BNF for Children 2011-2012

BNFC 2011–2012 5.3.1 HIV infection 319Non-nucleoside reverse transcriptaseinhibitorsEFAVIRENZCautions history of mental illness or seizures; monitorliver function if receiving other hepatotoxic drugs;interactions: Appendix 1 (efavirenz)Rash Rash, usually in the first 2 weeks, is the most commonside-effect; discontinue if severe rash with blistering, desquamation,mucosal involvement or fever; if rash mild ormoderate, may continue without interruption—usuallyresolves within 1 monthPsychiatric disorders Children or their carers should beadvised to seek immediate medical attention if symptomssuch as severe depression, psychosis or suicidal ideationoccurContra-indications acute porphyria (but see section9.8.2)Hepatic impairment in mild to moderate liver disease,monitor for dose-related side-effects (e.g. CNSeffects) and liver function; avoid in severe impairment;greater risk of hepatic side-effects in chronichepatitis B or CRenal impairment manufacturer advises caution insevere renal failure—no information availablePregnancy manufacturer advises avoid (effectivecontraception required during treatment and for 12weeks after treatment); use efavirenz only if no alternativeavailableBreast-feeding see p. 310Side-effects rash including Stevens-Johnsonsyndrome (see Rash above); abdominal pain, diarrhoea,nausea, vomiting; anxiety, depression, sleepdisturbances, abnormal dreams, dizziness, headache,fatigue, impaired concentration (administration atbedtime especially in first 2–4 weeks reduces CNSeffects); pruritus; less commonly pancreatitis, hepatitis,flushing, psychosis, mania, suicidal ideation,amnesia, ataxia, tremor, convulsions, gynaecomastia,blurred vision, tinnitus; rarely hepatic failure, photosensitivity;also reported raised serum cholesterol (seeLipodystrophy syndrome, p. 310); see also Osteonecrosis,p. 311Indication and doseSee preparationsSustiva c (Bristol-Myers Squibb) ACapsules, efavirenz 50 mg (yellow/white), net price30-cap pack = £16.73; 100 mg (white), 30-cap pack =£33.41; 200 mg (yellow), 90-cap pack = £200.27.Label: 23DoseHIV infection in combination with other antiretroviraldrugs. By mouthChild 3–18 yearsBody-weight 13–15 kg 200 mg once dailyBody-weight 15–20 kg 250 mg once dailyBody-weight 20–25 kg 300 mg once dailyBody-weight 25–32.5 kg 350 mg once dailyBody-weight 32.5–40 kg 400 mg once dailyBody-weight 40 kg and over 600 mg once dailyAdministration Capsules may be opened and contentsadded to food (contents have a peppery taste) [unlicenseduse]Tablets, f/c, yellow, efavirenz 600 mg, net price 30-tabpack = £200.27. Label: 23DoseHIV infection in combination with other antiretroviraldrugs. By mouthChild body-weight over 40 kg 600 mg once dailyOral solution, sugar-free, strawberry and mint flavour,efavirenz 30 mg/mL, net price 180-mL pack =£53.84DoseHIV infection in combination with other antiretroviraldrugs. By mouthChild 3–5 yearsBody-weight 13–15 kg 360 mg once dailyBody-weight 15–20 kg 390 mg once dailyBody-weight 20–25 kg 450 mg once dailyBody-weight 25–32.5 kg 510 mg once dailyChild 5–18 yearsBody-weight 13–15 kg 270 mg once dailyBody-weight 15–20 kg 300 mg once dailyBody-weight 20–25 kg 360 mg once dailyBody-weight 25–32.5 kg 450 mg once dailyBody-weight 32.5–40 kg 510 mg once dailyBody-weight 40 kg and over 720 mg once dailyNote The bioavailability of Sustiva c oral solution is lowerthan that of the capsules and tablets; the oral solution is notinterchangeable with either capsules or tablets on amilligram-for-milligram basisWith emtricitabine and tenofovirSee under TenofovirETRAVIRINECautions interactions: Appendix 1 (etravirine)Hypersensitivity reactions Rash, usually in the secondweek, is the most common side-effect and appears morefrequently in females. Life-threatening hypersensitivityreactions reported usually during week 3–6 of treatment andcharacterised by rash, eosinophilia, and systemic symptoms(including fever, general malaise, myalgia, arthralgia, blistering,oral lesions, conjunctivitis, and hepatitis). Discontinuepermanently if hypersensitivity reaction or severe rashdevelop. If rash mild or moderate (without signs of hypersensitivityreaction), may continue without interruption—usually resolves within 2 weeksCounselling Children and carers should be told how torecognise hypersensitivity reactions and advised to seekimmediate medical attention if hypersensitivity reaction orsevere rash developContra-indications acute porphyria (but see section9.8.2)Hepatic impairment use with caution in moderateimpairment; avoid in severe impairment—no informationavailable; greater risk of hepatic side-effects inchronic hepatitis B or CPregnancy manufacturer advises use only if potentialbenefit outweighs riskBreast-feeding see p. 310Side-effects rash (including Stevens-Johnsonsyndrome rarely and toxic epidermal necrolysis veryrarely; see also Hypersensitivity Reactions above);gastro-oesophageal reflux, nausea, abdominal pain,flatulence, gastritis; hypertension; peripheral neuropathy;diabetes, hyperlipidaemia (see also Lipody-5 Infections