BNF for Children 2011-2012

BNFC 2011–2012 10.1.3 Drugs that suppress the rheumatic disease process 509cally significant drop in white cell count or platelet countcalls for immediate withdrawal of methotrexate and introductionof supportive therapyGastro-intestinal toxicity Withdraw treatment if stomatitisdevelops—may be first sign of gastro-intestinal toxicityLiver toxicity Persistent 2–fold rise in liver transaminasesmay necessitate dose reduction or rarely discontinuation;abrupt withdrawal should be avoided as this can lead todisease flarePulmonary toxicity Acute pulmonary toxicity is rare inchildren treated for juvenile idiopathic arthritis, but childrenand carers should seek medical attention if dyspnoea, coughor fever develops; discontinue if pneumonitis suspected.NSAIDs Children and carers should be advised to avoid selfmedicationwith over-the-counter ibuprofenContra-indications see Cautions above; also activeinfection and immunodeficiency syndromesHepatic impairment avoid—dose-related toxicity;see also Cautions aboveRenal impairment section 8.1.3Pregnancy section 8.1.3Breast-feeding section 8.1.3Side-effects section 8.1.3; chronic pulmonary fibrosis;blood dyscrasias (including fatalities); liver cirrhosisLicensed use Metoject c injection licensed for use inchildren over 3 years for polyarticular forms ofjuvenile idiopathic arthritis; other preparations notlicensed for use in children for non-malignantconditionsIndication and doseJuvenile idiopathic arthritis, juvenile dermatomyositis,vasculitis, uveitis, systemic lupuserythematosus, localised scleroderma, sarcoidosis. By mouth, subcutaneous injection, or intramuscularinjectionChild 1 month–18 years 10–15 mg/m 2 onceweekly initially, increased if necessary to max.25 mg/m 2 once weeklySafe 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).Severe Crohn’s disease section 1.5.3Malignant disease section 8.1.3Psoriasis section 13.5.3Methotrexate (Non-proprietary) ATablets, yellow, methotrexate 2.5 mg, net price 28-tabpack = £3.27. Counselling, dose, NSAIDsBrands include Maxtrex cTablets, yellow, methotrexate 10 mg, net price 100-tab pack = £56.49. Counselling, dose, NSAIDsSuspension, various strengths available from ‘special-order’manufacturers or specialist importingcompanies, see p. 809Parenteral preparationsSee also section 8.1.3Metoject c (Medac) AInjection, prefilled syringe, methotrexate (asdisodium salt) 50 mg/mL, net price 0.15 mL (7.5 mg)= £14.85, 0.2 mL (10 mg) = £15.29, 0.3 mL (15 mg) =£16.57, 0.4 mL (20 mg) = £17.84, 0.5 mL (25 mg) =£18.48, 0.6 mL (30 mg) = £18.95Cytokine modulatorsCytokine modulators should be used under specialistsupervision.Adalimumab, etanercept, and infliximab inhibit theactivity of tumour necrosis factor alpha (TNF-a). Adalimumaband etanercept can be used for the managementof active polyarticular juvenile idiopathic arthritis. Infliximabhas been used in refractory polyarticular juvenileidiopathic arthritis [unlicensed indication] when othertreatments, such as etanercept, have failed.NICE guidanceEtanercept for the treatment of juvenileidiopathic arthritis (March 2002)Etanercept is recommended in children aged 4–17years with active polyarticular-course juvenile idiopathicarthritis who have not responded adequatelyto methotrexate or who are intolerant of it. Etanerceptshould be used under specialist supervisionaccording to the guidelines of the British Societyfor Paediatric and Adolescent Rheumatology [previouslythe British Paediatric Rheumatology Group].Etanercept should be withdrawn if severe sideeffectsdevelop or if there is no response after 6months or if the initial response is not maintained. Adecision to continue therapy beyond 2 years shouldbe based on disease activity and clinical effectivenessin individual cases.Prescribers of etanercept should register consentingpatients with the Biologics Registry of the BritishSociety for Paediatric and Adolescent Rheumatology.Side-effects Adalimumab, etanercept, and infliximabhave been associated with infections, sometimes severe,including tuberculosis, septicaemia, and hepatitis Breactivation. Other side-effects include nausea, abdominalpain, worsening heart failure, hypersensitivityreactions, fever, headache, depression, antibody formation(including lupus erythematosus-like syndrome),pruritus, injection-site reactions, and blood disorders(including anaemia, leucopenia, thrombocytopenia,pancytopenia, aplastic anaemia).Abatacept prevents the full activation of T-lymphocytes;it can be used for the management of activepolyarticular juvenile idiopathic arthritis. Abatacept isnot recommended for use in combination with TNFinhibitors.10 Musculoskeletal and joint diseases