What is the recommended treatment regimen for relapsing forms of multiple sclerosis using Tecfidera (dimethyl fumarate)?

Tecfidera (Dimethyl Fumarate) Treatment Regimen for Relapsing Forms of Multiple Sclerosis

The recommended treatment regimen for Tecfidera (dimethyl fumarate) in relapsing forms of MS is a starting dose of 120 mg twice daily for 7 days, followed by a maintenance dose of 240 mg twice daily, taken orally with or without food. 1

Indication and Administration

• Tecfidera is FDA-approved for treating relapsing forms of multiple sclerosis, including:

  • Clinically isolated syndrome
  • Relapsing-remitting disease
  • Active secondary progressive disease 1

• Administration guidelines:

  • Capsules should be swallowed whole and intact
  • Do not crush, chew, or sprinkle capsule contents on food
  • Can be taken with or without food (taking with food may reduce flushing and GI side effects) 1, 2

Managing Common Side Effects

Flushing

• Occurs in approximately 60% of patients 3
• Management:
  • Administer aspirin 325 mg 30 minutes before Tecfidera during the first month of therapy 2
  • Ensure adequate hydration

Gastrointestinal Effects

• Common GI events include nausea, vomiting, diarrhea, and abdominal pain 2
• Management:
  • Take with food, particularly protein-rich foods (e.g., sausage, peanut butter) 2
  • Consider temporary dose reduction if symptoms are severe
  • Use symptomatic therapies as needed

Monitoring Requirements

Laboratory Monitoring

• Complete blood count (CBC) with lymphocyte count:

  • Before initiating treatment
  • After 6 months of therapy
  • Every 6-12 months thereafter 4
  • Consider interrupting treatment if lymphocyte counts <0.5 x 10^9/L persist for more than 6 months 4

• Liver function tests:

  • Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels before initiating treatment
  • Monitor periodically during treatment as clinically indicated
  • Discontinue if clinically significant liver injury is suspected 4

MRI Monitoring

• Perform baseline MRI before initiating treatment
• Annual brain MRI is recommended for monitoring disease activity 4
• MRI should include:
  • T2-weighted FLAIR sequences
  • T2-weighted fast/turbo spin echo sequences
  • Gadolinium-enhanced T1-weighted sequences 4

Important Warnings and Precautions

• Progressive Multifocal Leukoencephalopathy (PML): Withhold Tecfidera at the first sign or symptom suggestive of PML 1

• Lymphopenia: Tecfidera significantly decreases CD4 and CD8 T cell counts, particularly affecting memory T cells 5

• Herpes Zoster and Opportunistic Infections: Consider withholding treatment in cases of serious infection until resolved 1

• Anaphylaxis and Angioedema: Discontinue and do not restart if these occur 1

Efficacy Profile

Tecfidera has demonstrated effectiveness in reducing:

• Clinical relapses
• MRI measures of disease activity
• Disability progression (in the DEFINE trial)
• Some aspects of health-related quality of life 6, 7

Patient Education

Before starting therapy, counsel patients on:

• The importance of treatment adherence
• The likely occurrence and management of flushing and GI adverse events
• The need for regular blood monitoring
• Signs and symptoms that require immediate medical attention

Tecfidera is an effective oral treatment option for relapsing forms of MS with the convenience of twice-daily oral administration, but requires careful monitoring and management of side effects to ensure optimal treatment outcomes.