Everolimus has not been studied in patients with severe hepatic insufficiency. It is recommended to carefully monitor everolimus concentration in blood plasma in patients with impaired hepatic function.
All patients are advised to regularly monitor kidney function. An increase in serum creatinine concentration should consider correction mode immunosuppressive therapy, in particular to reduce the dose of cyclosporine. Caution must be exercised with concomitant use of other drugs with an adverse effect on renal function.
Sertikan should not be used in patients with rare parabolan steroid hereditary disorders associated with galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.
Pregnancy and lactation
Data on the use of Sertikana in pregnant women are missing. In experimental studies have shown the presence of toxic effects on fertility, including embryotoxicity and fetotoxicity. It is not known whether there is a potential risk to humans. Do not use Sertikan in pregnant women unless the expected benefit of therapy outweighs the potential risk to the fetus. Women of childbearing age should be advised to use effective contraception during treatment Sertikanom and for 8 weeks after the end of therapy. It is not known whether everolimus is excreted in breast milk in humans. Experimental studies have shown that everolimus and / or its metabolites are rapidly penetrated into the milk of lactating rats. Therefore, women receiving Sertikan should not breastfeed.
Use in children
Data on the use of Sertikana in children and adolescents is not enough to recommend the use of the drug in these patients. However, there are limited data in pediatrics at kidney transplantation.
DOSAGE AND ADMINISTRATION
The drug is taken orally.
As a rule, the recommended initial dose for patients with kidney and heart transplant is at 0.75 mg 2 times a day, the drug should start to apply as soon as possible after transplantation. The daily dose always divided into 2 admission; take medication or always with food or always without it. Sertikan received at the same time with cyclosporin in microemulsion form. It may require correction dosing regimen taking into account the achieved plasma concentrations, tolerability, individual response to treatment, changes in concomitant drug therapy and the clinical situation. Correction of dosage regimen can be carried out with 4-5 days intervals.
incidence of acute rejection confirmed by biopsy was higher in blacks compared with the others. According to available information Limited blacks may require a higher dose parabolan steroid to achieve the same effect as the other patients receiving the drug in doses recommended for adults. Currently available data on the efficacy and safety enough to provide specific recommendations for use of everolimus in blacks.
Elderly patients (> 65 years)
Clinical experience with Sertikana in patients aged> 65 years is limited. However, obvious differences pharmacokinetics of everolimus in patients aged> 65-70 years of age compared with younger adult patients were observed.
Patients with impaired renal function
In patients with impaired renal function dose adjustment is required.
Patients with impaired hepatic function
In patients with hepatic impairment should be carefully monitored basal concentration of everolimus whole blood. Patients with mild to moderate hepatic impairment .
Further dose titration is carried out based on therapeutic monitoring. In patients with severe hepatic insufficiency parabolan steroid Everolimus has not been studied.