The long anticipated oral MS drug known as BG12 has been approved by the FDA for use in relapsing forms of multiple sclerosis.  The new drug will be sold by Biogen Idec under the brand name Tecfidera (dimethyl fumarate).

Tec-fi-dera is an oral drug which is taken twice daily with or without food.  Take Tecfidera exactly as your doctor instructs you to take it.  Biogen states that the recommended starting dose is one 120mg capsule taken by mouth 2 times a day for 7 days.  The recommended dose after 7 days is one 240 mg capsule taken by mouth 2 times a day.  Swallow Tecfidera whole, without crushing, crewing, or sprinkling capsule contents on food.

What are the possible side effects of Tecfidera?

Flushing (warmth, redness, itching, and/or burning sensations) and stomach problems (nausea, vomiting, diarrhea, abdominal pain, or indigestion) are the most common side effects, especially when first starting treatment, and may decrease over time.  According to the drug label, taking Tecfidera with food may reduce the incidence of flushing which was experienced by 40% of patients taking Tecfidera during clinical trials.  Gatrointestinal symptoms occurred mostly during the first month of treatment.

Tecfidera may cause decreases in a person’s white blood cell count (lymphocytes) and increase a patient's risk of infection, although there were no signs of increased infection rates in studies of the drug.  A recent complete blood cell count (CBC) (i.e., within 6 months) is recommended before starting Tecfidera to identify patients with pre-existing low lymphocyte counts.  The FDA recommends that white blood cell counts of patients on Tecfidera should be checked each year.

It is not known if Tecfidera will harm an unborn baby, tell your doctor if you are pregnant or plan to become pregnant.  Biogen has established the Tecfidera Pregnancy Registry.  If you become pregnancy while taking Tecfidera, talk to your doctor about enrolling in the Registry (1-800-456-2255) which is established to monitor your health and the health of your baby.  It is not known if Tecfidera passes into break milk.  Talk to your doctor if you are breastfeeding or plan to breastfeed.

To report suspected adverse reactions, contact Biogen Idec at 1-800-456-2255 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

How does Tecfidera work?

The exact mechanism by which Tecfidera works in multiple sclerosis is unknown.  Dimethyl fumarate and its active metabolite, monomethyl fumarate, have been shown to activate the Nrf2 (nuclear factor-like 2) pathway which is involved in the cellular response to oxidative stress.  Tecfidera is metabolized in the gastrointestinal tract, blood and tissues, and eliminated primarily through the exhalation of carbon dioxide (CO2).

Clinical trials of Tecfidera

The efficacy and safety of Tecfidera were demonstrated in two placebo-controlled studies that evaluated Tecfidera (diimethyl fumarate, also known as BG12) taken either twice or three times a day in patients with RRMS.  Both studies included patients who had experienced at least 1 relapse in the year before starting the trial or had at least one gadolinium-enhancing (Gd+) lesion on brain MRI within 6 weeks of randomization. Trial participants had baseline EDSS disability scores between 0 and 5.