Long-term safety profile for GILENYA from clinical trials and post-marketing experience.
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
Adverse events (AEs) reported with GILENYA in trials and post-marketing experience6
|Infections and infestations|
Herpes viral infections
Progressive multifocal leukoencephalopathy (PML)**
|Neoplasms benign, malignant and unspecified (incl. cysts and polyps)|
|Common:||Basal cell carcinoma|
Squamous cell carcinoma****
|Very rare:||Kaposi’s sarcoma****|
|Not known:||Merkel cell carcinoma***|
|Blood and lymphatic system disorders|
|Rare:||Autoimmune haemolytic anaemia***|
|Not known:||Peripheral oedema***|
|Immune system disorders|
|Not known:||Hypersensitivity reactions, including rash, urticaria and angioedema upon treatment initiation***|
|Nervous Sytem disorders|
|Rare:||Posterior reversible encephalopathy syndrone (PRES)*|
|Not known:||Severe exacerbation of disease after GILENYA discontinuation***|
|Very rare:||T-wave inversion***|
|Respiratory, thoracic and mediastinal disorders|
|Skin and subcutaneous tissue disorders|
|Musculoskeletal and connective tissue disorders|
|Very common:||Back pain|
|General disorders and administration site conditions|
|Very common:||Hepatic enzyme increased (increased ALT, GGT, AST)|
Blood triglycerides increased
|Uncommon:||Neutrophil count decreased|
Frequencies defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
* Not reported in Studies FREEDOMS, FREEDOMS II and TRANSFORMS. The frequency category was based on an estimated exposure of approximately 10,000 patients to GILENYA in all clinical trials.
** PML and cryptococcal infections (including cases of cryptococcal meningitis) have been reported in the post-marketing setting.
*** Adverse drug reactions from spontaneous reports and literature.
**** The frequency category and risk assessment were based on an estimated exposure of more than 24,000 patients to GILENYA 0.5 mg in all clinical trials.
AE: adverse event; ALT: alanine aminotransferase; AST: aspartate aminotransferase; Gd+: gadolinium enhancing; GGT: gamma glutamyltransferase; MRI: magnetic resonance imaging; PML: Progressive multifocal leukoencephalopathy; PRES: posterior reversible encephalopathy syndrome; RES: rapidly evolving severe; RRMS: relapsing remitting multiple sclerosis.
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.6
- 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.
- GILENYA (ﬁngolimod) Summary of Product Characteristics.