Anidulafungin S.K

/ K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL

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.
Paediatric population (1 month to < 18 years) (dosing and treatment duration)
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.
The safety and efficacy of Anidulafungin have not been established in neonates (< 1 month old).
See prescribing information for full details.

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.
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.
Exacerbation of infusion-related reactions by co-administration of anaesthetics has been seen in a non- clinical (rat) study. The clinical relevance of this is unknown. Nevertheless, care should be taken when co-administering anidulafungin and anaesthetic agents.
Fructose content
Anidulafungin S.K 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.
See prescribing information for full details.

Very Common: Hypokalaemia, diarrhoea, nausea.
Common: 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.
Paediatric population
Interaction studies have only been performed in adults.

Pregnancy: There are no data from the use of anidulafungin in pregnant women. Anidulafungin 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 utilised as necessary.
During a paediatric clinical trial, one subject received two doses of anidulafungin that were 143% of the expected dose. No clinical adverse reactions were reported.
This medical product is not dialysable.

Contains fructose.