Prescribing information

 

Safety outcomes with GILENYA in real-world clinical practice

GILENYA has a well-established safety profile2-5

Long-term and real-world evidence in adults with RRMS has reported similar adverse event rates to pivotal trials.2-5

GILENYA is well tolerated2

More than 96% of patients and physicians reported good/very good tolerability over 5 years in the real-world PANGAEA study in adults.2

Bar chart showing the proportion of patients and physicians rating the tolerability of Gilenya as good or very good over 5 years in the PANGAEA study

Figure adapted from Ziemssen T, et al. 2017.2

Poster presented at AAN 2017. Data from PANGAEA, a real-world non-interventional study. A total of 4,052 adult patients documented up to 60 months at 342 sites were included in this analysis.2

GILENYA is well tolerated after first-dose administration6,7

Monitoring is conducted as a precautionary measure; first-dose effects are rare.6,7

99% of adult patients continue past the first dose on GILENYA.6,7

Bar charts showing safety with Gilenya on first-dose administration in the START and EPOC trials. Bar chart showing the proportion of patients who had symptomatic bradycardia or were discharged within 8 hours in the START trial. Bar chart showing the proportion of patients who had symptomatic bradycardia or were discharged within 6 hours in the EPOC trial.

Based on data from Limmroth V, et al. 20166 and Hughes B, et al. 2014.7

‡No patients required medication due to bradycardia.

¶Symptomatic events were typically mild or moderate in severity; all resolved spontaneously without intervention while continuing treatment with GILENYA.

§Three patients returned for extended observation on day 2.

EPOC, Evaluate Patient OutComes; Gd+: gadolinium enhancing; MRI: magnetic resonance imaging; RES: rapidly evolving severe; RRMS: relapsing remitting multiple sclerosis; START, STudy to vAlidate telemetRic ECG systems for firsT dose administration of fingolimod.

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.3 As of January 2018, a total of 726 patients had completed the 5-year documentation period of GILENYA treatment, including 417 of the 1,936 patients who were previously on interferons 1

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.8

References

  1. Ziemssen T, et al. Poster P6.393 presented at the 70th AAN Meeting, 21-27 April 2018, Los Angeles, CA, USA.
  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. Limmroth V, et al. Poster P12128 presented at the 2nd EAN Congress, 28-31 May 2016, Copenhagen, Denmark.
  7. Hughes B, et al. Mult Scler Relat Disord 2014; 3(5): 620-628.
  8. GILENYA (fingolimod) Summary of Product Characteristics.
GIL19-C053b March 2020.
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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the patient safety information (PSI) tool at https://psi.novartis.com
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