Prophylaxis of transplant rejection in renal allograft recipients

Indication for Tacrolimus

Population group: Suitable for both men and women, only adults (18 years old or older)
Therapeutic intent: Preventive action

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

0.05-0.10 mg/kg/day as a continuous 24-hour infusion

Route of admnistration

Intravenous

Defined daily dose

0.05 - 0.1 mg per kg of body weight

Dosage regimen

From 0.05 To 0.1 mg per kg of body weight once every day

Detailed description

Oral tacrolimus therapy should commence at 0.20-0.30 mg/kg/day administered as two divided doses (e.g. morning and evening). Administration should commence within 24 hours after the completion of surgery.

If the dose cannot be administered orally as a result of the clinical condition of the patient, intravenous therapy of 0.05-0.10 mg/kg/day should be initiated 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.

0.2-0.3 mg/kg/day in 2 divided doses daily

Route of admnistration

Oral

Defined daily dose

0.2 - 0.3 mg per kg of body weight

Dosage regimen

From 0.1 To 0.15 mg per kg of body weight 2 time(s) per day every day

Detailed description

Oral tacrolimus therapy should commence at 0.20-0.30 mg/kg/day administered as two divided doses (e.g. morning and evening). Administration should commence within 24 hours after the completion of surgery.

If the dose cannot be administered orally as a result of the clinical condition of the patient, intravenous therapy of 0.05-0.10 mg/kg/day should be initiated 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-based dual-therapy. 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 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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