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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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Woman pregnant_v1

As of September 25, 2021, 32 pregnancies were reported from Novartis safety database with siponimod

  • Maternal exposure to siponimod was reported in 21 women during pregnancy; 5 women had exposure before pregnancy
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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 siponimod4

 

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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 29, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209884s000lbl.pdf.
2. Siponimod Summary of Product Characteristics. Accessed June 29, 2021. https://www.ema.europa.eu/en/documents/product-information/mayzent-epar-product-information_en.pdf.
3. Data on File, cutoff date 28-May-2021, Novartis Pharma AG.
4. Data on File, PSUR, cutoff date 25-September-2021, 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.