Prescribing information

 

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

GILENYA® (fingolimod) has a consistent and well-understood safety and tolerability profile

More than 96% of patients and physicians reported good/very good tolerability over 5 years2

Assessment of Gilenya tolerability

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

Very common: Influenza
Sinusitis
Common: Herpes viral infections
Bronchitis
Tinea versicolor
Uncommon: Pneumonia
Not known: Progressive multifocal leukoencephalopathy (PML)**
Cryptococcal infections**
Common: Basal cell carcinoma
Uncommon: Malignant melanoma****
Rare: Lymphoma***
Squamous cell carcinoma****
Very rare: Kaposi’s sarcoma****
Not known: Merkel cell carcinoma***
Common: Lymphopenia
Leucopenia
Uncommon: Thrombocytopenia
Not known: Autoimmune haemolytic anaemia***
Peripheral oedema***
Not known: Hypersensitivity reactions, including rash, urticaria and angioedema upon treatment initiation***
Common: Depression
Uncommon: Depressed mood
Very common: Headache
Common: Dizziness
Migraine
Uncommon: Seizure
Rare: Posterior reversible encephalopathy syndrome (PRES)*
Not known: Severe exacerbation of disease after GILENYA discontinuation***
Common: Vision blurred
Uncommon: Macular oedema
Common: Bradycardia
Atrioventricular block
Very rare: T-wave inversion***
Common: Hypertension
Very common: Cough
Common: Dyspnoea
Very common: Diarrhoea
Uncommon: Nausea***
Common: Eczema
Alopecia
Pruritus
Very common: Back pain
Common: Myalgia
Arthralgia
Very common: Hepatic enzyme increased (increased ALT, GGT, AST)
Common: Blood triglycerides increased
Weight decreased***
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.

References

  1. Cohen JA et al. Poster P591 presented at the 31st Congress of the ECTRIMS, 7–10 October 2015, Barcelona, Spain.
  2. Ziemssen T et al. Poster P5.365 presented at the 70th AAN Meeting, 21–27 April 2018, Los Angeles, CA, USA.
  3. Ziemssen T et al. Poster P6.393 presented at the 70th AAN Meeting, 21–27 April 2018, Los Angeles, CA, USA.
  4. Chitnis T et al. N Engl J Med 2018;379(11):1017–1027.
  5. Novartis data on file created from PARADIGMS Clinical Study Report, 20 Jan, 2014.
  6. Novartis data on file.
  7. Kappos L et al. Mult Scler Relat Disord 2014;3:494–504.
  8. Kappos L et al. Neurology 2015;84:1–10.
  9. Limmroth V et al. Poster P12128 presented at the 2nd EAN Congress, 28–31 May 2016, Copenhagen, Denmark.
  10. Hughes B et al. Mult Scler Relat Disord 2014;3(5):620–628.
  11. GILENYA (fingolimod) Summary of Product Characteristics.
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GIL19-C053c(1) November 2020.
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]