BNF for Children 2011-2012

440 8.2.4 Other immunomodulating drugs BNFC 2011–20128 Malignant disease and immunosuppressionChronic active hepatitis C infection see underpreparations belowIntronA c (Schering-Plough) AInjection, interferon alfa-2b (rbe) 10 million units/mL,net price 1-mL vial = £42.35, 2.5-mL vial = £105.95.For subcutaneous injection or intravenous infusionInjection pen, interferon alfa-2b (rbe), net price15 million units/mL, 1.5-mL cartridge = £76.28;25 million units/mL, 1.5-mL cartridge = £127.14;50 million units/mL, 1.5-mL cartridge = £254.28. Forsubcutaneous injectionNote Each 1.5-mL multidose cartridge delivers 6 doses of0.2 mL i.e. a total of 1.2 mLDoseChronic active hepatitis B. By subcutaneous injectionChild 2–18 years 5–10 million units/m 2 3 times weeklyChronic active hepatitis C (in combination with oralribavirin, see p. 328). By subcutaneous injectionChild 3–18 years 3 million units/m 2 3 times weeklyRoferon-A c (Roche) AInjection, interferon alfa-2a (rbe). Net price 6 millionunits/mL, 0.5-mL (3 million-unit) prefilled syringe =£14.20; 9 million units/mL, 0.5-mL (4.5 million-unit)prefilled syringe = £21.29; 12 million units/mL, 0.5-mL (6 million-unit) prefilled syringe = £28.37; 18 millionunits/mL, 0.5-mL (9 million-unit) prefilled syringe= £42.57; 30 million units/mL, 0.6-mL (18 millionunit)cartridge = £85.15, for use with Roferon pendevice. For subcutaneous injection (cartridges, vials,and prefilled syringes) and intramuscular injection(cartridges and vials)Excipients include benzyl alcohol (avoid in neonates, see Excipients,p. 2)DoseChronic active hepatitis B. By subcutaneous injectionChild 2–18 years 2.5–5 million units/m 2 3 times weekly;up to 10 million units/m 2 has been used 3 times weeklyRenal impairment manufacturer advises caution insevere impairment—risk of accumulationPregnancy manufacturers advise avoid unless potentialbenefit outweighs risk (toxicity in animal studies);effective contraception required during treatment—consult product literatureBreast-feeding manufacturer advises avoid—noinformation availableSide-effects nausea, vomiting; headache, fatigue,fever; myalgia, arthralgia; rash, injection-site reactions;rarely confusion and systemic lupus erythematosus;also reported, neutropenia, thrombocytopenia,and raised liver enzymesIndication and doseSee notes above and under Preparations belowImmukin c (Boehringer Ingelheim) AInjection, recombinant human interferon gamma-1b200 micrograms/mL, net price 0.5-mL vial = £66.67Dose. By subcutaneous injectionBody surface area 0.5 m 2 or less 1.5 micrograms/kg 3times a weekBody surface area greater than 0.5 m 2 50 micrograms/m 2 3 times a weekNot recommended for infant under 6 months withchronic granulomatous diseaseCanakinumabCanakinumab is a recombinant human monoclonalantibody that selectively inhibits interleukin-1betareceptor binding. It is licensed for the treatment ofcryopyrin-associated periodic syndromes, includingsevere forms of familial cold auto-inflammatorysyndrome (or familial cold urticaria), Muckle-Wellssyndrome, and neonatal-onset multisystem inflammatorydisease (also known as chronic infantile neurologicalcutaneous and articular syndrome). These are rareinherited auto-inflammatory disorders.Interferon gammaInterferon gamma-1b is used to reduce the frequencyof serious infection in chronic granulomatous diseaseand in severe malignant osteopetrosis.INTERFERON GAMMA-1b(Immune interferon)Cautions seizure disorders (including seizures associatedwith fever); cardiac disease (including ischaemia,congestive heart failure, and arrhythmias);monitor before and during treatment: haematologicaltests (including full blood count, differential white cellcount, and platelet count), blood chemistry tests(including renal and liver function tests) and urinalysis;avoid simultaneous administration of foreignproteins including immunological products (risk ofexaggerated immune response); interactions:Appendix 1 (interferons)Driving May impair ability to perform skilled tasks; effectsmay be enhanced by alcoholHepatic impairment manufacturer advises caution insevere impairment—risk of accumulationCANAKINUMABCautions history of recurrent infection or predispositionto infection; monitor neutrophil count beforestarting treatment, 1–2 months after starting treatment,and periodically thereafter; children shouldreceive all recommended vaccinations (includingpneumococcal and inactivated influenza vaccine)before starting treatment; avoid live vaccines unlesspotential benefit outweighs risk—consult product literaturefor further information and section 14.1,p. 599Tuberculosis Children should be evaluated for latent andactive tuberculosis before starting treatment and monitoredfor signs and symptoms of tuberculosis during and aftertreatmentContra-indications severe active infection (see alsoCautions); neutropenia; concomitant use with tumournecrosis factor inhibitors (possible increased risk ofinfections)Hepatic impairment no information availableRenal impairment limited information available butmanufacturer advises no dose adjustment requiredPregnancy manufacturer advises avoid unless potentialbenefit outweighs risk; effective contraception