safetyriskБезопасность и риск фармакотерапииSafety and Risk of Pharmacotherapy2312-78212619-1164Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)safetyrisk-41Research ArticleОБЗОРЫ И ОРИГИНАЛЬНЫЕ СТАТЬИREVIEWS AND ORIGINAL ARTICLESО взаимозаменяемости ингибиторов кальциневринаOn the interchangeability of calcineurine inhibitorsЗатолочинаК. Э.ZatolochinaK. E.noemail@neicon.ruАляутдинР. Н.AlyautdinR. N.noemail@neicon.ruЖуравлеваЕ. О.ZhuravlevaE. O.noemail@neicon.ruПастернакЕ. Ю.PasternakE. Yu.noemail@neicon.ruДармостуковаМ. А.DarmostukovaM. A.noemail@neicon.ruКолесниковаЕ. Ю.KolesnikovaE. Yu.noemail@neicon.ruРомановБ. К.RomanovB. K.noemail@neicon.ruРоссийский университет дружбы народовРоссияPeoples’ Friendship University of RussiaRussian FederationНаучный центр экспертизы средств медицинского примененияРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation20162002201802510Copyright © Затолочина К.Э., Аляутдин Р.Н., Журавлева Е.О., Пастернак Е.Ю., Дармостукова М.А., Колесникова Е.Ю., Романов Б.К., 20182018Затолочина К.Э., Аляутдин Р.Н., Журавлева Е.О., Пастернак Е.Ю., Дармостукова М.А., Колесникова Е.Ю., Романов Б.К.Zatolochina K.E., Alyautdin R.N., Zhuravleva E.O., Pasternak E.Y., Darmostukova M.A., Kolesnikova E.Y., Romanov B.K.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.risksafety.ru/jour/article/view/41

Ингибиторы кальциневрина, циклоспорин и такролимус, являются основными иммуносупрессорами при трансплантации органов, однако особенности их фармакокинетики позволяют отнести их к группе средств с узким терапевтическим диапазоном. В России используются более 10 воспроизведенных препаратов циклоспорина и такролимуса. В обзоре обсуждены проблемы взаимозаменяемости оригинальных и воспроизведенных препаратов этих иммуносупрессоров. Рассмотрены фармакокинетические и технологические факторы, влияющие на биоэквивалентность ингибиторов кальциневрина. Представлены результаты исследований взаимозаменяемости этих препаратов в развитых странах.

Calcineurin inhibitors, cyclosporine and tacrolimus, are the main immunosuppressants used in solid organ transplantation, but the peculiarities of their pharmacokinetics allow to classify them to a group of medicines with a narrow therapeutic range. Currently in Russia more than 10 generic drugs of cyclosporine and tacrolimus are used. In this review the problem of interchangeability of cyclosporine and tacrolimus is discussed. The pharmacokinetic and technological factors that affect the bioequivalence of calcineurin inhibitors are presented.

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The authors declare that there are no conflicts of interest present.