BNF for Children 2011-2012

328 5.3.5 Respiratory syncytial virus BNFC 2011–20125 Infectionsrespiratory syncytial virus (RSV) in infants, especiallywhen they have other serious diseases. However, thereis no evidence that ribavirin produces clinically relevantbenefit in RSV bronchiolitis. Ribavirin is given by mouthwith peginterferon alfa or interferon alfa for the treatmentof chronic hepatitis C infection (see Viral Hepatitis,section 5.3.3). Ribavirin is also effective in Lassafever and has also been used parenterally in the treatmentof life-threatening RSV, parainfluenza virus, andadenovirus infections in immunocompromised children[unlicensed indications].Palivizumab is a monoclonal antibody licensed forpreventing serious lower respiratory-tract diseasecaused by respiratory syncytial virus in children athigh risk of the disease; it should be prescribed underspecialist supervision and on the basis of the likelihoodof hospitalisation.Palivizumab is recommended for:. children under 9 months of age with chronic lungdisease (defined as requiring oxygen for at least 28days from birth) and who were born preterm 1 ;. children under 6 months of age with haemodynamicallysignificant, acyanotic congenital heart diseasewho were born preterm 1 .Palivizumab should be considered for:. children under 2 years of age with severe combinedimmunodeficiency syndrome;. children under 1 year of age who require long-termventilation;. children 1–2 years of age who require long-termventilation and have an additional co-morbidity(including cardiac disease or pulmonary hypertension).PALIVIZUMABCautions moderate to severe acute infection or febrileillness; thrombocytopenia; serum-palivizumab concentrationmay be reduced after cardiac surgery;hypersensitivity to humanised monoclonal antibodiesSide-effects fever, injection-site reactions, nervousness;less commonly diarrhoea, vomiting, constipation,haemorrhage, rhinitis, cough, wheeze, pain,drowsiness, asthenia, hyperkinesia, leucopenia, andrash; also reported, apnoea, hypersensitivity reactions(including anaphylaxis), convulsions and thrombocytopeniaLicensed use not licensed in children with congenitalimmunodeficiency or in children born at 35weeks gestation or less and older than 6 months(licensed in children under 6 months)Indication and dosePrevention of serious disease caused by respiratorysyncytial virus infection (see notesabove). By intramuscular injection (preferably in anterolateralthigh)Neonate 15 mg/kg once a month during season ofRSV risk1. For details of the preterm age groups included in therecommendations, see Immunisation against InfectiousDisease (2006), available at www.dh.gov.uk/immunisationChild 1 month–2 years 15 mg/kg once a monthduring season of RSV risk (child undergoing cardiacbypass surgery, 15 mg/kg as soon as stableafter surgery, then once a month during season ofrisk); injection volume over 1 mL should be dividedbetween 2 or more sitesSynagis c (Abbott) TAInjection, powder for reconstitution, palivizumab, netprice 50-mg vial = £360.40; 100-mg vial = £663.11RIBAVIRIN(Tribavirin)CautionsSpecific cautions for inhaled treatment Maintain standardsupportive respiratory and fluid management therapy;monitor electrolytes closely; monitor equipment for precipitation;pregnant women (and those planning pregnancy)should avoid exposure to aerosolSpecific cautions for systemic treatment Excludepregnancy before treatment in females of childbearing age;effective contraception essential during treatment and for 4months after treatment in females and for 7 months aftertreatment in males of childbearing age; routine monthlypregnancy tests recommended; condoms must be used ifpartner of male patient is pregnant (ribavirin excreted insemen); cardiac disease (assessment including ECG recommendedbefore and during treatment—discontinue if deterioration);determine full blood count, platelets, electrolytes,serum creatinine, liver function tests and uric acid beforestarting treatment and then on weeks 2 and 4 of treatment,then as indicated clinically—adjust dose if adverse reactionsor laboratory abnormalities develop (consult product literature);eye examination recommended before oral treatment;eye examination also recommended during oral treatment ifpre-existing ophthalmological disorder or if decrease invision reported—discontinue treatment if ophthalmologicaldisorder deteriorates or if new ophthalmological disorderdevelops; test thyroid function before treatment and thenevery 3 months; risk of growth retardation, the reversibilityof which is uncertain—if possible, consider starting treatmentafter pubertal growth spurtInteractions: Appendix 1 (ribavirin)Contra-indicationsSpecific contra-indications for systemic treatmentSevere, uncontrolled cardiac disease in children with chronichepatitis C; haemoglobinopathies; severe debilitating medicalconditions; severe hepatic dysfunction or decompensatedcirrhosis; autoimmune disease (including autoimmunehepatitis); history of severe psychiatric conditionHepatic impairment no dosage adjustment required;use oral ribavirin with caution in severe hepatic dysfunctionor decompensated cirrhosisRenal impairment plasma-ribavirin concentrationincreased; manufacturer advises avoid oral ribavirin ifestimated glomerular filtration rate less than 50 mL/minute/1.73 m 2 ; manufacturer advises use intravenouspreparation with caution if estimated glomerularfiltration rate less than 30 mL/minute/1.73 m 2Pregnancy avoid; teratogenicity in animal studies; seealso Cautions aboveBreast-feeding avoid—no information availableSide-effectsSpecific side-effects for inhaled treatment Worseningrespiration, bacterial pneumonia, and pneumothoraxreported; rarely non-specific anaemia and haemolysisSpecific side-effects for oral treatment Haemolytic anaemia(anaemia may be improved by epoetin); also (in combinationwith peginterferon alfa or interferon alfa) nausea,vomiting, dyspepsia, abdominal pain, flatulence, constipation,diarrhoea, colitis, chest pain, palpitation, tachycardia,peripheral oedema, changes in blood pressure, syncope,flushing, pallor, cough, dyspnoea, tachypnoea, headache,dizziness, hyperkinesia, asthenia, impaired concentrationand memory, sleep disturbances, abnormal dreams, anxiety,depression, suicidal ideation, psychoses, dysphagia, weightloss, dysphonia, paraesthesia, hypoaesthesia, ataxia, hypertonia,influenza-like symptoms, growth retardation (includ-