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Drug Details

ECALTA 100 mg powder for concentrate for solution for infusion'

• Drug Class Description
  Other antimycotics for systemic use - ATC code: JO2AX06
• Generic Name
  Anidulafungin
• Presentation
  Powder for concentrate for solution for infusion. White to off-white lyophilised solid. The reconstituted solution has a pH of 3.5 to 5.5
• Description
  Each vial contains 100 mg anidulafungin. The reconstituted solution contains 3.33 mg/ml anidulafungin and the diluted solution contains 0.77 mg/ml anidulafungin. Excipients: Fructose 102.5 mg per vial
• Indications
  

  Treatment of invasive candidiasis in adult non-neutropenic patients.

  ECALTA has been studied primarily in patients with candidaemia and only in a limited number of patients with deep tissue Candida infections or with abscess-forming disease.

• Adult Dosage
  

  Treatment with ECALTA 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.

  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.

  ECALTA should be reconstituted with water for injections to a concentration of 3.33 mg/ml and subsequently diluted to a concentration of 0.77 mg/ml before use.

  It is recommended that ECALTA be administered at a rate of infusion that does not exceed 1.1 mg/minute (equivalent to 1.4 ml/minute when reconstituted and diluted per instructions). Infusion associated reactions are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/minute.

  ECALTA should not be administered as a bolus injection.

  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. ECALTA can be given without regard to the timing of haemodialysis.

  There are insufficient data to support the 100 mg dose for longer than 35 days of treatment.

  Other special populations

  No dosing adjustments are required for adult patients based on gender, weight, ethnicity, HIV positivity, or geriatric status

• Child Dosage
  

  Children and adolescents

  ECALTA is not recommended for use in children below 18 due to insufficient data on safety and efficacy

• Elderly Dosage
  

  No dosing adjustments are required

• Contra Indications
  

  Hypersensitivity to the active substance, or to any of the excipients.

  Hypersensitivity to other medicinal products of the echinocandin class.

• Special Precautions
  

  The efficacy of ECALTA in neutropenic patients with candidaemia and in patients with deep tissue Candida infections or intra-abdominal abscess and peritonitis has not been established.

  Clinical efficacy has been evaluated primarily in non-neutropenic patients with C. albicans infections and in a smaller number of patients infected with non-albicans, mainly C. glabrata, C. parapsilosis and C. tropicalis. Patients with candida endocarditis, osteomyelitis or meningitis and known C.krusei infection have not been studied.

  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.

  Infusion-related reactions

  Exacerbation of infusion-related reactions by coadministration 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

  Patients with rare hereditary problems of fructose intolerance should not take this medicine.

• Interactions
  

  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

• Adverse Drug Reactions
  

  Nine hundred and twenty-nine (929) subjects received single or multiple doses of intravenous anidulafungin in clinical trials: 672 in Phase 2/3 trials (287 patients with candidaemia/invasive candidiasis, 355 patients with oral/oesophageal candidiasis, 30 patients with invasive aspergillosis), and 257 in Phase I studies.

  Three studies (one comparative vs fluconazole, two non-comparative) assessed the efficacy of anidulafungin in patients with candidaemia and a limited number of patients with deep tissue Candida infections. A total of 204 patients received the recommended daily dose of 100 mg; the mean duration of intravenous treatment in these patients was 13.5 days (range, 1 to 38 days). One hundred and nineteen patients received 14 days of anidulafungin. Adverse reactions were typically mild to moderate and seldom led to discontinuation.

  Infusion-related adverse reactions have been reported with anidulafungin; in the pivotal ICC study, these included flushing/hot flush (2.3%), pruritus (2.3%), rash (1.5%), and urticaria (0.8%). Other treatment-related adverse reactions that occurred in 1% of patients in the pivotal study included hypokalaemia (3.1%), diarrhoea (3.1%), ALT increased (2.3%), hepatic enzyme increased (1.5%), blood alkaline phosphatase increased (1.5%), and blood bilirubin increased (1.5%).

  The following table includes, the drug-related adverse reactions (MedDRA terms) from the 100 mg ICC database (N = 204),with frequency corresponding to Common (1/100 to <1/10) or Uncommon (1/1,000 to <1/100) 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.

  Table of Adverse Reactions
  MedDRA System Organ Class	Frequency of Reported MedDRA Preferred Term
  	Common	Uncommon	Not Known^
  Blood and lymphatic system disorders	Coagulopathy	-	-
  Metabolism and nutrition disorders	Hypokalaemia	Hyperglycaemia	-
  Nervous system disorders	Convulsion, headache	-	-
  Vascular disorders	Flushing	Hypertension, hot flush	Hypotension
  Respiratory , thoracic and mediastinal disorders	-	-	Bronchospasm, dyspnoea
  Gastrointestinal disorders	Diarrhoea, vomiting, nausea	Abdominal pain upper	-
  Hepatobiliary disorders	Alanine aminotransferase increased, blood alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, gamma-glutamyltransferase increased	Cholestasis	-
  Skin and subcutaneous tissue disorders	Rash, pruritus	Urticaria	-
  Renal and urinary disorders	Blood creatinine increased	-	-
  General disorders and administration site conditions	-	Infusion site pai