Delayed-release Oral Dimethyl fumarate Capsules: Tecfidera


Dimethyl fumarate is available as 120 mg and 240 mg delayed-release oral capsules under the brand name, Tecfidera. It is marketed by Biogen Idec pharmaceuticals for the treatment of Multiple Sclerosis.

It is the third oral treatment for multiple sclerosis to get FDA approval, after fingolimod and teriflunomide. It is sold under the trade name Tecfidera.

It is unclear how dimethyl fumarate affects the body physiologically. It contains cytoprotective and anti-inflammatory properties that are probably responsible for its benefits in people with multiple sclerosis (MS).

Dimethyl fumarate (Tecfidera) Uses:

Tecfidera is used to treat the following conditions:

➔    Relapsing Forms of MS
➔    Active Secondary Progressive Multiple Sclerosis (SPMS)
➔    Relapsing-Remitting Multiple Sclerosis (RRMS)
➔    Clinically Isolated Syndrome (CIS)

As per the FDA prescribing leaflet, it is only indicated for the treatment of relapsing forms of MS (multiple sclerosis).

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How to take Dimethyl fumarate (Tecfidera)?

Before beginning to take dimethyl fumarate and each moment you receive a refill, review the Patient Information Leaflet, if one is provided by your pharmacist.

Tecfidera is administered orally with or without meals two times a day. It is initially recommended in a low dose for one week after which the dose is increased to twice daily.

If you have a sensitive stomach, taking this medicine with meals might help to lessen the flushing of the skin if it happens.

Also, flushing of the skin may be reduced by taking a regular (non-enteric coated) aspirin 30 min before taking this drug. Ask your doctor if this course of therapy is appropriate for you.

Do not crush the pill in half. Take the whole pill. The capsules should not be broken open or chewed. By doing so, the entire medicine dosage may be released at once, raising the possibility of negative effects.

To get the most out of this drug, take it on the prescribed schedule. If your situation deteriorates, inform your doctor.

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Tecfidera Dose and strength of capsules:

Initial dosage: 120 mg twice daily by mouth for seven days [Ref]. After 7 days, the dose is increased to 240 mg two times a day which is then continued as a regular maintenance dose.

If you miss your scheduled dose,

  • Take the missed dosage as soon as you recall it.
  • Skip the missed dosage if it is almost time for the subsequent dose.
  • At the scheduled time, take your following dose.
  • Do not increase the dosage to make up for the lost dose.
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Side effects of Tecfidera (Dimethyl fumarate):

  • Skin flushing:

It is possible for the skin to feel flushed or heated, red, itchy, or burning. This medication may cause less flushing if taken with meals.

  • Gastrointestinal side effects:

Diarrhea, nausea, and vomiting can also happen, along with stomach/ abdominal discomfort. Inform your doctor or pharmacist right at once if any of these symptoms persist or grow worse.

You should keep in mind that your doctor recommended this drug because she or he thought it would benefit you more than it would harm you. Several users report no significant negative effects from this drug.

  • Infections:

Your capacity to fight infections might be decreased by this drug. This might increase your risk of contracting a major illness (rarely fatal) or aggravate any current infection.

If you have any infection-related symptoms, such as a persistent sore throat, a fever, chills, a cough, or blisters, call your doctor straight at once.

Your chance of developing an uncommon but extremely dangerous (and occasionally deadly) brain infection, PML (progressive multifocal leukoencephalopathy) may rise if you take this medicine.

  • Allergic reactions:

It is not common to get an allergic reaction from these medications, however, if you do face symptoms of such a reaction take immediate action.

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Tecfidera MOA (Dimethyl Fumarate Mechanism of Action):

Dimethyl fumarate’s mode of action in multiple sclerosis is not well known. It is believed to entail the breakdown of dimethyl fumarate to its active metabolite, monomethyl fumarate (MMF).

The Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway, which is triggered in response to oxidative stress, is upregulated by both dimethyl fumarate and MMF.

Additionally, dimethyl fumarate reduces pro-inflammatory genes via inhibiting nuclear factor kappa B. The significance of MMF’s additional nicotinic acid receptor agonist activity is uncertain.

It has been hypothesized that dimethyl fumarate modifies the phenotype and composition of immune cells in order to exercise its immunomodulatory effects.

In particular for cytotoxic and effector T cells, it decreases CNS infiltration and modifies the makeup of all lymphocyte subpopulations.

This results in a change from a phenotype that is mostly pro-inflammatory to one that is anti-inflammatory.

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Some additional info about Tecfidera

It is unknown if Tecfidera is effective and safe for use in kids under the age of 18.

Dimethyl fumarate was used to cure psoriasis in Germany prior to FDA clearance.

Dimethyl fumarate is mostly eliminated by CO2 exhalation, which contributes to 60% of the dosage. Urine and feces are the only other minor elimination pathways. Urine contains minute quantities of monomethyl fumarate, an active metabolite of dimethyl fumarate.

Monomethyl fumarate (MMF), is a short-lived metabolite of dimethyl fumarate, with a half-life of only around an hour.

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Written by Dr. Ahmed

I am Dr. Ahmed (MBBS; FCPS Medicine), an Internist and a practicing physician. I am in the medical field for over fifteen years working in one of the busiest hospitals and writing medical posts for over 5 years.

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