Tecfidera (Dimethyl Fumarate)

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According to the European Medicines Agency, brand name Tecfidera originating from Europe is manufactured at the following site(s): Biogen Netherlands B.V. Prins Mauritslaan 13 1171 LP Badhoevedorp The Netherlands FUJIFILM Diosynth Biotechnologies Denmark ApS Biotek Allé 1 DK-3400 Hillerød Denmark

Prescription Tecfidera (dimethyl fumarate) is taken in the treatment of relapsing multiple sclerosis. Tecfidera is a disease modifying therapy and has proven clinical results in the treatment of MS.

According to clinical studies, Tecfidera cut flare ups or relapses in half, significantly delayed to progression of physical disability, and slowed brain lesion development. Tecfidera works by lowering your body's own defence from damaging your spinal cord and brain.  

Tecfidera is usually started at 120mg twice daily.  After the first week, the most common dose is Tecfidera 240mg twice daily. Take Tecfidera exactly as prescribed by your doctor. Tecfidera is a capsules that is swallowed whole with water.  Do not crush or chew or dissolve the capsules. Take Tecfidera with food to help reduce side effects in the stomach.

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Information about Tecfidera (Dimethyl Fumarate)

Tecfidera is the brand name for dimethyl fumarate, an oral medication primarily used in the treatment of multiple sclerosis (MS). Dimethyl fumarate is believed to work by reducing inflammation, protecting nerve cells from damage, and modulating the immune system. It is classified as an immunomodulatory agent and is designed to help manage relapsing forms of MS by reducing the frequency of flare-ups and slowing disease progression.

Product Highlights

• Tecfidera is indicated for the treatment of RRMS, a form of MS characterized by periodic flare-ups or relapses followed by periods of remission.
• In some cases, Tecfidera is used in patients with active secondary progressive MS, which is a later stage of MS that follows RRMS and involves gradual progression of disability with or without relapses.

Key Ingredient

• Dimethyl Fumarate

Key Benefits

• Tecfidera has been shown to significantly reduce the frequency of MS relapses, thereby improving long-term outcomes for people with relapsing forms of MS.
• It can help slow the progression of disability in MS patients by protecting nerve cells and reducing inflammation.
• As a pill, Tecfidera offers an easier alternative to injectable medications, making adherence to the treatment regimen simpler for many patients.
• Tecfidera may have a more favorable side-effect profile compared to some other disease-modifying therapies for MS.

Direction of Use

• The typical starting dose of Tecfidera is 120 mg twice daily for the first 7 days, followed by a maintenance dose of 240 mg twice daily.
• The capsules should be taken with food to improve absorption and reduce the risk of gastrointestinal side effects like nausea or abdominal pain.
• It is important to take Tecfidera regularly as prescribed to maintain its effectiveness in reducing MS relapses and slowing disease progression.

Safety Concerns

• Common side effects, especially during the initial phase of treatment, may include flushing, nausea, diarrhea, abdominal pain, and vomiting. Taking the medication with food may help reduce the likelihood of these effects. 
• Tecfidera can cause a decrease in white blood cell count, specifically lymphocytes, which may increase the risk of infections. Regular blood monitoring is recommended to check for lymphopenia.
• Because Tecfidera may affect immune system function, patients may be more susceptible to infections, including opportunistic infections such as progressive multifocal leukoencephalopathy (PML).
• There is a potential for liver toxicity, so liver function tests should be monitored during treatment.
• One of the common side effects of Tecfidera is flushing, which can include redness, warmth, and a sensation of heat, typically occurring soon after taking the medication.

Avoid Tecfidera (Dimethyl Fumarate) If

• Tecfidera should be avoided if you have a known allergy to dimethyl fumarate or any of its ingredients.
• Patients with active infections, including tuberculosis or fungal infections, should not take Tecfidera, as it could worsen the infection.
• Tecfidera is contraindicated in individuals with severe liver dysfunction, as it may exacerbate liver problems.
• Tecfidera is classified as a Category C drug during pregnancy, meaning it may cause harm to a developing fetus. It should only be used during pregnancy if the benefits outweigh the risks. The safety of Tecfidera during breastfeeding is not well-established, so it is recommended to avoid use during this time or to consider alternative treatments.
• Tecfidera should be used cautiously or avoided in patients with a history of conditions that involve lymphocyte depletion or who are immunocompromised due to the potential risk of infections.