BNF for Children 2011-2012

BNFC 2011–2012 1.5.3 Drugs affecting the immune response 55Indication and doseRefractory ulcerative colitis. By mouthChild 2–18 years initially 2 mg/kg twice daily,dose adjusted according to blood-ciclosporinconcentration and response; max. 5 mg/kg twicedailyImportant For advice on counselling and conversionbetween preparations, see section 8.2.2. By intravenous infusionChild 3–18 years initially 0.5–1 mg/kg twicedaily, dose adjusted according to blood-ciclosporinconcentration and responseNephrotic syndrome section 8.2.2Transplantation rejection and auto-immuneconditions section 8.2.2Atopic dermatitis and psoriasis section 13.5.3Administration for intermittent intravenous infusion,dilute to a concentration of 0.5–2.5 mg/mL withGlucose 5% or Sodium Chloride 0.9% and give over2–6 hours; not to be used with PVC equipment;observe patient for signs of anaphylaxis for at least 30minutes after starting infusion and at frequent intervalsthereafterPreparationsSection 8.2.2MERCAPTOPURINE(6-Mercaptopurine)Cautions section 8.1.3; see also Azathioprine, section8.2.1Contra-indications section 8.1.3Hepatic impairment section 8.1.3Renal impairment section 8.1.3Pregnancy section 8.1.3Breast-feeding section 8.1.3Side-effects section 8.1.3Licensed use not licensed for use in severe ulcerativecolitis and Crohn’s disease; for other indications,see section 8.1.3Indication and doseSevere ulcerative colitis and Crohn’s disease. By mouthChild 2–18 years 1–1.5 mg/kg once daily (initialmax. 50 mg; may be increased to 75 mg once daily)Acute leukaemias section 8.1.3PreparationsSection 8.1.3METHOTREXATECautions section 10.1.3Contra-indications section 10.1.3Hepatic impairment section 10.1.3Renal impairment section 8.1.3Pregnancy section 8.1.3Breast-feeding section 8.1.3Side-effects section 10.1.3Licensed use not licensed for use in children fornon-malignant conditionsIndication and doseSevere acute Crohn’s disease. By subcutaneous or intramuscular injectionChild 7–18 years 15 mg/m 2 (max. 25 mg) onceweeklyMaintenance of remission of severe Crohn’sdisease. By mouth or by subcutaneous or intramuscularinjectionChild 7–18 years 15 mg/m 2 (max. 25 mg) onceweekly; dose reduced according to response tolowest effective doseSafe PracticeNote that the above dose is a weekly dose. To avoiderror with low-dose methotrexate, it is recommendedthat:. the child or their carer is carefully advised of the dose andfrequency and the reason for taking methotrexate and anyother prescribed medicine (e.g. folic acid);. only one strength of methotrexate tablet (usually 2.5 mg) isprescribed and dispensed;. the prescription and the dispensing label clearly show thedose and frequency of methotrexate administration;. the child or their carer is warned to report immediately theonset of any feature of blood disorders (e.g. sore throat,bruising, and mouth ulcers), liver toxicity (e.g. nausea,vomiting, abdominal discomfort, and dark urine), and respiratoryeffects (e.g. shortness of breath).Malignant disease section 8.1.3Rheumatic disease section 10.1.3Psoriasis section 13.5.3PreparationsSection 10.1.3Cytokine modulatorsInfliximab is a monoclonal antibody which inhibits thepro-inflammatory cytokine, tumour necrosis factoralpha. It should be administered under specialist supervisionwhere adequate resuscitation facilities are availableand is used in the treatment of severe refractory orfistulating Crohn’s disease in children. Infliximab shouldbe used only when treatment with other immunomodulatingdrugs has failed or is not tolerated and for childrenin whom surgery is inappropriate.INFLIXIMABCautions monitor for infections before, during, and for6 months after treatment (see also Tuberculosisbelow); predisposition to infection; chronic hepatitisB—monitor for active infection; heart failure (discontinueif symptoms develop or worsen; avoid inmoderate or severe heart failure); demyelinating CNSdisorders (risk of exacerbation); history of malignancy(consider discontinuing treatment if malignancy1 Gastro-intestinal system