Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
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.
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).
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, including shock, were reported with the use of anidulafungin. If these reactions occur, anidulafungin should be discontinued and appropriate treatment administered.
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.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
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.
Interaction studies have only been performed in adults.
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.
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.
For anidulafungin, there were no effects on fertility in studies conducted in male and female rats (see section 5.3).
Not relevant.
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).
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.
Uncommon: Coagulopathy
Not Known: Anaphylactic shock, anaphylactic reaction*
Very common: Hypokalaemia
Common: Hyperglycaemia
Common: Convulsion, headache
Common: Hypotension, hypertension
Uncommon: Flushing, hot flush
Common: Bronchospasm, Dyspnoea
Very common: Diarrhoea, Nausea
Common: Vomiting
Uncommon: Abdominal pain upper
Common: Alanine aminotransferase increased, blood alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, cholestasis
Uncommon: Gamma-glutamyltrans ferase increased
Common: Rash, pruritus
Uncommon: Urticaria
Common: Blood creatinine increased
Uncommon: Infusion site pain
* See section 4.4.
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.
This medicinal product must not be mixed with other medicinal products or electrolytes except those mentioned in section 6.6.
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