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Indication & Dosage |
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| Oral |
| PROPHYLAXIS OF ORGAN REJECTION IN KIDNEY ALLOGRAFT RECIPIENTS |
| Child:
Used with ciclosporin and corticosteroids: >13 yr and weighing <40 kg: Loading dose of 3 mg/m2 BSA, followed by initial maintenance of 1 mg/m2/day. Adjust dose to obtain whole blood trough concentrations of 4-12 ng/ml, and reduce doses of ciclosporin and corticosteroids gradually. After 2-3 mth, ciclosporin should be gradually discontinued over 4-8 wk while dose of sirolimus adjusted to obtain trough concentrations of 12-20 ng/ml. If ciclosporin withdrawal is unsuccessful, usage of sirolimus should not exceed 3 mth after transplantation. |
| Max Dosage: 40 mg/day. |
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| Oral |
| PROPHYLAXIS OF ORGAN REJECTION IN KIDNEY ALLOGRAFT RECIPIENTS |
| Adult:
Used with ciclosporin and corticosteroids: Loading dose: 6 mg immediately after surgery; followed by a maintenance dose of 2 mg once daily, given 4 hr after ciclosporin. Adjust dose to obtain whole blood trough concentrations of 4-12 ng/ml, and reduce doses of ciclosporin and corticosteroids gradually. After 2-3 mth, ciclosporin should be gradually discontinued over 4-8 wk while dose of sirolimus adjusted to obtain trough concentrations of 12-20 ng/ml. If ciclosporin withdrawal is unsuccessful, usage of sirolimus should not exceed 3 mth after transplantation. |
| Max Dosage: 40 mg/day. |
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| Administration |
May be taken with or without food. (Take consistently either always w/ or always without meals. Avoid grapefruit juice.) |
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| Precautions |
Hepatic or renal impairment. Kidney function should be monitored. Avoid exposure to sun or ultraviolet light. May increase risk of infection and development of lymphoma. Use in lung or liver transplant patients is not recommended as the safety and efficacy of sirolimus in such patients have not been established. |
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Potentially Life-threatening
Adverse Drug Reactions |
GI disturbances, tremor, acne, impaired renal function, hyperlipidaemia, peripheral oedema, headache, pain, asthenia and hypertension. Arthralgia, hypokalaemia, pyelonephritis, leucopenia, anaemia and angioedema. |
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| Adverse Drug Reactions |
Fatal hepatic necrosis |
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| Interactions |
Inhibitors of CYP3A4 such as ketoconazole and protease inhibitors may increase the plasma concentrations of sirolimus. Concurrent admin with ciclosporin may lead to changes in the rate and extent of sirolimus absorption thus the drugs should be taken at least 4 hr apart. Increased risk of calcineurin inhibitor-induced haemolytic uraemic syndrome, thrombotic thrombocytopenic purpura or thrombotic microangiopathy when used with a calcineurin inhibitor. May lead to angioneurotic oedema-type reactions when used with ACE inhibitor. May decrease response to vaccines. |
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