LOZANOC

What it is

LOZANOC is itraconazole 50 mg capsules.

Approved indications

— Superficial dermatomycoses not responding to topical treatment in adults. — Fungal keratitis which has failed to respond to topical treatment or where the disease is either progressing rapidly or is immediately sight threatening in adults. — Pityriasis versicolor not responding to any other treatment in adults. — Vulvovaginal candidiasis not responding to topical treatment in adults. — Oral candidiasis in immunocompromised patients. — Onychomycosis caused by dermatophytes in adults. — Systemic aspergillosis, histoplasmosis, and lymphocutaneous or cutaneous sporotrichosis. — Treatment and maintenance therapy in AIDS patients with disseminated or chronic pulmonary histoplasmosis infection. — Treatment of oropharyngeal and oesophageal candidiasis when first line systemic antifungal therapy is inappropriate or has proven ineffective. — Treatment of non-invasive candidiasis in non-neutropenic patients when first-line systemic antifungal therapy is inappropriate or has proven ineffective.

Dosing overview

LOZANOC capsules must be taken immediately after a meal for maximal absorption. The capsules must be swallowed whole.

Key safety warnings

LOZANOC should not be administered to patients with evidence of ventricular dysfunction such as congestive heart failure or a history of congestive heart failure except for the treatment of life-threatening or other serious infections. Itraconazole has a negative inotropic effect and has been associated with reports of congestive heart failure, with heart failure reported more frequently among spontaneous reports of 400 mg total daily dose than among those of lower total daily doses. LOZANOC should not be used in patients with evidence of ventricular dysfunction such as congestive heart failure or with a history of congestive heart failure unless the benefit clearly outweighs the risk. Rare cases of cholestatic jaundice and very rare cases of hepatitis have been reported, and very rare cases of serious hepatotoxicity, including some cases of fatal acute liver failure, have occurred with the use of itraconazole. Liver function monitoring should be considered in patients receiving LOZANOC treatment, and patients should be instructed to promptly report to their physician signs and symptoms suggestive of hepatitis such as anorexia, nausea, vomiting, fatigue, abdominal pain or dark urine, in which case treatment should be stopped immediately and liver function testing should be conducted. Isolated cases of peripheral neuropathy have been reported, predominantly during long-term treatment with itraconazole, and if neuropathy occurs that may be attributable to LOZANOC, the treatment should be discontinued. Transient or permanent hearing loss has been reported in patients receiving treatment with itraconazole, and the hearing loss usually resolves when treatment is stopped, but can persist in some patients. Several cases of hypokalaemia have been reported, and serum potassium should be monitored in patients at risk during high-dose itraconazole therapy.

Contraindications

LOZANOC is contraindicated in patients with a known hypersensitivity to the drug or its excipients. Itraconazole is contraindicated in pregnant women except for the treatment of life-threatening cases of systemic mycoses, where the potential benefits outweigh the potential harm to the foetus. Co-administration of the following drugs is contraindicated with LOZANOC: terfenadine, astemizole, aliskiren, bepridil, felodipine, lercanidipine, domperidone, disopyramide, dronedarone, methadone, lurasidone, quetiapine, dabigatran, ticagrelor, apixaban, rivaroxaban, halofantrine, isavuconazole, naloxegol, lomitapide, avanafil, darifenacin, dapoxetine, eliglustat, irinotecan, venetoclax (in patients with chronic lymphocytic leukaemia during dose initiation/titration/ramp-up phase), ivabradine, ranolazine, eplerenone, sildenafil (pulmonary hypertension), ombitasvir/paritaprevir/ritonavir (with or without dasabuvir), nisoldipine, mizolastine, cisapride, dofetilide, levacetylmethadol, quinidine, pimozide, sertindole, simvastatin, lovastatin, oral midazolam, triazolam, ergot alkaloids, fesoterodine (in subjects with moderate to severe renal or hepatic impairment), solifenacin (in subjects with severe renal or moderate to severe hepatic impairment), vardenafil (in patients older than 75 years), colchicine (in subjects with renal or hepatic impairment), vorapaxar, and edoxaban.

PBS listing

LOZANOC 50 mg capsule is listed on the PBS with streamlined authority-required restriction at an ex-manufacturer price of A$97.22.

Regulatory history

LOZANOC 50 mg capsules were first registered on the ARTG on 25 October 2013. In November 2015, the PBAC recommended PBS listing of the 50 mg capsule with streamlined authority-required restriction for systemic fungal infections (systemic aspergillosis, systemic sporotrichosis, systemic histoplasmosis, disseminated pulmonary histoplasmosis infection, chronic pulmonary histoplasmosis infection, oropharyngeal candidiasis, and oesophageal candidiasis).