that raltegravir (Isentress ®) is accepted for restricted use
within NHS Scotland for the treatment of HIV-1 infection
when non-nucleoside reverse transcriptase inhibitors or
protease inhibitors cannot be used because of intolerance,
drug interactions, or resistance.
The Scottish Medicines Consortium has advised
(November 2017) that raltegravir 600 mg film-coated
tablets (Isentress ®) are accepted for restricted use within
NHS Scotland for the treatment of HIV-1 infection in
adults and paediatric patients weighing at least 40 kg when
non-nucleoside reverse transcriptase inhibitors or
protease inhibitors cannot be used because of intolerance,
drug interactions, or resistance.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 25
▶ Isentress (Merck Sharp & Dohme Ltd)
Raltegravir 400 mg Isentress 400mg tablets | 60 tablet P £471.41
Raltegravir 600 mg Isentress 600mg tablets | 60 tablet P £471.41
ANTIVIRALS › NON-NUCLEOSIDE REVERSE
HIV-1 infection in combination with other antiretroviral
drugs (initiated by a specialist)
DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶ Manufacturer advises if concurrent use of moderate
inducers of CYP3A4, dabrafenib, modafinil, or
telotristat ethyl is unavoidable, increase dose to
100 mg twice daily. Manufacturer advises 100 mg twice
l INTERACTIONS → Appendix 1: doravirine
disorders . headache . hepatocellular injury . nausea . skin
reactions . sleep disorders . vomiting
imbalance . hypertension . malaise . memory loss . mood
altered . muscle tone increased . myalgia . paraesthesia . suicidal ideation
l PREGNANCY Manufacturer advises avoid—no information
l HEPATIC IMPAIRMENT Manufacturer advises caution in
severe impairment (no information available).
Missed doses If a dose is more than 12 hours late, the
missed dose should not be taken and the next dose should
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 fatigue,
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 25, 3
▶ Pifeltro (Merck Sharp & Dohme Ltd) A
Doravirine 100 mg Pifeltro 100mg tablets | 30 tablet P £471.41
Combinations available: Lamivudine with tenofovir disoproxil
HIV infection in combination with other antiretroviral
l CAUTIONS Acute porphyrias p. 1058 . elderly . history of
psychiatric disorders . history of seizures
l INTERACTIONS → Appendix 1: efavirenz
abnormal .tinnitus .tremor. vertigo . vision blurred
▶ Rare or very rare Delusions . photosensitivity reaction
▶ Frequency not known Immune reconstitution
inflammatory syndrome . osteonecrosis
SIDE-EFFECTS, FURTHER INFORMATION For further
information regarding osteonecrosis, immune
reconstitution syndrome and lipodystrophy, see HIV
Rash Rash, usually in the first 2 weeks, is the most
common side-effect; discontinue if severe rash with
blistering, desquamation, mucosal involvement or fever; if
rash mild or moderate, may continue without
interruption—usually resolves within 1 month.
CNS effects Administration at bedtime especially in
first 2–4 weeks reduces CNS effects.
l PREGNANCY Reports of neural tube defects when used in
l HEPATIC IMPAIRMENT Greater risk of hepatic side-effects
in chronic hepatitis B or C. Avoid in moderate to severe
Monitoring In mild liver disease, monitor for dose related
side-effects (e.g. CNS effects) and monitor liver function.
l RENAL IMPAIRMENT Manufacturer advises caution in
severe renal failure—no information available.
l MONITORING REQUIREMENTS Monitor liver function if
receiving other hepatotoxic drugs.
l DIRECTIONS FOR ADMINISTRATION For patients who
cannot swallow capsules, the capsule may be opened and
contents added to a small amount of food—consult
product literature. No additional food should be consumed
for up to 2 hours after administration of efavirenz.
Psychiatric disorders Patients or their carers should be
advised to seek immediate medical attention if symptoms
such as severe depression, psychosis or suicidal ideation
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 23
▶ Sustiva (Bristol-Myers Squibb Pharmaceuticals Ltd)
Efavirenz 600 mg Sustiva 600mg tablets | 30 tablet P £200.27
CAUTIONARY AND ADVISORY LABELS 23
▶ Sustiva (Bristol-Myers Squibb Pharmaceuticals Ltd)
Efavirenz 50 mg Sustiva 50mg capsules | 30 capsule P £16.73
Efavirenz 100 mg Sustiva 100mg capsules | 30 capsule P £33.41 (Hospital only)
Efavirenz 200 mg Sustiva 200mg capsules | 90 capsule P £200.27 (Hospital only)
Combinations available: Efavirenz with emtricitabine and
HIV infection resistant to other non-nucleoside reverse
transcriptase inhibitor and protease inhibitors in
combination with other antiretroviral drugs (including a
▶ Adult: 200 mg twice daily, to be taken after food
l CONTRA-INDICATIONS Acute porphyrias p. 1058
l INTERACTIONS → Appendix 1: etravirine
▶ Rare or very rare Severe cutaneous adverse reactions
▶ Frequency not known Haemorrhagic stroke . osteonecrosis . weight increased
SIDE-EFFECTS, FURTHER INFORMATION For further
information regarding osteonecrosis, immune
reconstitution syndrome and lipodystrophy, see HIV
Hypersensitivity reactions Rash, usually in the second
week, is the most common side-effect and appears more
frequently in females. Life-threatening hypersensitivity
reactions reported usually during week 3–6 of treatment
and characterised by rash, eosinophilia, and systemic
symptoms (including fever, general malaise, myalgia,
arthralgia, blistering, oral lesions, conjunctivitis, and
hepatitis). Discontinue permanently if hypersensitivity
reaction or severe rash develop. If rash mild or moderate
(without signs of hypersensitivity reaction), may continue
without interruption—usually resolves within 2 weeks.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
moderate impairment and in patients with hepatitis B or C
(increased risk of hepatic side effects); avoid in severe
impairment (no information available).
l DIRECTIONS FOR ADMINISTRATION Patients with
swallowing difficulties may disperse tablets in a glass of
water just before administration.
l PRESCRIBING AND DISPENSING INFORMATION Dispense in
original container (contains desiccant).
Hypersensitivity reactions Patients or carers should be told
how to recognise hypersensitivity reactions and advised to
seek immediate medical attention if hypersensitivity
reaction or severe rash develop.
Missed doses If a dose is more than 6 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
▶ Intelence (Janssen-Cilag Ltd)
Etravirine 25 mg Intelence 25mg tablets | 120 tablet P £75.32
Etravirine 100 mg Intelence 100mg tablets | 120 tablet P £301.27
Etravirine 200 mg Intelence 200mg tablets | 60 tablet P £301.27
HIV infection in combination with other antiretroviral
▶ BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶ Adult: Initially 200 mg once daily for first 14 days,
initial dose titration using ‘immediate-release’
preparation should not exceed 28 days; if rash occurs
and is not resolved within 28 days, alternative
treatment should be sought. If treatment interrupted
for more than 7 days, restart using the lower dose of
the ‘immediate-release’ preparation for the first
HIV infection in combination with other antiretroviral
drugs (maintenance dose following initial dose titration
▶ BY MOUTH USING IMMEDIATE-RELEASE MEDICINES
▶ BY MOUTH USING MODIFIED-RELEASE MEDICINES
l CONTRA-INDICATIONS Acute porphyrias p. 1058 . postexposure prophylaxis
▶ Hepatic effects Patients with chronic hepatitis B or C, high
CD4 cell count, and women are at increased risk of hepatic
side effects—if plasma HIV-1 RNA detectable,
manufacturer advises avoid in women with CD4 cell count
greater than 250 cells/mm3 or in men with CD4 cell count
greater than 400 cells/mm3 unless potential benefit
l INTERACTIONS → Appendix 1: nevirapine
▶ Uncommon Anaemia . arthralgia . myalgia . severe
cutaneous adverse reactions (SCARs)
▶ Frequency not known Eosinophilia . osteonecrosis . weight
SIDE-EFFECTS, FURTHER INFORMATION Hepatic effects
Potentially life-threatening hepatotoxicity including fatal
fulminant hepatitis reported usually in first 6 weeks;
discontinue permanently if abnormalities in liver function
tests accompanied by hypersensitivity reaction (rash,
fever, arthralgia, myalgia, lymphadenopathy, hepatitis,
renal impairment, eosinophilia, granulocytopenia);
suspend if severe abnormalities in liver function tests but
no hypersensitivity reaction—discontinue permanently if
significant liver function abnormalities recur; monitor
patient closely if mild to moderate abnormalities in liver
function tests with no hypersensitivity reaction.
Rash Rash, usually in first 6 weeks, is most common
side-effect; incidence reduced if introduced at low dose
and dose increased gradually (after 14 days); Discontinue
permanently if severe rash or if rash accompanied by
blistering, oral lesions, conjunctivitis, facial oedema,
general malaise or hypersensitivity reactions; if rash mild
or moderate may continue without interruption but dose
should not be increased until rash resolves.
Osteonecrosis Osteonecrosis has been reported in
patients with advanced HIV disease or following long-term
exposure to combination antiretroviral therapy.
l HEPATIC IMPAIRMENT For modified-release preparations,
manufacturer advises avoid (no information available). For
immediate-release preparations, manufacturer advises
caution in moderate impairment and chronic hepatitis
(increased risk of hepatic side effects; consider
interrupting or discontinuing treatment if hepatic function
worsens); avoid in severe impairment (no information
l RENAL IMPAIRMENT Manufacturer advises avoid modifiedrelease preparation—no information available.
▶ Hepatic disease Close monitoring of liver function required
during first 18 weeks; monitor liver function before
treatment then every 2 weeks for 2 months then after
▶ Rash Monitor closely for skin reactions during first
Hypersensitivity reactions Patients or carers should be told
how to recognise hypersensitivity reactions and advised to
discontinue treatment and seek immediate medical
attention if severe skin reaction, hypersensitivity
reactions, or symptoms of hepatitis develop.
Missed doses If a dose is more than 8 hours late with the
‘immediate-release’ preparation (or more than 12 hours
late with the modified-release preparation), the missed
dose should not be taken and the next dose should be
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Viramune (Boehringer Ingelheim Ltd)
Nevirapine (as Nevirapine hemihydrate) 10 mg per 1 ml Viramune
50mg/5ml oral suspension | 240 ml P £50.40
CAUTIONARY AND ADVISORY LABELS 25
▶ Nevirapine (Non-proprietary)
Nevirapine 400 mg Nevirapine 400mg modified-release tablets | 30 tablet P £52.13–£170.00 DT = £83.18
▶ Viramune (Boehringer Ingelheim Ltd)
Nevirapine 100 mg Viramune 100mg modified-release tablets |
90 tablet P £127.50 (Hospital only)
▶ Nevirapine (Non-proprietary)
Nevirapine 200 mg Nevirapine 200mg tablets | 60 tablet P £21.45–£170.00
HIV infection in combination with other antiretroviral
drugs in patients not previously treated with
antiretroviral therapy and if plasma HIV-1 RNA
concentration less than or equal to 100 000 copies/mL
l CAUTIONS Acute porphyrias p. 1058
l INTERACTIONS → Appendix 1: rilpivirine
▶ Uncommon Immune reconstitution inflammatory
SIDE-EFFECTS, FURTHER INFORMATION For further
information regarding lipodystrophy, see HIV infection
l PREGNANCY Manufacturer advises avoid unless
essential— no information available.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
moderate impairment (limited information available);
avoid in severe impairment (no information available).
l RENAL IMPAIRMENT Manufacturer advises caution in
l PATIENT AND CARER ADVICE Patients or carers should be
given advice on how to administer rilpivirine tablets.
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 3, 21, 25
Rilpivirine (as Rilpivirine hydrochloride) 25 mg Edurant 25mg
p. 651 . Emtricitabine with rilpivirine and tenofovir disoproxil,
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