Read more about the established safety and tolerability profile, including patient and physician assessments of long-term tolerability.
GILENYA®▼ (ﬁngolimod) has a consistent and well-understood safety and tolerability profile2,3,4–8
More than 96% of patients and physicians reported good/very good tolerability over 5 years2
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
99% of adult patients continue past the first dose on GILENYA9,10
Based on data from Limmroth V et al. 20169 and Hughes B et al. 2014.10
†Monitoring is conducted as a precautionary measure; first-dose effects are rare.
‡No patients required medication due to bradycardia.
§Three patients returned for extended observation on day 2.
¶Symptomatic events were typically mild or moderate in severity; all resolved spontaneously without intervention while continuing treatment with GILENYA.
Adverse events (AEs) reported with GILENYA in trials and post-marketing experience11
|Common:||Herpes viral infections
|Not known:||Progressive multifocal leukoencephalopathy (PML)**
|Common:||Basal cell carcinoma|
Squamous cell carcinoma****
|Very rare:||Kaposi’s sarcoma****|
|Not known:||Merkel cell carcinoma***|
|Not known:||Autoimmune haemolytic anaemia***
|Not known:||Hypersensitivity reactions, including rash, urticaria and angioedema upon treatment initiation***|
|Rare:||Posterior reversible encephalopathy syndrome (PRES)*|
|Not known:||Severe exacerbation of disease after GILENYA discontinuation***|
|Very rare:||T-wave inversion***|
|Very common:||Back pain|
|Very common:||Hepatic enzyme increased (increased ALT, GGT, AST)|
|Common:||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.
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.11
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; EPOC, Evaluate Patient OutComes; 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; START, STudy to vAlidate telemetRic ECG systems for firsT dose administration of fingolimod.
- Cohen JA et al. Poster P591 presented at the 31st Congress of the ECTRIMS, 7–10 October 2015, Barcelona, Spain.
- Ziemssen T et al. Poster P5.365 presented at the 70th AAN Meeting, 21–27 April 2018, Los Angeles, CA, USA.
- Ziemssen T et al. Poster P6.393 presented at the 70th AAN Meeting, 21–27 April 2018, Los Angeles, CA, USA.
- Chitnis T et al. N Engl J Med 2018;379(11):1017–1027.
- Novartis data on file created from PARADIGMS Clinical Study Report, 20 Jan, 2014.
- Novartis data on file.
- Kappos L et al. Mult Scler Relat Disord 2014;3:494–504.
- Kappos L et al. Neurology 2015;84:1–10.
- Limmroth V et al. Poster P12128 presented at the 2nd EAN Congress, 28–31 May 2016, Copenhagen, Denmark.
- Hughes B et al. Mult Scler Relat Disord 2014;3(5):620–628.
- GILENYA (fingolimod) Summary of Product Characteristics.