Eraxis Special Precautions

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 Pharmacology: Pharmacodynamics under Actions).
Hepatic effects: Laboratory abnormalities in liver function tests have been seen in healthy subjects and patients treated with anidulafungin. In some patients with serious underlying medical conditions who were receiving multiple concomitant medications along with anidulafungin, clinically significant hepatic abnormalities have occurred. Isolated cases of significant hepatic dysfunction, hepatitis, or hepatic failure have been reported in patients; a causal relationship to anidulafungin has not been established. Patients who develop abnormal liver function tests 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 (see Adverse Reactions).
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/minute (see Dosage & Administration, Adverse Reactions and Special precautions for disposal and other handling under Cautions for Usage).
Exacerbation of infusion-related reactions by co-administration of anaesthetics has been seen in a non-clinical (rat) study (see Pharmacology: Toxicology: Preclinical safety data under Actions). The clinical relevance of this is unknown. Nevertheless, care should be taken when co-administering anidulafungin and anaesthetic agents.
Patients with hereditary fructose intolerance: Patients with hereditary problems of fructose intolerance (HFI) should not take this medicine unless strictly necessary.
A detailed history with regard to HFI symptoms should be taken of each patient prior to being given this medicinal product.
Infants and 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.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.
Use in Children: Treatment with anidulafungin in neonates (less than 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 Pharmacology: Toxicology: Preclinical safety data under Actions), 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 Dosage & Administration.