Special Warning : אזהרת שימוש

4.4     Special warnings and precautions for use

ERAXIS® has not been studied in patients with Candida endocarditis, osteomyelitis or meningitis.
The efficacy of ERAXIS® has only been evaluated in a limited number of neutropenic patients (see section 5.1)
Paediatric population

Treatment with ERAXIS® 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 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, dyspnea, 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.

Fructose content
ERAXIS® 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.

A detailed history with regard to HFI symptoms has to be taken of each patient prior to being given this medicinal product.

Sodium content

ERAXIS® contains less than 1 mmol sodium (23 mg) per vial. Patients on low sodium diets can be informed that this medicinal product is essentially ‘sodium-free’.

ERAXIS® may be diluted with sodium-containing solutions (see section 6.6) and this should be considered in relation to the total sodium from all sources that will be administered to the patient.

Effects on Driving

4.7     Effects on ability to drive and use machines

Not relevant