Dimethyl Fumarate Delayed-Release Capsules — Oral Disease-Modifying Therapy for Relapsing Forms of Multiple Sclerosis
Tecfidera® (Dimethyl Fumarate) — Oral Immunomodulator for Relapsing Multiple Sclerosis
A Sourcing Guide for Hospitals, Neurology Centres, and Pharmacies
Tecfidera® (Dimethyl Fumarate) is an oral fumaric acid ester immunomodulator indicated, according to its approved prescribing information, for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS), including clinically isolated syndrome (CIS), relapsing-remitting disease, and active secondary progressive disease. As with all disease-modifying therapies for multiple sclerosis, the decision to prescribe Tecfidera, including patient selection, baseline monitoring, and dose titration, rests entirely with the treating neurologist, in accordance with the approved label. This page provides sourcing and procurement information for hospitals and pharmacies, not clinical or treatment guidance.
As both a trusted medicine distributor in Delhi and a licensed pharma distribution company, A.K. Pharma supplies genuine Tecfidera (Dimethyl Fumarate) in both 120mg and 240mg delayed-release capsules to hospitals, neurology centres, and pharmacies across India, manufactured by Biogen. Among pharmaceutical distribution companies operating in Delhi, A.K. Pharma maintains one of the most comprehensive specialty and imported medicine portfolios — hospitals and neurology departments can source companion medicines through A.K. Pharma’s full product range.
Tecfidera (Dimethyl Fumarate) is a delayed-release capsule used for multiple sclerosis to help decrease the number of flare-ups (relapses), delay the progression of physical disability, and slow brain lesion development. uspto
Mechanism of Action — Dual Neuroprotective and Anti-Inflammatory Activity:
According to the approved prescribing information and published neurology literature, Dimethyl Fumarate works through two complementary mechanisms:
Anti-Inflammatory Activity: Dimethyl Fumarate and its primary active metabolite Monomethyl Fumarate (MMF) activate the nuclear factor erythroid-2-related factor 2 (Nrf2) transcriptional pathway, which regulates cellular responses to oxidative stress. This activation reduces inflammatory immune cell activity — particularly that of T lymphocytes, B lymphocytes, and dendritic cells — which are centrally involved in the autoimmune-mediated demyelination process underlying multiple sclerosis.
Neuroprotective Activity: Beyond its immunomodulatory effects, Nrf2 pathway activation is understood to upregulate antioxidant pathways within neurons and astrocytes, potentially providing a degree of neuroprotective benefit that goes beyond simply reducing inflammatory relapses — supporting the hypothesis that Dimethyl Fumarate may help protect nerve cells from ongoing oxidative stress damage.
In humans, Dimethyl Fumarate is extensively metabolised by esterases before it reaches the systemic circulation and further metabolism occurs through the tricarboxylic acid cycle, with no involvement of the cytochrome P450 (CYP) system. This metabolic profile means Tecfidera has a relatively low drug-interaction risk compared to many other disease-modifying therapies. clinicaltrials
Full prescribing information is available from the FDA label for Dimethyl Fumarate, with additional clinical background available from the National Multiple Sclerosis Society and the European Medicines Agency (EMA).
DEFINE Trial (Dimethyl Fumarate vs Placebo in RRMS)
Published in the New England Journal of Medicine (2012), the pivotal DEFINE trial evaluated Dimethyl Fumarate 240mg twice daily versus placebo in 1,234 patients with relapsing-remitting multiple sclerosis over 2 years. Key findings demonstrated a statistically significant 49% reduction in annualised relapse rate compared to placebo, a 38% reduction in risk of 12-week confirmed disability progression, and significant reductions in new or enlarging T2-hyperintense brain lesions on MRI — establishing Dimethyl Fumarate as an effective oral disease-modifying therapy with a meaningful impact on both clinical and radiological measures of MS activity.
CONFIRM Trial (Dimethyl Fumarate vs Placebo and Glatiramer Acetate)
Also published in the New England Journal of Medicine (2012), the CONFIRM trial evaluated Dimethyl Fumarate against both placebo and Glatiramer Acetate in 1,417 RRMS patients. Key findings demonstrated a 44% reduction in annualised relapse rate versus placebo and significant reductions in MRI lesion burden — while the comparison with Glatiramer Acetate was not powered for superiority, Dimethyl Fumarate demonstrated numerically superior relapse reduction.
For current clinical guidance on multiple sclerosis disease-modifying therapy selection and monitoring, the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and American Academy of Neurology (AAN) publish updated treatment guidelines.
Tecfidera is available as gastro-resistant hard capsules in two strengths — 120mg and 240mg Dimethyl Fumarate per capsule. Cleveland Clinic
| Presentation | Strength | Role in Treatment |
|---|---|---|
| Tecfidera Delayed-Release Capsules | 120mg Dimethyl Fumarate | Starter dose — first 7 days only |
| Tecfidera Delayed-Release Capsules | 240mg Dimethyl Fumarate | Maintenance dose — long-term treatment |
Standard Dosing Schedule (per approved prescribing information):
| Phase | Dose | Duration |
|---|---|---|
| Starter dose | 120mg twice daily | First 7 days |
| Maintenance dose | 240mg twice daily | Ongoing long-term treatment |
| Temporary dose reduction (if tolerability issues) | 120mg twice daily | Up to 4 weeks, then resume 240mg BID |
Dimethyl Fumarate is administered as a single 240mg capsule twice per day. A seven-day starter pack of 120mg capsules twice per day is available and recommended to help improve tolerability. Food does not alter DMF’s absorption. AmeriPharma Specialty
Relapsing Remitting Multiple Sclerosis (RRMS):
Clinically Isolated Syndrome (CIS):
Active Secondary Progressive Multiple Sclerosis (SPMS):
For detailed indication information refer to MedlinePlus Dimethyl Fumarate and the National MS Society Tecfidera page.
Oral Administration — No Injections Required
Tecfidera is taken as an oral delayed-release capsule twice daily — a significant quality-of-life benefit compared to injectable disease-modifying therapies (interferons, Glatiramer Acetate) that require regular self-injection. For patients managing long-term MS treatment, the convenience of an oral therapy contributes meaningfully to adherence.
Established Efficacy in Relapse Reduction
The DEFINE and CONFIRM trials demonstrated approximately 44-49% reduction in annualised relapse rate compared to placebo — placing Dimethyl Fumarate within the moderate-to-high efficacy tier of oral disease-modifying therapies for relapsing MS.
Dual Mechanism — Immunomodulatory and Potentially Neuroprotective
Unlike immunosuppressants that simply reduce immune activity, Dimethyl Fumarate’s Nrf2 pathway activation is understood to provide both anti-inflammatory and potentially neuroprotective benefits — addressing both the inflammatory and oxidative stress components of MS pathology.
Favourable Drug Interaction Profile
Because Dimethyl Fumarate is metabolised independently of the cytochrome P450 system, it has a relatively low risk of pharmacokinetic drug interactions compared to many other disease-modifying therapies — simplifying management in MS patients who typically take multiple medications.
Long-Term Real-World Safety Data
Over a decade of post-approval use since its 2013 FDA approval has generated extensive real-world safety data across hundreds of thousands of patients, providing neurologists and patients with a well-characterised long-term safety profile.
Dosing of Tecfidera is determined by the treating neurologist according to the approved label. Tecfidera is a delayed-release capsule taken twice daily, with or without food. For the first 7 days, the dose is one 120mg capsule taken by mouth twice daily. After 7 days, the dose increases to one 240mg capsule taken by mouth twice daily.
General administration information from the manufacturer’s prescribing information includes:
Baseline and Ongoing Monitoring (per manufacturer prescribing information):
A CBC with differential every 6 months while patients are on Dimethyl Fumarate is recommended. If the absolute lymphocyte count is 500-750, recheck in 3 months then every 3 months until the count rises above 750. If the absolute lymphocyte count is under 500, recheck CBC monthly and obtain JCV serology. AmeriPharma Specialty
Full dosing guidelines are available in the manufacturer’s official prescribing information and should always be followed exactly as directed by the treating neurologist.
Tecfidera is prescribed by neurologists specialising in multiple sclerosis for:
Tecfidera is a prescription medicine requiring initiation and ongoing monitoring by a qualified neurologist. A.K. Pharma supplies Tecfidera to hospitals, neurology centres, and pharmacies across Delhi and India.
The most commonly reported side effects with Tecfidera are flushing and gastrointestinal reactions — both are typically most pronounced during the starter dose period and tend to improve after the first month of treatment.
Common side effects include:
Flushing (sudden warmth, redness, itching, or tingling — particularly of the face and upper body), nausea, diarrhoea, abdominal pain, vomiting, dyspepsia, and rash.
Serious side effects include:
Lymphopenia: Dimethyl Fumarate can cause a reduction in lymphocyte count, which typically decreases by approximately 30% from baseline over the first year of treatment and then stabilises. Severe lymphopenia (absolute lymphocyte count persistently below 500 cells/μL) requires treatment reassessment, as it has been associated with a small number of cases of progressive multifocal leukoencephalopathy (PML).
Progressive Multifocal Leukoencephalopathy (PML): A rare but serious brain infection caused by the JC virus has been reported in a very small number of Tecfidera patients with prolonged severe lymphopenia. Regular lymphocyte monitoring is required to identify patients at risk. All confirmed PML cases in Tecfidera-treated patients had severe prolonged lymphopenia.
Serious Infections: Herpes zoster and other serious infections have been reported, particularly in the context of lymphopenia.
Hepatotoxicity: Clinically significant liver enzyme elevations have been reported — baseline hepatic assessment is recommended before initiating treatment.
Anaphylaxis and Angioedema: Rare cases of anaphylaxis and angioedema have been reported — patients should be advised to seek immediate medical attention for signs of a serious allergic reaction.
Full side effect information is available at FDA Tecfidera Safety Information and Drugs.com Dimethyl Fumarate.
As one of Delhi’s most trusted pharmaceutical distribution companies, A.K. Pharma stores all neurology medicines including Tecfidera under manufacturer-recommended conditions ensuring product integrity for every supply.
Tecfidera (Dimethyl Fumarate) is manufactured by Biogen, one of the world’s leading neuroscience-focused biopharmaceutical companies and the originator of multiple disease-modifying therapies for multiple sclerosis. Biogen developed Tecfidera as the first oral fumaric acid ester approved for relapsing MS, and it has been in clinical use globally since 2013. A.K. Pharma supplies only genuine Tecfidera sourced from authorised Biogen distribution channels. Unlike general wholesale pharmaceutical distributors, A.K. Pharma maintains verified sourcing directly from authorised channels for every specialty medicine it supplies. Learn more about Biogen’s neuroscience portfolio directly from the manufacturer.
Q. What is Tecfidera used for?
Tecfidera (Dimethyl Fumarate) is used for the treatment of relapsing forms of multiple sclerosis — including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS — in adults and paediatric patients aged 13 years and older, per the approved prescribing information.
Q. What are the available strengths of Tecfidera?
Tecfidera is available as delayed-release capsules in 120mg and 240mg strengths. The 120mg capsule is used for the 7-day starter dose period to improve tolerability. The 240mg capsule is the maintenance dose taken long-term, twice daily.
Q. How does Tecfidera work for multiple sclerosis?
Dimethyl Fumarate activates the Nrf2 transcriptional pathway, which reduces inflammatory immune cell activity involved in the autoimmune demyelination process underlying MS, and may provide neuroprotective benefits through antioxidant pathway upregulation — addressing both the inflammatory and oxidative stress components of MS pathology.
Q. Why is blood count monitoring required during Tecfidera treatment?
Tecfidera can reduce lymphocyte counts over time. Regular CBC monitoring identifies patients who develop lymphopenia, which in rare cases of severe prolonged lymphopenia has been associated with a very rare but serious brain infection called PML. Monitoring allows the treating neurologist to intervene before lymphopenia reaches clinically significant levels.
Q. What can be done to manage flushing from Tecfidera?
Flushing — warmth, redness, or tingling particularly of the face — is the most commonly reported side effect, typically most pronounced during the first month of treatment. Taking Tecfidera with food may reduce flushing. The treating neurologist may also recommend taking aspirin 30 minutes before each dose to help manage flushing per clinical guidance. Flushing typically improves significantly after the first 4 weeks.
Q. Is Tecfidera safe for patients aged 13 to 18 years?
Yes — Tecfidera is approved for paediatric patients aged 13 years and older with relapsing-remitting MS, per the approved European prescribing information. The dosing schedule is the same as for adults. Treatment should be initiated and managed by a neurologist experienced in paediatric MS.
Q. How does Tecfidera compare to injectable MS medicines?
Tecfidera offers the convenience of oral dosing — twice daily capsules — compared to injectable disease-modifying therapies like interferons or Glatiramer Acetate that require regular self-injection. In clinical trials, Tecfidera demonstrated approximately 44-49% reduction in annualised relapse rate, which is generally higher than older injectable therapies. The treating neurologist will advise on appropriate therapy selection based on the individual patient’s disease characteristics.
Q. Is Tecfidera available as a generic in India?
Dimethyl Fumarate is available as a generic in some markets. For India specifically, availability of originator Tecfidera versus generic Dimethyl Fumarate through authorised channels should be confirmed with A.K. Pharma. Contact us at 011 4172 6999 or WhatsApp +91 9810034827 for current availability and pricing.
Q. Is Tecfidera available in India?
Tecfidera can be supplied to hospitals and neurology centres across India through licensed pharmaceutical distributors. Contact A.K. Pharma — one of Delhi’s trusted pharmaceutical distribution companies — for availability and pricing.
Q. What is the price of Tecfidera in India?
Tecfidera price in India varies by strength and order quantity. Contact A.K. Pharma at 011 4172 6999 or WhatsApp +91 9810034827 for current pricing and bulk supply rates.
Q. How to order Tecfidera from A.K. Pharma?
Call us at 011 4172 6999 or WhatsApp +91 9810034827 with your requirements and we will respond promptly.
Q. Does A.K. Pharma supply Tecfidera in bulk?
Yes. As one of Delhi’s established pharmaceutical distribution companies, A.K. Pharma supplies Tecfidera in bulk to hospitals and neurology centres across Delhi and India.
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Disclaimer: This page is intended for informational and sourcing/procurement purposes only and does not constitute medical or clinical advice. All treatment decisions for multiple sclerosis, including drug selection, baseline monitoring, and ongoing management, should be made by a qualified neurologist in accordance with the approved prescribing information. A.K. Pharma is a licensed medicine distributor and does not provide clinical guidance.
