Ecalta · 4.8 Undesirable effects · 1

HOS-154212 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile Infusion-related adverse reactions have been reported with anidulafungin in clinical studies, including rash, pruritus, dyspnoea, bronchospasm, hypotension (common events), flushing, hot flush, and urticaria (uncommon events), summarized in Table 1 (see section 4.4). 5 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. Table of Adverse Reactions System Organ Very Common Uncommon Rare Very Not Known Class Common ≥ 1/100 ≥ 1/1000 ≥ Rare ≥ 1/10 to to 1/10,000 < < 1/10 <1/100 to 1/10,000 <1/1,000 Blood and Coagulopathy Lymphatic System Disorders Immune System Anaphylacti Disorders c shock, anaphylactic reaction* Metabolism and Hypokalaemia Hyperglycaemia Nutrition Disorders Nervous System Convulsion, Disorders headache Vascular Disorders Hypotension, Flushing, hypertension hot flush Respiratory, Bronchospasm, Thoracic and Dyspnoea Mediastinal Disorders Gastrointestinal Diarrhoea, Vomiting Abdominal Disorders Nausea pain upper Hepat

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HOS-154208 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to other medicinal products of the echinocandin class.

HOS-154207 · has-indication-information · PDF-Seite 2

Treatment of invasive candidiasis in adults and paediatric patients aged 1 month to < 18 years (see sections 4.4 and 5.1).

HOS-154210 · has-interaction-information · PDF-Seite 5

Anidulafungin is not a clinically relevant substrate, inducer, or inhibitor of cytochrome P450 isoenzymes (1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A). Of note, in vitro studies do not fully exclude possible in vivo interactions. Drug interaction studies were performed with anidulafungin and other medicinal products likely to be co-administered. No dosage adjustment of either medicinal product is recommended when anidulafungin is co-administered with ciclosporin, voriconazole or tacrolimus, and no dosage adjustment for anidulafungin is recommended when co-administered with amphotericin B or rifampicin. Paediatric population Interaction studies have only been performed in adults.

HOS-154211 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are no data from the use of anidulafungin in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). ECALTA is not recommended during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus. Breast-feeding It is unknown whether anidulafungin is excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of anidulafungin in milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ECALTA therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility For anidulafungin, there were no effects on fertility in studies conducted in male and female rats (see section 5.3).

HOS-154209 · has-warning-information · PDF-Seite 3

ECALTA has not been studied in patients with Candida endocarditis, osteomyelitis or meningitis. The efficacy of ECALTA has only been evaluated in a limited number of neutropenic patients (see section 5.1). Paediatric population Treatment with ECALTA in neonates (< 1 month old) is not recommended. Treating neonates requires consideration for coverage of disseminated candidiasis including central nervous system (CNS); nonclinical infection models indicate that higher doses of anidulafungin are needed to achieve adequate CNS penetration (see section 5.3), resulting in higher doses of polysorbate 80, a formulation 3 excipient. High doses of polysorbates have been associated with potentially life-threatening toxicities in neonates as reported in the literature. There is no clinical data to support the efficacy and safety of higher doses of anidulafungin than recommended in 4.2. 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. Infusion-related adverse events are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/min (see section 4.8). Exacerbation of infusion-related reactions by co-administration of anaesthetics has been seen in a non-clinical (rat) study (see section 5.3). 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 int

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