Ecalta

Treatment with ECALTA should be initiated by a physician experienced in the management of invasive fungal infections. Posology 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 population (dosing and treatment duration) 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.

There are insufficient data to support the 100 mg dose for longer than 35 days of treatment. 3 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. 2). 2). 5 mg/kg (not to exceed 100 mg) 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. 4). Method of administration For intravenous use only. 77 mg/mL for the final infusion solution. For a paediatric patient, the volume of infusion solution required to deliver the dose will vary depending on the weight of the child.

6). 4 mL/min when reconstituted and diluted per instructions). 4). ECALTA must not be administered as a bolus injection.

4). 6 Tabulated list of adverse reactions The following table includes, the all-causality adverse reactions (MedDRA terms) from 840 subjects receiving 100 mg anidulafungin with frequency corresponding to very common (≥1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and from spontaneous reports with frequency not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Table 1. 4. 1). The frequencies of certain hepatobiliary adverse events, including alanine aminotransferase (ALT) increased and aspartate aminotransferase (AST) increased appeared at a higher frequency (7-10%) in these paediatric patients than has been observed in adults (2%).

Although chance or differences in underlying disease severity may have contributed, it cannot be excluded that hepatobiliary adverse reactions occur more frequently in paediatric patients compared to adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

ECALTA has not been studied in patients with Candida endocarditis, osteomyelitis or meningitis. 1). Paediatric population Treatment with ECALTA in neonates (< 1 month old) is not recommended. 3), resulting in higher doses of polysorbate 80, a formulation 4 excipient.

High doses of polysorbates have been associated with potentially life-threatening toxicities in neonates as reported in the literature. 2. Hepatic effects Increased levels of hepatic enzymes have been seen in healthy subjects and patients treated with anidulafungin.

In some patients with serious underlying medical conditions who were receiving multiple concomitant medicines along with anidulafungin, clinically significant hepatic abnormalities have occurred. Cases of significant hepatic dysfunction, hepatitis, and hepatic failure were uncommon in clinical trials.

Patients with increased hepatic enzymes during anidulafungin therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing anidulafungin therapy. Anaphylactic reactions Anaphylactic reactions, including shock, were reported with the use of anidulafungin.

If these reactions occur, anidulafungin should be discontinued and appropriate treatment administered. Infusion-related reactions Infusion-related adverse events have been reported with anidulafungin, including rash, urticaria, flushing, pruritus, dyspnoea, bronchospasm and hypotension.

8). 3). The clinical relevance of this is unknown. Nevertheless, care should be taken when co-administering anidulafungin and anaesthetic agents. Excipients with known effect Fructose ECALTA contains fructose. Patients with hereditary fructose intolerance (HFI) should not be given this medicine unless strictly necessary.

Babies and young children (below 2 years of age) may not yet be diagnosed with HFI. Medicines (containing fructose) given intravenously may be life-threatening and should not be administered in this population unless there is an overwhelming clinical need and no alternatives are available.

1. Hypersensitivity to other medicinal products of the echinocandin class.