New medicines
Noxafil
Composition: Posaconazole 40mg.
Presentation: Oral suspension.
Class: Antimycotic.
Indications: Treatment of invasive aspergillosis (in patients whose disease
is refractory to, or who are themselves intolerant of, amphotericin B
or itraconazole), fusariosis (in patients refractory to or intolerant
of amphotericin B), chromoblastomycosis and mycetoma (in patients refractory
to or intolerant of itraconazole), coccidioidomycosis (in patients refractory
to or intolerant of amphotericin B, itraconazole or fluconazole). Treatment
should be initiated by a physician experienced in the management of invasive
fungal infections.
Dosage: 400mg (10ml) twice a day with a meal, or with 240ml of a nutritional
supplement. In patients who cannot tolerate a meal or a nutritional supplement,
Noxafil should be administered at a dose of 200mg (5ml) four times a
day.
Precautions: Posaconazole is not recommended for use in patients below
18 years of age. Co-administration with ergot alkaloids, terfenadine,
astemizole, cisapride, pimozide, halofantrine, quinidine, simvastatin,
lovastatin or atorvastatin is contraindicated. Concomitant use with rifampicin,
rifabutin, phenytoin, carbamazepine, phenobarbital, primidone and cimetidine
should be avoided unless the benefit to the patient outweighs the risk.
Caution should be used in patients with hypersensitivity to other azoles,
pro-arrhythmic conditions and severe hepatic impairment. Noxafil must
not be administered with CYP3A4 substrates known to prolong the QTc interval.
Electrolyte disturbances should be monitored and corrected as necessary.
Patients with glucose-galactose malabsorption should not take Noxafil.
Side effects: Common (>1/100, <1/10): neutropenia, anorexia, insomnia,
dizziness, headache, paraesthesia, somnolence, hot flushes, abdominal
pain, diarrhoea, dyspepsia, flatulence, dry mouth, nausea, vomiting,
dry skin, pruritis, rash, back pain, asthenia, fatigue and fever.
Legal category: POM.
Net price: 105ml, £500.69.
Contact details: Schering-Plough, Shire Park, Welwyn Garden City, Hertfordshire
AL7 1TW. Telephone 01707 363636, fax 01707 363763.
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