Prophylaxis of transplant rejection in liver allograft recipients

Active Ingredient: Tacrolimus

Indication for Tacrolimus

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old)
Therapeutic intent: Preventive action

Prophylaxis of transplant rejection in liver allograft recipients.

For this indication, competent medicine agencies globally authorize below treatments:

0.05 mg/kg/day as a continuous 24-hour infusion

Route of admnistration

Intravenous

Defined daily dose

0.05 - 0.05 mg per kg of body weight

Dosage regimen

From 0.05 To 0.05 mg per kg of body weight once every day

Detailed description

An initial oral dose of 0.30 mg/kg/day should be administered in two divided doses (e.g. morning and evening). If the clinical condition of the patient prevents oral dosing, an initial intravenous dose of 0.05 mg/kg/day should be administered as a continuous 24-hour infusion.

Dosage considerations

The concentration of a solution for infusion should be within the range 0.004-0.100 mg/ml. The total volume of infusion during a 24-hour period should be in the range 20–500 ml.

The diluted solution should not be given as a bolus.

0.30 mg/kg/day in 2 divided doses daily

Route of admnistration

Oral

Defined daily dose

0.05 - 0.05 mg per kg of body weight

Dosage regimen

From 0.05 To 0.05 mg per kg of body weight once every day

Detailed description

An initial oral dose of 0.30 mg/kg/day should be administered in two divided doses (e.g. morning and evening). If the clinical condition of the patient prevents oral dosing, an initial intravenous dose of 0.05 mg/kg/day should be administered as a continuous 24-hour infusion.

Dose adjustment during post-transplant period in adults and children

Tacrolimus doses are usually reduced in the post-transplant period. It is possible in some cases to withdraw concomitant immunosuppressive therapy, leading to tacrolimus monotherapy. Post-transplant improvement in the condition of the patient may alter the pharmacokinetics of tacrolimus and may necessitate further dose adjustments.

Dosage considerations

The capsules should be swallowed with fluid (preferably water).

Capsules should generally be administered on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal, to achieve maximal absorption.

Active ingredient

Tacrolimus

Tacrolimus is a highly potent immunosuppressive agent. In particular, tacrolimus inhibits the formation of cytotoxic lymphocytes, which are mainly responsible for graft rejection. Tacrolimus suppresses T-cell activation and T-helper-cell dependent B-cell proliferation, as well as the formation of lymphokines (such as interleukins-2, -3, and γ-interferon) and the expression of the interleukin-2 receptor.

Read more about Tacrolimus

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