Prograf Dosage/Direction for Use



Astellas Pharma


Full Prescribing Info
Dosage/Direction for Use
Prograf therapy requires careful monitoring by adequately qualified and equipped personnel. The medicinal product should only be prescribed, and changes in immunosuppressive therapy initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients. For patients with lupus nephritis, this product should be prescribed by physicians experienced in lupus nephritis therapy.
The dosage recommendations given as follows for oral and intravenous administration are intended to act as a guideline. Prograf doses should be adjusted according to individual patient requirements.
Dosing should commence orally, if necessary via an intranasal gastric tube. If the clinical condition of the patient does not allow oral therapy, initial intravenous dosing may be necessary.
Dosage Level Recommendations: Initial dose level recommendation.
Primary Immunosuppression Dose Levels - Adults: Liver and kidney transplantation: Oral tacrolimus therapy should commence at 0.10 - 0.20 mg/kg/day for liver transplantation and at 0.15 - 0.30 mg/kg/day for kidney transplantation administered as two divided doses. Administration should start approximately 6 hours after the completion of liver transplant surgery and within 24 hours of kidney transplant surgery.
If clinical condition of the patient does not allow oral dosing, then intravenous tacrolimus therapy should be initiated as a continuous 24 hour infusion at 0.01 to 0.05 mg/kg for liver transplant and 0.05 to 0.10 mg/kg for kidney transplant.
Primary Immunosuppression Dose Levels - Paediatric Patients: Paediatric patients generally require doses 1.5 to 2 times higher than the recommended adult doses to achieve the same blood levels.
Liver and kidney transplantation: An initial dose of 0.3 mg/kg/day for liver and kidney transplantation should be administered in two divided doses. If the dose cannot be given orally, an initial intravenous dose of 0.05 mg/kg/day for liver transplantation or 0.1 mg/kg/day for kidney transplantation should be administered as a continuous 24-hour infusion.
Maintenance Therapy Dose Levels: It is necessary to continue immunosuppression with oral Prograf to maintain graft survival. Dose can frequently be reduced during maintenance therapy. Dosing should be primarily based on clinical assessments of rejection and tolerability of the patient.
If progression of disease occurs (e.g., signs of acute rejection) alteration of the immunosuppressive regimen should be considered. Increase the amount of corticosteroids, introduction of short courses of mono /polyclonal antibodies and increase in the dose of Prograf have been used to manage rejection episodes.
If signs of toxicity (e.g., pronounced adverse event) are noted, the dose of Prograf should be reduced.
When Prograf is administered in combination with a corticosteroid these may often be reduced and in rare cases the treatment has continued as monotherapy.
Therapy Dose Levels for Liver and Kidney Allograft Rejection Resistant to Conventional Immunosuppressive Regimens: In patients experiencing rejections episodes which are unresponsive to conventional immunosuppressive therapy, Prograf treatment should begin with the initial dose recommended for primary immunosuppression in that particular allograft.
Care should be taken when converting patients from ciclosporin-based to Prograf-based therapy (see Precautions and Interactions). Prograf should be initiated after considering cyclosporin blood concentrations and the clinical condition of the patient. In practice, Prograf therapy has been initiated 12 - 24 hours after discontinuation of cyclosporin. Monitoring of cyclosporin blood levels should be continued following conversion as the clearance of cyclosporin may be affected.
Duration of Dosing: For oral dosing the capsules normally have to be taken continuously to suppress graft rejection and no limit for therapy duration can be given.
Patients should be converted from intravenous to oral medication as soon as individual circumstances permit. Intravenous therapy should not be continued for more than 7 days.
Monitoring of Whole Blood Concentrations: Drug level monitoring is recommended during the early post-transplantation period, following dose adjustment of Prograf therapy after switching from another immunosuppressive regimen or following co-administration of drugs which are likely to lead to a drug interaction. Trough blood levels of Prograf should also be monitored periodically during maintenance therapy. The frequency of blood level monitoring should be based on clinical need. As tacrolimus has a long half life, it can take several days for adjustments in Prograf dosing to be reflected in changes in blood levels.
Only for Prograf Capsules 0.5mg and 1mg: Lupus nephritis: For adults, usually, a dose of 3mg as tacrolimus is orally administered, once daily after supper.
In order to avoid the development of adverse reactions in patients with lupus nephritis, it is recommended that the blood levels should 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 urinary protein excretion, or the immunological findings after continuous treatment for 2 months or more, the treatment with this product should be discontinued, or the patient should be switched to another product. In cases where this product is sufficiently effective, it is recommended that the dose should be reduced to a level at which the effect can be maintained.
Patient with Liver Impairment: A dose reduction is necessary.
Patient with Kidney Impairment: Careful monitoring of renal function including serial creatinine estimations, calculations of creatinine clearance and monitoring urine output is recommended.
Elderly Patients: Limited experience suggests that doses should be the same as for adults.
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