Prescribing information


Explore the extensive body of real-world evidence with GILENYA®▼ (fingolimod) treatment.

PANGAEA: Post-Authorization Non-interventional German safety study of GILENYA in RRMS patients. PANGAEA is a German registry study that enrolled 4,229 adult patients with RRMS from 374 centres. As of January 2018, 729 patients had completed the 5-year documentation period of GILENYA treatment, including 417 of the 1,936 patients who were previously on interferons.8

PASSAGE: World-wide post-approval safety programme to assess the long-term safety of GILENYA in a real-world clinical setting. It comprises two ongoing parallel-cohort studies, predominantly in the USA (PASSAGE USA) and in Europe (PASSAGE EU). PASSAGE plans to recruit up to 5,000 GILENYA-treated patients and 2,500 patients treated with other DMTs, and is expected to be completed by 2020.9

Indication: GILENYA is indicated as a single disease modifying therapy in highly active RRMS for the following groups of adult patients and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with ≥1 disease modifying therapy, or patients with RES RRMS defined by ≥2 disabling relapses in 1 year, and with 1 or more Gd+ lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.10

ARR, annualised relapse rate; DMF, dimethyl fumarate; DMT, disease modifying therapy; EDSS, expanded disability status scale; Gd+, gadolinium-enhancing; MRI, magnetic resonance imaging; RES, rapidly evolving severe; RRMS, relapsing-remitting multiple sclerosis.


  1. Cohen JA et al. Poster P591 presented at the 31st Congress of the ECTRIMS, 7–10 October 2015, Barcelona, Spain.

  2. Ziemssen T, et al. Poster P5.365 presented at the 69th AAN Meeting, 22–28 April 2017, Boston, MA, USA.

  3. Kappos L, et al. Neurology 2015;84:1–10.

  4. Kappos L, et al. Mult Scler Relat Disord 2014;3:494–504.

  5. Cohen JA, et al. J Neurol Neurosurg Psychiatry 2016;87(5):468–475.

  6. Ziemssen T et al. Poster P6.345 presented at the 69th AAN Meeting, 22–28 April 2018, Boston, MA, USA.

  7. Cohen JA et al. Ther Adv Neurol Disord 2019:12:1–16.

  8. Ziemssen T et al. Poster P6.393 presented at the 70th AAN Meeting, 21–27 April 2018, Los Angeles, CA, USA.

  9. Ziemssen T et al. Poster P790 presented at the 7th joint ECTRIMS-ACTRIMS meeting, 25–28 October 2017, Paris, France.

  10. GILENYA (fingolimod) Summary of Product Characteristics.

  11. Novartis data on file.

  12. Schulze-Topphoff U et al. Poster EP1648 presented at the 34th ECTRIMS Congress, 10–12 October 2018, Berlin, Germany.

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UK | December 2020 | 102204

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