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Frequently asked questions

1. What are the objectives of the siponimod safety website?

Novartis is fully committed toward the transparent and timely communication of adverse events and safety information associated with the use of siponimod in patients with MS to 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, journal publications, and other communication platforms

2. How often is the website updated?

The website will be updated in alignment with the annual PSUR 

3. What are the limitations of the content of the website?

The safety website is not the primary source of in-depth efficacy and safety information for siponimod but provides a timely high-level overview of safety information to HCPs as new information becomes available. Owing to the inherent nature of the spontaneous and postmarketing 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 siponimod. The local prescribing information should be the primary source of product information for siponimod

4. Why is information on only selected data/topics available on the website?

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

5. How do I get additional information on the safety of siponimod?

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

6. Are there differences in the reported rates of adverse events between this site and those in the FAERS database?

This website includes postmarketing and clinical trial adverse event reports received by Novartis. Novartis continuously monitors the reporting of adverse events through a global pharmacovigilance system. Novartis carefully assesses and evaluates all adverse events received and then submits a report to the regulatory authorities per requirements

FAERS is a FDA adverse event reporting system. The FAERS database contains information on adverse events and medication error reports submitted to the FDA by HCPs, consumers, and manufacturers. It generally includes postmarketing reports. However, FAERS may also include clinical trial reports based on FDA-specific reporting requirements. Limitations to the data remain. For example:

  • FAERS contains reports on a particular drug or biologic. This does not mean that the drug or biologic caused the adverse event. Importantly, FAERS data by themselves are not indicators of the safety profile of the drug or biologic
  • The information collected by the FAERS database could be duplicate and is limited in scope/detail compared with Novartis’ pharmacovigilance procedures
  • The information in these reports cannot be used to estimate the incidence (occurrence rates) of the reactions reported

EudraVigilance is an EMA-operated, centralized European database of suspected adverse reactions to medicines authorized in the EEA. The reported cases in the database are suspected adverse events, ie, 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 or another MAH or regulatory authority but not directly by HCPs or consumers

7. What is Novartis safety database?

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, and protocol-triggered events of interest from clinical trials in accordance with international guidelines. The database captures adverse events reported to Novartis from HCPs, patients, or other sources.

8. What is siponimod, and what is its proposed mechanism of action in MS?

Siponimod is an S1P receptor modulator. Siponimod binds with high affinity to S1P receptors 1 and 5. Siponimod blocks the capacity of the lymphocytes to egress from the lymph nodes, reducing the number of lymphocytes in peripheral blood. The mechanism by which siponimod exerts therapeutic effects in MS is unknown but may involve the reduction of lymphocyte migration into the central nervous system.1 Additionally siponimod is able to enter effectively within the CNS, where reaching appropriate concentrations in the CNS allows for potential concomitant anti-inflammatory and promyelinating effects.2,3

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EEA, European Economic Area; FAERS, FDA Adverse Event Reporting System; HCPs, health care professionals; MAH, marketing authorization holder; MS, multiple sclerosis; PSUR, periodic safety update report; S1P, sphingosine1-phosphate
1. Behrangi N, et al. cells.2019;8(1):24.
2. Colombo E et al. Front Immunol 2020 11:635.
3. Kipp M Cells2020 Aug; 9(8): 1771.
* Indication varies in different countries. Current website is a global information resource. Local Prescribing Information/ Summary of Product Characteristics approved by individual country’s regulatory authority is the primary source of information for the indication of siponimod in the individual country.

The Pregnancy outcome Intensive Monitoring (PRIM) program is based on enhanced pharmacovigilance of the Novartis spontaneous reporting system. PRIM is an adverse event outcomes intensive monitoring program to collect information (targeted follow-up checklists) about pregnancy in patients exposed to siponimod immediately before or during pregnancy and infant outcomes 12 months after delivery.