BNF for Children 2011-2012

BNFC 2011–2012 8.1.5 Other antineoplastic drugs 429taxis; dry skin, sweating, rash, pruritus, photosensitivity;less commonly gastric ulceration, pancreatitis,hepatic dysfunction (rarely hepatic failure, hepaticnecrosis), dysphagia, heart failure, tachycardia, palpitation,syncope, hypertension, hypotension, coldextremities, cough, acute respiratory failure, depression,drowsiness, anxiety, peripheral neuropathy, tremor,migraine, impaired memory, vertigo, gynaecomastia,menorrhagia, irregular menstruation, sexualdysfunction, electrolyte disturbances, renal failure,urinary frequency, gout, tinnitus, hearing loss; skinhyperpigmentation; rarely intestinal obstruction,gastro-intestinal perforation, inflammatory boweldisease, arrhythmia, atrial fibrillation, myocardialinfarction, angina, pulmonary fibrosis, pulmonaryhypertension, increased intracranial pressure, convulsions,confusion, haemolytic anaemia, rhabdomyolysis,myopathy, aseptic necrosis of bone, cataract,glaucoma, angioedema, exfoliative dermatitis,and Stevens-Johnson syndromeIndication and doseChronic phase and advanced phase chronicmyeloid leukaemia. By mouthConsult local treatment protocol for detailsGlivec c (Novartis) TATablets, f/c, imatinib (as mesilate) 100 mg (yellowbrown,scored), net price 60-tab pack = £802.04;400 mg (yellow), 30-tab pack = £1604.08. Label: 21, 27Counselling Tablets may be dispersed in water or applejuiceMitotaneMitotane is used in children for the symptomatic treatmentof advanced or inoperable adrenocortical carcinoma.It selectively inhibits the activity of the adrenalcortex, necessitating corticosteroid replacement therapy(section 6.3.1); the dose of glucocorticoid should beincreased in case of shock, trauma, or infection. Neuropsychologicalimpairment can occur, possibly secondaryto hypothyroidism, and growth retardation has alsobeen reported in children treated with mitotane.MITOTANECautions see notes above; risk of accumulation inoverweight patients; monitor plasma-mitotane concentration—consultproduct literature; avoid in acuteporphyria (section 9.8.2); interactions: Appendix 1(mitotane)Skilled tasks Central nervous system toxicity may affectperformance of skilled tasksCounselling Children and their carers should be warned tocontact doctor immediately if injury, infection, or illnessoccurs (because of the risk of acute adrenal insufficiency)Hepatic impairment manufacturer advises caution inmild to moderate impairment—monitoring of plasmamitotaneconcentration recommended; avoid insevere impairmentRenal impairment manufacturer advises caution inmild to moderate renal impairment—monitoring ofplasma-mitotane concentration recommended; avoidin severe impairmentPregnancy manufacturer advises avoid—women ofchild-bearing age should use effective contraceptionduring and after treatment; see also Pregnancy andReproductive Function, p. 416Breast-feeding discontinue breast-feedingSide-effects see section 8.1 and notes above; alsogastro-intestinal disturbances (including nausea,vomiting, diarrhoea, epigastric discomfort), anorexia,liver disorders; hypercholesterolaemia, hypertriglyceridaemia;ataxia, confusion, asthenia, myasthenia,paraesthesia, drowsiness, neuropathy, cognitiveimpairment, movement disorder, dizziness, headache;gynaecomastia; prolonged bleeding time, leucopenia,thrombocytopenia, anaemia; rash; rarely hypersalivation,hypertension, postural hypotension, flushing,pyrexia, haematuria, proteinuria, haemorrhagic cystitis,hypouricaemia, visual disturbances and oculardisordersLicensed use not licensed for use in childrenIndication and doseSymptomatic treatment of advanced or inoperableadrenocortical carcinoma. By mouthConsult local treatment protocol for detailsLysodren c (HRA Pharma) ATablets, scored, mitotane 500 mg, net price 100-tabpack = £590.97. Label: 2, 10, 21, counselling, skilledtasks, adrenal suppressionPlatinum compoundsCarboplatin is used in the treatment of a variety ofpaediatric malignancies; it is given by intravenous infusion.Carboplatin can be given in an outpatient settingand is better tolerated than cisplatin; nausea and vomitingare less severe and nephrotoxicity, neurotoxicity,and ototoxicity are much less of a problem. Carboplatinis, however, more myelosuppressive than cisplatin.Cisplatin is of value in children with a variety ofmalignancies; it is given by intravenous infusion. Cisplatinrequires intensive intravenous hydration; routineuse of intravenous fluids containing potassium ormagnesium may also be required to help control hypokalaemiaand hypomagnesaemia. Treatment may becomplicated by severe nausea and vomiting; delayedvomiting may occur and is difficult to control. Cisplatinhas dose-related and potentially cumulative side-effectsincluding nephrotoxicity, neurotoxicity, and ototoxicity.Baseline testing of renal function and hearing isrequired; for children with pre-existing renal or hearingimpairment or marked bone-marrow suppression, considerationshould be given to withholding treatment orusing another drug.CARBOPLATINCautions see section 8.1 and notes above; considertherapeutic drug monitoring; interactions: Appendix1 (platinum compounds)Renal impairment reduce dose and monitor haematologicalparameters and renal function; avoid ifcreatinine clearance less than 20 mL/minute/1.73 m 2Pregnancy avoid (teratogenic and embryotoxic inanimal studies); see also Pregnancy and ReproductiveFunction, p. 416Breast-feeding discontinue breast-feedingSide-effects see section 8.1 and notes aboveLicensed use not licensed for use in children8 Malignant disease and immunosuppression