lINTERACTIONS→Appendix 1 : etravirine
lSIDE-EFFECTS
▶Common or very commonDiabetes mellitus.diarrhoea.
headache.hyperglycaemia.myocardial infarction.nausea
.skin reactions.vomiting
▶UncommonAngioedema.bronchospasm.dry mouth.
dyslipidaemia.gynaecomastia.haematemesis.hepatic
disorders.hyperhidrosis.hypersensitivity.hypersomnia.
numbness.pancreatitis.sluggishness.vision blurred
▶Rare or very rareSevere cutaneous adverse reactions
(SCARs)
▶Frequency not knownHaemorrhagic stroke.osteonecrosis.
weight increased
SIDE-EFFECTS, FURTHER INFORMATIONFor further
information regardingosteonecrosis, immune
reconstitution syndromeandlipodystrophy,see HIV
infection p. 409.
Hypersensitivity reactionsRash, usually in the second
week, is the most common side-effect and appears more
frequently in females. Life-threatening hypersensitivity
reactions reported usually during week^3 -^6 of treatment
and characterised by rash, eosinophilia, and systemic
symptoms (including fever, general malaise, myalgia,
arthralgia, blistering, oral lesions, conjunctivitis, and
hepatitis). Discontinue permanently if hypersensitivity
reaction or severe rash develop. If rash mild or moderate
(without signs of hypersensitivity reaction), may continue
without interruption—usually resolves within 2 weeks.
lHEPATIC IMPAIRMENTManufacturer advises caution in
moderate impairment; avoid in severe impairment—no
information available; greater risk of hepatic side-effects
in chronic hepatitis B or C.
lDIRECTIONS FOR ADMINISTRATIONPatients with
swallowing difficulties may disperse tablets in a glass of
water just before administration.
lPRESCRIBING AND DISPENSING INFORMATIONDispense in
original container (contains desiccant).
lPATIENT AND CARER ADVICE
Hypersensitivity reactionsPatients or carers should be told
how to recognise hypersensitivity reactions and advised to
seek immediate medical attention if hypersensitivity
reaction or severe rash develop.
Missed dosesIf a dose is more than 6 hours late, the
missed dose should not be taken and the next dose should
be taken at the normal time.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Tablet
CAUTIONARY AND ADVISORY LABELS 21
▶Intelence(Janssen-Cilag Ltd)
Etravirine 25 mgIntelence 25 mg tablets| 120 tabletP£ 75. 32
Etravirine 100 mgIntelence 100 mg tablets| 120 tabletP
£ 301. 27
Etravirine 200 mgIntelence 200 mg tablets| 60 tabletP
£ 301. 27Nevirapine
lINDICATIONS AND DOSE
HIV infection in combination with other antiretroviral
drugs (initial dose)
▶BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶Child:Initially 150 – 200 mg/m^2 once daily (max. per
dose 200 mg) forfirst 14 days, initial dose titration
using‘immediate-release’preparation should not
exceed 28 days; if rash occurs and is not resolved
within 28 days, alternative treatment should be sought.
If treatment interrupted for more than 7 days, restartusing the lower dose of the‘immediate-release’
preparation for thefirst 14 days as for new treatment
HIV infection in combination with other antiretroviral
drugs (maintenance dose following initial dose titration
if no rash present)
▶BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶Child 1 month–2 years: 150 – 200 mg/m^2 twice daily (max.
per dose 200 mg), alternatively 300 – 400 mg/m^2 once
daily (max. per dose 400 mg)
▶Child 3–17 years: 150 – 200 mg/m^2 twice daily (max. per
dose 200 mg)
HIV infection in combination with other antiretroviral
drugs (maintenance dose following initial dose titration
if no rash present)
▶BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶Child 3–17 years (body surface area 0.58–0.83 m^2 ): 200 mg
once daily
▶Child 3–17 years (body surface area 0.84–1.17 m^2 ): 300 mg
once daily
▶Child 3–17 years (body surface area 1.18 m^2 and
above): 400 mg once daily
▶BY MOUTH USING MODIFIED-RELEASE MEDICINES
▶Child 3–17 years (body surface area 0.58–0.83 m^2 ): 200 mg
once daily
▶Child 3–17 years (body surface area 0.84–1.17 m^2 ): 300 mg
once daily
▶Child 3–17 years (body surface area 1.18 m^2 and
above): 400 mg once dailylUNLICENSED USE’Immediate-release’tablets not licensed
for use in children weighing less than 50 kg or with body
surface area less than 1. 25 m^2 ;‘immediate-release’tablets
and suspension not licensed for once daily dose after the
initial dose titration.
lCONTRA-INDICATIONSAcute porphyrias p. 603 .post-
exposure prophylaxis
lCAUTIONSFemales (at greater risk of hepatic side effects).
high CD4 cell count (at greater risk of hepatic side effects)
lINTERACTIONS→Appendix 1 : nevirapine
lSIDE-EFFECTS
▶Common or very commonAbdominal pain.angioedema.
diarrhoea.fatigue.fever.headache.hepatic disorders.
hypersensitivity.hypertransaminasaemia.nausea.skin
reactions.vomiting
▶UncommonAnaemia.arthralgia.myalgia.severe
cutaneous adverse reactions (SCARs)
▶Frequency not knownEosinophilia.osteonecrosis.weight
increased
SIDE-EFFECTS, FURTHER INFORMATION
Hepatic effectsPotentially life-threatening
hepatotoxicity including fatal fulminant hepatitis reported
usually infirst 6 weeks; discontinue permanently if
abnormalities in liver function tests accompanied by
hypersensitivity reaction (rash, fever, arthralgia, myalgia,
lymphadenopathy, hepatitis, renal impairment,
eosinophilia, granulocytopenia); suspend if severe
abnormalities in liver function tests but no
hypersensitivity reaction—discontinue permanently if
significant liver function abnormalities recur; monitor
patient closely if mild to moderate abnormalities in liver
function tests with no hypersensitivity reaction.
RashRash, usually infirst 6 weeks, is most common side-
effect; incidence reduced if introduced at low dose and
dose increased gradually (after 14 days). Discontinue
permanently if severe rash or if rash accompanied by
blistering, oral lesions, conjunctivitis, facial oedema,
general malaise or hypersensitivity reactions; if rash mild
or moderate may continue without interruption but dose
should not be increased until rash resolves.414 Viral infection BNFC 2018 – 2019
Infection5