GILENYA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and children 10 years of age and older.
This is the only FDA approved treatment for people with relapsing multiple sclerosis as young as 10.
The most common side effects with GILENYA were headache, abnormal liver tests, diarrhea, cough, flu, sinusitis, back pain, abdominal pain, and pain in arms or legs.
Serious side effects include Atrio ventricular block, increased risk of serious infections, some of which could be life threatening and cause death, progressive multifocal leukoencephalopathy, macular edema.
Recently, regulators from worldwide updated restrictions for Gilenya for use in pregnant women due to increased risk of congenital anomalies.
In July 2019 the European Medicines Agency (EMA) has recommended that “the multiple sclerosis medicine Gilenya (fingolimod) must not be used in pregnant women and in women able to have children who are not using effective contraception. This is because the active substance in Gilenya, fingolimod, can harm the unborn baby and may cause birth defects”
These recommendations follow a review triggered by reports suggesting that the risk of birth defects in infants who have been exposed to Gilenya during pregnancy is twice as high as the 2 to 3% risk observed in the general population. The most frequently reported birth defects in infants exposed to Gilenya were those affecting the heart, kidneys, bones and muscles.
In September 2019 the Medicines and Healthcare products Regulatory Agency (MHRA) issued this Drug Safety Update, “Fingolimod (Gilenya): increased risk of congenital malformations; new contraindication during pregnancy and in women of childbearing potential not using effective contraception”, which had this summary at the start: Fingolimod is associated with an increased risk of major congenital malformations including cardiac, renal, and musculoskeletal defects, when used in pregnancy. Women of childbearing potential must use effective contraception during fingolimod treatment and for 2 months after discontinuation.
In December 2019 Healthy Canada issued GILENYA (fingolimod) – Risk of Congenital Malformations which had this summary:
- 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.
In connection with those actions by European drug safety regulators, Novartis Pharmaceuticals UK Ltd. sent out a Direct Healthcare Professional Communication titled “Gilenya (fingolimod) – New contraindication in pregnant women and in women of childbearing potential not using effective contraception”.
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