Tecfidera

Generic name:

Dimethyl fumarate

Drug class:

Immunomodulator; fumaric acid ester

Dosage form:

Delayed-release capsules: 120 mg and 240 mg

Root of administration:

Oral

Dose:

Start with 120 mg orally twice daily for 7 days; then increase to 240 mg orally twice daily. Dose adjustments may be required based on tolerability and lymphocyte counts.

Mechanism of action:

Activates the nuclear factor erythroid 2–related factor 2 (Nrf2) pathway, leading to anti-inflammatory and cytoprotective effects. Exact mechanism in MS is not fully elucidated.

Drug usage cases:

• Relapsing-remitting multiple sclerosis
• Active secondary progressive multiple sclerosis
• Off-label: psoriasis (varies by indication; consult label)

Drug contra indications:

• Hypersensitivity to dimethyl fumarate or any fumaric acid ester

Side effects:

• Flushing (erythema, warmth)
• Gastrointestinal disturbances: nausea, diarrhea, abdominal pain, vomiting, dyspepsia
• Leukopenia and lymphopenia
• Elevated liver enzymes
• Increased risk of infections (e.g., PML, herpes zoster)
• Rash, pruritus
• Headache
• Fatigue
• Back pain
• Proteinuria
• Renal dysfunction (rare)

Warnings:

• Progressive multifocal leukoencephalopathy (PML): monitor for new/worsening neurological signs
• Persistent lymphopenia: monitor CBC every 6–12 months; consider discontinuation if severe
• Hepatic injury: monitor liver function tests before and during treatment
• Hypersensitivity reactions, including angioedema
• Infection risk: use caution in immunocompromised patients
• Dermatologic reactions: monitor for severe rash
• Renal impairment: monitor renal function

Use during pregnancy or breastfeeding:

Pregnancy: Limited human data; animal studies show developmental toxicity at high doses. Use only if potential benefit justifies risk. Breastfeeding: Data lacking; excretion in human milk unknown. Advise discontinuation of breastfeeding during treatment.