BNF for Children 2011-2012

422 8.1.2 Cytotoxic antibiotics BNFC 2011–20128 Malignant disease and immunosuppressionDACTINOMYCIN(Actinomycin D)Cautions see section 8.1 and notes above; caution inhandling—irritant to tissuesHepatic impairment consider dose reduction if raisedserum bilirubin or biliary obstruction; consult localtreatment protocolsPregnancy avoid (teratogenic in animal studies); seealso Pregnancy and Reproductive Function, p. 416Breast-feeding discontinue breast-feedingSide-effects see section 8.1 and notes above; lesscommonly cheilitis, dysphagia; fever, malaise,lethargy; anaemia, hypoglycaemia; myalgia; acne;rarely hepatotoxicity (possibly dose-related)Licensed use not licensed for use in children under12 yearsIndication and doseWilms’ tumour, childhood rhabdomyosarcomaand other soft tissue sarcomas, Ewing’s sarcoma. By intravenous injectionConsult local treatment protocol for detailsCosmegen Lyovac c (Ovation) AInjection, powder for reconstitution, dactinomycin,net price 500-microgram vial = £6.75DAUNORUBICINCautions see section 8.1 and notes above; caution inhandling—irritant to tissuesContra-indications myocardial insufficiency, recentmyocardial infarction, severe arrhythmia; previoustreatment with maximum cumulative doses of daunorubicinor other anthracyclineHepatic impairment reduce dose according to serumbilirubin concentration—consult local treatment protocolfor details; avoid in severe impairmentRenal impairment reduce dose—consult local treatmentprotocol for details; avoid in severe impairmentPregnancy avoid (teratogenic and carcinogenic inanimal studies), see also Pregnancy and ReproductiveFunction, p. 416Breast-feeding discontinue breast-feedingSide-effects see section 8.1 and notes above, leucopenia,less commonly mucositis; cardiac toxicity(usually 1–6 months after initiation of therapy); fever;red urine discolourationLicensed use DaunoXome c not licensed for use inchildrenIndication and doseAcute myelogenous leukaemia, acute lymphocyticleukaemia. By intravenous infusionConsult local treatment protocol for detailsDaunorubicin (Non-proprietary) AInjection, powder for reconstitution, daunorubicin (ashydrochloride), net price 20-mg vial = £55.00Lipid formulationDaunoXome c (Gilead) AConcentrate for intravenous infusion, daunorubicinencapsulated in liposomes. For dilution before use, netprice 50-mg vial = £137.67DOXORUBICIN HYDROCHLORIDECautions see section 8.1 and notes above; caution inhandling—irritant to tissues; interactions: Appendix1 (doxorubicin)Contra-indications severe myocardial insufficiency,recent myocardial infarction, severe arrhythmia; previoustreatment with maximum cumulative doses ofdoxorubicin or other anthracyclineHepatic impairment reduce dose according to bilirubinconcentration—consult local treatment protocolfor details; avoid in severe impairmentPregnancy avoid (teratogenic and toxic in animalstudies); manufacturer of liposomal product adviseseffective contraception during and for at least 6months after treatment in men or women; see alsoPregnancy and Reproductive Function, p. 416Breast-feeding discontinue breast-feedingSide-effects see section 8.1 and notes above; redurine discoloration; thrombophlebitis over injectionsite; less commonly bronchospasm, fever, amenorrhoea,and skin rashLicensed use not licensed for use in childrenIndication and dosePaediatric malignancies including Ewing’s sarcoma,osteogenic sarcoma, Wilms’ tumour,neuroblastoma, retinoblastoma, some livertumours, acute lymphoblastic leukaemia,Hodgkin’s lymphoma, non-Hodgkin’s lymphoma. By intravenous infusionConsult local treatment protocol for detailsDoxorubicin (Non-proprietary) AInjection, powder for reconstitution, doxorubicinhydrochloride, net price 10-mg vial = £18.72; 50-mgvial = £96.86Injection, doxorubicin hydrochloride 2 mg/mL, netprice 5-mL vial = £20.60, 25-mL vial = £103.00, 100-mL vial = £275.00EPIRUBICIN HYDROCHLORIDECautions see section 8.1 and notes above; caution inhandling—irritant to tissuesContra-indications severe myocardial insufficiency,recent myocardial infarction, severe arrhythmia,unstable angina, myocardiopathy; previous treatmentwith maximum cumulative doses of epirubicin orother anthracyclineHepatic impairment reduce dose according to bilirubinconcentration—consult local treatment protocolfor details; avoid in severe impairmentRenal impairment dose reduction may be necessaryin severe impairmentPregnancy avoid (carcinogenic in animal studies); seealso Pregnancy and Reproductive Function, p. 416Breast-feeding discontinue breast-feedingSide-effects see section 8.1 and notes above; redurine discoloration; anaphylaxisLicensed use not licensed for use in childrenIndication and doseRecurrent acute lymphoblastic leukaemia,rhabdomyosarcoma, other soft tissue tumoursof childhood. Intravenous infusionConsult local treatment protocol for details