Select a medication above to begin.
sirolimus
generic
Black Box Warnings .
Appropriate Use
admin. only by physicians experienced in immunosuppress. tx and mgmt of renal transplant pts in adequate medical facility; physician responsible for maintenance tx should have all info needed for pt follow-up
Immunosuppressant
immunosuppression incr. infection, lymphoma, and other malignancy risks
Liver Transplantation
use not recommended as safety and efficacy of sirolimus not established; excess mortality and graft loss assoc. w/ sirolimus plus tacrolimus and incr. hepatic artery thrombosis (HAT) assoc. w/ sirolimus plus cyclosporine or tacrolimus in de novo liver transplant pts; most HAT cases w/in 30 days post-transplant and led to graft loss or death
Lung Transplantation
use not recommended as safety and efficacy of sirolimus not established; cases of bronchial anastomotic dehiscence, most fatal, reported in de novo lung transplant pts w/ sirolimus as part of immunosuppressive regimen
Adult Dosing .
Dosage forms: TAB: 0.5 mg, 1 mg, 2 mg; SOL: 1 mg per mL
Special Note
- [formulation clarification]
- 2 mg oral solution is equivalent and interchangeable w/ 2 mg tab, but dosage forms may not be clinically equivalent at higher doses on a mg to mg basis
kidney transplant rejection prophylaxis
- [low-mod immunologic risk, <40 kg]
- Dose: 1 mg/m^2/dose PO qd; Start: 3 mg/m^2/dose PO x1 ASAP after transplant; Max: 40 mg/day; Info: refer to institution protocols for risk classification; overlap tx w/ cyclosporine and corticosteroids x2-4mo after transplant, then taper cyclosporine; adjust dose based on trough levels; adjust maint. dose no more frequently than q7-14 days; give consistently w/ or w/o food; do not cut/crush/chew tab
- [low-mod immunologic risk, >40 kg]
- Dose: 2 mg PO qd; Start: 6 mg PO x1 ASAP after transplant; Max: 40 mg/day; Info: refer to institution protocols for risk classification; overlap tx w/ cyclosporine and corticosteroids x2-4mo after transplant, then taper cyclosporine; adjust dose based on trough levels; adjust maint. dose no more frequently than q7-14 days; give consistently w/ or w/o food; do not cut/crush/chew tab
- [high immunologic risk, <40 kg]
- Dose: 1 mg/m^2/dose PO qd; Start: 3 mg/m^2/dose PO x1 ASAP after transplant; Max: 40 mg/day; Info: refer to institution protocols for risk classification; overlap tx w/ cyclosporine and corticosteroids x12mo after transplant; adjust dose based on trough levels starting between days 5 and 7; adjust maint. dose no more frequently than q7-14 days; give consistently w/ or w/o food; do not cut/crush/chew tab
- [high immunologic risk, >40 kg]
- Dose: 5 mg PO qd; Start: up to 15 mg PO x1 ASAP after transplant; Max: 40 mg/day; Info: refer to institution protocols for risk classification; overlap tx w/ cyclosporine and corticosteroids x12mo after transplant; adjust dose based on trough levels starting between days 5 and 7; adjust maint. dose no more frequently than q7-14 days; give consistently w/ or w/o food; do not cut/crush/chew tab
lymphangioleiomyomatosis
- [individualize dose PO qd]
- Start: 2 mg PO qd; Info: adjust dose based on trough levels starting between days 10 and 20; adjust maint. dose no more frequently than q7-14 days; give consistently w/ or w/o food; do not cut/crush/chew tab
renal dosing
- [no adjustment]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement
hepatic dosing
- [adjust dose amount]
- Child-Pugh Class A or B: decr. usual maint. dose by 33%; Child-Pugh Class C: decr. usual maint. dose by 50%
Peds Dosing .
- Dosage forms: TAB: 0.5 mg, 1 mg, 2 mg; SOL: 1 mg per mL
Special Note
- [formulation clarification]
- 2 mg oral solution is equivalent and interchangeable w/ 2 mg tab, but dosage forms may not be clinically equivalent at higher doses on a mg to mg basis
kidney transplant rejection prophylaxis
- [low-mod immunologic risk, 13 yo and older, <40 kg]
- Dose: 1 mg/m^2/dose PO qd; Start: 3 mg/m^2/dose PO x1 ASAP after transplant; Max: 40 mg/day; Info: refer to institution protocols for risk classification; overlap tx w/ cyclosporine and corticosteroids x2-4mo after transplant, then taper cyclosporine; adjust dose based on trough levels; adjust maint. dose no more frequently than q7-14 days; give consistently w/ or w/o food; do not cut/crush/chew tab
- [low-mod immunologic risk, 13 yo and older, >40 kg]
- Dose: 2 mg PO qd; Start: 6 mg PO x1 ASAP after transplant; Max: 40 mg/day; Info: refer to institution protocols for risk classification; overlap tx w/ cyclosporine and corticosteroids x2-4mo after transplant, then taper cyclosporine; adjust dose based on trough levels; adjust maint. dose no more frequently than q7-14 days; give consistently w/ or w/o food; do not cut/crush/chew tab
renal dosing
- [no adjustment]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement
hepatic dosing
- [adjust dose amount]
- Child-Pugh Class A or B: decr. usual maint. dose by 33%; Child-Pugh Class C: decr. usual maint. dose by 50%