In the course of preparation of requirements to safety, efficiency of medicines based on modern scientifically grounded information about the experience of clinical use of medicinal products containing phingolimod, it was found necessary to supplement the sections "Special instructions" and "Side effects" of the instructions for use.
We consider it advisable to include information on the risk of developing progressive multifocal encephalopathy in the instructions for the use of phylogenide medications, including the procedure for monitoring patients with a high risk of developing progressive multifocal encephalopathy; on the inversion of the T wave on the electrocardiogram (ECG) in accordance with the current information about the experience of the clinical application of phylogolimide and the information contained in the instruction for the use of the innovator drug approved in the countries of the European Union.
Relevant information is recommended to be submitted in the following edition:
1. in the section "Side effect":
"In the post-marketing period, cases of development of opportunistic infections caused by viruses (varicella Zoster virus, JC-Virus, leading to progressive multifocal leukoencephalopathy, herpes simplex virus), pathogenic fungi (cryptococci, including cryptococcal meningitis) and bacteria (atypical mycobacteria). 2. in the section "Special instructions":
"In the post-marketing period, cases of development of progressive multifocal leukoencephalopathy (PML) are noted.PML is an opportunistic infectious disease caused by JCvirus, with a possible fatal outcome or development of severe disability. Development of PML is possible only with concomitant infection JCvirus. When analyzing the JC- the virus should take into account that the effect of lymphopenia on the correctness of the test results for the presence of antibodies to JC-virus in patients treated with phylogolimide, was not studied. It was also noted that a negative result of the analysis for the presence of the virus does not exclude the possibility of subsequent infection. Before appointment финголимода it is necessary to receive information about the results of magnetic resonance imaging for the previous 3 months. For routine MRI studies, the frequency of which is determined by the standards for the diagnosis and control of multiple sclerosis, care should be taken with regard to data that can be suspected PML. Thus, magnetic resonance therapy is considered to be a priority method for diagnosing patients with a high risk of developing PML.If a PML is suspected, magnetic resonance imaging should be performed immediately and the drug should be stopped until the diagnosis of PML is excluded. " "Patients who received phingolimod, very rare cases of inversion of the T wave on the ECG have been recorded. In case of inversion of the T wave, it is necessary to exclude the presence of other signs of myocardial ischemia in the patient. If suspected of myocardial ischemia, it is recommended to seek advice from a cardiologist. "