Direct healthcare professional communication on the risks related to the effects of fingolimod (Gilenya) on the immune system


Novartis Hrvatska d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) and the European Medicines Agency (EMA), has informed healthcare professionals of recent product information changes in relation to the immunosuppressive effects of fingolimod (Gilenya) and of some important recommendations for use of this medicinal product.

The adverse effects listed below have been reported in patients receiving fingolimod.

  • Basal cell carcinoma
    • Medical evaluation of the skin before treatment initiation and during treatment is recommended.
  • Progressive multifocal leukoencephalopathy (PML):
    • Physicians should be alert to the risk of PML. They should inform patients and carers of early symptoms suggestive of PML and instruct them to seek medical advice if such symptoms occur.
    • Before initiating treatment with fingolimod, a baseline MRI should be available (usually within 3 months) as a reference.
    • During routine MRI, physicians should pay close attention to lesions suggestive of PML.
    • If PML is suspected MRI should be performed immediately for diagnostic purposes and treatment with fingolimod should be suspended until PML has been excluded.
  • Other infections with opportunistic pathogens, including infections of the central nervous system - in the event of infection:
    • Initiation of treatment should be delayed in patients with severe active infection until resolution.
    • Suspension of treatment should be considered if a patient develops a serious infection, and benefit/risk should be carefully considered prior to re-initiation of therapy.
  • Complete blood count (CBC) should be monitored in accordance with requirements specified in the Summary of Product Characteristics.

Further information
Fingolimod is licensed for use as disease-modifying monotherapy in highly active relapsing remitting multiple sclerosis.

Due to its immunosuppressive effects, fingolimod may predispose to serious adverse reactions. As soon as possible, the data on the specified adverse reactions will be included in the product information (Summary of Product Characteristics and Package Leaflet), which will be available in the Medicinal Products Database at the HALMED portal. The letter provides healthcare professionals with information on important new recommendations for use of fingolimod and provides additional information regarding this safety concern.

Here you may view the direct healthcare professional communication.

The healthcare professionals are being reminded that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED. HALMED recommends the patients to contact their doctor or pharmacist regarding any adverse reaction they notice.