Sirolimus

Indications & Dose:

Prophylaxis of organ rejection in kidney allograft recipients

• BY MOUTH

Adult: Initially 6 mg for 1 dose, to be given after surgery once wound has healed, then 2 mg once daily; to be given in combination with ciclosporin and corticosteroid for 2–3 months (sirolimus doses should be given 4 hours after ciclosporin), ciclosporin should then be withdrawn over 4–8 weeks (if not possible, sirolimus should be discontinued and an alternate immunosuppressive regimen used), dose to be adjusted according to whole blood-sirolimus trough concentration

Contraindications:

Side Effects:

Common or very common Abdominal pain . acne . anaemia . arthralgia . ascites . constipation . diarrhoea . epistaxis . haemolytic uraemic syndrome . headache . hypercholesterolaemia . hyperglycaemia . hypertension . hypertriglyceridaemia . hypokalaemia . hypophosphataemia . impaired healing . leucopenia . lymphocele . nausea . neutropenia . oedema . osteonecrosis . pleural effusion . pneumonitis . proteinuria . pyrexia . rash . stomatitis . tachycardia . thrombocytopenia . thrombotic thrombocytopenic purpura . venous thromboembolism

Uncommon Nephrotic syndrome . pancreatitis . pancytopenia . pericardial effusion . pulmonary embolism . pulmonary haemorrhage

Rare Alveolar proteinosis . anaphylactic reactions . angioedema . exfoliative dermatitis . hepatic necrosis . hypersensitivity reactions . hypersensitivity vasculitis . interstitial lung disease . lymphoedema

Frequency not known Focal segmental glomerulosclerosis . reversible impairment of male fertility

CONCEPTION AND CONTRACEPTION Effective contraception must be used during treatment and for 12 weeks after stopping.

PREGNANCY Avoid unless essential—toxicity in animal studies.

BREAST FEEDING Discontinue breast-feeding.

HEPATIC IMPAIRMENT In severe impairment decrease dose by 50% and monitor whole bloodsirolimus trough concentration every 5–7 days until 3 consecutive measurements have shown stable blood-sirolimus concentration. Clearance reduced in mild to moderate impairment. Monitor whole blood-sirolimus level closely and consult local treatment protocol in hepatic impairment.

Cautions:

Hyperlipidaemia . increased susceptibility to infection (especially urinary-tract infection) . increased susceptibility to lymphoma and other malignancies, particularly of the skin (limit exposure to UV light).

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