BNF for Children 2011-2012

384 6.5.1 Hypothalamic and anterior pituitary hormones BNFC 2011–20126 Endocrine systemPrader-Willi syndrome); severe obesity or severerespiratory syndrome in Prader-Willi syndromePregnancy interrupt treatment if pregnancy occursBreast-feeding absorption from milk unlikelySide-effects headache, funduscopy for papilloedemarecommended if severe or recurrent headache, visualproblems, nausea and vomiting occur—if papilloedemaconfirmed consider benign intracranial hypertension(rare cases reported); fluid retention (peripheraloedema), arthralgia, myalgia, carpal tunnelsyndrome, paraesthesia, antibody formation, hypothyroidism,insulin resistance, hyperglycaemia, hypoglycaemia,reactions at injection site; leukaemia inchildren with growth hormone deficiency alsoreportedLicensed use not licensed for use in NoonansyndromeIndication and doseGonadal dysgenesis (Turner’s syndrome). By subcutaneous injection45–50 micrograms/kg daily or 1.4 mg/m 2 dailyDeficiency of growth hormone. By subcutaneous or intramuscular injection23–39 micrograms/kg daily or 0.7–1 mg/m 2 dailyPrader-Willi syndrome. By subcutaneous injectionChildren with growth velocity greater than1 cm/year in combination with energy-restricteddiet, 35 micrograms/kg daily or 1 mg/m 2 daily;max. 2.7 mg dailyChronic renal insufficiency (renal functiondecreased to less than 50%). By subcutaneous injection45–50 micrograms/kg daily or 1.4 mg/m 2 daily(higher doses may be needed) adjusted if necessaryafter 6 monthsGrowth disturbance in children born small forgestational age whose growth has not caughtup by 4 years of age or later; Noonan syndrome. By subcutaneous injection35 micrograms/kg daily or 1 mg/m 2 dailySHOX deficiency. By subcutaneous injection45–50 micrograms/kg dailyGenotropin c (Pharmacia) LInjection, two-compartment cartridge containingpowder for reconstitution, somatropin (rbe) and diluent,net price 5.3-mg (16-unit) cartridge = £122.87, 12-mg (36-unit) cartridge = £278.20. For use with Genotropinc Pen D device (available free of chargefrom clinics). For subcutaneous injectionGoQuick c injection, two-compartment, multi-dosedisposable, prefilled pen containing powder forreconstitution, somatropin (rbe) and diluents, netprice 5.3-mg (16-unit) prefilled pen = £122.87; 12-mg(36-unit) prefilled pen = £278.20. For subcutaneousinjectionMiniQuick c injection, two-compartment single-dosesyringe containing powder for reconstitution, somatropin(rbe) and diluent, net price 0.2-mg (0.6-unit)syringe = £4.64; 0.4-mg (1.2-unit) syringe = £9.27; 0.6-mg (1.8-unit) syringe = £13.91; 0.8-mg (2.4-unit)syringe = £18.55; 1-mg (3-unit) syringe = £23.18; 1.2-mg (3.6-unit) syringe = £27.82; 1.4-mg (4.2-unit)syringe = £32.46; 1.6-mg (4.8-unit) syringe = £37.09;1.8-mg (5.4-unit) syringe = £41.73; 2-mg (6-unit)syringe = £46.37. For subcutaneous injectionHumatrope c (Lilly) LInjection, powder for reconstitution, somatropin(rbe), net price 6-mg (18-unit) cartridge = £108.00; 12-mg (36-unit) cartridge = £216.00; 24-mg (72-unit)cartridge = £432.00; all supplied with diluent. Forsubcutaneous or intramuscular injection; cartridgesfor subcutaneous injectionNorditropin c (Novo Nordisk) LSimpleXx c injection, somatropin (epr) 3.3 mg(10 units)/mL, net price 1.5-mL (5-mg, 15-unit)cartridge = £106.35; 6.7 mg (20 units)/mL, 1.5-mL(10-mg, 30-unit) cartridge = £212.70; 10 mg(30 units)/mL, 1.5-mL (15-mg, 45-unit) cartridge =£319.05. For use with appropriate NordiPen c Ddevice (available free of charge from clinics). Forsubcutaneous injectionNutropinAq c (Ipsen) LInjection, somatropin (rbe), net price 10 mg (30 units)2-mL cartridge = £203.00. For use with NutropinAq cPen D device (available free of charge from clinics).For subcutaneous injectionOmnitrope c (Sandoz) LInjection, somatropin (rbe) 3.3 mg (10 units)/mL, netprice 1.5 mL (5-mg, 15-unit) cartridge = £86.77;6.7 mg (20 units)/mL, 1.5 mL (10-mg, 30-unit) cartridge= £173.50. For use with Omnitrope Pen 5 c Dand Omnitrope Pen 10 c D devices respectively(available free of charge from clinics). For subcutaneousinjectionExcipients include benzyl alcohol (in 5-mg cartridge) (avoid in neonates,see Excipients, p. 2)Note Biosimilar medicine, see p. 2Saizen c (Merck Serono) LInjection, powder for reconstitution, somatropin(rmc), net price 1.33-mg (4-unit) vial (with diluent) =£29.28; 3.33-mg (10-unit) vial (with diluent) = £73.20.For subcutaneous or intramuscular injectionExcipients include benzyl alcohol (avoid in neonates, see Excipients,p. 2)Injection, somatropin (rmc), 5.83 mg (17.5 units)/mL,net price 1.03-mL (6-mg, 18-unit) cartridge = £139.08;8 mg (24 units)/mL, 1.5-mL (12-mg, 36-unit) cartridge= £278.16, 2.5-mL (20-mg, 60-unit) cartridge =£463.60. For use with cool.click c Dneedle-freedevice (available free of charge from clinics). Forsubcutaneous injectionClick.easy c , powder for reconstitution, somatropin(rmc), net price 8-mg (24-unit) vial (in Click.easy cdevice with diluent) = £185.44. For use withOne.click c D autoinjector device or cool.click c Dneedle-free device (both available free of charge fromclinics). For subcutaneous injectionExcipients include benzyl alcohol (in diluent for 3.33 mg vial) (avoid inneonates, see Excipients, p. 2)Note Saizen c 3.33 mg vial may be reconstituted withsodium chloride intravenous infusion or water for injectionsfor immediate use when administering to children under 3years of age