▶Neonate up to 7 days (body-weight 4 kg): 7 mg once daily.▶Neonate 7 days to 28 days (body-weight 2 kg): 8 mg twice
daily.▶Neonate 7 days to 28 days (body-weight 3 kg): 10 mg twice
daily.▶Neonate 7 days to 28 days (body-weight 4 kg): 15 mg twice
daily.▶Child (body-weight 3 kg): 25 mg twice daily
▶Child (body-weight 4–5kg): 30 mg twice daily
▶Child (body-weight 6–7 kg): 40 mg twice daily
▶Child (body-weight 8–10 kg): 60 mg twice daily
▶Child (body-weight 11–13 kg): 80 mg twice daily
▶Child (body-weight 14–19 kg): 100 mg twice daily
DOSE EQUIVALENCE AND CONVERSION
▶Raltegravir granules for oral suspension and chewable
tablets arenotbioequivalent or interchangeable with
the 400 mg and 600 mgstandardtablets.lCONTRA-INDICATIONSPre-term neonates—no information
available
lCAUTIONSPsychiatric illness (may exacerbate underlying
illness including depression).risk factors for myopathy.
risk factors for rhabdomyolysis
lINTERACTIONS→Appendix 1 : raltegravir
lSIDE-EFFECTS
▶Common or very commonAkathisia.appetite abnormal.
asthenia.behaviour abnormal.depression.diarrhoea.
dizziness.fever.gastrointestinal discomfort.
gastrointestinal disorders.headaches.nausea.skin
reactions.sleep disorders.vertigo.vomiting
▶UncommonAlopecia.anaemia.anxiety.arrhythmias.
arthralgia.arthritis.body fat disorder.burping.cachexia.
chest discomfort.chills.cognitive disorder.concentration
impaired.confusion.constipation.diabetes mellitus.
drowsiness.dry mouth.dyslipidaemia.dysphonia.
erectile dysfunction.feeling jittery.glossitis.
gynaecomastia.haemorrhage.hepatic disorders.hot
flush.hyperglycaemia.hypersensitivity.hypertension.
immune reconstitution inflammatory syndrome.
increased risk of infection.lipodystrophy.lymph node
abscess.lymphatic abnormalities.malaise.memory loss.
menopausal symptoms.mood altered.myalgia.myopathy
.nasal congestion.nephritis.nephrolithiasis.nerve
disorders.neutropenia.nocturia.odynophagia.oedema.
osteopenia.pain.palpitations.pancreatitis acute.
polydipsia.psychiatric disorder.renal cyst.renal
impairment.sensation abnormal.severe cutaneous
adverse reactions (SCARs).skin papilloma.submandibular
mass.suicidal tendencies.sweat changes.taste altered.
tendinitis.thrombocytopenia.tinnitus.tremor.visual
impairment.weight increased
▶Frequency not knownOsteonecrosis
SIDE-EFFECTS, FURTHER INFORMATIONRash occurs
commonly. Discontinue if severe rash or rash accompanied
by fever, malaise, arthralgia, myalgia, blistering, mouth
ulceration, conjunctivitis, angioedema, hepatitis, or
eosinophilia.
For further information regardinglipodystrophyand
osteonecrosissee HIV infection p. 409.
lPREGNANCYManufacturer advises avoid—toxicity in
animalstudies.
lHEPATIC IMPAIRMENTManufacturer advises caution in
severe impairment—no information available. Use with
caution in patients with chronic hepatitis B or C (at greater
risk of hepatic side-effects).lDIRECTIONS FOR ADMINISTRATIONManufacturer advises
forchewable tablets,the 100 mg strength can be divided
into equal 50 mg doses.
lPRESCRIBING AND DISPENSING INFORMATIONDispense
raltegravir chewable tablets in original container (contains
desiccant).
lNATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) Decisions
TheScottish Medicines Consortiumhas advised (September
2013 ) that raltegravir (Isentress®) is accepted for restricted
use within NHS Scotland for the treatment of HIV- 1
infection in adolescents and children aged 2 to 17 years
when non-nucleoside reverse transcriptase inhibitors or
protease inhibitors cannot be used because of intolerance,
drug interactions, or resistance; raltegravir should be
prescribed under the supervision of specialists in
paediatric HIV.
TheScottish Medicines Consortiumhas advised
(November 2015 ) that raltegravir granules for oral
suspension (Isentress®) are accepted for restricted use
within NHS Scotland for the treatment of HIV- 1 infection
in adults, adolescents, children, toddlers and infants from
the age of 4 weeks when non-nucleoside reverse
transcriptase inhibitors or protease inhibitors cannot be
used because of intolerance, drug interactions, or
resistance; raltegravir granules should be prescribed under
the supervision of specialists in paediatric HIV.
TheScottish Medicines Consortiumhas advised
(November 2015 ) that raltegravir chewable tablets
(Isentress®) are accepted for restricted use within NHS
Scotland for the treatment of HIV- 1 infection in children
from the age of 4 weeks to< 2 years when non-nucleoside
reverse transcriptase inhibitors or protease inhibitors
cannot be used because of intolerance, drug interactions,
or resistance; raltegravir chewable tablets should be
prescribed under the supervision of specialists in
paediatric HIV.
TheScottish Medicines Consortiumhas advised
(November 2017 ) that raltegravir 600 mgfilm-coated
tablets (Isentress®) are accepted for restricted use within
NHS Scotland for the treatment of HIV- 1 infection in
adults and paediatric patients weighing at least 40 kg when
non-nucleoside reverse transcriptase inhibitors or
protease inhibitors cannot be used because of intolerance,
drug interactions, or resistance.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Granules
EXCIPIENTS:May contain Sorbitol
▶Isentress(Merck Sharp & Dohme Ltd)
Raltegravir 100 mgIsentress 100 mg granules sachets|
60 sachetP£ 213. 02 DT = £ 213. 02
Tablet
CAUTIONARY AND ADVISORY LABELS 25
▶Isentress(Merck Sharp & Dohme Ltd)
Raltegravir 400 mgIsentress 400 mg tablets| 60 tabletP
£ 471. 41
Raltegravir 600 mgIsentress 600 mg tablets| 60 tabletP
£ 471. 41
Chewable tablet
CAUTIONARY AND ADVISORY LABELS 24
EXCIPIENTS:May contain Aspartame
▶Isentress(Merck Sharp & Dohme Ltd)
Raltegravir 25 mgIsentress 25 mg chewable tablets|
60 tabletP£ 29. 46 DT = £ 29. 46
Raltegravir 100 mgIsentress 100 mg chewable tablets|
60 tabletP£ 117. 85 DT = £ 117. 85412 Viral infection BNFC 2018 – 2019
Infection5