▶Child 3–17 years (body-weight 40 kg and above): 600 mg
twice daily
▶Child 12–17 years: 800 mg once daily, once daily dose
only to be used if no resistance to darunavir, if plasma
HIV-RNA concentration less than100 000copies/mL,
and if CD 4 cell count greater than 100 cells 6106 / litre
HIV infection in combination with other antiretroviral
drugs in patients not previously treated with
antiretroviral therapy—with low-dose ritonavir
▶BY MOUTH
▶Child 12–17 years (body-weight 40 kg and above): 800 mg
once dailylINTERACTIONS→Appendix 1 : HIV-protease inhibitors
lSIDE-EFFECTS
▶Common or very commonHyperlipidaemia.skin reactions.
sleep disorders
▶UncommonAbdominal discomfort.angina pectoris.
arrhythmias.burping.chest pain.concentration impaired
.confusion.constipation.cough.depression.dry eye.
eye erythema.feeling hot.flushing.gastritis.gout.
gynaecomastia.haemorrhage.hepatic disorders.herpes
simplex.hyperglycaemia.hypothyroidism.lethargy.
leucopenia.memory loss.mood altered.muscle weakness
.myocardial infarction.nail discolouration.
nephrolithiasis.oral disorders.osteoporosis.pain.
peripheral oedema.polydipsia.QT interval prolongation.
renal impairment.sensation abnormal.sexual
dysfunction.sweat changes.throat irritation.
thrombocytopenia.urinary disorders.urine abnormalities
.vertigo
▶Rare or very rareArthritis.chills.feeling abnormal.joint
stiffness.musculoskeletal stiffness.palpitations.
restlessness.rhinorrhoea.severe cutaneous adverse
reactions (SCARs).syncope.taste loss.visual impairment
SIDE-EFFECTS, FURTHER INFORMATIONMild to moderate
rash occurs commonly, usually within thefirst 4 weeks of
therapy and resolves without stopping treatment. Severe
skin rash (including Stevens-Johnson syndrome and toxic
epidermal necrolysis) occurs less frequently and may be
accompanied by fever, malaise, arthralgia, myalgia, oral
lesions, conjunctivitis, hepatitis, or eosinophilia;
treatment should be stopped if this develops.
lALLERGY AND CROSS-SENSITIVITYUse with caution in
patients with sulfonamide sensitivity.
lPREGNANCYManufacturer advises use only if potential
benefit outweighs risk; if required, use the twice daily dose
regimen.
lHEPATIC IMPAIRMENTManufacturer advises caution in
mild to moderate impairment; avoid in severe
impairment—no information available.
lMONITORING REQUIREMENTSMonitor liver function
before and during treatment.
lPRESCRIBING AND DISPENSING INFORMATIONFlavours of
oral liquid formulations may include strawberry.
lPATIENT AND CARER ADVICE
Missed dosesIf a dose is more than 6 hours late on the
twice daily regimen (or more than 12 hours late on the
once daily regimen), 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.
Oral suspension
CAUTIONARY AND ADVISORY LABELS 21
▶Prezista(Janssen-Cilag Ltd)
Darunavir (as Darunavir ethanolate) 100 mg per 1 mlPrezista
100 mg/ml oral suspension sugar-free| 200 mlP£ 248. 17Tablet
CAUTIONARY AND ADVISORY LABELS 21
▶Prezista(Janssen-Cilag Ltd)
Darunavir (as Darunavir ethanolate) 75 mgPrezista 75 mg tablets
| 480 tabletP£ 446. 70
Darunavir (as Darunavir ethanolate) 150 mgPrezista 150 mg
tablets| 240 tabletP£ 446. 70
Darunavir (as Darunavir ethanolate) 400 mgPrezista 400 mg
tablets| 60 tabletP£ 297. 80
Darunavir (as Darunavir ethanolate) 600 mgPrezista 600 mg
tablets| 60 tabletP£ 446. 70
Darunavir (as Darunavir ethanolate) 800 mgPrezista 800 mg
tablets| 30 tabletP£ 297. 80Darunavir with cobicistat,
emtricitabine and tenofovir
alafenamide 06-Feb-2018
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, darunavir p. 423 , cobicistat, emtricitabine
p. 418 , tenofovir alafenamide p. 400.lINDICATIONS AND DOSE
HIV infection (initiated by a specialist)
▶BY MOUTH
▶Child 12–17 years (body-weight 40 kg and above): 1 tablet
once dailylINTERACTIONS→Appendix 1 : cobicistat.HIV-protease
inhibitors.tenofovir alafenamide
lPREGNANCYManufacturer advises use only if potential
benefit outweighs risk.
lRENAL IMPAIRMENTManufacturer advises avoid if
estimated glomerularfiltration rate less than
30 mL/minute/ 1. 73 m2
—no information available.
lPATIENT AND CARER ADVICE
Driving and skilled tasksManufacturer advises patients and
carers should be counselled on the effects on driving and
performance of skilled tasks—increased risk of dizziness.
lNATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) Decisions
SMC No. 1290/18
TheScottish Medicines Consortiumhas advised (January
2018 ) that darunavir with cobicistat, emtricitabine and
tenofovir alafenamide (Symtuza®) is accepted for use
within NHS Scotland for the treatment of human
immunodeficiency virus type 1 (HIV- 1 ) infection in adults
and adolescents (aged 12 years and older with body weight
at least 40 kg).
All Wales Medicines Strategy Group (AWMSG) Decisions
AWMSG No. 2418
TheAll Wales Medicines Strategy Grouphas advised (March
2018 ) that darunavir with cobicistat, emtricitabine and
tenofovir alafenamide (Symtuza®) is recommended as an
option for use within NHS Wales for the treatment of
human immunodeficiency virus type 1 (HIV- 1 ) infection in
adults and adolescents (aged 12 years and older with body
weight at least 40 kg).lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Tablet
CAUTIONARY AND ADVISORY LABELS 21
▶Symtuza(Janssen-Cilag Ltd)A
Tenofovir alafenamide (as Tenofovir alafenamide fumarate)
10 mg, Cobicistat 150 mg, Emtricitabine 200 mg, Darunavir (as
Darunavir ethanolate) 800 mgSymtuza
800 mg/ 150 mg/ 200 mg/ 10 mg tablets| 30 tabletP£ 672. 97424 Viral infection BNFC 2018 – 2019
Infection5