Tecfidera (dimethyl fumarate) is a prescription medicine developed by Biogen for adults with relapsing forms of multiple sclerosis. This article provides an overview of how the drug works, its administration, and other relevant patient information.
Understanding Tecfidera and Multiple Sclerosis
Tecfidera is a medication specifically used to address multiple sclerosis (MS), a chronic condition that impacts the brain, spinal cord, and optic nerves. MS is characterized by the immune system mistakenly attacking the protective sheath covering nerve fibers, leading to communication problems between the brain and the rest of the body. This damage can result in a range of symptoms and disability over time.
It is approved for treating relapsing forms of MS in adults, including clinically isolated syndrome, often the first episode of MS-like symptoms. It also covers relapsing-remitting disease, where periods of new or worsening symptoms are followed by recovery.
Tecfidera is also indicated for active secondary progressive disease, a stage where the disease gradually worsens after an initial relapsing-remitting course. Its use is restricted to adult patients, as safety and effectiveness have not been established for those under 18 years of age.
How Tecfidera Impacts MS Progression
The full way Tecfidera works within the body is not completely understood, but its main component, known as BG-12, is thought to play a role in calming inflammatory responses. This action helps to reduce the immune system’s attack on nerve cells in the central nervous system. The drug is also believed to offer some protection against nerve cell damage and death, which are common issues in multiple sclerosis.
Studies show that the medication can decrease the frequency of relapses, which are sudden flare-ups of symptoms. It has also been observed to slow the progression of disability in individuals with MS.
The medication also impacts the development of brain lesions, areas of damage visible on MRI scans. Studies indicate that Tecfidera can reduce the formation and enlargement of these lesions. These effects collectively contribute to managing the disease and preserving neurological function over time.
Administration and Potential Side Effects
Tecfidera is taken orally, and patients begin with a lower dose to help their body adjust. The initial dosage is 120 mg, taken twice daily for the first seven days. Afterward, the dosage increases to a maintenance dose of 240 mg, also taken twice daily.
The capsules should be swallowed whole and not crushed, chewed, or sprinkled on food. Tecfidera can be taken with or without food, providing flexibility for patients.
Patients may experience common side effects, such as flushing, which can involve redness, itching, or a rash. Gastrointestinal issues like nausea, vomiting, diarrhea, stomach pain, or indigestion are also frequently reported. These effects often lessen over time as the body adjusts to the medication.
More serious side effects can occur. These include:
- Allergic reactions, such as swelling of the face, lips, mouth, or tongue, or difficulty breathing.
- Progressive Multifocal Leukoencephalopathy (PML), a rare but serious brain infection.
- Decreases in white blood cell counts, which can affect the body’s ability to fight infections.
- Liver problems, indicated by symptoms like yellowing of the skin or eyes, dark urine, or unusual tiredness.
- Herpes zoster infections, commonly known as shingles.
- Severe gastrointestinal issues, beyond common stomach upset.
Any unusual or concerning symptoms should be promptly discussed with a healthcare professional.
Broader Context for Patients
Tecfidera has been involved in legal disputes concerning its patents, which impacts the availability of generic versions. Biogen has worked to protect its market rights for the medication, particularly in Europe. These efforts resulted in marketing authorizations for generic versions being revoked in Europe until February 2025, meaning that only Biogen’s branded Tecfidera is available in those regions during this period.
The situation differs in the United States, where Biogen was unsuccessful in preventing generic versions from entering the market. Consequently, generic forms of dimethyl fumarate are available in the U.S., offering alternative options for patients and healthcare providers. The presence of generic versions can influence treatment decisions and access to medication.
Patients undergoing treatment with Tecfidera require ongoing medical supervision and monitoring. Regular check-ups and laboratory tests are performed to monitor for potential serious side effects, such as changes in white blood cell counts or liver function. This consistent oversight helps ensure the medication is being used safely and effectively, allowing for timely intervention if any complications arise.