▶ Zidovudine (Non-proprietary)
Zidovudine 100 mg Zidovudine 100mg capsules | 60 capsule P £53.31
Zidovudine 250 mg Zidovudine 250mg capsules | 60 capsule P £13.32
▶ Retrovir (ViiV Healthcare UK Ltd)
Zidovudine 100 mg Retrovir 100mg capsules | 100 capsule P £104.54
Zidovudine 250 mg Retrovir 250mg capsules | 40 capsule P £104.54
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, zidovudine p. 655, lamivudine p. 653.
HIV infection in combination with other antiretroviral
l INTERACTIONS → Appendix 1: lamivudine . zidovudine
l RENAL IMPAIRMENT Avoid if eGFR less than
50 mL/minute/1.73 m2 (consult product literature).
l DIRECTIONS FOR ADMINISTRATION
COMBIVIR ® TABLETS Tablets may be crushed and mixed
with semi-solid food or liquid just before administration.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Zidovudine with lamivudine (Non-proprietary)
Lamivudine 150 mg, Zidovudine 300 mg Zidovudine 300mg /
Lamivudine 150mg tablets | 60 tablet P £240.10–£255.10
▶ Combivir (ViiV Healthcare UK Ltd)
Lamivudine 150 mg, Zidovudine 300 mg Combivir 150mg/300mg
ANTIVIRALS › PROTEASE INHIBITORS, HIV
l CONTRA-INDICATIONS Acute porphyrias p. 1058
l CAUTIONS Haemophilia (increased risk of bleeding)
discomfort. gastrointestinal disorders . headache . hepatic
reactions . sleep disorders .taste altered . vomiting
▶ Uncommon Drowsiness . immune reconstitution
inflammatory syndrome . osteonecrosis . Stevens-Johnson
l HEPATIC IMPAIRMENT In general, manufacturers advise
use with caution in patients with chronic hepatitis B or C
(increased risk of hepatic side-effects).
HIV infection in combination with other antiretroviral
HIV infection in combination with other antiretroviral
l CAUTIONS Cardiac conduction disorders . electrolyte
disturbances . predisposition to QT interval prolongation
l INTERACTIONS → Appendix 1: HIV-protease inhibitors
▶ Uncommon Chest pain . depression . disorientation . drug
reaction with eosinophilia and systemic symptoms
(DRESS). gallbladder disorders . gynaecomastia . haematuria . memory loss . myopathy . nephritis
SIDE-EFFECTS, FURTHER INFORMATION Mild to moderate
rash occurs commonly, usually within the first 3 weeks of
therapy. Severe rash occurs less frequently and may be
accompanied by systemic symptoms. Discontinue if severe
l PREGNANCY Theoretical risk of hyperbilirubinaemia in
l HEPATIC IMPAIRMENT Manufacturer advises caution in
mild impairment; avoid in moderate to severe impairment
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 5, 21
▶ Reyataz (Bristol-Myers Squibb Pharmaceuticals Ltd)
Atazanavir (as Atazanavir sulfate) 150 mg Reyataz 150mg
capsules | 60 capsule P £303.38 (Hospital only)
Atazanavir (as Atazanavir sulfate) 200 mg Reyataz 200mg
capsules | 60 capsule P £303.38 (Hospital only)
Atazanavir (as Atazanavir sulfate) 300 mg Reyataz 300mg
capsules | 30 capsule P £303.38 (Hospital only)
Atazanavir with cobicistat 18-Apr-2017
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, atazanavir above, cobicistat p. 661.
HIV infection, in combination with other antiretroviral
drugs (initiated by a specialist)
▶ Adult: 300/150 mg once daily
DOSE EQUIVALENCE AND CONVERSION
▶ Dose expressed as x/y mg of atazanavir/cobicistat.
l CONTRA-INDICATIONS Haemodialysis
l INTERACTIONS → Appendix 1: cobicistat. HIV-protease
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 5, 21
▶ Evotaz (Bristol-Myers Squibb Pharmaceuticals Ltd) A
Cobicistat 150 mg, Atazanavir (as Atazanavir sulfate)
300 mg Evotaz 300mg/150mg tablets | 30 tablet P £323.38
HIV infection in combination with other antiretroviral
drugs in patients previously treated with antiretroviral
therapy—with low-dose ritonavir
▶ Adult: 600 mg twice daily, alternatively 800 mg once
daily, once daily dose only to be used if no resistance to
darunavir, if plasma HIV-RNA concentration less than
100 000 copies/mL, and if CD4 cell count greater than
HIV infection in combination with other antiretroviral
drugs in patients previously treated with antiretroviral
▶ Adult: 800 mg once daily, dose appropriate if no
resistance to darunavir, if plasma HIV-RNA
concentration less than 100 000 copies/mL, and if CD4
cell count greater than 100 cells 6106
HIV infection in combination with other antiretroviral
drugs in patients not previously treated with
antiretroviral therapy—with low-dose ritonavir
HIV infection in combination with other antiretroviral
drugs in patients not previously treated with
antiretroviral therapy—with cobicistat
l INTERACTIONS → Appendix 1: HIV-protease inhibitors
▶ Uncommon Angina pectoris . arrhythmias . burping . chest
infarction . nail discolouration . nephrolithiasis . oral
▶ Rare or very rare Arthritis . chills . feeling abnormal . joint
SIDE-EFFECTS, FURTHER INFORMATION Mild to moderate
rash occurs commonly, usually within the first 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.
l ALLERGY AND CROSS-SENSITIVITY Use with caution in
patients with sulfonamide sensitivity.
l PREGNANCY Manufacturer advises use only if potential
benefit outweighs risk; if required, use the twice daily dose
regimen. For use with cobicistat, see darunavir with
cobicistat below or darunavir with cobicistat, emtricitabine
and tenofovir alafenamide p. 658.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
mild to moderate impairment; avoid in severe impairment
l MONITORING REQUIREMENTS Monitor liver function
l PRESCRIBING AND DISPENSING INFORMATION Flavours of
oral liquid formulations may include strawberry.
Missed doses If 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.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 21
▶ Prezista (Janssen-Cilag Ltd)
Darunavir (as Darunavir ethanolate) 100 mg per 1 ml Prezista
100mg/ml oral suspension sugar-free | 200 ml P £248.17
CAUTIONARY AND ADVISORY LABELS 21
Darunavir (as Darunavir ethanolate) 400 mg Darunavir 400mg
Darunavir (as Darunavir ethanolate) 600 mg Darunavir 600mg
Darunavir (as Darunavir ethanolate) 800 mg Darunavir 800mg
tablets | 30 tablet P £253.13–£297.80
▶ Prezista (Janssen-Cilag Ltd)
Darunavir (as Darunavir ethanolate) 75 mg Prezista 75mg tablets
Darunavir (as Darunavir ethanolate) 150 mg Prezista 150mg
tablets | 240 tablet P £446.70
Darunavir (as Darunavir ethanolate) 400 mg Prezista 400mg
Darunavir (as Darunavir ethanolate) 600 mg Prezista 600mg
Darunavir (as Darunavir ethanolate) 800 mg Prezista 800mg
Darunavir with cobicistat 25-Jul-2018
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, cobicistat p. 661, darunavir above.
HIV infection, in combination with other antiretroviral
drugs (initiated by a specialist)
▶ Adult: 800/150 mg once daily, dosage should not be
altered or therapy discontinued without instruction
DOSE EQUIVALENCE AND CONVERSION
▶ Dose expressed as x/y mg of darunavir/cobicistat.
MHRA/CHM ADVICE: DARUNAVIR BOOSTED WITH COBICISTAT:
AVOID USE IN PREGNANCY DUE TO RISK OF TREATMENT FAILURE
AND MATERNAL-TO-CHILD TRANSMISSION OF HIV-1 (JULY 2018)
Pharmacokinetic data show mean exposure of darunavir
boosted with cobicistat (available in combination in
Rezolsta ® and Symtuza ®) to be lower during the second
and third trimesters of pregnancy than during
6–12 weeks postpartum. Low darunavir exposure may be
associated with an increased risk of treatment failure
and an increased risk of HIV-1 transmission to the
unborn child. For further information, see Pregnancy.
l CONTRA-INDICATIONS Treatment-experienced patients
with 1 or more darunavir resistance-associated mutations,
plasma HIV-RNA concentration of 100 000 copies/mL or
greater, or CD4 count less than 100 cells6106
l INTERACTIONS → Appendix 1: cobicistat. HIV-protease
l PREGNANCY Manufacturer advises not to be initiated
during pregnancy due to low darunavir exposure; women
who become pregnant during therapy should be switched
to an alternative regimen. Darunavir with ritonavir may be
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (August
2015) that darunavir with cobicistat (Rezolsta ®) is accepted
for use within NHS Scotland for the treatment of human
immunodeficiency virus-1 (HIV-1) infection in adults, in
combination with other antiretrovirals. Genotypic testing
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 21
▶ Rezolsta (Janssen-Cilag Ltd) A
Cobicistat 150 mg, Darunavir (as Darunavir ethanolate)
800 mg Rezolsta 800mg/150mg tablets | 30 tablet P £317.24
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, darunavir p. 657, cobicistat p. 661,
emtricitabine p. 651, tenofovir alafenamide p. 622.
HIV infection (initiated by a specialist)
MHRA/CHM ADVICE: DARUNAVIR BOOSTED WITH COBICISTAT:
AVOID USE IN PREGNANCY DUE TO RISK OF TREATMENT FAILURE
AND MATERNAL-TO-CHILD TRANSMISSION OF HIV-1 (JULY 2018)
Pharmacokinetic data show mean exposure of darunavir
boosted with cobicistat (available in combination in
Rezolsta ® and Symtuza ®) to be lower during the second
and third trimesters of pregnancy than during
6–12 weeks postpartum. Low darunavir exposure may be
associated with an increased risk of treatment failure
and an increased risk of HIV-1 transmission to the
unborn child. For further information, see Pregnancy.
l INTERACTIONS → Appendix 1: cobicistat. HIV-protease
inhibitors .tenofovir alafenamide
l PREGNANCY Manufacturer advises not to be initiated
during pregnancy due to low darunavir exposure; women
who become pregnant during therapy should be switched
l RENAL IMPAIRMENT Manufacturer advises avoid if eGFR
less than 30 mL/minute/1.73 m2
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 (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
All Wales Medicines Strategy Group (AWMSG) decisions
The All Wales Medicines Strategy Group has 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
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
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 mg Symtuza
800mg/150mg/200mg/10mg tablets | 30 tablet P £672.97
l DRUG ACTION Fosamprenavir is a pro-drug of amprenavir.
HIV infection in combination with other antiretroviral
DOSE EQUIVALENCE AND CONVERSION
▶ 700 mg fosamprenavir is equivalent to approximately
l INTERACTIONS → Appendix 1: HIV-protease inhibitors
▶ Common or very common Oral paraesthesia
SIDE-EFFECTS, FURTHER INFORMATION Rash may occur,
usually in the second week of therapy; discontinue
permanently if severe rash with systemic or allergic
symptoms or, mucosal involvement; if rash mild or
moderate, may continue without interruption—usually
resolves and may respond to antihistamines.
l PREGNANCY Toxicity in animal studies; manufacturer
advises use only if potential benefit outweighs risk.
l HEPATIC IMPAIRMENT Manufacturer advises caution.
Dose adjustments Manufacturer advises dose reduction to
450 mg twice daily in moderate impairment and 300 mg
twice daily in severe impairment.
l DIRECTIONS FOR ADMINISTRATION In adults, oral
suspension should be taken on an empty stomach.
l PRESCRIBING AND DISPENSING INFORMATION Flavours of
oral liquid formulations may include grape, bubblegum, or
l PATIENT AND CARER ADVICE Patients or carers should be
given advice on how to administer fosamprenavir oral
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Propylene glycol
▶ Telzir (ViiV Healthcare UK Ltd)
Fosamprenavir (as Fosamprenavir calcium) 50 mg per 1 ml Telzir
50mg/ml oral suspension | 225 ml P £69.06
▶ Telzir (ViiV Healthcare UK Ltd)
Fosamprenavir (as Fosamprenavir calcium) 700 mg Telzir 700mg
Lopinavir with ritonavir 19-Mar-2018
HIV infection in combination with other antiretroviral
▶ Adult: 400/100 mg twice daily, alternatively
800/200 mg once daily, once daily dose to be used only
in adults with a HIV strain that has less than 3
mutations to protease inhibitors
▶ BY MOUTH USING ORAL SOLUTION
DOSE EQUIVALENCE AND CONVERSION
▶ Oral solution contains 400 mg lopinavir, 100 mg
ritonavir/5 mL (or 80 mg lopinavir, 20 mg ritonavir/mL).
10-year cardiovascular risk greater than 20%). structural
l INTERACTIONS → Appendix 1: HIV-protease inhibitors
▶ Common or very common Increased risk of infection . leucopenia . lymphadenopathy . menstrual cycle
irregularities . migraine . muscle weakness . myopathy . night sweats . pain . sexual dysfunction
SIDE-EFFECTS, FURTHER INFORMATION Signs and
symptoms suggestive of pancreatitis (including raised
serum lipase) should be evaluated—discontinue if
l PREGNANCY Avoid oral solution due to high alcohol and
propylene glycol content; use tablets only if potential
benefit outweighs risk (toxicity in animal studies).
l HEPATIC IMPAIRMENT For oral solution, manufacturer
advises avoid due to propylene glycol content (risk of
toxicity). For tablets, manufacturer advises avoid in severe
impairment (no information available).
l RENAL IMPAIRMENT Avoid oral solution due to high
propylene glycol content. Use tablets with caution in
▶ Monitor liver function before and during treatment.
▶ With oral solution, monitor for signs of alcohol and
propylene glycol toxicity (particularly in infants).
l PRESCRIBING AND DISPENSING INFORMATION With oral
solution, manufacturer advises high alcohol (42 % v/v) and
propylene glycol content—consider total amounts from all
medicines that are to be given to infants in order to avoid
toxicity; caution in patients for which consumption may
l PATIENT AND CARER ADVICE Oral solution tastes bitter.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (November
2006) that lopinavir with ritonavir tablet (Kaletra ®) is
accepted for use within NHS Scotland in combination with
other antiretrovirals for the treatment of HIV-1 infected
adults and children above the age of 2 years.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 21
EXCIPIENTS: May contain Alcohol, propylene glycol
Ritonavir 20 mg per 1 ml, Lopinavir 80 mg per 1 ml Kaletra
80mg/20mg/1ml oral solution | 120 ml P £122.96 | 300 ml P £307.39
CAUTIONARY AND ADVISORY LABELS 25
Ritonavir 25 mg, Lopinavir 100 mg Kaletra 100mg/25mg tablets | 60 tablet P £76.85
Ritonavir 50 mg, Lopinavir 200 mg Kaletra 200mg/50mg tablets | 120 tablet P £285.41
HIV infection in combination with other antiretroviral
▶ Adult: Initially 300 mg every 12 hours for 3 days,
increased in steps of 100 mg every 12 hours over not
longer than 14 days; increased to 600 mg every
Low-dose booster to increase effect of other protease
▶ Adult: 100–200 mg 1–2 times a day
l CAUTIONS Cardiac conduction disorders . pancreatitis . structural heart disease
l INTERACTIONS → Appendix 1: HIV-protease inhibitors
▶ Common or very common Back pain . concentration
▶ Uncommon Myocardial infarction
▶ Rare or very rare Hyperglycaemia .toxic epidermal
SIDE-EFFECTS, FURTHER INFORMATION Signs and
symptoms suggestive of pancreatitis (including raised
serum lipase) should be evaluated — discontinue if
Dose adjustments Only use low-dose booster to increase
the effect of other protease inhibitors.
l HEPATIC IMPAIRMENT When used as a low-dose booster,
manufacturer advises caution in severe impairment; avoid
in decompensated liver disease. When used in high-doses,
manufacturer advises avoid in severe impairment.
Dose adjustments Manufacturer advises consult product
literature of co-administered protease inhibitor.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 21, 25
Ritonavir 100 mg Ritonavir 100mg tablets | 30 tablet P £16.52–
Ritonavir 100 mg Norvir 100mg tablets | 30 tablet P £19.44
HIV infection in combination with other antiretrovirals in
patients previously treated with antiretroviral therapy—
HIV infection in combination with other antiretrovirals in
patients not previously treated with antiretroviral
therapy—with low-dose ritonavir
▶ Adult: 500 mg every 12 hours for 7 days, then increased
l CONTRA-INDICATIONS Bradycardia . congenital QT
prolongation . electrolyte disturbances . heart failure with
reduced left ventricular ejection fraction . history of
symptomatic arrhythmias . predisposition to cardiac
l INTERACTIONS → Appendix 1: HIV-protease inhibitors
▶ Uncommon Mucosal ulceration .renal impairment. visual
▶ Frequency not known QT interval prolongation
l HEPATIC IMPAIRMENT Manufacturer advises caution in
moderate impairment (limited information available);
avoid in decompensated liver disease.
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