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.
Study 1 included 1234 patients with RRMS randomized to receive Tecfidera 240 mg twice a day (n=410), Tecfidera 240 mg three times a day (n=416), or placebo (n=408) for up to 2 years with 69%, 69%, and 65% completing the study, respectively. In a subgroup of patients tested by MRI at various points in time throughout the study, 45% experienced no new or newly enlarging lesions. In patients taking Tecfidera twice daily, only 27% experienced relapses, representing a 49% relative risk reduction rate, and 84% experienced no disability progression, representing a 38% relative risk reduction.
In Study 2, patients were randomized to receive Tecfidera 240 mg twice a day (n=359), Tecfidera 240 mg three times a day (n=345), an open-label comparator (n=350), or placebo (n=363) for up to 2 years with 64-72% of participants completing the study. In Study 2, Tecfidera had a positive statistically significant effect on relapse rate and number of new and/or enlarging lesions as seen on MRI. In patients taking Tecfidera twice daily, annualized relapse rate at two years was reduced by 44%. Although there was no statistically significant effect on disability progression in Study 2, only 13% of patients taking the twice daily dose experienced confirmed disability progress as measured by at least a 1 point increase in EDSS score which was sustained for 12 weeks.
What do you think about Tecfidera?
At my recent visit at the neurology clinic, I asked for opinions on Tecfidera. My nurse practitioner expressed that patients and neurologists have been anxiously awaiting the approval of Tecfidera (BG12). They are excited about the safety profile, efficacy, and ease of administration. My nurse expressed that she would not be surprised if Tecfidera became one of the first go-to treatments for newly diagnosed patients.
What do you think about the arrival of Tecfidera? Do you plan to stick with your current treatment or do you think you might consider switching drugs?
Tecfidera, full prescribing information, accessed at http://tecfidera.com/tecfidera-prescribing-information.html
FDA announcement regarding approval of Tecfidera accessed at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm345528.htm