Tacrograf Dosage/Direction for Use

Recommended Doses: General dosing considerations: Because of inter-subject variability in tacrolimus pharmacokinetics, individualization of dosing regimen is necessary for optimal therapy. Frequent monitoring of tacrolimus trough concentrations is recommended in the early transplant period to ensure adequate drug exposure. (See Therapeutic drug monitoring as follows).
Tacrolimus extended release (ER) is not interchangeable or substitutable with Tacrograf.
Adult: Organ transplant: Initial dosage: Kidney transplant: 0.2 mg/kg/day in combination with azathioprine or 0.1 mg/kg/day in combination with mycophenolate mofetil and interleukin-2 receptor antagonist. Administer in 2 divided doses given every 12 hours.
Initial dose may be administered within 24 hours of transplantation but should be delayed until renal function has recovered.
Liver transplant: 0.1-0.15 mg/kg/day in 2 divided doses every 12 hours. The initial dose should be administered no sooner than 6 hours after transplantation.
Dosage titration: Titrate dose based on clinical assessments of rejection and tolerability. Reduce dose if nephrotoxicity develops.
Maintenance dosage: Lower dosages than the recommended initial dosage may be sufficient as maintenance therapy.
Concomitant therapy: Adjunct therapy with adrenal corticosteroids is recommended early post-transplant. In kidney transplant recipients, it is recommended that Tacrograf also be used in conjunction with azathioprine or mycophenolate mofetil.
Lupus nephritis: For adults, usually, a dose of 3 mg as tacrolimus is orally administered, once daily after supper.
In order to avoid development of adverse reactions in patients with lupus nephritis, it is recommended that the blood levels be monitored monthly for 3 months after the start of tacrolimus therapy; thereafter, the blood levels approximately 12 hours after the administration should be monitored periodically, and the dosage should be adjusted. If this product does not improve the clinical signs of nephritis, such as urine protein excretion, or the immunological finding after continuous treatment for 2 months, the treatment with this product should be discontinued, or the patients should be switched to another product. If the treatment with this product is sufficiently effective, it is recommended that the dose should be reduced to the lowest level possible that will still allow the effect to be maintained.
Pediatric: Organ transplant: Initial dosage: Liver transplant: 0.15 to 0.2 mg/kg/day in 2 divided doses every 12 hours. The initial dose should be administered no sooner than 6 hours after transplantation.
Special populations: Renal function impairment: Give consideration to dosing Tacrograf at the lower end of the therapeutic dosing range in patients who have received a liver transplant and have pre-existing renal impairment. Further reductions in dose below the targeted range may be required.
In kidney transplant patients with post-operative oliguria, the initial dose of Tacrograf should be administered no sooner than 6 hours and within 24 hours, but may be delayed until renal function shows evidence of recovery.
Hepatic function impairment: Patients with severe hepatic impairment (Child-Pugh score of 10 or more) may require lower doses. Close monitoring of blood concentrations is warranted.
The use of Tacrograf in liver transplant recipients experiencing post-transplant hepatic impairment may be associated with increased risk of developing renal insufficiency related to high whole blood concentrations of tacrolimus. Monitor these patients closely and consider dosage adjustments. Some evidence suggests that lower doses should be used in these patients.
Special risk patients: Black patients: Black kidney transplant patients may require higher doses of tacrolimus to attain comparable trough concentrations. (See also Therapeutic drug monitoring as follows).
Conversion: Conversion from another immunosuppressive therapy: Tacrograf should not be used simultaneously with cyclosporine. Tacrograf or cyclosporine should be discontinued at least 24 hours before initiating the other. In the presence of elevated tacrolimus or cyclosporine concentrations, dosing with the other drug usually should be further delayed.
Use with sirolimus is not recommended in liver transplant. The safety and efficacy of tacrolimus with sirolimus have not been established in kidney transplant.
Therapeutic drug monitoring: The relative risks of toxicity and efficacy failure are related to tacrolimus whole blood trough concentrations; therefore, monitoring of whole blood trough concentrations is recommended to assist in the clinical evaluation of toxicity and efficacy failure. (See Tables 1 and 2.)

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Mode of Administration: Administer Tacrograf consistently with or without food.