What is the primary clinical consideration when monitoring a patient started on Tecfidera (Dimethyl Fumarate) for Clinically Isolated Syndrome (CIS)?

From the FDA Drug Label

Flushing is one of the most common reactions, especially at the initiation of therapy, and may decrease over time. Gastrointestinal (GI) events (abdominal pain, diarrhea, and nausea) are some of the most common adverse reactions, especially at the initiation of therapy, and may decrease over time.

The primary clinical consideration when monitoring a patient started on Tecfidera (Dimethyl Fumarate) for Clinically Isolated Syndrome (CIS) is to monitor for signs and symptoms of gastrointestinal discomfort, such as nausea, diarrhea, and flushing.

• Key considerations include:
  • Flushing
  • Gastrointestinal events (abdominal pain, diarrhea, nausea) 1 1

From the Research

The primary clinical consideration when monitoring a patient started on Tecfidera (dimethyl fumarate) for Clinically Isolated Syndrome is to monitor for signs and symptoms of gastrointestinal discomfort, such as nausea, diarrhea, and flushing, as these are common adverse effects of the treatment 2, 3, 4. When initiating Tecfidera, it is essential to counsel patients about these potential side effects, which typically improve after the first month of treatment.

• Taking Tecfidera with food and administering aspirin 30 minutes before dosing can help reduce flushing reactions.
• The standard dosing regimen is 120 mg twice daily for 7 days, followed by the maintenance dose of 240 mg twice daily. Although other considerations, such as monitoring for cardiotoxicity, Steven-Johnson syndrome, or tremor, diplopia, and headache, are not directly supported by the most recent and highest-quality evidence as the primary concern, it is crucial to be aware of the overall clinical picture and adjust monitoring accordingly. Regular complete blood count monitoring with particular attention to lymphocyte counts is also important, as Tecfidera can cause lymphopenia, increasing the risk of progressive multifocal leukoencephalopathy (PML), a rare but potentially fatal brain infection 5, 6. However, based on the most recent evidence, gastrointestinal discomfort is the most relevant consideration when monitoring a patient started on Tecfidera for Clinically Isolated Syndrome.