BNF for Children 2011-2012

BNFC 2011–2012 6.6.2 Bisphosphonates 389dissolution, and therefore reducing the rate of boneturnover.A bisphosphonate such as disodium pamidronate isused in the management of severe forms of osteogenesisimperfecta and other causes of osteoporosis in childrento reduce the number of fractures; the long-term effectsof bisphosphonates in children have not been established.Single doses of biphosphonates are also used tomanage hypercalaemia (section 9.5.1.2). Treatmentshould be initiated under specialist advice only.MHRA/CHM advice (October 2007 and November2009)The risk of osteonecrosis of the jaw is substantiallygreater for patients receiving intravenous bisphosphonatesin the treatment of cancer than for patientsreceiving oral bisphosphonates for osteoporosis orPaget’s disease.Risk factors for developing osteonecrosis of the jawthat should be considered are: potency of bisphosphonate(highest for zoledronate), route of administration,cumulative dose, duration and type ofmalignant disease, concomitant treatment, smoking,comorbid conditions, and history of dental disease.All patients receiving bisphosphonates for cancershould have a dental check-up (and any necessaryremedial work should be performed) before bisphosphonatetreatment. However, urgent bisphosphonatetreatment should not be delayed, and a dentalcheck-up should be carried out as soon as possible inthese patients. All other patients who are prescribedbisphosphonates should have a dental examinationonly if they have poor dental health.During bisphosphonate treatment patients shouldmaintain good oral hygiene, receive routine dentalcheck-ups, and report any oral symptoms.ALENDRONIC ACIDCautions upper gastro-intestinal disorders (dysphagia,symptomatic oesophageal disease, gastritis, duodenitis,or ulcers—see also under Contra-indications andSide-effects); history (within 1 year) of ulcers, activegastro-intestinal bleeding, or surgery of the uppergastro-intestinal tract; correct disturbances of calciumand mineral metabolism (e.g. vitamin-D deficiency,hypocalcaemia) before starting and monitor serumcalciumconcentration during treatment; considerdental check-up before initiating bisphosphonate (riskof osteonecrosis of the jaw, see MHRA/CHM advice,above); exclude other causes of osteoporosis; atypicalstress fractures reported (discontinue unless benefitsof continued treatment clearly outweigh risks); interactions:Appendix 1 (bisphosphonates)Contra-indications abnormalities of oesophagus andother factors which delay emptying (e.g. stricture orachalasia), hypocalcaemia,Renal impairment avoid if estimated glomerular filtrationrate is less than 35 mL/minute/1.73 m 2Pregnancy avoidBreast-feeding no information availableSide-effects oesophageal reactions (see below),abdominal pain and distension, dyspepsia, regurgitation,melaena, diarrhoea or constipation, flatulence,musculoskeletal pain, headache; rarely rash, pruritus,erythema, photosensitivity, uveitis, scleritis, transientdecrease in serum phosphate; nausea, vomiting, gastritis,peptic ulceration, hypersensitivity reactions(including urticaria and angioedema), and atypicalstress fractures with long term use also reported;myalgia, malaise, and fever at initiation of treatment;very rarely severe skin reactions (including Stevens-Johnson syndrome), osteonecrosis of the jaw (seeMHRA/CHM advice, above)Oesophageal reactions Severe oesophageal reactions(oesophagitis, oesophageal ulcers, oesophageal stricture andoesophageal erosions) have been reported; patients shouldbe advised to stop taking the tablets and to seek medicalattention if they develop symptoms of oesophageal irritationsuch as dysphagia, new or worsening heartburn, pain onswallowing or retrosternal painLicensed use not licensed for use in childrenIndication and doseSee notes above, specialist use onlyCounselling Swallow the tablets whole with a full glass ofwater on an empty stomach at least 30 minutes beforebreakfast (and any other oral medication); stand or sit uprightfor at least 30 minutes and do not lie down until after eatingbreakfast. Do not take the tablets at bedtime or before rising.Fosamax c (MSD) ATablets, alendronic acid (as sodium alendronate)10 mg, 28-tab pack = £23.12. Counselling, administrationFosamax c Once Weekly (MSD) ATablets, alendronic acid (as sodium alendronate)70 mg, net price 4-tab pack = £22.80. Counselling,administrationDISODIUM PAMIDRONATEDisodium pamidronate was formerly called aminohydroxypropylidenediphosphonatedisodium (APD)Cautions cardiac disease; previous thyroid surgery(risk of hypocalcaemia); monitor serum electrolytes,calcium, and phosphate—possibility of convulsionsdue to electrolyte changes; ensure adequate hydration;avoid concurrent use with other bisphosphonates;consider dental check-up before initiatingbisphosphonate (risk of osteonecrosis of the jaw, seeMHRA/CHM advice, above); interactions: Appendix1 (bisphosphonates)Skilled tasks Patients should be warned against driving,cycling, or performing skilled tasks immediately after treatment(somnolence or dizziness can occur)Hepatic impairment use with caution in severeimpairment—no information availableRenal impairment monitor renal function in renaldisease or predisposition to renal impairment (e.g. intumour-induced hypercalcaemia)Pregnancy avoid—toxicity in animal studiesBreast-feeding avoidSide-effects hypophosphataemia, transient rise inbody temperature, fever and influenza-like symptoms(sometimes accompanied by malaise, rigors, fatigue,and flushes); arthralgia, myalgia, bone pain, nausea,vomiting, headache, lymphocytopenia, hypomagnesaemia;rarely muscle cramps, anorexia, abdominalpain, diarrhoea, constipation, dyspepsia, agitation,confusion, dizziness, insomnia, somnolence, lethargy,anaemia, leucopenia, hypotension or hypertension,rash, pruritus, symptomatic hypocalcaemia (paraesthesia,tetany), hyperkalaemia or hypokalaemia,6 Endocrine system