New medicines
Prezista
Composition: Darunavir.
Presentation: Film-coated tablet.
Class: Protease inhibitor.
Indications: Treatment of HIV-1 infection in combination with other antiretroviral
drugs in highly pretreated adult patients who have failed more than one
regimen containing a protease inhibitor.
Dosage: 600mg twice daily taken with ritonavir 100mg twice daily and
with food.
Contraindications: Co-administration with rifampicin, with herbal preparations
containing St John’s wort, or with active substances that are highly
dependent on CYP3A for clearance and for which elevated plasma concentrations
are associated with serious or life-threatening events. Prezista is not
recommended for use in children, adolescents or patients with severe
hepatic impairment.
Precautions: Prezista should be used with caution in patients with mild
or moderate hepatic impairment. Patients should be advised that precautions
against transmission of HIV should continue to be used. Caution should
be exercised in administering Prezista to elderly patients and to patients
with a known sulphonamide allergy. Treatment with Prezista should be
discontinued if severe rash develops. Haemophiliac patients should be
warned of the possibility of increased bleeding when taking Prezista.
Although the aetiology is considered to be multifactorial (including
corticosteroid use, alcohol consumption, severe immunosuppression, higher
body mass index), cases of osteonecrosis have been reported, particularly
in patients with advanced HIV disease and/or long-term exposure to combination
antiretroviral therapy (CART). Patients should be advised to seek medical
advice if they experience joint aches and pain, joint stiffness or difficulty
in movement.
Side effects: Common (>1/100, <1/10) headache, dizziness, vomiting
diarrhoea, nausea, abdominal pain, constipation, flatulence, abdominal
distension, dyspepsia, hypertriglyceridaemia, anorexia, asthenia, fatigue,
insomnia.
Legal category: POM.
Net price: 120 x 300mg, £446.70.
Contact details: Janssen-Cilag, PO Box 79, Saunderton, Buckinghamshire
HP14 4HJ
(tel 01494 567444).
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