Tecfidera

Tecfidera is the brand name for dimethyl fumarate (DMF), an oral disease-modifying therapy used to treat adults with relapsing forms of multiple sclerosis, including relapsing-remitting MS. It was approved by regulatory authorities in the United States in 2013 and has since received approvals in other regions. Tecfidera is manufactured by Biogen.

Tecfidera is a prodrug that is rapidly metabolized to the active compound monomethyl fumarate. Its mechanism is thought to involve activation of the Nrf2 pathway, which promotes cellular defenses against oxidative stress and modulates inflammatory responses in the nervous system.

Clinical use and efficacy evidence come mainly from trials in relapsing MS. In these studies, Tecfidera reduced the rate of clinical relapses and decreased inflammatory activity seen on MRI. Effects on long-term disability progression were variable across trials and differ from one study to another.

Dosing and administration involve taking capsules twice daily with or without food. The recommended regimen starts with 120 mg twice daily for seven days, followed by 240 mg twice daily. Flushing and gastrointestinal symptoms are among the most common early adverse effects. Lymphopenia and increased susceptibility to infections can occur, so periodic monitoring of lymphocyte counts is recommended. Other potential adverse effects include abdominal pain, nausea, and diarrhea. Rare cases of liver injury have been reported; liver function should be assessed if clinically indicated.

Contraindications include known hypersensitivity to dimethyl fumarate or any component of the product. Tecfidera should be used with caution in individuals with active infections or significant lymphopenia. Use in pregnancy or lactation should weigh potential benefits against risks, as data are limited.