Medicinal Products

Dear Healthcare Professional Letter about the haemophagocytic syndrome reported in patients treated with fingolimod (Gilenya)


Novartis Europharm Limited, the marketing authorisation holder for the medicinal product Gilenya 0.5 mg hard capsules (fingolimod), has in collaboration with the Agency for Medicinal Products and Medical Devices sent out a letter to healthcare professionals about the two reported fatal cases of haemophagocytic syndrome in patients with multiple sclerosis (MS) treated with fingolimod.


  • Two fatal cases of haemophagocytic syndrome (HPS), both in the context of an infection have been reported in patients treated with fingolimod 0.5 mg/day for 9 and 15 months, respectively.
  • An early diagnosis of HPS is important in order to improve the prognosis by early initiation of treatment of the HPS and/or the underlying condition, e.g. viral infection
  • Symptoms and signs often associated with HPS are:
    • fever, asthenia, hepato-splenomegaly and adenopathy which may be associated with more severe manifestations such as hepatic failure or respiratory distress
    • progressive cytopenia, markedly elevated serum ferritin levels, hypertriglyceridemia, hypofibrinogenemia, coagulopathy, hepatic cytolysis and hyponatremia.

Further information on haemophagocytic syndrome and the recommendations

The present letter aims to raise awareness of the healthcare professionals regarding the difficulty to diagnose HPS and the importance of an early diagnosis as there is a risk of a worse outcome when the diagnosis and thus the treatment are delayed.

HPS is a very rare and potentially life-threatening hyper-inflammatory syndrome, that has been described in association with infections (primary or reactivation of virus infections e.g. Epstein Barr Virus), malignancies (e.g. lymphoma), immune deficiency and a variety of autoimmune diseases (e.g. lupus).

The medicinal product Gilenya is a selective immunosuppressant and its effect on the immune system increases the risk of infections. Cases of severe infections have been reported during its use. The Summary of Product Characteristics (SmPC) of Gilenya has been updated to mention that fatal cases of HPS have been reported.

Here you may see the Dear Healthcare Professional Letter (in Croatian).

HALMED has not received any adverse reaction report regarding the haemophagocytic effect of infection associated with the use of the medicinal product Gilenya. HALMED will continue monitoring the safe use of Gilenya and will promptly inform the public about any new information.

We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.