BNF for Children 2011-2012

320 5.3.1 HIV infection BNFC 2011–2012strophy Syndrome, p. 310); renal failure; anaemia; lesscommonly pancreatitis, haematemesis, hepatitis,chest pain, bronchospasm, drowsiness, malaise,gynaecomastia, blurred vision, dry mouth, andsweating; also reported, haemorrhagic stroke; see alsoOsteonecrosis, p. 311Licensed use not licensed for use in childrenIndication and doseIn combination with other antiretroviral drugs(including a boosted protease inhibitor) for HIVinfection resistant to other non-nucleosidereverse transcriptase inhibitors and proteaseinhibitorsFor dose, consult Guidelines (see notes above)Administration for children with swallowing difficulties,tablets may be dispersed in a glass of water justbefore administrationIntelence c (Janssen) TATablets, etravirine 100 mg, net price 120-tab pack =£301.27. Label: 21counselling, rash, and hypersensitivity reactionsNote Dispense in original container (contains desiccant)and rash, see Hepatic Disease above), arthralgia,anaemia, and granulocytopenia; very rarely neuropsychiatricreactions; see also Osteonecrosis, p. 311Licensed use tablets, not licensed for use in childrenweighing less than 50 kg or with body surface arealess than 1.25 m 2Indication and doseHIV infection in combination with other antiretroviraldrugs. By mouthNeonate 14–28 days 150–200 mg/m 2 once dailyfor first 14 days, then (if no rash present)150–200 mg/m 2 twice dailyChild 1 month–18 years 150–200 mg/m 2 (max.200 mg) once daily for first 14 days, then (if no rashpresent) 150–200 mg/m 2 (max. 200 mg) twicedaily or 300–400 mg/m 2 (max. 400 mg) once dailyNote Initial dose titration should not exceed 28 days; if rashnot resolved within 28 days, alternative treatment should besought. If treatment interrupted for more than 7 days, restartusing the lower dose for the first 14 days as for new treatment5 InfectionsNEVIRAPINECautions chronic hepatitis B or C, high CD4 cell count,and females (all at greater risk of hepatic side-effects);interactions: Appendix 1 (nevirapine)Hepatic disease Potentially life-threatening hepatotoxicityincluding fatal fulminant hepatitis reported usually in first 6weeks; close monitoring required during first 18 weeks;monitor liver function before treatment then every 2 weeksfor 2 months then after 1 month and then regularly; discontinuepermanently if abnormalities in liver function testsaccompanied by hypersensitivity reaction (rash, fever,arthralgia, myalgia, lymphadenopathy, hepatitis, renalimpairment, eosinophilia, granulocytopenia); suspend ifsevere abnormalities in liver function tests but no hypersensitivityreaction—discontinue permanently if significantliver function abnormalities recur; monitor patient closely ifmild to moderate abnormalities in liver function tests with nohypersensitivity reactionRash Rash, usually in first 6 weeks, is most common sideeffect;incidence reduced if introduced at low dose and doseincreased gradually; monitor closely for skin reactions duringfirst 18 weeks; discontinue permanently if severe rash or ifrash accompanied by blistering, oral lesions, conjunctivitis,facial oedema, general malaise or hypersensitivity reactions;if rash mild or moderate may continue without interruptionbut dose should not be increased until rash resolvesCounselling Children and carers should be told how torecognise hypersensitivity reactions and advised to discontinuetreatment and seek immediate medical attention ifsevere skin reaction, hypersensitivity reactions or symptomsof hepatitis developContra-indications acute porphyria (but see section9.8.2); post-exposure prophylaxisHepatic impairment manufacturer advises caution inmoderate impairment; avoid in severe impairment;see also Hepatic Disease, abovePregnancy although manufacturer advises caution,may be appropriate to use if clearly indicated; see alsop. 310Breast-feeding see p. 310Side-effects rash including Stevens-Johnsonsyndrome and rarely, toxic epidermal necrolysis (seealso Cautions above); nausea, hepatitis (see alsoHepatic Disease above), headache; less commonlyvomiting, abdominal pain, fatigue, fever, and myalgia;rarely diarrhoea, angioedema, anaphylaxis, hypersensitivityreactions (may involve hepatic reactionsViramune c (Boehringer Ingelheim) ATablets, nevirapine 200 mg, net price 14-tab pack =£39.67, 60-tab pack = £170.00. Counselling, hypersensitivityreactionsSuspension, nevirapine 50 mg/5 mL, net price 240-mL pack = £50.40. Counselling, hypersensitivityreactionsOther antiretroviralsENFUVIRTIDECautionsHypersensitivity reactions Hypersensitivity reactionsincluding rash, fever, nausea, vomiting, chills, rigors, lowblood pressure, respiratory distress, glomerulonephritis, andraised liver enzymes reported; discontinue immediately ifany signs or symptoms of systemic hypersensitivity developand do not rechallengeCounselling Children and carers should be told how torecognise signs of hypersensitivity, and advised to discontinuetreatment and seek prompt medical attention ifsymptoms developHepatic impairment manufacturer advises caution—no information available; chronic hepatitis B or C(possibly greater risk of hepatic side-effects)Pregnancy manufacturer advises use only if potentialbenefit outweighs riskBreast-feeding see p. 310Side-effects injection-site reactions; pancreatitis,gastro-oesophageal reflux disease, anorexia, weightloss; hypertriglyceridaemia; peripheral neuropathy,asthenia, tremor, anxiety, nightmares, irritability,impaired concentration, vertigo; pneumonia, sinusitis,influenza-like illness; diabetes mellitus; haematuria;renal calculi, lymphadenopathy; myalgia; conjunctivitis;dry skin, acne, erythema, skin papilloma; lesscommonly hypersensitivity reactions (see Cautions);see also Osteonecrosis, p. 311