Anidulafungin

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Invasive candidiasis, including candidaemia

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to other medicinal products of the echinocandin class

Cautions

• Breastfeeding
• Candida endocarditis
• Osteomyelitis
• Meningitis
• Infusion rate greater than 1.1mg/min
• Fructose intolerance
• Neutropaenia
• Coadministration of hepatotoxic agents
• Coadministration of anaesthetic agents

Forms avail. in SA and covered in this monograph: inj

Infections caused by: Candida spp.; Aspergillus fumigatus

Invasive candidiasis
- Candidaemia

• IV: Initial: 200mg on day 1; Maintenance: 100mg, dly; Treatment duration: 14 days after last positive culture

Max infusion rate: 1.1mg/min

Not established for use in children below 18 years

Pregnancy

• Caution
• There are no data from the use of anidulafungin in pregnant women. Studies in animals have shown reproductive toxicity 
• Anidulafungin is not recommended during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus

Breastfeeding

• Caution
• 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 breastfeeding or to discontinue/abstain from anidulafungin therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Convulsion
• Headache

Cardiovascular Disorders

• Hypotension
• Hypertension
• Flushing
• Hot flush

Respiratory Disorders

• Bronchospasm
• Dyspnoea

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting
• Upper abdominal pain 

Hepatobiliary Disorders

• Increased alanine aminotransferase
• Increased blood alkaline phosphatase
• Increased aspartate aminotransferase 
• Increased blood bilirubin 
• Cholestasis
• Increased gamma-glutamyltransferase

Genitourinary Disorders

• Increased blood creatinine

Endocrine and Metabolic Disorders

• Hypokalaemia
• Hyperglycaemia

Skin and Subcutaneous Tissue Disorders

• Rash
• Pruritus
• Urticaria
• Infusion site pain

Immune, Blood and Lymphatic System Disorders

• Anaphylactic shock
• Anaphylactic reaction
• Coagulopathy

• Hepatotoxic agents
• Anaesthetic agents

None routine. Specific cases may require

• Hepatic function

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

Anidulafungin selectively inhibits 1,3-β-D glucan synthase, an enzyme present in fungal, but not mammalian cells. This results in inhibition of the formation of 1,3-β-D-glucan, an essential component of the fungal cell wall. Anidulafungin has shown fungicidal activity against Candida species and activity against regions of active cell growth of the hyphae of Aspergillus fumigatus.

Spectrum of activity: Candida spp.; Aspergillus fumigatus

Injection (per vial) 100mg

• Carixan (Teva Pharmaceuticals)
• Eraxis (Pfizer) originator