Novartis is fully committed to transparent and timely communication of adverse events and safety information associated with the use of fingolimod in patients with multiple sclerosis (MS) to health care professionals (HCPs). The primary objective of the safety website is to provide a digital resource that is easily accessible and has up-to-date and verified safety information for HCPs. Novartis will also continue to provide regular efficacy and safety updates through presentations at major congresses, in journal publications and other communication platforms

The website will be updated in alignment with the PSUR which is updated in every 2 years (except for COVID-19 and PML topics, which will be updated twice a year)

The safety website is not the primary source of in-depth efficacy and safety information for fingolimod but provides a high-level overview of safety information timely to HCPs as new information becomes available. Due to the inherent nature of spontaneous and post marketing reports, information may be incomplete and/or duplicated. Further, information is likely to change, considering the ongoing updates to information. The occurrence and report of an adverse event does not imply proven causality to fingolimod. The local prescribing information should be the primary source of product information used for fingolimod

The scope of this website is to provide up-to-date information on the safety of fingolimod. Based on the feedback from HCPs, Novartis experience with pharmacological profile of S1P modulators, and experience from Novartis Multiple Sclerosis franchise, Novartis decided to select key safety areas of interest in patients who received fingolimod for multiple sclerosis as the primary focus. Selection of these topics is not related to causation. Novartis is fully committed to transparent and timely communication of safety updates associated with fingolimod in the treatment of MS patients

The local label from your country is the primary source of information related to safety and associated risks of treatment with fingolimod in MS. For any additional questions on fingolimod, you may reach out to the appropriate Novartis Medical Information associate in your country

Novartis continuously monitors reporting of adverse events through a global pharmacovigilance system. Novartis carefully assesses and evaluates all adverse events received and then submits a report to regulatory authorities as per requirements

The FAERS database contains information on adverse events and medication error reports submitted to the FDA by HCPs, consumers, and manufacturers. It also includes case reports from other indications outside of MS. However, the information collected by the FAERS database is limited in scope/detail compared to Novartis pharmacovigilance procedures. This restricts the ability to rigorously evaluate an event and verify the causality of the event. Furthermore, duplicate reports can be submitted to the FAERS system, for example by both the sponsor and consumer. Therefore, FAERS data cannot be used to calculate the incidence of an adverse event, and rates of adverse events reported via the two systems can be expected to be different

EudraVigilance is an EMA-operated, centralised European database of suspected adverse reactions to medicines authorised in the European Economic Area (EEA). The reported cases in the database are suspected adverse events, i.e. medical events that have been observed following the use of a medicine, but which are not necessarily related to or caused by the medicine. The reported cases are by Novartis, another MAH or Regulatory Authority, but not directly by HCPs or consumers

The Novartis safety database is a system to collect, code, assess, and report adverse events to health authorities from 

• The postmarketing setting (ie, spontaneously reported to Novartis, from a postmarketing surveillance program or cases identified in the published literature)
• Serious adverse events
• Protocol-triggered events of interest from clinical trials in accordance with international guidelines 

The database captures adverse events reported to Novartis from health care professionals (HCPs), patients, or other sources

Fingolimod is a sphingosine1-phosphate receptor modulator. Fingolimod binds to four of the five S1P receptors. The functional antagonism of lymphocytic S1P1 slows S1P-driven egress of lymphocytes from lymph nodes, thereby reducing the numbers of autoaggressive TH17 cells that recirculate via lymph and blood to the central nervous system. The mechanism by which fingolimod exerts therapeutic effects in multiple sclerosis is unknown, but may involve reduction of lymphocyte migration into the central nervous system¹