From the FDA Drug Label
Use of an accelerated elimination procedure may decrease this risk, but may also potentially result in return of disease activity if the patient had been responding to teriflunomide tablet treatment [see Warnings and Precautions (5.3)].
The risk of discontinuing teriflunomide in multiple sclerosis (MS) patients includes a potential return of disease activity. To mitigate this risk, an accelerated elimination procedure may be used, but it may not completely eliminate the risk of disease recurrence.
- Key considerations:
- Disease activity may return after discontinuation
- Accelerated elimination procedure may decrease this risk but is not a guarantee
- Patients should be closely monitored after discontinuation 1
From the Research
Discontinuing teriflunomide in MS patients carries significant risks, primarily the potential for disease reactivation or rebound, as evidenced by a case report in 2020 2 and another in 2017 3, highlighting the need for careful consideration and planning before stopping the medication. The main concern is that teriflunomide has a very long half-life (approximately 15-19 days) and can remain in the body for up to 2 years without an accelerated elimination procedure. To safely discontinue teriflunomide, an accelerated elimination protocol using cholestyramine (8g three times daily for 11 days) or activated charcoal (50g every 12 hours for 11 days) is recommended, as this protocol reduces plasma concentrations of teriflunomide by 98%, minimizing risks 2. Some key points to consider when discontinuing teriflunomide include:
- Blood tests should confirm that plasma concentrations are below 0.02 mg/L before considering the medication fully eliminated 2
- Women planning pregnancy require special attention, as teriflunomide is contraindicated during pregnancy due to potential teratogenic effects 4
- Patients should always consult their neurologist before stopping teriflunomide and should have an alternative MS treatment plan ready to prevent disease reactivation during the transition period The most recent and highest quality study, a case report from 2020 2, suggests that even after accelerated elimination, patients may still experience a relapse, emphasizing the importance of close monitoring and having a plan in place for alternative treatment. Overall, the decision to discontinue teriflunomide should be made with caution and under the guidance of a neurologist, taking into account the individual patient's risk factors and disease history.