BNF for Children 2011-2012

158 3.4.2 Allergen immunotherapy BNFC 2011–20123 Respiratory systemContra-indications see notes above and consult productliteraturePregnancy avoidSide-effects consult product literatureIndication and doseTreatment of seasonal allergic hay fever due tograss or tree pollen (see notes above)See under preparations, belowPollinex c (Allergy) AGrasses and rye or tree pollen extract, net price initialtreatment set (3 vials) and extension course treatment(1 vial) = £450.00Dose. By subcutaneous injectionConsult product literatureGrass pollen extractGrazax c (ALK-Abelló) AOral lyophilisates (= freeze-dried tablets), grasspollen extract 75 000 units, net price 30-tab pack =£66.56. Counselling, administrationDose. By mouthChild 5–18 years 1 tablet daily; start treatment at least 4months before start of pollen season and continue for upto 3 yearsCounselling Tablets should be placed under the tongue andallowed to disperse. Advise carer and child that child not toswallow for 1 minute, or eat or drink for 5 minutes, aftertaking the tabletresponse should be assessed at 16 weeks and omalizumabtreatment discontinued in patients who have notshown a marked improvement in overall asthma control.NICE guidanceOmalizumab for severe persistent allergicasthma (November 2007)Omalizumab is recommended as additional therapyfor the prophylaxis of severe persistent allergicasthma in children over 12 years, who cannot becontrolled adequately with high-dose inhaled corticosteroidsand long-acting beta 2 agonists in additionto leukotriene receptor antagonists, theophylline,oral corticosteroids, oral beta 2agonists, andsmoking cessation where clinically appropriate.The following conditions apply:. confirmation of IgE-mediated allergy to a perennialallergen by clinical history and allergyskin testing;. either 2 or more severe exacerbations of asthmarequiring hospital admission within the previousyear, or 3 or more severe exacerbations ofasthma within the previous year, at least oneof which required hospital admission, and afurther 2 which required treatment or monitoringin excess of the patient’s usual regimen, in anaccident and emergency unit.Omalizumab should be initiated and monitored by aphysician experienced in both allergy and respiratorymedicine in a specialist centre, and discontinuedat 16 weeks in patients who have not shown anadequate response to therapy.OmalizumabOmalizumab is a monoclonal antibody that binds toimmunoglobulin E (IgE). It is licensed for use as additionaltherapy in children over 6 years with proven IgEmediatedsensitivity to inhaled allergens, whose severepersistent allergic asthma cannot be controlled adequatelywith high-dose inhaled corticosteroid togetherwith a long-acting beta 2agonist. Omalizumab should beinitiated by physicians experienced in the treatment ofsevere persistent asthma.Churg-Strauss syndrome has occurred rarely in patientsgiven omalizumab; the reaction is usually associatedwith the reduction or withdrawal of oral corticosteroidtherapy. Churg-Strauss syndrome can present as eosinophilia,vasculitic rash, cardiac complications, worseningpulmonary symptoms, or peripheral neuropathy. Hypersensitivityreactions can also occur immediately followingtreatment with omalizumab or sometimes more than24 hours after the first injection.For details on the management of anaphylaxis, seesection 3.4.3.The Scottish Medicines Consortium, p. 3 has advised(September 2007 and March 2010) that omalizumab isaccepted for restricted use within NHS Scotland as addontherapy to improve asthma control in children (6 to12 years), adolescents, and adults with severe persistentallergic asthma. Omalizumab is restricted to patientswho are prescribed chronic systemic corticosteroidsand in whom all other treatments have failed. TheNICE guidanceOmalizumab for the treatment of severepersistent allergic asthma in children aged 6to 11 years (October 2010)Omalizumab is not recommended for the treatmentof severe persistent allergic asthma in children aged6 to 11 years.OMALIZUMABCautions autoimmune disease; susceptibility to helminthinfections—discontinue if infection does notrespond to anthelminticHepatic impairment manufacturer advises caution—no information availableRenal impairment manufacturer advises caution—noinformation availablePregnancy manufacturer advises avoid unless essential;no evidence of teratogenicity in animal studiesBreast-feeding manufacturer advises avoid—presentin milk in animal studiesSide-effects headache; injection-site reactions; lesscommonly nausea, diarrhoea, dyspepsia, flushing,fatigue, dizziness, drowsiness, paraesthesia, influenzalikesymptoms, photosensitivity, hypersensitivityreactions (including hypotension, bronchospasm, laryngoedema,rash, pruritus, serum sickness, andanaphylaxis); arterial thromboembolic events, Churg-Strauss syndrome (see notes above), thrombocytopenia,arthralgia, myalgia, and alopecia also reported