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Medical information request
Medical information request

Reproductive toxicity

  • Due to risk to the fetus, fingolimod is contraindicated during pregnancy and in women of childbearing potential not using effective contraception. Before initiation of treatment, women of childbearing potential must be informed of this risk to the fetus, must have a negative pregnancy test and must use effective contraception during treatment and for two months after treatment discontinuation1,2
  • Prevalence of major congenital malformations (EUROCAT classification) in prospective pregnancies exposed to fingolimod is presented below
    • The prevalence of major malformations in the Safety database is higher than in EUROCAT with no overlap in confidence intervals3,4,5,6 
    • The prevalence of congenital heart defects in both the safety database and GPR is higher than in the EUROCAT general population
Reproductive toxicity_v3.jpg
Major congenital malformations: Any structural defect with surgical, medical, or cosmetic importance recognized) are presented as a proportion of fetal cases in live births, or in live births, stillbirths, and termination of pregnancy due to fetal anomaly
a The denominator is all prospective pregnancies with known outcome. The prevalence is calculated as the number of fetuses/infants with at least one major malformation per 100 fetuses/infants. If any infants had multiple  anomalies, only the worst anomaly was counted. 
 
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Abbreviations
CI, Confidence Interval; EUROCAT, European Registry of Congenital Anomalies and Twins; TOPFA, Termination of Pregnancy due to Fetal Anomaly
References
1. Gilenya US Prescribing Information. Accessed 28-Feb-2023. https://www.novartis.us/sites/www.novartis.us/files/gilenya.pdf
2. Gilenya Summary of Product Characteristics. Accessed 28-Feb-2023. https://www.ema.europa.eu/en/medicines/human/EPAR/gilenya
3. Lopez-Leon S, et al. J Neurol. 2020;267:2721-2731. 
4. Prevalence data tables. EUROCAT website. http://www.eurocatnetwork.eu/ACCESSPREVALENCEDATA/ PrevalenceTables. Accessed on 17-Nov-2023
5. Persson M, et al. BMIJ. 2017;357:j2563.
6. Data on File, PSUR 14, cutoff date 28 Feb 2023, Novartis Pharma AG.
7.  Thiel S et al, Multiple Sclerosis Journal 2016; 22(6) 801–809
8. Quelsser-Luft A et al Arch Gynecol Obstet 2002; 266:163–167
9. Garne E et al, Dan Med J 2014;61(6):A4825
* Indication wording varies in different countries. The 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 fingolimod in the individual country.