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olimus therapy) or alternatively in clinically stable patients without antibody induction.Following antibody induction, oral Tacrolimus therapy should commence at a dose of 0.075 mg/kg/day administered as two divided doses (e.g. morning and evening). Administration should commence within 5 days after the completion of surgery as soon as the patient's clinical condition is stabilised. If the dose cannot be administered orally as a result of the clinical condition of the patient, intravenous therapy of 0.01 to 0.02 mg/kg/day should be initiated as a continuous 24 hour infusion.An alternative strategy was published where oral tacrolimus was administered within 12 hours post transplantation. This approach was reserved for patients without organ dysfunction (e.g. renal dysfunction). In that case, an initial oral tacrolimus dose of 2 to 4 mg per day was used in combination with mycophenolate mofetil and corticosteroids or in combination with sirolimus and corticosteroids.Prophylaxis of transplant rejection – childrenTacrolimus has been used with or without antibody induction in paediatric heart transplantation.In patients without antibody induction, if tacrolimus therapy is initiated intravenously, the recommended starting dose is 0.03-0.05 mg/kg/day as a continuous 24-hour infusion targeted to achieve tacrolimus whole blood concentrations of 15-25 ng/ml. Patients should be converted to oral therapy as soon as clinically practicable. The first dose of oral therapy should be 0.30 mg/kg/day starting 8 to 12 hours after discontinuing intravenous therapy.Following antibody induction, if tacrolimus therapy is initiated orally, the recommended starting dose is 0.10-0.30 mg/kg/day administered as two divided doses (e.g. morning and evening).Dose adjustment during post-transplant period in adults and childrenTacrolimus doses are usually reduced in the post-transplant period. Post-transplant improvement in the condition of the patient may alter the pharmacokinetics of tacrolimus and may necessitate further dose adjustments.Rejection therapy – adults and childrenIncreased tacrolimus doses, supplemental corticosteroid therapy, and introduction of short courses of mono-/polyclonal antibodies have all been used to manage rejection episodes.In adult patients converted to tacrolimus , an initial oral dose of 0.15 mg/kg/day should be administered in two divided doses (e.g. morning and evening).In paediatric patients converted to tacrolimus , an initial oral dose of 0.20-0.30 mg/kg/day should be administered in two divided doses (e.g. morning and evening).For information on conversion from ciclosporin to tacrolimus , see below under “Dose adjustments in specific patient populations”.Dosage recommendations - Rejection therapy, other allograftsThe dose recommendations for lung, pancreas and intestinal transplantation are based on limited prospective clinical trial data. In lung-transplanted patients tacrolimus has been used at an initial oral dose of 0.10-0.15 mg/kg/day, in pancreas-transplanted patients at an initial oral dose of 0.2 mg/kg/day and in intestinal transplantation at an initial oral dose of 0.3 mg/kg/day.Dosage adjustments in specific patient populationsPatients with liver impairmentDose reduction may be necessary in patients with severe liver impairment in order to maintain the blood trough levels within the recommended target range.Patients with kidney impairmentAs the pharmacokinetics of |
