l PATIENT AND CARER ADVICE Patients or carers should be
given advice on how to administer Stribild ®.
Missed doses If a dose is more than 18 hours late, the
missed dose should not be taken and the next dose should
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 21
▶ Stribild (Gilead Sciences International Ltd)
Cobicistat 150 mg, Elvitegravir 150 mg, Emtricitabine 200 mg,
Tenofovir disoproxil (as Tenofovir disoproxil fumarate)
245 mg Stribild 150mg/150mg/200mg/245mg tablets | 30 tablet P £879.51
HIV infection in combination with other antiretroviral
▶ BY MOUTH USING ORAL SOLUTION
DOSE EQUIVALENCE AND CONVERSION
▶ 240 mg oral solution : 200 mg capsule; where
appropriate the capsule may be used instead of the oral
Monitoring On discontinuation, monitor patients with
hepatitis B (risk of exacerbation of hepatitis).
Dose adjustments Reduce dose if eGFR less than
l PRESCRIBING AND DISPENSING INFORMATION Flavours of
oral liquid formulations may include candy.
Missed doses If a dose is more than 12 hours late, the
missed dose should not be taken and the next dose should
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
ELECTROLYTES: May contain Sodium
▶ Emtriva (Gilead Sciences International Ltd)
Emtricitabine 10 mg per 1 ml Emtriva 10mg/ml oral solution sugarfree | 170 ml P £39.53
▶ Emtriva (Gilead Sciences International Ltd)
Emtricitabine 200 mg Emtriva 200mg capsules | 30 capsule P £138.98
Combinations available: Darunavir with cobicistat,
emtricitabine and tenofovir alafenamide, p. 658
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 above, rilpivirine p. 646,
HIV infection in patients with plasma HIV-1 RNA
concentration of 100 000 copies/mL or less (specialist
l INTERACTIONS → Appendix 1: rilpivirine .tenofovir
▶ Uncommon Anaemia . angioedema . arthralgia . immune
reconstitution inflammatory syndrome
▶ Frequency not known Conjunctivitis . drug reaction with
eosinophilia and systemic symptoms (DRESS). eosinophilia . fever. osteonecrosis . QT interval
prolongation . weight increased
SIDE-EFFECTS, FURTHER INFORMATION Systemic symptoms
reported with severe skin reactions include fever, blisters,
conjunctivitis, angioedema, elevated liver function tests,
l HEPATIC IMPAIRMENT Manufacturer advises caution in
l RENAL IMPAIRMENT Manufacturer advises avoid if
creatinine clearance less than 30 mL/minute—no
Vomiting Manufacturer advises if vomiting occurs within
4 hours of taking a dose, a replacement dose should be
Driving and skilled tasks Manufacturer advises patients and
carers should be counselled on the effects on driving and
performance of skilled tasks—increased risk of dizziness.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has 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
All Wales Medicines Strategy Group (AWMSG) decisions
The All Wales Medicines Strategy Group has 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
tenofovir or emtricitabine, and with viral load HIV-1 RNA
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 3, 21
▶ Odefsey (Gilead Sciences International Ltd) A
Rilpivirine (as Rilpivirine hydrochloride) 25 mg, Tenofovir
alafenamide (as Tenofovir alafenamide fumarate) 25 mg,
Emtricitabine 200 mg Odefsey 200mg/25mg/25mg tablets | 30 tablet P £525.95
Emtricitabine with rilpivirine and
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, tenofovir disoproxil p. 654, emtricitabine
HIV infection in patients with plasma HIV-1 RNA
concentration less than 100 000 copies/mL
l INTERACTIONS → Appendix 1: rilpivirine .tenofovir
l HEPATIC IMPAIRMENT Manufacturer advises caution in
l RENAL IMPAIRMENT Avoid Eviplera ® if eGFR less than
l PATIENT AND CARER ADVICE Patients or carers should be
given advice on how to administer Eviplera ®.
Missed doses If a dose is more than 12 hours late, the
missed dose should not be taken and the next dose should
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 21, 25
▶ Eviplera (Gilead Sciences International Ltd)
Rilpivirine (as Rilpivirine hydrochloride) 25 mg, Emtricitabine
200 mg, Tenofovir disoproxil (as Tenofovir disoproxil fumarate)
245 mg Eviplera 200mg/25mg/245mg tablets | 30 tablet P £525.95
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, emtricitabine p. 651, tenofovir alafenamide
HIV infection in combination with other antiretroviral
▶ Adult: 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
l INTERACTIONS → Appendix 1: tenofovir alafenamide
▶ Uncommon Anaemia . arthralgia
▶ Frequency not known Angioedema . osteonecrosis
l HEPATIC IMPAIRMENT Manufacturer advises use with
caution (greater risk of hepatic side-effects).
l RENAL IMPAIRMENT Manufacturer advises avoid if
creatinine clearance less than 30 mL/minute—limited
Driving and skilled tasks Manufacturer advises patients and
carers should be counselled on the effects on driving and
performance of skilled tasks—increased risk of dizziness.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has 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
The All Wales Medicines Strategy Group has 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
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Descovy (Gilead Sciences International Ltd) A
Tenofovir alafenamide (as Tenofovir alafenamide fumarate)
25 mg, Emtricitabine 200 mg Descovy 200mg/25mg tablets | 30 tablet P £355.73
Tenofovir alafenamide (as Tenofovir alafenamide fumarate)
10 mg, Emtricitabine 200 mg Descovy 200mg/10mg tablets | 30 tablet P £355.73
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, tenofovir disoproxil p. 654, emtricitabine
HIV-1 infection (initiated by a specialist)
▶ Adult: 200/245 mg once daily
Pre-exposure prophylaxis of HIV-1 infection (initiated by a
▶ Adult: 200/245 mg once daily
DOSE EQUIVALENCE AND CONVERSION
▶ Dose expressed as x/y mg emtricitabine/tenofovir
l INTERACTIONS → Appendix 1: tenofovir disoproxil
▶ When used for HIV-1 infection Manufacturer advises avoid in
▶ When used for Pre-exposure prophylaxis of HIV-1
infection Manufacturer advises avoid if creatinine
clearance less than 60 mL/minute.
▶ When used for HIV-1 infection Manufacturer advises use
normal dose every 2 days in moderate impairment.
l DIRECTIONS FOR ADMINISTRATION Patients with
swallowing difficulties may disperse tablet in half a glass of
water, orange juice, or grape juice (but bitter taste).
l PATIENT AND CARER ADVICE Patients or carers should be
given advice on how to administer emtricitabine with
Missed doses If a dose is more than 12 hours late, the
missed dose should not be taken and the next dose should
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (April 2017)
that emtricitabine with tenofovir disoproxil (Truvada ®) is
accepted for use within NHS Scotland in combination with
safer sex practices for pre-exposure prophylaxis of sexually
acquired HIV-1 infection in adults at high risk.
All Wales Medicines Strategy Group (AWMSG) decisions
The All Wales Medicines Strategy Group has advised
(September 2017) that emtricitabine/tenofovir disoproxil
(Truvada ®) is not recommended for use within NHS Wales
in combination with safer sex practices for pre-exposure
prophylaxis to reduce the risk of sexually acquired HIV 1
infection in adults at high risk. The case for costeffectiveness has not been proven.
Subsequent to this AWMSG recommendation, Truvada ®
has been made available in Wales and is being provided
through NHS Wales from 17 July 2017 for up to three years
for use as pre-exposure prophylaxis. During this time,
eligible patients will receive Truvada ® and data will be
collected to assess its effectiveness at preventing HIV and
address some of the concerns of AWMSG in relation to
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 21
▶ Emtricitabine with tenofovir disoproxil (Non-proprietary)
Emtricitabine 200 mg, Tenofovir disoproxil (as Tenofovir
disoproxil fumarate) 245 mg Emtricitabine 200mg / Tenofovir
245mg tablets | 30 tablet P £355.73 DT = £355.73 (Hospital only)
| 30 tablet P £106.72–£355.73 DT = £355.73
Emtricitabine 200 mg, Tenofovir disoproxil (as Tenofovir
▶ Truvada (Gilead Sciences International Ltd)
Emtricitabine 200 mg, Tenofovir disoproxil (as Tenofovir
disoproxil fumarate) 245 mg Truvada 200mg/245mg tablets | 30 tablet P £355.73 DT = £355.73
HIV infection in combination with other antiretroviral
▶ Adult: 150 mg every 12 hours, alternatively 300 mg
HIV infection in combination with other antiretroviral
▶ Adult: 150 mg every 12 hours, alternatively 300 mg
Chronic hepatitis B infection either with compensated
liver disease (with evidence of viral replication and
histology of active liver inflammation or fibrosis) when
first-line treatments cannot be used, or (in combination
with another antiviral drug without cross-resistance to
lamivudine) with decompensated liver disease
▶ Adult: 100 mg once daily, patients receiving
lamivudine for concomitant HIV infection should
continue to receive lamivudine in a dose appropriate
l CAUTIONS Recurrent hepatitis in patients with chronic
hepatitis B may occur on discontinuation of lamivudine
l INTERACTIONS → Appendix 1: lamivudine
▶ Common or very common Hepatitis aggravated . muscle
▶ Rare or very rare Angioedema
▶ Frequency not known Abdominal discomfort. malaise . respiratory tract infection .throat complaints
l BREAST FEEDING Can be used with caution in women
infected with chronic hepatitis B alone, providing that
adequate measures are taken to prevent hepatitis B
Dose adjustments Reduce dose if eGFR less than
l MONITORING REQUIREMENTS When treating chronic
hepatitis B with lamivudine, monitor liver function tests
every 3 months, and viral markers of hepatitis B every
3–6 months, more frequently in patients with advanced
liver disease or following transplantation (monitoring to
continue for at least 1 year after discontinuation—
recurrent hepatitis may occur on discontinuation).
l PRESCRIBING AND DISPENSING INFORMATION Flavours of
oral liquid formulations may include banana and
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Sucrose
▶ Epivir (ViiV Healthcare UK Ltd)
Lamivudine 10 mg per 1 ml Epivir 50mg/5ml oral solution | 240 ml P £39.01
▶ Epivir (ViiV Healthcare UK Ltd)
Lamivudine 150 mg Epivir 150mg tablets | 60 tablet P £143.32
Lamivudine 300 mg Epivir 300mg tablets | 30 tablet P £157.51
▶ Zeffix (GlaxoSmithKline UK Ltd)
Lamivudine 100 mg Zeffix 100mg tablets | 28 tablet P £78.09
Lamivudine with tenofovir disoproxil
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, lamivudine above, tenofovir disoproxil
HIV-1 infection (initiated by a specialist)
Comments
Post a Comment
اكتب تعليق حول الموضوع