eiiiiF 423Fosamprenavir
lDRUG ACTIONFosamprenavir is a pro-drug of amprenavir.
lINDICATIONS AND DOSE
HIV infection in combination with other antiretroviral
drugs—with low-dose ritonavir
▶BY MOUTH
▶Child 6–17 years (body-weight 25–39 kg): 18 mg/kg twice
daily (max. per dose 700 mg)
▶Child 6–17 years (body-weight 40 kg and above): 700 mg
twice daily
DOSE EQUIVALENCE AND CONVERSION
▶ 700 mg fosamprenavir is equivalent to approximately
600 mg amprenavir.lINTERACTIONS→Appendix 1 : HIV-protease inhibitors
lSIDE-EFFECTS
▶Common or very commonOral paraesthesia
▶Frequency not knownRash erythematous
SIDE-EFFECTS, FURTHER INFORMATIONRash 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.lPREGNANCYToxicity inanimalstudies; manufacturer
advises use only if potential benefit outweighs risk.
lHEPATIC IMPAIRMENTManufacturer advises caution in
mild impairment.
Dose adjustmentsReduce dose in moderate to severe
impairment.
lDIRECTIONS FOR ADMINISTRATIONIn children, oral
suspension should be taken with food.
lPRESCRIBING AND DISPENSING INFORMATIONFlavours of
oral liquid formulations may include grape, bubblegum, or
peppermint.
lPATIENT AND CARER ADVICEPatients or carers should be
given advice on how to administer fosamprenavir oral
suspension.
lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Oral suspension
EXCIPIENTS:May contain Propylene glycol
▶Telzir(ViiV Healthcare UK Ltd)
Fosamprenavir (as Fosamprenavir calcium) 50 mg per 1 mlTelzir
50 mg/ml oral suspension| 225 mlP£ 69. 06
Tablet
▶Telzir(ViiV Healthcare UK Ltd)
Fosamprenavir (as Fosamprenavir calcium) 700 mgTelzir 700 mg
tablets| 60 tabletP£ 258. 97
eiiiiF 423Lopinavir with ritonavir 19-Mar-2018
lINDICATIONS AND DOSE
HIV infection in combination with other antiretroviral
drugs
▶BY MOUTH USING TABLETS
▶Child 2–17 years (body-weight up to 40 kg and body surface
area 0.5–0.7 m^2 ): 200 / 50 mg twice daily
▶Child 2–17 years (body-weight up to 40 kg and body surface
area 0.8–1.1 m^2 ): 300 / 75 mg twice daily
▶Child 2–17 years (body-weight 40 kg and above and body
surface area 1.2 m^2 and above): 400 / 100 mg twice daily
▶BY MOUTH USING ORAL SOLUTION
▶Child 14 days–5 months: 3. 75 mL/m2
twice daily
▶Child 6 months–17 years: 2. 9 mL/m^2 twice daily (max. per
dose 5 mL)DOSE EQUIVALENCE AND CONVERSION
▶Oral solution contains 400 mg lopinavir, 100 mg
ritonavir/ 5 mL (or 80 mg lopinavir, 20 mg ritonavir/mL).lCAUTIONSCardiac conduction disorders.pancreatitis.
structural heart disease
lINTERACTIONS→Appendix 1 : HIV-protease inhibitors
lSIDE-EFFECTS
▶Common or very commonGastrointestinal discomfort.
gastrointestinal disorders.increased risk of infection.
leucopenia.lymphadenopathy.menstrual cycle
irregularities.migraine.muscle weakness.myopathy.
night sweats.pain.sexual dysfunction.skin reactions
▶UncommonAbnormal dreams.atherosclerosis.
atrioventricular block.cholangitis.constipation.deep
vein thrombosis.haemorrhage.hepatic disorders.
hyperbilirubinaemia.hypogonadism.myocardial
infarction.nephritis.stomatitis.stroke.taste loss.
tinnitus.tremor.tricuspid valve incompetence.vasculitis
.vertigo.visual impairment
SIDE-EFFECTS, FURTHER INFORMATIONSigns and
symptoms suggestive of pancreatitis (including raised
serum lipase) should be evaluated—discontinue if
pancreatitis diagnosed.
lPREGNANCYAvoid oral solution due to high alcohol and
propylene glycol content; use tablets only if potential
benefit outweighs risk (toxicity inanimalstudies).
lHEPATIC IMPAIRMENTAvoid oral solution due to
propylene glycol content; manufacturer advises avoid
tablets in severe impairment.
lRENAL IMPAIRMENTAvoid oral solution due to high
propylene glycol content.
lMONITORING REQUIREMENTS
▶Monitor liver function before and during treatment.
▶With oral solution, monitor for signs of alcohol and
propylene glycol toxicity (particularly in infants).
lPRESCRIBING AND DISPENSING INFORMATIONWith 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
be harmful.
lPATIENT AND CARER ADVICEOral solution tastes bitter.
lNATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) Decisions
SMC No. 1302/18
TheScottish Medicines Consortiumhas advised (February
2018 ) that lopinavir with ritonavir oral solution (Kaletra®)
is accepted for use within NHS Scotland in combination
with other antiretrovirals for the treatment of HIV- 1
infected children aged from 14 days up to 2 years.
SMC No. 326/06
TheScottish Medicines Consortiumhas 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.
All Wales Medicines Strategy Group (AWMSG) Decisions
AWMSG No. 3557
TheAll Wales Medicines Strategy Grouphas advised (March
2018 ) that lopinavir with ritonavir oral solution (Kaletra®)
is recommended as an option for use within NHS Wales in
combination with other antiretroviral medicinal products
for the treatment of human immunodeficiency virus (HIV-
1 ) infected children aged from 14 days to less than 2 years
old.BNFC 2018 – 2019 HIV infection 425
Infection5