BNF for Children 2011-2012

434 8.2.2 Corticosteroids and other immunosuppressants BNFC 2011–20128 Malignant disease and immunosuppressionIndication and doseHeart transplantation. By intravenous infusion over at least 6 hoursChild 1 month–18 years 1–2.5 mg/kg daily for 3–5 days starting the day of transplantationNote To avoid excessive dosage in obese patients, calculatedose on the basis of ideal body weightRenal transplantation. By intravenous infusion over at least 6 hoursChild 1–18 years 1–1.5 mg/kg daily for 3–9 daysstarting the day of transplantationNote To avoid excessive dosage in obese patients, calculatedose on the basis of ideal body weightCorticosteroid-resistant renal graft rejection. By intravenous infusion over at least 6 hoursChild 1–18 years 1.5 mg/kg daily for 7–14 daysNote To avoid excessive dosage in obese patients, calculatedose on the basis of ideal body weightAdministration For continuous intravenous infusionreconstitute each vial with 5 mL water for injections toproduce a solution of 5 mg/mL; gently rotate to dissolve.Dilute requisite dose with Glucose 5% or SodiumChloride 0.9% to an approx. concentration of0.5 mg/mL; begin infusion immediately after dilution;give through an in-line filter (pore size 0.22 micron);incompatible with unfractionated heparin and hydrocortisonein glucose infusion—precipitation reportedThymoglobuline c (Genzyme) TAIntravenous infusion, powder for reconstitution,rabbit anti-human thymocyte immunoglobulin, netprice 25-mg vial = £158.77BASILIXIMABPregnancy manufacturer advises avoid—no informationavailable; adequate contraception must be usedduring treatment and for 16 weeks after last doseBreast-feeding manufacturer advises avoid—noinformation availableSide-effects severe hypersensitivity reactions andcytokine release syndrome reportedIndication and doseProphylaxis of acute rejection in allogeneicrenal transplantation used in combination withciclosporin and corticosteroid-containingimmunosuppression regimens. By intravenous injection or by intravenousinfusionConsult local treatment protocol for detailsChild over 1 year, body-weight under 35 kg10 mg within 2 hours before transplant surgery and10 mg 4 days after surgeryChild body-weight over 35 kg 20 mg within 2hours before transplant surgery and 20 mg 4 daysafter surgeryNote withhold second dose if severe hypersensitivity or graftloss occursAdministration For intravenous infusion, dilutereconstituted solution to a concentration notexceeding 400 micrograms/mL, with Glucose 5% orSodium Chloride 0.9%; give over 20–30 minutesSimulect c (Novartis) AInjection, powder for reconstitution, basiliximab, netprice 10-mg vial = £758.69, 20-mg vial = £842.38(both with water for injections). For intravenous infusionCICLOSPORIN(Cyclosporin)Cautions monitor kidney function—dose dependentincrease in serum creatinine and urea during first fewweeks may necessitate discontinuation (excluderejection of kidney transplant); monitor liver function(see also Hepatic Impairment below); monitor bloodpressure—discontinue if hypertension develops thatcannot be controlled by antihypertensives; hyperuricaemia;monitor serum potassium especially inrenal dysfunction (risk of hyperkalaemia); monitorserum magnesium; measure blood lipids beforetreatment and thereafter as appropriate; monitorwhole blood ciclosporin concentration (trough leveldependent on indication—consult local treatmentprotocol for details); use with tacrolimus specificallycontra-indicated; for patients other than transplantrecipients, preferably avoid other immunosuppressants(increased risk of infection and malignancies,including lymphoma and skin cancer); avoid excessiveexposure to UV light, including sunlight; interactions:Appendix 1 (ciclosporin)Additional cautions in nephrotic syndrome Contra-indicatedin uncontrolled hypertension, uncontrolled infections,and malignancy; in long-term management, perform renalbiopsies every 1–2 yearsAdditional cautions Atopic Dermatitis and Psoriasis, section13.5.3; Rheumatoid Arthritis, section 10.1.3Hepatic impairment dosage adjustment based onbilirubin and liver enzymes may be neededRenal impairment dose as in normal renal functionbut see Cautions above; in nephrotic syndromereduce dose by 25–50% if serum creatinine more than30% above baseline on more than one measurementPregnancy crosses placenta; see ImmunosuppressantTherapy, p. 431Breast-feeding present in milk—manufactureradvises avoidSide-effects anorexia, nausea, vomiting, abdominalpain, diarrhoea, gingival hyperplasia, hepatic dysfunction,hypertension, tremor, headache, paraesthesia,fatigue, renal dysfunction (renal structuralchanges on long-term administration; see also underCautions), hyperuricaemia, hyperkalaemia, hypomagnesaemia,hyperlipidaemia, hypercholesterolaemia,muscle cramps, myalgia, hypertrichosis; lesscommonly oedema, weight gain, signs of encephalopathy,anaemia, thrombocytopenia; rarely pancreatitis,motor polyneuropathy, menstrual disturbances,gynaecomastia, micro-angiopathic haemolytic anaemia,haemolytic uraemic syndrome, hyperglycaemia,muscle weakness, myopathy, visual disturbancessecondary to benign intracranial hypertension (discontinue);also reported with infusion anaphylaxisLicensed use not licensed for use in children under 3months