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Zortress
everolimus
Black Box Warnings .
Appropriate Use
should only be administered by physicians experienced in immunosuppressive tx and management of transplant patients in adequate medical facility; physician responsible for maintenance tx should have all info needed for patient follow-up
Malignancies and Serious Infections
incr. susceptibility to infection and possible development of malignancies may result from immunosuppression
Kidney Graft Thrombosis
incr. thrombosis risk resulting in graft loss has been reported, mostly within 30 days post-transplant
Nephrotoxicity
can occur with standard doses of cyclosporine in combo with everolimus; use reduced doses of cyclosporine with everolimus; monitor cyclosporine and everolimus whole blood trough levels
Mortality in Heart Transplantation
incr. mortality, often associated with serious infection, within first 3mo post-transplant observed in clinical trial of de novo heart transplant patients receiving immunosuppressive tx with or without induction tx; use in heart transplantation is not recommended
Adult Dosing .
Dosage forms: TAB: 0.25 mg, 0.5 mg, 0.75 mg, 1 mg
kidney transplant rejection prophylaxis
- [0.75 mg PO q12h]
- Start: ASAP post-transplant; Info: for patients with low-moderate immunologic risk; part of multi-drug regimen; may adjust dose q4-5 days based on trough levels; if trough level <3 ng/mL double total daily dose; if 2 consecutive trough level >8 ng/mL decr. dose by 0.5 mg/day; give consistently with food or on empty stomach; do not cut/crush/chew tab
liver transplant rejection prophylaxis
- [1 mg PO q12h]
- Start: >30 days post-transplant; Info: part of multi-drug regimen; may adjust dose q4-5 days based on trough levels; if trough level <3 ng/mL double total daily dose; if 2 consecutive trough level >8 ng/mL decr. dose by 0.5 mg/day; give consistently with food or on empty stomach; do not cut/crush/chew tab
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [adjust dose amount]
- Child-Pugh Class A: decr. usual start dose by 33%; Child-Pugh Class B or C: decr. usual start dose by 50%
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.