Prescribing information

 

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 experience.6

Infections and infestations
Very common: Influenza

Sinusitis
Common: Herpes viral infections

Bronchitis

Tinea versicolor
Uncommon: Pneumonia
Not known: Progressive multifocal leukoencephalopathy (PML)**

Cryptococcal infections**
Neoplasms benign, malignant and unspecified (incl. cysts and polyps)
Common: Basal cell carcinoma
Uncommon: Malignant melanoma****
Rare: Lymphoma***

Squamous cell carcinoma****
Very rare: Kaposi’s sarcoma****
Not known: Merkel cell carcinoma***
Blood and lymphatic system disorders
Common: Lymphopenia

Leucopenia
Uncommon: Thrombocytopenia
Rare: Autoimmune haemolytic anaemia***
Not known: Peripheral oedema***
Immune system disorders
Not known: Hypersensitivity reactions, including rash, urticaria and angioedema upon treatment initiation***
Psychiatric disorders
Common: Depression
Uncommon: Depressed mood
Nervous system disorders
Very common: Headache
Common: Dizziness

Migraine
Uncommon: Seizure
Rare: Posterior reversible encephalopathy syndrome (PRES)*
Not known: Severe exacerbation of disease after GILENYA discontinuation***
Eye disorders
Common: Vision blurred
Uncommon: Macular oedema
Cardiac disorders
Common: Bradycardia

Atrioventricular block
Very rare: T-wave inversion***
Vascular disorders
Common: Hypertension
Respiratory, thoracic and mediastinal disorders
Very common: Cough
Common: Dyspnoea
Gastrointestinal disorders
Very common: Diarrhoea
Uncommon: Nausea***
Skin and subcutaneous tissue disorders
Common: Eczema

Alopecia

Pruritus
Musculoskeletal and connective tissue disorders
Very common: Back pain
Common: Myalgia

Arthralgia
General disorders and administration site conditions
Common: Asthenia
Investigations
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.

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

References

  1. Derfuss T, et al. Poster P1215 presented at the 32nd Congress of the ECTRIMS, 14-17 September 2016, London, UK.
  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. GILENYA (fingolimod) Summary of Product Characteristics.

 

GIL19-C053a 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
If you have a question about the product, please contact Medical Information on 01276 692255 or by email at [email protected]