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
(n=107) n (%)
IFN β-1a IM
(n=107) n (%)
|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
- 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.
- Ziemssen T, et al. Poster P5.365 presented at the 70th AAN Meeting, 21-27 April 2018, Los Angeles, CA, USA.
- Kappos L, et al. Neurology 2015; 84: 1-10.
- Kappos L, et al. Mult Scler Relat Disord 2014; 3: 494-504.
- Cohen JA, et al. J Neurol Neurosurg Psychiatry 2016; 87(5): 468-475.
- Chitnis T, et al. N Engl J Med 2018; 379(11): 1017-1027.
- GILENYA (fingolimod) Summary of Product Characteristics.