Results of a Yearly Surveillance Program for Evaluating Nescler Drug Safety Profile
In 2016–17 BioIntegrator conducted a big surveillance program to approve safety profile of domestic drug Nescler (INN Fingolimod) for Russian patients suffering remitting multiple sclerosis.
The program confirmed a favorable safety profile of Nescler that was comparable to the original product, Gilenia.
Results of the observational program were published in 2018 in the 1st issue of Volume 6 of Safety and Risk of Pharmacotherapy magazine of FSBI Scientific Centre for Expert Evaluation of Medicinal Products of Russian Ministry of Health. Authors of the “Safety of the Reproduced Fingolimod” article are employees of Scientific and Practical Center for Medical Technologies Clinical Research and Evaluation of City of Moscow’s Public Health Department — O. M. Koval, N. V. Hachanova, M. V. Zhuravleva, A.G. Fisun, M. V. Davydovskaya, and K. A. Kokushkin. The analysis included 94 patients from 8 Russian regions.
The details of the program are found on the website: http://www.risksafety.ru/jour/article/view/96
In accordance with the obtained results, initiation of Nescler therapy was not complicated with serious adverse events. Patients naive to the treatment of this drug showed a rapid decrease in lymphocyte level. However, patients did not show any significant lymphopenia during the year of treatment. Moreover, change in liver enzyme activity at the start of treatment was never a cause of the treatment withdrawal.