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.

The typical pharmacovigilance system master file (PSMF) is presented. MPSF was created on the basis of the Rules of good pharmacovigilance practice for the members of Eurasian economic Union countries. Possible ways of the description of the pharmacovigilance system, all the possible types of MPSP and constituent standard operating procedures are considered. Practical recommendations on preparation and using of MFSF are given.

One of the main causes of death and disability in the world are the thrombotic complications. Using of anticoagulants is the effective method of preventing of these life-threatening conditions. However, the use of anticoagulants involves a significant risk of the bleeding. Safety of anticoagulants predominately are determined by the availability of specific antidotes. Until now new oral directly acting anticoagulants do not have any specific antagonists. Idarutsizumab is the dagibatran-specific antagonist which increases its safety.

SGLT2 inhibitors form a new class of hypoglycemic drugs. Despite of the pharmacodynamic profile, at the moment the opinion about their safety is controversial. This is due to increased number of reports given by FDA and EMA on the risk of serious adverse reactions - ketoacidosis, which is not specified in the instruction as a possible adverse effects. Ketatsidosis in patients with type 2 diabetes on therapy with SGLT2 inhibitors was appeared at moderately elevated glucose levels (200 mg/dL/11.1 mmol/L). The article deals with reports of ketoacidosis, caused by inhibition of SGLT2 and describes the alleged internal pathophysiological mechanisms associated with its development.