Dear Doctor Letter (Rote-Hand-Brief) on ▼Fingolimod (Gilenya®): new contraindication in pregnant women and in women of childbearing potential not using effective contraception
2019.09.02
Active substance: fingolimod
Novartis would like to inform you in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) of the new contraindication of fingolimod (Gilenya) in pregnant women and women of childbearing potential not using effective contraception due to the risk of congenital malformations in fetuse.
Post-marketing data suggest that infants born to mothers who have been exposed to fingolimod during pregnancy have a two-fold increased risk for congenital malformations compared with the rate observed in the general population (2-3 %; EUROCAT).
For women of childbearing potential, ensure before treatment initiation and during the treatment that the patient is informed on the risk of harmful effects to the fetus associated with fingolimod treatment, a negative pregnancy test result is available before any treatment initiation, effective contraception is used during treatment and for 2 months after treatment discontinuation and likewise fingolimod treatment is stopped 2 months before planning a pregnancy.
If a woman becomes pregnant during treatment, fingolimod must be discontinued, medical advice should be given to the patient regarding the risk of harmful effects to the fetus, the pregnancy should be closely monitored and ultrasonography examinations should be performed.
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