The need to supplement the instructions for the use of medicines containing tacrolimus the following information:
1. In the section "Pharmacotherapeutic group" the information should be stated in the following edition "immunosuppressive agent - calcineurin inhibitor".
2. Section "Side effect" is supplemented with the following information:
- subsection "Violations from the heart" supplement - "very rarely: lengthening the interval QT, disturbance of the rhythm of the heart such as "pirouette" (bi-directional spindle-shaped ventricular tachycardia) ";
- subsection "General disorders and disorders at the injection site" supplement "rarely: ulcer";
- subsection "Disturbances from the liver and bile ducts" to supplement "often: pathological changes in functional liver tests." 3. In the section "Interaction with other medicinal products"
subsection "Metabolic interactions" description of recommendations "... with concomitant administration with drugs capable of altering activity CYP3A4..." the following information: "Also follows monitor the interval QT (by electrocardiography), renal function and possible side effects. " 4. The section "Special instructions" should be supplemented with the following information:
- when describing the possibility of extending the interval QT "a pirouette (a bi-directional spindle-shaped ventricular tachycardia)", "Caution should be exercised in the treatment of patients with suspected or diagnosed congenital or acquired syndrome of an elongated interval QT, as well as patients receiving drugs that extend the interval QT, causing electrolyte disturbances or increasing the concentration (exposure) of tacrolimus in the blood. It should also pay attention to patients with risk factors for lengthening the interval QT, including patients with episodes of lengthening the interval QT in an individual or family anamnesis, congestive heart failure, bradyarrhythmias and electrolyte disturbances ";
- the section should be supplemented with the following information: "Perforation of the gastrointestinal tract was noted in patients receiving tacrolimus therapy, since perforation of the gastrointestinal tract is a medically significant event that can lead to a serious) or life-threatening condition, symptoms of perforation it is necessary to begin immediately medical measures ";
- when describing the possibility of development of PTLZ, indicate: "... antilymphocytic antibodies (for example, daclizumab, basiliximab)..."
- when describing the possibility of developing post-transplantation lymphoproliferative disease (PTLZ), "Children under 2 years old, as well as children with a negative test for the capsid antigen of the Epstein-Barr virus, are considered to be at high risk of developing PTLZ."