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Medical information request
Medical information request


Reproductive toxicity

Based on animal studies, siponimod may cause fetal harm. Women of childbearing potential should use effective contraception to avoid pregnancy during and for 10 days after stopping siponimod treatment1,2


Non-US PRIM

About PRIM
If pregnancy test shows positive, please contact the registry 

 


For US Registry

About US Registry
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As of March 25, 2024, 47 pregnancies (34 prospectivea and 13 retrospectiveb) were reported from Novartis safety database with siponimod

aProspective cases are defined as cases for which, at the time of initial reporting (i.e., first receipt by Novartis), the pregnancy outcome has not yet occurred or there is no report of an abnormal prenatal testing result (including cases where prenatal testing has not yet been performed, or cases where prenatal testing has been performed but results were either normal or not specified

bRetrospective cases are defined as cases for which at the time of initial reporting (i.e., first receipt by Novartis), the pregnancy outcome has already occurred, or prenatal testing results were abnormal (regardless of whether the pregnancy outcome has occurred)

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No events of congenital malformation (including major and minor) and fetal or maternal complication related to pregnancy and delivery have been reported in pregnant women exposed to siponimod3

 

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Abbreviations
CSF, cerebrospinal fluid; EU, Europe; PRIM, Pregnancy outcome Intensive Monitoring; RoW, rest of the world; US, United Sates.
References
1. Siponimod® Prescribing Information, Accessed June 7, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209884s019lbl.pdf.
2. Siponimod Summary of Product Characteristics. Accessed June 7, 2024. https://www.ema.europa.eu/en/documents/product-information/mayzent-epar-product-information_en.pdf.
3. Data on File, PSUR, cutoff date 25-March-2024, Novartis Pharma AG.
* 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.