Description: Tecfidera, containing the active substance Dimethyl Fumarate, is an oral medication used for the treatment of multiple sclerosis (MS), specifically relapsing forms of MS. It is designed to reduce the frequency of relapses and delay the progression of disability. Tecfidera offers a convenient oral dosing option for patients managing this chronic condition.
Active Substance:
- Dimethyl Fumarate: An immunomodulatory drug that works by activating the Nrf2 pathway, which helps reduce inflammation and protect against oxidative stress, thereby contributing to the management of multiple sclerosis.
Disease Indications: Tecfidera is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults. This includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Manufacturer: Tecfidera is manufactured by Biogen, a global leader in neuroscience that focuses on discovering, developing, and delivering innovative therapies for neurological and neurodegenerative diseases.
Usage:
- Form: Oral capsules
- Administration: Tecfidera should be taken orally, twice daily. The capsules should be swallowed whole and not crushed, chewed, or opened.
Dosage:
- Initial Dosage: The starting dose is 120 mg twice daily for the first 7 days.
- Maintenance Dosage: After the initial 7 days, the dose is increased to the maintenance dose of 240 mg twice daily.
Storage Conditions: Store Tecfidera capsules at room temperature, away from moisture, heat, and direct sunlight. Keep the medication in its original packaging and out of reach of children and pets.
Mechanism of Action: Dimethyl Fumarate works by activating the Nrf2 (nuclear factor erythroid-derived 2-like 2) pathway. This pathway is involved in the cellular response to oxidative stress, providing a protective effect against inflammation and neurodegeneration associated with multiple sclerosis.
Precautions:
- Tecfidera should be used with caution in patients with a history of gastrointestinal disorders or low white blood cell counts.
- Liver function tests and complete blood cell counts should be performed before starting treatment and monitored regularly during treatment.
- Patients should be advised to report any signs of infection, as Tecfidera can lower the body’s ability to fight infections.
Contraindications:
- Hypersensitivity to Dimethyl Fumarate or any of the excipients in the formulation.
- Severe active gastrointestinal disorders.
Side Effects: Common side effects of Tecfidera may include flushing, abdominal pain, diarrhea, and nausea. Serious side effects can include lymphopenia (low white blood cell count), liver injury, and progressive multifocal leukoencephalopathy (PML), a rare brain infection. If any severe or unusual symptoms occur, seek medical attention immediately.
Interactions:
- Tecfidera may interact with other immunosuppressive or immunomodulatory therapies.
- Caution should be exercised when co-administering Tecfidera with medications that affect the gastrointestinal tract or immune system.
Overdose: In case of an overdose, supportive measures should be taken as necessary. Symptoms of an overdose may include severe gastrointestinal symptoms, flushing, and immune suppression. Immediate medical attention is required.
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