BNF for Children 2011-2012

572 13.5.3 Drugs affecting the immune response BNFC 2011–201213 SkinNeotigason c (Actavis) ACapsules, acitretin 10 mg (brown/white), net price60-cap pack = £23.80; 25 mg (brown/yellow), 60-cappack = £55.24. Label: 10, patient information leaflet,11, 21Extemporaneous formulations available seeExtemporaneous Preparations, p. 613.5.3 Drugs affecting theimmune responseDrugs affecting the immune response are used for eczemaor psoriasis.Pimecrolimus by topical application is licensed for mildto moderate atopic eczema. Tacrolimus is licensed fortopical use in moderate to severe atopic eczema. Bothare drugs whose long-term safety is still being evaluatedand they should not usually be considered first-linetreatment unless there is a specific reason to avoid orreduce the use of topical corticosteroids. Treatmentwith topical pimecrolimus or topical tacrolimus shouldbe initiated only by prescribers experienced in treatingatopic eczema.NICE guidanceTacrolimus and pimecrolimus for atopiceczema (August 2004)Topical pimecrolimus and tacrolimus are options foratopic eczema not controlled by maximal topicalcorticosteroid treatment or if there is a risk ofimportant corticosteroid side-effects (particularlyskin atrophy).Topical pimecrolimus is recommended for moderateatopic eczema on the face and neck of children aged2–16 years and topical tacrolimus is recommendedfor moderate to severe atopic eczema in childrenover 2 years. Pimecrolimus and tacrolimus should beused within their licensed indications.The Scottish Medicines Consortium (p. 3) has advised(March 2010) that tacrolimus ointment (Protopic c ) isaccepted for restricted use within NHS Scotland for theprevention of flares in children aged over 2 years withmoderate to severe atopic eczema in accordance withthe licensed indication; it’s use is restricted to initiationby doctors (including general practioners) with aspecialist interest and experience in treating atopiceczema with immunomodulatory therapy.For the role of topical corticosteroids in eczema, seesection 13.5.1, and for comment on their limited role inpsoriasis, see section 13.4. A systemic corticosteroid(section 6.3.2) such as prednisolone may be used insevere refractory eczema.Systemic drugs acting on the immune system are generallyused by specialists in a hospital setting.Ciclosporin by mouth can be used for severe psoriasisand for severe eczema. Azathioprine (section 8.2.1) ormycophenolate mofetil (section 8.2.1) are also used forsevere refractory eczema in children.Methotrexate can be used for severe resistant psoriasis;the dose is given once weekly and adjusted accordingto severity of the condition and haematological andbiochemical measurements. Folic acid (section 9.1.2)should be given to reduce the possibility of methotrexatetoxicity. Folic acid can be given at a dose of5 mg once weekly [unlicensed indication]; alternativeregimens may be used in some settings.Etanercept (a cytokine modulator) is licensed in childrenover 8 years of age for the treatment of severeplaque psoriasis that is inadequately controlled by othersystemic treatments and photochemotherapy, or whenthese other treatments cannot be used because of intoleranceor contra-indications.CICLOSPORIN(Cyclosporin)Cautions section 8.2.2Additional cautions in atopic dermatitis and psoriasisContra-indicated in abnormal renal function, uncontrolledhypertension (see also below), infections not under control,and malignancy (see also below). Dermatological and physicalexamination, including blood pressure and renal functionmeasurements required at least twice before starting.During treatment, monitor serum creatinine every 2 weeksfor first 3 months then every month; reduce dose by 25–50%if serum creatinine increases more than 30% above baseline(even if within normal range) and discontinue if reductionnot successful within one month. Discontinue if hypertensiondevelops that cannot be controlled by dose reduction orantihypertensive therapy. Avoid excessive exposure to sunlightand avoid use of UVB or PUVA. In atopic dermatitis,also allow herpes simplex infections to clear before starting(if they occur during treatment withdraw if severe); Staphylococcusaureus skin infections not absolute contra-indicationproviding controlled (but avoid erythromycin unless noother alternative—see also interactions: Appendix 1(ciclosporin)); investigate lymphadenopathy that persistsdespite improvement in atopic dermatitis. In psoriasis, alsoexclude malignancies (including those of skin and cervix)before starting (biopsy any lesions not typical of psoriasis)and treat patients with malignant or pre-malignant conditionsof skin only after appropriate treatment (and if no otheroption); discontinue if lymphoproliferative disorder developsHepatic impairment section 8.2.2Renal impairment see Cautions abovePregnancy section 8.2.2Breast-feeding section 8.2.2Side-effects section 8.2.2Licensed use not licensed for use in children under16 years for atopic eczema (dermatitis) or psoriasisIndication and doseShort-term treatment (usually max. 8 weeksbut may be used for longer under specialistsupervision) of severe atopic dermatitis whereconventional therapy ineffective or inappropriate. By mouth, administered in accordance withexpert adviceChild 1 month–18 years initially 1.25 mg/kgtwice daily, if good initial response not achievedwithin 2 weeks, increase rapidly to max. 2.5 mg/kgtwice daily; initial dose of 2.5 mg/kg twice daily ifvery severeImportant For preparations and counselling and foradvice on conversion between the preparations, seesection 8.2.2Severe psoriasis where conventional therapyineffective or inappropriate. By mouth, administered in accordance withexpert adviceChild 1 month–18 years initially 1.25 mg/kgtwice daily, increased gradually to max.2.5 mg/kg twice daily if no improvement within 1