Health Canada: GILENYA (fingolimod) - Risk of Congenital Malformations

Health Canada is advising Canadians that there is a risk of congenital malformations in a fetus exposed to GILENYA. Available human data (post-marketing data and pregnancy registry information) suggest that the use of GILENYA is associated with an increased risk of overall major congenital malformation (approximately 5%) when administered during pregnancy in comparison with the prevalence observed in the general population (2-4%).

  • When used during pregnancy, GILENYA (fingolimod) has been associated with an increased risk of major congenital malformations, including congenital heart disease such as atrial septal defect, and renal and musculoskeletal abnormalities.
  • GILENYA is now contraindicated in women who are pregnant or in women of childbearing potential who are not using effective contraception.
  • Healthcare professionals should discuss the following with all female patients of reproductive potential (including female adolescents and their parent/guardian/caregiver) treated with, or to be treated with, GILENYA:
    - the risk of harmful effects associated with GILENYA to a fetus during pregnancy;
    - the need for a negative pregnancy test before starting treatment with GILENYA, which is then repeated at appropriate intervals during treatment;
    - the necessity to use effective contraception during therapy with GILENYA, and for 2 months after stopping GILENYA treatment; and
    - the need to discontinue GILENYA 2 months before planning a pregnancy.
  • The Canadian Product Monograph (CPM) for GILENYA has been updated to include this new contraindication and new safety information.
  • Health Canada will work with the manufacturers of generic versions of fingolimod to update their respective CPMs.

See full alert here.