Eraxis

/ Pfizer

Treatment with Anidulafungin should be initiated by a physician experienced in the management of invasive fungal infections. 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.
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. Anidulafungin can be given without regard to the timing of haemodialysis.
Other special populations: No dosing adjustments are required for adult patients based on gender, weight, ethnicity, HIV positivity, or elderly.
Paediatric population (1 month to < 18 years): 
A single loading dose of 3.0 mg/kg (not to exceed 200 mg) should be administered on Day 1 followed by a daily maintenance dose of 1.5 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.

Treatment of invasive candidiasis in adults and paediatric patients aged 1 month to < 18 years

Hypersensitivity to the active substance or to any of the excipients. Hypersensitivity to other medicinal products of the echinocandin class.      

Anidulafungin has not been studied in patients with Candida endocarditis, osteomyelitis or meningitis. The efficacy of anidulafungin. Has only been evaluated in a limited number of neutropenic patients.
Paediatric population: Treatment with anidulafungin 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, 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.
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.
Fructose content: Patients with hereditary fructose intolerance (HFI) should not be given this medicine unless strictly necessary.
A detailed history with regard to HFI symptoms has to be taken of each patient prior to being given this medicinal product.
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.
See prescribing information for full details. 

Very Common: Hypokalaemia, diarrhoea, nausea.
Commn: Hyperglycaemia, convulsion, headache, hypotension, hypertension, bronchospasm, dyspnoea, vomiting, alanine aminotransferase increased,
blood alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, cholestasis, rash, pruritus, blood creatinine increased.
See prescribing information for full details.

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. 

Pregnancy: There are no data from the use of anidulafungin in pregnant women. Studies in animals have shown reproductive toxicity.
This medical product is not recommended during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.
Lactation: 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 anidulafungin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

As with any overdose, general supportive measures should be utilized as necessary. This medical product is not dialysable.
See prescribing information for full details.

Storage: Store in a Refrigerator (2°C – 8°C).
Fructose: This drug contains 102.5 mg fructose in each vial.
Sodium content:  This drug 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 and this should be considered in relation to the total sodium from all sources that will be administered to the patient.
Dilution and infusion: Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit. If particulate matter or discolouration is identified, discard the solution.