Gilenya® (fingolimod): New contraindication in pregnant women and in women of childbearing potential who are not using effective contraception

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In Malaysia, fingolimod is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients and in paediatric patients of 10 years old and above to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.

Based on European post-marketing surveillance of congenital anomalies, fingolimod has been associated with a two-fold increased risk of major congenital malformations when used during pregnancy as compared to the rate observed in the general population (2-3%).1 The most commonly reported major malformations are congenital heart diseases, renal and musculoskeletal abnormalities.

Due to this risk, fingolimod is now contraindicated in pregnant women and in women of childbearing potential who are not using effective contraception.

The prescribing information of Gilenya® will be updated to reflect this new contraindication. On 18th August 2020, NPRA has approved a Direct Healthcare Professional Communication (DHPC) letter issued by Novartis (Malaysia) Sdn. Bhd. to highlight this safety issue. For further information, please contact your local sales person for a copy of the DHPC.



  1. European Commission. European network of population-based registries for the epidemiological surveillance of congenital anomalies (EUROCAT). Available from:



This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, the NPRA shall not be held liable for any loss whatsoever arising from the use of or reliance on this publication.







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