Anidulafungin

What it is

Anidulafungin Medsurge is a sterile, lyophilised powder for injection that contains 100 mg anidulafungin. Anidulafungin selectively inhibits 1,3-β-D glucan synthase, an enzyme present in fungal, but not mammalian cells, which results in inhibition of the formation of 1,3-β-D-glucan, an essential component of the fungal cell wall.

Approved indications

— Treatment of invasive candidiasis, including candidaemia in adult and in paediatric patients one month and older.

Dosing overview

Adult patients receive a single 200 mg loading dose on Day 1, followed by 100 mg daily thereafter. Paediatric patients (one month and older) receive a recommended dose of 3.0 mg/kg (not to exceed 200 mg) loading dose on Day 1, followed by 1.5 mg/kg (not to exceed 100 mg) daily dose thereafter. Duration of treatment should be based on the patient's clinical response, with antifungal therapy continuing for at least 14 days after the last positive culture in general. No dosing adjustments are required for patients with mild, moderate, or severe hepatic impairment or with any degree of renal insufficiency, including those on dialysis.

Key safety warnings

Anaphylactic reactions, including shock, have been reported with the use of anidulafungin, and if these reactions occur, anidulafungin should be discontinued and appropriate treatment administered. Anidulafungin must not be given by bolus injection, as infusion-related adverse events including rash, urticaria, flushing, pruritus, dyspnoea, bronchospasm and hypotension have been reported, though these are infrequent when the infusion rate does not exceed 1.1 mg/minute. Laboratory abnormalities in liver function tests have been seen in healthy subjects and patients treated with anidulafungin, and in some patients with serious underlying medical conditions receiving multiple concomitant medications, clinically significant hepatic abnormalities have occurred, though isolated cases of significant hepatic dysfunction, hepatitis, or hepatic failure have been reported with uncertain causal relationship to anidulafungin. Patients who develop abnormal liver function tests during anidulafungin therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing anidulafungin therapy. Patients with hereditary fructose intolerance (HFI) should not be given this medicine unless strictly necessary, and a detailed history with regard to HFI symptoms should be taken of each patient prior to being given this medicinal product.

Contraindications

Anidulafungin is contraindicated in patients with hypersensitivity to the active substance, to any of the excipients, or to other medicinal products of the echinocandin class such as caspofungin.

Regulatory history

Anidulafungin Medsurge (ARTG 407031) was first listed on 16 July 2025. This medicinal product is subject to additional monitoring in Australia due to approval of an extension of indications, which will allow quick identification of new safety information.