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Astagraf XL
tacrolimus
Black Box Warnings .
Malignancies and Serious Infections
incr. risk of serious infections and malignancies in patients receiving immunosuppressants may lead to hospitalization or death
Mortality in Liver Transplantation
incr. mortality in female liver transplant patients observed; use in liver transplantation is not approved
Adult Dosing .
Dosage forms: ER CAP: 0.5 mg, 1 mg, 5 mg
Special Note
- [equivalency or interchangeability info]
- Info: tacrolimus ER products not interchangeable w/ other ER or IR products; do not substitute on a mg to mg basis
kidney transplant rejection prophylaxis
- [w/ basiliximab induction tx]
- Dose: 0.15-0.2 mg/kg/dose 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
- [w/o basiliximab induction tx]
- Dose: 0.2 mg/kg/dose 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
- [see below]
- 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: ER CAP: 0.5 mg, 1 mg, 5 mg
Special Note
- [equivalency or interchangeability info]
- Info: tacrolimus ER products not interchangeable w/ other ER or IR products; do not substitute on a mg to mg basis
kidney transplant rejection prophylaxis
- [w/ basiliximab induction tx, 4 yo and older]
- Dose: 0.3 mg/kg/dose 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
- [see below]
- 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