▶Common or very common Abdominal pain. angioedema.
diarrhoea. fatigue. fever. headache. hepatic disorders.
hypersensitivity. hypertransaminasaemia. nausea. skin
reactions. vomiting
▶Uncommon Anaemia. arthralgia. myalgia. severe
cutaneous adverse reactions (SCARs)
▶Frequency not known Eosinophilia. osteonecrosis. weight
increased
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, usually in first 6 weeks, is most common
Rash
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.
PDF pages 704, 705
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
available).
PDF page 705
