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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


For EU and RoW PRIM

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

 


For US Registry

About US Registry
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Woman pregnant

As of 25-September-2020, 15 pregnancies were reported from clinical trials2 and none from postmarketing setting3

  • Maternal exposure to siponimod during pregnancy was reported in 10 women and 5 women had maternal exposure before pregnancy
Baby_v8

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

 

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Abbreviations
EU, Europe; PRIM, PRegnancy outcome Intensive Monitoring; RoW, rest of the world; US, United Sates
References
1. Siponimod® Prescribing Information, Accessed December 21, 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209884s000lbl.pdf.
2. Data on File, cutoff date 6-Apr-2020, Novartis Pharma AG.
3. Data on File, PSUR 2, cutoff date 25-Sep-2020, Novartis Pharma AG.

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.