BNF for Children 2011-2012

BNFC 2011–2012 8.2.2 Corticosteroids and other immunosuppressants 435Indication and dosePrevention of graft rejection following bonemarrow,kidney, liver, pancreas, heart, lung,and heart-lung transplantation, prophylaxisand treatment of graft-versus-host disease. By mouth or by intravenous infusionConsult local treatment protocols for detailsNephrotic syndrome see also section 6.3.2, p. 371. By mouthChild 1 month–18 years 3 mg/kg twice daily,increase if necessary in corticosteroid-resistantdisease; for maintenance reduce to lowest effectivedose according to whole blood-ciclosporinconcentrations, proteinuria, and renal functionRefractory ulcerative colitis section 1.5.3Severe psoriasis, severe eczema section 13.5.3ImportantPatients should be stabilised on a particular brand oforal ciclosporin because switching between formulationswithout close monitoring may lead to clinicallyimportant changes in blood-ciclosporin concentration.Prescribing and dispensing of ciclosporin should be bybrand name to avoid inadvertent switching. If it isnecessary to switch a patient to a different brand ofciclosporin, the patient should be monitored closelyfor changes in blood-ciclosporin concentration,serum-creatinine, blood pressure, and transplant function.Capimune c (Mylan) ACapsules, ciclosporin 25 mg (grey), net price 30-cappack = £13.80; 50 mg (white), 30-cap pack = £27.00;100 mg (grey), 30-cap pack = £51.50. Counselling,administrationExcipients include propylene glycol (see Excipients, p. 2)Note Contains ethanolCounselling Total daily dose should be taken in 2 divideddosesDeximune c (Dexcel) ACapsules, grey, ciclosporin 25 mg, net price 30-cappack = £13.94; 50 mg 30-cap pack = £27.31; 100 mg30-cap pack = £51.83. Counselling, administrationNote Contains ethyl lactate which is metabolised to ethanolCounselling Total daily dose should be taken in 2 divideddosesNeoral c (Novartis) ACapsules, ciclosporin 10 mg (yellow/white), net price60-cap pack = £18.48; 25 mg (blue/grey), 30-cap pack= £18.59; 50 mg (yellow/white), 30-cap pack =£36.41; 100 mg (blue/grey), 30-cap pack = £69.11.Counselling, administrationExcipients include propylene glycol (see Excipients, p. 2)Note Contains ethanolOral solution, yellow, sugar-free, ciclosporin 100 mg/mL, net price 50 mL = £103.55. Counselling, administrationExcipients include propylene glycol (see Excipients, p. 2)Note Contains ethanolCounselling Total daily dose should be taken in 2 divideddosesMix solution with orange juice (or squash) or apple juice (toimprove taste) or with water immediately before taking (andrinse with more to ensure total dose). Do not mix withgrapefruit juice. Keep medicine measure away from otherliquids (including water)Sandimmun c (Novartis) AConcentrate for intravenous infusion (oily), ciclosporin50 mg/mL. To be diluted before use, net price 1-mL amp = £1.94; 5-mL amp = £9.17Excipients include polyoxyl castor oil (risk of anaphylaxis, see Excipients,p. 2)Note Contains ethanolAdministration For intravenous infusion, dilute to a concentrationof 0.5–2.5 mg/mL with Glucose 5% or Sodium Chloride 0.9%;give over 2–6 hours; not to be used with PVC equipment; observepatient for signs of anaphylaxis for at least 30 minutes afterstarting infusion and at frequent intervals thereafterSIROLIMUSCautions monitor renal function when given withciclosporin; monitor whole blood-sirolimus troughconcentration (Afro-Caribbean patients may requirehigher doses); hyperlipidaemia (monitor lipids);monitor urine proteins; increased susceptibility toinfection (especially urinary-tract infection); increasedsusceptibility to lymphoma and other malignancies,particularly of the skin (limit exposure to UV light);interactions: Appendix 1 (sirolimus)Hepatic impairment monitor blood-sirolimus troughconcentration; dose reduction may be necessary,consult local treatment protocol for detailsPregnancy avoid unless essential—toxicity in animalstudies; effective contraception must be used duringtreatment and for 12 weeks after stoppingBreast-feeding discontinue breast-feedingSide-effects abdominal pain, constipation, nausea,diarrhoea, ascites, stomatitis, oedema, tachycardia,hypertension, hypercholesterolaemia, hypertriglyceridaemia,venous thromboembolism, pleural effusion,pneumonitis, headache, pyrexia, proteinuria, haemolyticuraemic syndrome, anaemia, thrombocytopenia,thrombotic thrombocytopenic purpura, leucopenia,neutropenia, hypokalaemia, hypophosphataemia,hyperglycaemia, lymphocele, arthralgia, osteonecrosis,epistaxis, acne, rash, impaired healing; less commonlypancreatitis, pulmonary embolism, pulmonaryhaemorrhage, pericardial effusion, nephroticsyndrome, pancytopenia; rarely interstitial lung disease,alveolar proteinosis, hepatic necrosis, lymphoedema,hypersensitivity reactions (including anaphylacticreactions, angiodema, exfoliative dermatitis,hypersensitivity vasculitis); also reported focal segmentalglomerulosclerosis, reversible impairment ofmale fertilityLicensed use not licensed for use in childrenIndication and doseSee NICE guidance, p. 433. By mouthConsult local treatment protocols for detailsRapamune c (Wyeth) ATablets, coated, sirolimus 0.5 mg (tan), net price 30-tab pack = £69.00; 1 mg (white), 30-tab pack = £86.49;2 mg (yellow), 30-tab pack = £172.98. Counselling,administrationImportant The 0.5-mg tablet is not bioequivalent to the 1-mg, 2-mg, and 5-mg tablets. Multiples of 0.5-mg tabletsshould not be used as a substitute for other tablet strengthsOral solution, sirolimus 1 mg/mL, net price 60 mL =£162.41. Counselling, administrationAdministration food may affect absorption (give at the same timewith respect to food). Mix solution with at least 60 mL water ororange juice in a glass or plastic container immediately beforetaking; refill container with at least 120 mL of water or orangejuice and drink immediately (to ensure total dose). Do not mixwith any other liquids8 Malignant disease and immunosuppression