Emtricitabine with rilpivirine and
tenofovir alafenamide 05-Jun-2017
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, emtricitabine p. 418 , rilpivirine p. 415 ,
tenofovir alafenamide p. 400.
lINDICATIONS AND DOSE
HIV infection in patients with plasma HIV- 1 RNA
concentration of 100000 copies/mL or less (specialist
use only)
▶BY MOUTH
▶Child 12–17 years (body-weight 35 kg and above): 1 tablet
once dailylINTERACTIONS→Appendix 1 : rilpivirine.tenofovir
alafenamide
lSIDE-EFFECTS
▶Common or very commonAppetite decreased.depression.
diarrhoea.dizziness.drowsiness.dry mouth.fatigue.
flatulence.gastrointestinal discomfort.headache.nausea
.skin reactions.sleep disorders.vomiting
▶UncommonAnaemia.angioedema.arthralgia.immune
reconstitution inflammatory syndrome
▶Frequency not knownConjunctivitis.drug reaction with
eosinophilia and systemic symptoms (DRESS).
eosinophilia.fever.osteonecrosis.QT interval
prolongation.weight increased
SIDE-EFFECTS, FURTHER INFORMATIONSystemic symptoms
reported with severe skin reactions include fever, blisters,
conjunctivitis, angioedema, elevated liver function tests,
and eosinophilia.
lHEPATIC IMPAIRMENTManufacturer advises use with
caution in moderate impairment (greater risk of hepatic
side-effects); avoid in severe impairment—no information
available.
lRENAL IMPAIRMENTManufacturer advises avoid if
creatinine clearance less than 30 mL/minute—no
information available.
lPATIENT AND CARER ADVICE
VomitingManufacturer advises if vomiting occurs within
4 hours of taking a dose, a replacement dose should be
taken.
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
TheScottish Medicines Consortiumhas advised (October
2016 ) that emtricitabine with rilpivirine and tenofovir
alafenamide (Odefsey®) is accepted for use within NHS
Scotland for the treatment of human immunodeficiency
virus type 1 (HIV- 1 ), without known mutations associated
with resistance to the non-nucleoside reverse
transcriptase inhibitor (NNRTI) class, tenofovir or
emtricitabine, and with viral load HIV- 1 RNA of
100 000copies/mL or less.
All Wales Medicines Strategy Group (AWMSG) Decisions
TheAll Wales Medicines Strategy Grouphas advised
(November 2016 ) that emtricitabine with rilpivirine and
tenofovir alafenamide (Odefsey®) is recommended as an
option for use within NHS Wales for the treatment of
human immunodeficiency virus type 1 , without known
mutations associated with resistance to the non-
nucleoside reverse transcriptase inhibitor (NNRTI) class,
tenofovir or emtricitabine, and with viral load HIV- 1 RNA
of100 000copies/mL or less.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Tablet
CAUTIONARY AND ADVISORY LABELS3, 21
▶Odefsey(Gilead Sciences International Ltd)A
Rilpivirine (as Rilpivirine hydrochloride) 25 mg, Tenofovir
alafenamide (as Tenofovir alafenamide fumarate) 25 mg,
Emtricitabine 200 mgOdefsey 200 mg/ 25 mg/ 25 mg tablets|
30 tabletP£ 525. 95Emtricitabine with tenofovir
alafenamide 05-Jun-2017
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, emtricitabine p. 418 , tenofovir alafenamide
p. 400.lINDICATIONS AND DOSE
HIV infection in combination with other antiretroviral
drugs (specialist use only)
▶BY MOUTH
▶Child 12–17 years (body-weight 35 kg and
above): 200 / 10 – 200 / 25 mg once daily, dose is
dependent on drug regimen—consult product
literature
DOSE EQUIVALENCE AND CONVERSION
▶Dose expressed as x/y mg emtricitabine/tenofovir
alafenamide.lINTERACTIONS→Appendix 1 : tenofovir alafenamide
lSIDE-EFFECTS
▶Common or very commonAbnormal dreams.diarrhoea.
dizziness.fatigue.flatulence.gastrointestinal discomfort
.headache.nausea.skin reactions.vomiting
▶UncommonAnaemia.arthralgia
▶Frequency not knownAngioedema.osteonecrosis
lHEPATIC IMPAIRMENTManufacturer advises use with
caution (greater risk of hepatic side-effects).
lRENAL IMPAIRMENTManufacturer advises avoid if
creatinine clearance less than 30 mL/minute—limited
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
TheScottish Medicines Consortiumhas advised (August
2016 ) that emtricitabine with tenofovir alafenamide
(Descovy®) is accepted for use within NHS Scotland for the
treatment of human immunodeficiency virus type 1 in
combination with other antiretroviral agents.
All Wales Medicines Strategy Group (AWMSG) Decisions
TheAll Wales Medicines Strategy Grouphas advised
(September 2016 ) that emtricitabine with tenofovir
alafenamide (Descovy®) is recommended as an option for
use within NHS Wales for the treatment of human
immunodeficiency virus type 1 in combination with other
antiretroviral agents.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Tablet
▶Descovy(Gilead Sciences International Ltd)A
Tenofovir alafenamide (as Tenofovir alafenamide fumarate)
25 mg, Emtricitabine 200 mgDescovy 200 mg/ 25 mg tablets|
30 tabletP£ 355. 73BNFC 2018 – 2019 HIV infection 419
Infection5