ERAXIS 100MG FOR INJECTION [SIN13585P]

Product Info

ERAXIS 100MG FOR INJECTION

[SIN13585P]

4.1 Therapeutic indications

Treatment of invasive candidiasis in adult and in paediatric patients one month and older (see sections 4.4 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

Treatment with ERAXIS should be initiated by a physician experienced in the management of invasive fungal infections. Specimens for fungal culture should be obtained prior to therapy. Therapy may be initiated before culture results are known and can be adjusted accordingly once they are available.

Adult patients

A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter. Duration of treatment should be based on the patient’s clinical response. In general, antifungal therapy should continue for at least 14 days after the last positive culture.

Paediatric patients (one month and older)

The recommended dose is 3.0 mg/kg (not to exceed 200 mg) loading dose of anidulafungin on Day 1, followed by 1.5 mg/kg (not to exceed 100 mg) daily dose thereafter. In general, antifungal therapy should continue for at least 14 days after the last negative culture (defined as the second of two consecutive negative cultures, separated by at least 24 hours, following the last positive culture) and improvement of clinical signs and symptoms of invasive candidiasis including candidaemia (ICC).

Switch to an oral antifungal may occur after a minimum of 10 days on anidulafungin intravenous therapy.

The efficacy and safety of anidulafungin has not been established in neonates (less than 1 month) (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

ERAXIS should be reconstituted with water for injection to a concentration of 3.33 mg/ml and subsequently diluted to a concentration of 0.77 mg/ml. For instructions on reconstitution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

It is recommended that ERAXIS be administered at a rate of infusion that does not exceed 1.1 mg/minute (equivalent to 1.4 ml/minute or 84 ml/hour when reconstituted and diluted per instructions). Infusion associated reactions are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/minute (see sections 4.4, 4.8 and 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

ERAXIS must not be administered as a bolus injection.

For patients with hereditary fructose intolerance (HFI) see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Patients with renal and hepatic impairment

No dosing adjustments are required for patients with mild, moderate, or severe hepatic impairment. No dosing adjustments are required for patients with any degree of renal insufficiency, including those on dialysis. ERAXIS can be given without regard to the timing of haemodialysis (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Duration of treatment

There are insufficient data to support the 100 mg dose for longer than 35 days of treatment.

Other special populations

No dosing adjustments are required for adult patients based on gender, weight, ethnicity, HIV positivity, or elderly (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

Hypersensitivity to the active substance, or to any of the excipients.

Hypersensitivity to other medicinal products of the echinocandin class (e.g., caspofungin).