Tecfidera (dimethyl fumarate)

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Tecfidera (dimethyl fumarate) (formerly BG12) is an oral disease-modifying treatment (approved in March 2013) for people with MS made by Biogen Idec Inc. Tecfidera is indicated (which means that it is approved for use) for the treatment of relapsing forms of MS to slow the progress of disability and reduce how often exacerbations or relapses occur.
 

How does Tecfidera work?

Tecfidera is a formulation of fumaric acid, which has been used to treat psoriasis for decades. While the mechanism of action for Tecfidera in MS is not completely understood, it appears to operate as an immunomodulating agent inhibiting proinflammatory cytokines and chemokines (proteins secreted by cells to recruit immune cells to take part in an inflammatory response) and promoting anti-inflammatory activity. It also acts as an antioxidant and may have a neuroprotective effect in areas of CNS damage.

 

How is Tecfidera taken?

Tecfidera is taken orally (by mouth) twice daily. The recommended starting dose of Tecfidera is one 120-mg capsule taken orally twice daily for the first 7 days. After the first 7 days, the recommended dose of Tecfidera is one 240-mg capsule taken orally twice daily. Tecfidera can be taken with or without food.

Make sure that you swallow capsules of Tecfidera whole. Do not chew or crush them or sprinkle the contents of capsules on food.

 

How should Tecfidera be stored?

Tecfidera should be stored away from light. The original container for Tecfidera capsules was designed to keep the medication away from light and should be used for storage. You dispose of any remaining capsules of Tecfidera if the container has been opened for more than 90 days.

 

What if I miss a dose of Tecfidera?

The manufacturer of Tecfidera has not provided any direction on what you should do if you forget to take a dose of Tecfidera. Therefore, if you miss a dose, make sure you call your doctor for instructions.

 

Are there people who should not take Tecfidera?

Tecfidera can cause lymphopenia (sometimes also called lymphocytopenia), which is an abnormally low count of lymphocytes in the blood. Lymphocytes are a type of white blood cell that plays a key role in the immune system and help you fight off infections. Before you start taking Tecfidera, and periodically (annually) while you are taking the drug, your doctor will test your blood to determine whether you have normal levels of lymphocytes. You should have normal lymphocyte counts before you start receiving Tecfidera and while you are taking the drug. Your doctor may decide to withhold treatment with Tecfidera if you develop a serious infection while taking the drug.

There are to date no adequate studies of the safety of Tecfidera in pregnant women to determine whether the drug may cause adverse effects on the developing fetus. Therefore, Tecfidera should only be used during pregnancy if the potential benefits outweigh any possible risks. Speak to your doctor before starting Tecfidera if you are planning to become pregnant, or if you become pregnant while taking Tecfidera. Additionally, it is not known whether Tecfidera is secreted into human breast milk, so speak to your doctor before taking Tecfidera if you are nursing.

 

What evidence do we have that Tecfidera works?

The effectiveness of Tecfidera in people with relapsing-remitting MS (RRMS) has been tested in a Phase 2b study and two Phase 3 studies (DEFINE and CONFIRM). The Phase 2b study (a placebo-controlled, randomized study) found that the highest dose of Tecfidera (240 mg 3 times daily) resulted in a significant reduction (69%) in gadolinium (Gd for short)-enhancing brain lesions seen by magnetic resonance imaging or MRI compared with placebo, a significant decrease in the number of new T2 MRI lesions (a 48% decrease) compared with placebo, and a significantly lower annual rate of relapses (32% lower) compared with placebo.

In the Phase 3 DEFINE study, a 2-year randomized, placebo-controlled study, which included over 1,234 people with RRMS, both doses of Tecfidera (240 mg twice and three times daily) resulted in significantly lower percentage of people with relapses (the primary efficacy endpoint), with the 240 mg twice daily dose resulting in a 49% lower rate of relapses compared with placebo (P<0.0001). Additionally, compared with placebo, Tecfidera resulted significantly greater reductions in the annual rate of relapses, the number of new or enlarging T2 lesions on MRI (an 85% decrease), the number of new Gd-enhancing lesions (a 90% decrease), and the percentage of subjects with progression of disability at 2 years.

In the 2-year Phase 3 CONFIRM study (CONFIRM stands for Comparator and an Oral Fumarate In RRMS), a randomized, double-blind, placebo-controlled study, in which Tecfidera with Copaxone (glatiramer acetate) were compared with placebo in 1,430 people with RRMS, Tecfidera resulted in significant treatment effects versus placebo across all major efficacy outcome measures, including a significantly lower annual rate of relapse (the primary efficacy endpoint), a significantly greater reduction new or newly enlarging T2 MRI lesions, a significantly greater reduction in the number of Gd-enhancing lesions, and a significantly lower number of new T1 lesions. In all cases these effects were greater than those seen with Copaxone.
 

Is there a generic alternative to Tecfidera?

At this time there is no generic alternative to Tecfidera.

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