Prescribing information

 

Safety outcomes with GILENYA in patients with RRMS aged 10–17 years.

GILENYA has a well-established safety profile2-5

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

Safety of GILENYA in children is consistent with that seen in adults.6

AEs occurring in ≥10% of patients in either treatment arm6

  GILENYA

(n=107) n (%)
IFN β-1a IM

(n=107) n (%)
All events
Any AEs* 95 (88.8) 102 (95.3)
AE leading to interruption of study drug 12 (11.2) 3 (2.8)
AE leading to discontinuation of study drug 5 (4.7) 3 (2.8)
Any serious AE 18 (16.8) 7 (6.5)
Frequent AEs, by preferred term (>10% of patients in either treatment arm)
Headache 34 (31.8) 32 (29.9)
Viral URTI 23 (21.5) 26 (24.3)
URTI 17 (15.9) 5 (4.7)
Leucopenia 15 (14.0) 3 (2.8)
Influenza 12 (11.2) 4 (3.7)
Influenza-like illness 5 (4.7) 40 (37.4)
Cough 10 (9.3) 12 (11.2)
Chills 1 (0.9) 11 (10.3)
Pyrexia 8 (7.5) 22 (20.6)

 

Adapted from Chitnis T, et al. 2018.6

*Does not include MS relapses reported as AEs.

AE: adverse event; Gd+: gadolinium enhancing; IM: intramuscularly; MRI: magnetic resonance imaging; RES: rapidly evolving severe; RRMS: relapsing remitting multiple sclerosis; URTI: upper respiratory tract infection.

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.7

References

  1. Novartis press release, September 12, 2018. Available at: https://www.novartis.com/news/media-releases/novartis-announces-nejm-publication-landmark-paradigms-study-demonstrating-significant-benefit-gilenya-children-and-adolescents-ms. Last accessed August 2019.
  2. Ziemssen T, et al. Poster P5.365 presented at the 70th AAN Meeting, 21-27 April 2018, Los Angeles, CA, 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. Chitnis T, et al. N Engl J Med 2018; 379(11): 1017-1027.
  7. GILENYA (fingolimod) Summary of Product Characteristics.
GIL19-C053c 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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