Gilenya Use In Pregnancy & Lactation

Women of childbearing potential / Contraception in females: Fingolimod is contraindicated in women of childbearing potential not using effective contraception (see Contraindications). Therefore, before initiation of treatment in women of childbearing potential, a negative pregnancy test result must be available and counselling should be provided regarding the serious risk to the foetus. Women of childbearing potential must use effective contraception during treatment and for 2 months after discontinuation of Gilenya, since fingolimod takes approximately 2 months to eliminate from the body after treatment discontinuation (see Precautions).
Specific measures are also included in the Physician Information Pack. These measures must be implemented before fingolimod is prescribed to female patients and during treatment.
When stopping fingolimod therapy for planning a pregnancy, the possible return of disease activity should be considered (see Precautions).
Pregnancy: Based on human experience, post-marketing data suggest that use of fingolimod is associated with a 2-fold increased risk of major congenital malformations when administered during pregnancy compared with the rate observed in the general population (2-3%; EUROCAT).
The following major malformations were most frequently reported: Congenital heart disease such as atrial and ventricular septal defects, tetralogy of Fallot; Renal abnormalities; Musculoskeletal abnormalities.
There are no data on the effects of fingolimod on labour and delivery.
Animal studies have shown reproductive toxicity including foetal loss and organ defects, notably persistent truncus arteriosus and ventricular septal defect (see Pharmacology: Toxicology: Preclinical safety data under Actions). Furthermore, the receptor affected by fingolimod (sphingosine 1-phosphate receptor) is known to be involved in vascular formation during embryogenesis.
Consequently, fingolimod is contraindicated during pregnancy (see Contraindications).
Fingolimod should be stopped 2 months before planning a pregnancy (see Precautions). If a woman becomes pregnant during treatment, fingolimod must be discontinued. Medical advice should be given regarding the risk of harmful effects to the foetus associated with treatment and ultrasonography examinations should be performed.
Breast-feeding: Fingolimod is excreted in milk of treated animals during lactation (see Pharmacology: Toxicology: Preclinical safety data under Actions). Due to the potential for serious adverse reactions to fingolimod in nursing infants, women receiving Gilenya should not breastfeed.
Fertility: Data from preclinical studies do not suggest that fingolimod would be associated with an increased risk of reduced fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).