Kidney Transplantation
- PO (Adults and Children ≥13 yr and ≥40 kg): 6 mg loading dose, followed by 2 mg/day maintenance dose. Dosing following cyclosporine withdrawal: Patients at low to moderate risk for rejection after transplantation may be withdrawn from cyclosporine over 4–8 wk beginning 2–4 mo after transplant. Thereafter, sirolimus dose should be titrated upward to maintain a whole blood trough level of 12–14 ng/mL. Clinical assessment should also be used to gauge dose. Dose changes can be made at 7–14 day intervals. The following formula may also be used: sirolimus maintenance dose = current dose × (target concentration/current concentration). If a large ↑ is needed, a loading dose may be given and blood levels reassessed 3–4 days later. Loading dose may be calculated by the following formula: sirolimus loading dose = 3 × (new maintenance dose − current maintenance dose). Loading doses >40 mg should be spread over 2 days.
- PO (Adults and Children ≥13 yr and <40 kg): 3 mg/m2 loading dose, followed by 1 mg/m2/day maintenance dose. Dosing following cyclosporine withdrawal: Patients at low to moderate risk for rejection after transplantation may be withdrawn from cyclosporine over 4–8 wk beginning 2–4 mo after transplant. Thereafter, sirolimus dose should be titrated upward to maintain a whole blood trough level of 12–14 ng/mL. Clinical assessment should also be used to gauge dose. Dose changes can be made at 7–14 day intervals. The following formula may also be used: sirolimus maintenance dose = current dose × (target concentration/current concentration). If a large ↑ is needed, a loading dose may be given and blood levels reassessed 3–4 days later. Loading dose may be calculated by the following formula: sirolimus loading dose = 3 × (new maintenance dose − current maintenance dose). Loading doses >40 mg should be spread over 2 days.
Hepatic Impairment
- PO (Adults and Children ): Mild or moderate hepatic impairment:↓ maintenance dose by 33%; loading dose is unchanged; Severe hepatic impairment:↓ maintenance dose by 50%; loading dose is unchanged.
Lymphangioleiomyomatosis
- PO (Adults ): 2 mg once daily. Monitor whole blood trough level in 10–20 days and titrate dose to maintain level of 5–15 ng/mL. The following formula may also be used to adjust dose: sirolimus maintenance dose = current dose × (target concentration/current concentration). Further dose changes can be made at 7–14 day intervals. Once stable dose achieved, should monitor whole blood trough levels at least every 3 mo.
Hepatic Impairment
- (Adults ): Mild or moderate hepatic impairment:↓ dose by 33%; Severe hepatic impairment:↓ dose by 50%.