Women of childbearing potential must use effective contraception during treatment and for 2 months after discontinuation of treatment; since it takes approx. 2 months to eliminate fingolimod from the body after treatment discontinuation.
SPC also updated to that in the post-marketing setting, severe exacerbation of disease has been observed rarely in some patients stopping fingolimod. This has generally been observed within 12 weeks after stopping fingolimod, but has also been reported up to 24 weeks after fingolimod discontinuation. Caution is therefore indicated when stopping fingolimod therapy. If discontinuation of fingolimod is deemed necessary, possibility of recurrence of exceptionally high disease activity should be considered and patients should be monitored for relevant signs and symptoms and appropriate treatment initiated as required.
The MHRA has issued a warning and advice relating to this.