva is a generic version approved by the EMA based on bioequivalence studies demonstrating that it produces equivalent plasma levels of the active metabolite monomethyl fumarate compared with the reference product. Generic medications must meet the same rigorous quality, safety, and efficacy standards as brand-name products, and bioequivalence ensures that the generic product can be expected to have the same clinical effects.
Multiple sclerosis exists in several forms. Dimethyl fumarate is specifically approved for relapsing-remitting MS (RRMS), where patients experience distinct episodes of neurological symptoms followed by recovery periods. It is not approved for primary progressive MS (PPMS), in which disability accumulates steadily from the onset without distinct relapses. If you are unsure about your MS type, discuss this with your neurologist to ensure you are receiving the most appropriate treatment.
What Should You Know Before Taking Dimethyl fumarate Teva?
Contraindications
Dimethyl fumarate Teva is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients listed in the product information. If you have previously experienced an allergic reaction to any fumaric acid ester product, you should not take this medication. Rare cases of anaphylaxis and angioedema have been reported with dimethyl fumarate, typically occurring after the first dose but potentially at any time during treatment.
Dimethyl fumarate is also contraindicated in patients with suspected or confirmed progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection caused by the JC virus. PML has been reported in patients taking dimethyl fumarate, particularly in those with prolonged lymphopenia (low lymphocyte counts). Before starting treatment, your doctor should assess whether you are at increased risk for PML and should obtain baseline lymphocyte counts.
Warnings and Precautions
Dimethyl fumarate can cause a sustained decrease in lymphocyte counts. Severe prolonged lymphopenia (below 0.5 × 109/L for more than 6 months) increases the risk of opportunistic infections, including progressive multifocal leukoencephalopathy (PML), which can be fatal or result in severe disability. A complete blood count must be obtained before treatment initiation, at 6 months, then every 6 to 12 months, and as clinically indicated. If lymphocyte counts fall below 0.5 × 109/L and persist for more than 6 months, treatment discontinuation should be considered.
Before and during treatment with dimethyl fumarate, the following precautions should be observed:
- Blood monitoring: A complete blood count (CBC) including differential white blood cell count and lymphocyte count must be performed before starting treatment, at 6 months after initiation, and then every 6 to 12 months thereafter. Additional testing may be required if clinical signs of infection appear. Treatment should be initiated only if the lymphocyte count is within the normal range.
- Infections: Dimethyl fumarate may increase susceptibility to infections due to its immunomodulatory effects. Patients with active serious infections should not start treatment until the infection has resolved. During treatment, if a patient develops a serious infection, temporary discontinuation should be considered. Cases of herpes zoster (shingles) and other opportunistic infections have been reported.
- Liver function: Elevations in liver transaminases (ALT and AST) have been reported with dimethyl fumarate, including cases of transaminase levels greater than three times the upper limit of normal. Liver function tests should be checked before starting treatment and during treatment as clinically indicated. If significant liver injury is suspected, treatment should be discontinued.
- Renal function: Cases of Fanconi syndrome (a disorder of the proximal renal tubules) have been reported during post-marketing use of dimethyl fumarate. If Fanconi syndrome is suspected (unexplained metabolic acidosis, phosphaturia, glycosuria), treatment should be discontinued and appropriate evaluation initiated.
- Flushing: Flushing is one of the most common side effects and may be mediated by prostaglandins. Taking aspirin (up to 325 mg) 30 minutes before the dose may reduce flushing. Taking the capsules with food can also help. Flushing typically improves or resolves after the first month of treatment.
- Prior immunosuppressive therapy: When switching from another disease-modifying therapy, the potential for overlapping immune system effects must be considered. Your doctor will determine an appropriate washout period based on the half-life and mechanism of action of the prior therapy. Starting dimethyl fumarate concurrently with other immunosuppressive treatments is generally not recommended.
Pregnancy and Breastfeeding
Dimethyl fumarate is not recommended during pregnancy. Animal reproductive studies have shown adverse developmental effects (decreased fetal weight and delayed ossification in rats and rabbits) at doses that also caused maternal toxicity. While there are limited data from human pregnancies, the potential risk to the fetus cannot be ruled out. Women of childbearing potential should use effective contraception during treatment and for at least 4 weeks after stopping dimethyl fumarate.
If you discover that you are pregnant while taking dimethyl fumarate, contact your neurologist immediately. The decision to continue or discontinue treatment should be made on an individual basis, weighing the potential risk to the fetus against the risk of MS relapses to the mother if treatment is stopped. Pregnancy registries may be available in your country to collect data on outcomes of pregnancies exposed to dimethyl fumarate.
It is not known whether dimethyl fumarate or its metabolites are excreted in human breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue breastfeeding or to discontinue treatment, taking into account the benefit of breastfeeding to the child and the benefit of therapy to the mother. Discuss this with your healthcare provider.
No specific studies on the effect of dimethyl fumarate on human fertility have been conducted. Animal studies at high doses showed some effects on fertility parameters in males (reduced epididymal sperm count), but these effects occurred at doses substantially higher than the recommended human dose. Current evidence does not suggest a significant effect on human fertility at therapeutic doses, but if you have concerns, discuss them with your doctor.
How Does Dimethyl fumarate Teva Interact with Other Drugs?
Dimethyl fumarate is metabolized by esterases to its active metabolite monomethyl fumarate (MMF) before reaching the systemic circulation. MMF is further metabolized via the tricarboxylic acid (TCA) cycle, not through 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, and CYP inhibitors or inducers are unlikely to affect the pharmacokinetics of dimethyl fumarate. Formal drug interaction studies with common concomitant medications have not identified clinically significant pharmacokinetic interactions.
However, there are several important pharmacodynamic interactions and precautions to be aware of:
Major Interactions
| Drug / Class | Interaction | Recommendation |
|---|---|---|
| Other immunosuppressants (e.g., azathioprine, methotrexate, cyclosporine, natalizumab, fingolimod) | Additive immunosuppression; increased risk of infections including PML | Concurrent use not recommended; allow appropriate washout period when switching therapies |
| Live vaccines (e.g., MMR, varicella, yellow fever, BCG) | Reduced vaccine efficacy; risk of infection from live organisms due to immunomodulation | Avoid live vaccines during treatment; complete vaccinations at least 4–6 weeks before starting |
| Anti-neoplastic agents | Additive lymphopenia and immunosuppression | Concurrent use contraindicated |
Minor Interactions
| Drug / Class | Interaction | Recommendation |
|---|---|---|
| Nephrotoxic drugs (e.g., aminoglycosides, NSAIDs, certain diuretics) | Potential additive renal effects; dimethyl fumarate has rare reports of Fanconi syndrome | Monitor renal function; use with caution |
| Inactivated vaccines (e.g., influenza, COVID-19, hepatitis B) | Potentially reduced immune response due to lymphopenia | Can be given during treatment; response may be attenuated if lymphocytes are low; consider checking antibody titers |
| Aspirin (low-dose) | May reduce flushing associated with dimethyl fumarate (prostaglandin-mediated) | Aspirin 325 mg taken 30 min before dose may be beneficial; not required |
| Oral contraceptives | No pharmacokinetic interaction expected; severe diarrhea may reduce absorption of oral contraceptives | If persistent GI symptoms, consider additional contraceptive methods |
It is important to inform your doctor about all medications, supplements, and herbal products you are currently taking before starting dimethyl fumarate. While significant pharmacokinetic drug interactions are not expected due to the non-CYP metabolic pathway, the immunomodulatory effects of dimethyl fumarate mean that concomitant use of any medication that affects the immune system requires careful consideration.
When switching to dimethyl fumarate from another disease-modifying MS therapy, the washout period depends on the previous medication. For example, after fingolimod, a washout of at least 6 weeks is recommended to allow lymphocyte recovery. After natalizumab, a 2–3 month washout may be needed. After teriflunomide, an accelerated elimination procedure or a washout of up to 2 years (without accelerated elimination) may be required. Your neurologist will determine the appropriate timing for each individual situation.
What Is the Correct Dosage of Dimethyl fumarate Teva?
Dimethyl fumarate Teva should be prescribed and supervised by a physician experienced in the treatment of multiple sclerosis. The recommended dosing regimen involves a titration phase to reduce the incidence and severity of flushing and gastrointestinal side effects, which are most common during the initial weeks of treatment.
Adults
Standard Adult Dosing
Titration phase (Days 1–7): 120 mg (one 120 mg capsule) taken twice daily with food, once in the morning and once in the evening.
Maintenance dose (Day 8 onwards): 240 mg (one 240 mg capsule) taken twice daily with food, once in the morning and once in the evening.
The total daily maintenance dose is 480 mg (2 × 240 mg). The capsules should be swallowed whole with water. They must not be crushed, chewed, dissolved, or opened. The gastro-resistant coating prevents the active substance from being released in the stomach, which would increase gastrointestinal irritation. Taking the capsules with food significantly reduces flushing and GI side effects.
| Phase | Duration | Morning Dose | Evening Dose | Total Daily Dose |
|---|---|---|---|---|
| Titration | Days 1–7 | 120 mg | 120 mg | 240 mg |
| Maintenance | Day 8 onwards | 240 mg | 240 mg | 480 mg |
Children
Dimethyl fumarate is not approved for use in children and adolescents under 18 years of age. The safety and efficacy of dimethyl fumarate in the pediatric population have not been established in adequate and well-controlled clinical trials. While some off-label use has been reported in pediatric MS patients, decisions regarding treatment in this population should be made by specialist pediatric neurologists on a case-by-case basis, weighing potential benefits against unknown risks.
Elderly
Clinical trials of dimethyl fumarate did not include a sufficient number of patients aged 65 and older to determine whether they respond differently from younger patients. In general, dimethyl fumarate should be used with caution in elderly patients due to the greater frequency of decreased hepatic, renal, and immune function associated with aging. Age-related declines in lymphocyte counts may increase the risk of lymphopenia-related complications. No dose adjustment is recommended based solely on age, but more frequent monitoring of blood counts and organ function may be prudent.
Missed Dose
If you miss a dose of dimethyl fumarate, take it as soon as you remember, provided it is not close to the time of your next scheduled dose. Do not take a double dose to make up for a missed dose. If it is nearly time for your next dose, simply skip the missed dose and continue with your regular dosing schedule. Try to maintain approximately 12 hours between your morning and evening doses for optimal blood levels and tolerability.
Overdose
There is limited experience with dimethyl fumarate overdose. In clinical trials and post-marketing experience, cases of overdose have been associated with an increase in the known side effects of the medication, particularly flushing and gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain). There is no specific antidote for dimethyl fumarate overdose. Treatment should be symptomatic and supportive. If overdose is suspected, contact a poison control center or seek immediate medical attention. Given the short half-life of the active metabolite (approximately 1 hour), symptoms are expected to be self-limiting in most cases.
Always take dimethyl fumarate with food to reduce flushing and gastrointestinal side effects. Swallow the capsules whole; do not crush, chew, or dissolve them. If gastrointestinal side effects are intolerable during the titration period, temporary dose reduction back to 120 mg twice daily for up to 4 weeks may be considered. If the patient cannot tolerate the 240 mg twice-daily maintenance dose after further titration, discontinuation should be discussed with the treating neurologist.
What Are the Side Effects of Dimethyl fumarate Teva?
Like all medicines, Dimethyl fumarate Teva can cause side effects, although not everyone who takes it will experience them. The safety profile of dimethyl fumarate has been extensively characterized in clinical trials involving over 2,600 patients with RRMS and through more than a decade of post-marketing experience worldwide. The side effects are categorized below by their frequency of occurrence, based on data from the DEFINE and CONFIRM pivotal trials and post-marketing surveillance.
The most characteristic side effects of dimethyl fumarate are flushing and gastrointestinal events, which occur most frequently during the first month of treatment and typically diminish in frequency and intensity with continued use. The dose titration scheme (starting at 120 mg twice daily for the first week) and taking the medication with food are the primary strategies for managing these early side effects.
Very Common
May affect more than 1 in 10 people
- Flushing (warmth, redness, itching, or burning sensation of the skin)
- Diarrhea
- Nausea
- Abdominal pain or cramping
Common
May affect up to 1 in 10 people
- Vomiting
- Dyspepsia (indigestion)
- Gastritis (inflammation of the stomach lining)
- Gastrointestinal disorder
- Hot flush
- Pruritus (itching)
- Rash or erythema (skin redness)
- Lymphopenia (decreased lymphocyte count)
- Leukopenia (decreased white blood cell count)
- Burning sensation
- Feeling hot
- Proteinuria (protein in urine)
- Elevated liver transaminases (ALT, AST)
- Albumin in urine
Uncommon
May affect up to 1 in 100 people
- Herpes zoster (shingles)
- Eosinophilia (increased eosinophil count)
- Hypersensitivity reactions
- Gastroenteritis
Rare
May affect up to 1 in 1,000 people
- Progressive multifocal leukoencephalopathy (PML)
- Anaphylaxis and angioedema
- Severe lymphopenia (below 0.5 × 109/L sustained >6 months)
Not Known
Frequency cannot be estimated from available data
- Fanconi syndrome (renal tubular dysfunction)
- Severe prolonged lymphopenia with opportunistic infections
- Liver injury (including autoimmune hepatitis pattern)
Flushing is the most distinctive side effect of dimethyl fumarate, reported in approximately 34–40% of patients in clinical trials compared with 4–6% of placebo recipients. It typically manifests as warmth, redness, itching, or a burning sensation, most commonly affecting the face, neck, chest, and upper body. Flushing is thought to be mediated by prostaglandins released in response to dimethyl fumarate. It usually begins within 30 minutes of taking a dose and resolves within 1–2 hours. In the majority of patients, flushing diminishes significantly after the first month of treatment. Taking the medication with food and pre-treatment with low-dose aspirin (up to 325 mg, taken 30 minutes before the dose) can help reduce the severity and frequency of flushing episodes.
Gastrointestinal side effects (nausea, diarrhea, abdominal pain, vomiting) are also common, particularly during the first 2–4 weeks of treatment. In the DEFINE and CONFIRM trials, the incidence of GI events was approximately 36–40% versus 17–26% for placebo. These symptoms are related to the local irritant effect of the drug on the GI tract, which is why the gastro-resistant capsule formulation is important. Like flushing, GI symptoms generally improve significantly after the first month of treatment. Taking the capsules with food is the most effective measure to reduce these effects.
Lymphopenia is a pharmacologically expected effect of dimethyl fumarate and requires regular monitoring. In clinical trials, the mean lymphocyte count decreased by approximately 30% from baseline within the first year of treatment and then stabilized. Approximately 6% of patients developed severe lymphopenia (grade 3, below 0.5 × 109/L). Severe prolonged lymphopenia increases the risk of opportunistic infections, most critically progressive multifocal leukoencephalopathy (PML). As of the latest available data, cases of PML have been reported in patients treated with dimethyl fumarate, predominantly in the setting of prolonged moderate to severe lymphopenia. This underscores the importance of regular blood count monitoring and timely treatment discontinuation if lymphocyte counts remain critically low.
Contact your doctor or seek emergency care immediately if you experience: signs of a severe allergic reaction (difficulty breathing, swelling of face, lips, tongue, or throat, widespread rash); new or worsening neurological symptoms that differ from your usual MS symptoms and persist for several days (which could indicate PML); unexplained persistent fever or signs of serious infection; jaundice (yellowing of the skin or eyes) or dark urine suggesting liver injury; or severe, uncontrolled gastrointestinal symptoms.
How Should You Store Dimethyl fumarate Teva?
Proper storage of Dimethyl fumarate Teva is important to maintain the quality and effectiveness of the medication. As a gastro-resistant formulation, exposure to moisture, high temperatures, or light can compromise the integrity of the capsule coating, potentially leading to premature release of the active substance and increased gastrointestinal irritation.
- Temperature: Store at or below 30 °C (86 °F). Do not refrigerate or freeze. Avoid storing in locations subject to temperature extremes, such as in a car or near a window with direct sunlight.
- Light protection: Keep the capsules in the original blister packaging or bottle to protect them from light. Do not transfer capsules to a pill organizer for extended periods, as prolonged light exposure may degrade the coating.
- Moisture: The gastro-resistant coating is sensitive to moisture. Keep the packaging tightly closed. In humid climates, additional precautions may be necessary to avoid moisture exposure.
- Expiry date: Do not use Dimethyl fumarate Teva after the expiry date stated on the blister, bottle, or outer carton after “EXP.” The expiry date refers to the last day of that month.
- Keep out of reach of children: Store the medication in a secure location where children cannot access it.
- Disposal: Do not throw unused capsules in household waste or flush them down the toilet. Return any unused medication to your pharmacy for proper disposal in accordance with local regulations. This helps protect the environment.
When traveling with dimethyl fumarate, keep the medication in your hand luggage in its original packaging. Avoid exposing it to extreme heat or cold. If traveling to hot climates, take precautions to keep the capsules below 30 °C, such as using an insulated travel pouch. Airport security screening (x-ray machines) should not affect the medication.
What Does Dimethyl fumarate Teva Contain?
Understanding the full composition of your medication is important, particularly if you have known allergies or intolerances to specific pharmaceutical ingredients. Below is a detailed breakdown of what Dimethyl fumarate Teva contains.
Active Ingredient
The active substance is dimethyl fumarate (also known as dimethyl (E)-butenedioate), a methyl ester of fumaric acid with the molecular formula C6H8O4 and a molecular weight of 144.13 g/mol. Each gastro-resistant capsule contains either 120 mg or 240 mg of dimethyl fumarate. The gastro-resistant formulation ensures that the active substance is released in the small intestine rather than the stomach, which reduces local gastric irritation and improves tolerability.
Inactive Ingredients (Excipients)
| Ingredient | Role | Notes |
|---|---|---|
| Dimethyl fumarate | Active substance | 120 mg or 240 mg per capsule |
| Microcrystalline cellulose | Filler / bulking agent | Provides capsule bulk and aids uniform drug distribution |
| Croscarmellose sodium | Disintegrant | Helps capsule contents break apart for absorption |
| Talc | Glidant | Improves powder flow during manufacturing |
| Colloidal anhydrous silica | Glidant / anti-caking agent | Prevents powder clumping |
| Magnesium stearate | Lubricant | Prevents ingredients from sticking to equipment |
| Methacrylic acid–methyl methacrylate copolymer | Enteric coating polymer | Provides gastro-resistance; dissolves at intestinal pH |
| Triethyl citrate | Plasticizer | Makes the enteric coating flexible |
Appearance and Pack Sizes
Dimethyl fumarate Teva 120 mg gastro-resistant capsules typically have a green and white capsule shell containing white to off-white gastro-resistant micro-tablets or granules. The 240 mg capsules typically have a green capsule shell also containing white to off-white gastro-resistant micro-tablets or granules. The capsules are available in various pack sizes, which may include a starter pack (containing both 120 mg and 240 mg capsules for the titration and initial maintenance phases) and continuation packs of 240 mg capsules. Not all pack sizes may be marketed in every country.
Marketing Authorization
Dimethyl fumarate Teva is manufactured and marketed by Teva Pharmaceuticals. It is a generic medicinal product approved based on demonstrated bioequivalence to the reference product. The marketing authorization covers use in the European Union and other jurisdictions where generic approval has been granted. The medication is subject to the same ongoing pharmacovigilance monitoring as the reference product to ensure continued safety.
Frequently Asked Questions About Dimethyl fumarate Teva
Dimethyl fumarate Teva is used to treat adult patients with relapsing-remitting multiple sclerosis (RRMS). It is a disease-modifying therapy (DMT) that reduces the frequency and severity of MS relapses and slows the accumulation of physical disability. It works by activating antioxidant pathways that protect nerve cells and by modulating the immune system to reduce the inflammatory processes that damage the myelin sheath in MS. It is taken as an oral capsule twice daily.
There are several effective strategies: (1) Always take the capsules with food – this is the most important step and can significantly reduce both flushing and GI symptoms. (2) Follow the dose titration schedule – start with 120 mg twice daily for the first 7 days before increasing to the full 240 mg twice daily dose. (3) Consider taking low-dose aspirin (up to 325 mg) approximately 30 minutes before each dose, which can reduce flushing. (4) Be patient – both flushing and GI side effects typically diminish significantly after the first 4 weeks of treatment. If symptoms remain intolerable, your doctor may extend the titration period or temporarily reduce the dose.
A complete blood count (CBC) including a lymphocyte count must be obtained before you start treatment, then at 6 months after starting, and at least every 6 to 12 months thereafter for as long as you continue treatment. Additional blood tests may be required if your doctor suspects an infection or if your lymphocyte counts are declining. Liver function tests should also be monitored. These blood tests are essential for the early detection of lymphopenia, which if severe and prolonged, can increase the risk of serious infections including progressive multifocal leukoencephalopathy (PML).
Dimethyl fumarate should generally not be used in combination with other immunosuppressive or immunomodulatory therapies for MS due to the risk of additive immune suppression. This includes medications such as fingolimod, natalizumab, teriflunomide, interferon beta, glatiramer acetate, or any other disease-modifying therapy. When switching between MS therapies, an appropriate washout period is needed to avoid overlapping immune effects. However, dimethyl fumarate can be used alongside symptomatic MS treatments (e.g., medications for spasticity, fatigue, or pain) and acute relapse treatments (e.g., corticosteroids) without pharmacokinetic interactions.
Dimethyl fumarate Teva is a generic version of the original dimethyl fumarate product. It contains the same active ingredient at the same doses (120 mg and 240 mg gastro-resistant capsules) and has been approved based on bioequivalence studies that demonstrate it produces equivalent blood levels of the active metabolite. Generic medications undergo rigorous regulatory review and must meet the same quality, safety, and efficacy standards as the original brand-name product. The therapeutic effects and side effect profile are expected to be equivalent. Minor differences in inactive ingredients (excipients) or capsule appearance may exist, but these do not affect clinical efficacy.
If you forget to take a dose, take it as soon as you remember, as long as it is not too close to the time of your next scheduled dose. Do not take two doses at the same time or a double dose to make up for the missed one. Try to maintain approximately 12 hours between your morning and evening doses. If you frequently forget doses, consider setting alarms or using a medication reminder app. Consistently missing doses may reduce the effectiveness of the treatment and increase the risk of MS relapses.
References
- European Medicines Agency (EMA). Dimethyl fumarate Teva – Summary of Product Characteristics. Available at: EMA Dimethyl fumarate Teva EPAR.
- U.S. Food and Drug Administration (FDA). Tecfidera (dimethyl fumarate) – Prescribing Information. Biogen Inc. Revised 2024.
- Gold R, Kappos L, Arnold DL, et al. Placebo-Controlled Phase 3 Study of Oral BG-12 for Relapsing Multiple Sclerosis (DEFINE). 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). N Engl J Med. 2012;367(12):1087–1097. doi:10.1056/NEJMoa1206328.
- 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. Mult Scler. 2017;23(2):253–265. doi:10.1177/1352458516649037.
- Montalban X, Gold R, Thompson AJ, et al. ECTRIMS/EAN Guideline on the pharmacological treatment of people with relapsing multiple sclerosis. Mult Scler. 2018;24(2):96–120. doi:10.1177/1352458517751049.
- 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.
- 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). Atlas of MS. 3rd edition. 2020. Available at: Atlas of MS.
- British National Formulary (BNF). Dimethyl fumarate. National Institute for Health and Care Excellence (NICE). 2025.
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