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tacrolimus
generic
Black Box Warnings .
Appropriate Use
admin. only by physicians experienced in immunosuppress. tx and mgmt of organ transplant pts in adequate medical facility; physician responsible for maintenance tx should have all info needed for pt follow-up
Malignancies and Serious Infections
incr. risk of infections, lymphomas, and other malignancies in pts receiving immunosuppressants, may lead to hospitalization or death
Mortality in Liver Transplantation
incr. mortality in female liver transplant pts observed w/ ER cap; ER cap use in liver transplantation is not approved
Adult Dosing .
Dosage forms: CAP: 0.5 mg, 1 mg, 5 mg; ER CAP: 0.5 mg, 1 mg, 5 mg
Special Note
- [formulation clarification]
- Info: tacrolimus IR products not interchangeable w/ ER products; tacrolimus ER products not interchangeable w/ other ER or IR products; do not substitute on a mg to mg basis
heart transplant rejection prophylaxis
- [immediate-release form]
- Dose: 0.075 mg/kg/day PO divided q12h; Start: >6h post-transplant; Info: adjust dose based on serum levels
liver transplant rejection prophylaxis
- [immediate-release form]
- Dose: 0.1-0.15 mg/kg/day PO divided q12h; Start: >6h post-transplant; Info: adjust dose based on serum levels
lung transplant rejection prophylaxis
- [immediate-release form]
- Dose: 0.075 mg/kg/day PO divided q12h; Start: >6h post-transplant; Info: adjust dose based on serum levels; pts w/ cystic fibrosis may require higher doses
kidney transplant rejection prophylaxis
- [immediate-release form]
- Dose: 0.1-0.2 mg/kg/day PO divided q12h; Start: w/in 24h post-transplant; delay if renal fxn not adequate; Info: adjust dose based on serum levels
- [extended-release form, w/ basiliximab induction tx]
- Dose: 0.15-0.2 mg/kg/dose ER PO qam; Start: before reperfusion or w/in 48h post-transplant; Info: adjust dose based on serum levels; give on empty stomach; do not open/crush/chew cap
- [extended-release form, w/o basiliximab induction tx]
- Dose: 0.2 mg/kg/dose ER PO qam; Start: 0.1 mg/kg/dose PO x1 preop and w/in 12h before reperfusion; Info: give initial maint. dose postop >4h after preop dose and w/in 12h after reperfusion; Info: adjust dose based on serum levels; give on empty stomach; do not open/crush/chew cap
renal dosing
- [kidney transplant, immediate-release form]
- renal impairment: give lowest recommended dose, may consider further dose decr.; postop oliguria: start 6-24h post-transplant; may delay until renal fxn adequate
- HD/PD: not defined
- [kidney transplant, extended-release form]
- renal impairment: give lowest recommended dose, may consider further dose decr.
- HD/PD: not defined
- [all other transplants]
- renal impairment: give lowest recommended dose, may consider further dose decr.
- HD/PD: not defined
hepatic dosing
- [see below]
- mild impairment: no adjustment; moderate impairment: not defined; severe impairment: consider decr. usual dose
Peds Dosing .
- Dosage forms: CAP: 0.5 mg, 1 mg, 5 mg; ER CAP: 0.5 mg, 1 mg, 5 mg
Special Note
- [formulation clarification]
- Info: tacrolimus IR products not interchangeable w/ ER products; tacrolimus ER products not interchangeable w/ other ER or IR products; do not substitute on a mg to mg basis
heart transplant rejection prophylaxis
- [immediate-release form]
- Dose: 0.3 mg/kg/day PO divided q12h; Start: >6h post-transplant; Alt: 0.1 mg/kg/day PO divided q12h if cell depleting induction tx given; Info: adjust dose based on serum levels
liver transplant rejection prophylaxis
- [immediate-release form]
- Dose: 0.15-0.2 mg/kg/day PO divided q12h; Start: >6h post-transplant; Info: adjust dose based on serum levels
lung transplant rejection prophylaxis
- [immediate-release form]
- Dose: 0.3 mg/kg/day PO divided q12h; Start: >6h post-transplant; Alt: 0.1 mg/kg/day PO divided q12h if cell depleting induction tx given; Info: adjust dose based on serum levels; pts w/ cystic fibrosis may require higher doses
kidney transplant rejection prophylaxis
- [immediate-release form]
- Dose: 0.3 mg/kg/day PO divided q12h; Start: w/in 24h post-transplant; delay if renal fxn not adequate; Info: adjust dose based on serum levels
- [extended-release form, w/ basiliximab induction tx, 4 yo and older]
- Dose: 0.3 mg/kg/dose ER PO qam; Start: w/in 24h after reperfusion; Info: adjust dose based on serum levels; give on empty stomach; do not open/crush/chew cap
renal dosing
- [kidney transplant, immediate-release form]
- renal impairment: give lowest recommended dose, may consider further dose decr.; postop oliguria: start 6-24h post-transplant; may delay until renal fxn adequate
- HD/PD: not defined
- [kidney transplant, extended-release form]
- renal impairment: give lowest recommended dose, may consider further dose decr.
- HD/PD: not defined
- [all other transplants]
- renal impairment: give lowest recommended dose, may consider further dose decr.
- HD/PD: not defined
hepatic dosing
- [see below]
- mild impairment: no adjustment; moderate impairment: not defined; severe impairment: consider decr. usual dose