Anidulafungin is a semi-synthetic echinocandin with antifungal activity. Anidulafungin inhibits 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 is an echinocandin antifungal indicated for the treatment of the following infections:

• Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric patients (1 month of age and older).
• Esophageal candidiasis in adults.

Limitations of use:

• Anidulafungin has not been studied in adult and pediatric patients with endocarditis, osteomyelitis, and meningitis due to Candida or in sufficient numbers of neutropenic patients. The dosage of Anidulafungin for the treatment of Candida dissemination into the CNS and the eye has not been established.
• Anidulafungin is associated with high relapse rates in esophageal candidiasis.

Candidemia and other forms of Candida infections-

• Adults: 200 mg loading dose on Day 1, followed by 100 mg once daily maintenance dose thereafter for at least 14 days after the last positive culture.
• Pediatric Patients 1 Month of Age and Older: 3 mg/kg (not to exceed 200 mg) loading dose on Day 1, followed by 1.5 mg/kg (not to exceed 100 mg) once daily maintenance dose thereafter for at least 14 days after the last positive culture.

Esophageal candidiasis-

• Adults: 100 mg loading dose on Day 1, followed by 50 mg once daily maintenance dose thereafter for a minimum of 14 days and for at least 7 days following resolution of symptoms.
• Pediatric Patients 1 Month of Age and Older: Not Approved.

Rate of Infusion for Adults and Pediatric Patients: The rate of infusion should not exceed 1.1 mg/minute [equivalent to 1.4 mL/minute or 84 mL/hour when reconstituted and diluted per instructions]

Anidulafungin is contraindicated in:

• Patients with known hypersensitivity to anidulafungin, any component of Anidulafungin, or other echinocandins.
• Patients with known or suspected Hereditary Fructose Intolerance (HFI).

Adults-

• Candidemia and other forms of Candida infections: Most common adverse reactions (≥15%) are hypokalemia, nausea, diarrhea, vomiting, pyrexia, insomnia, hypotension.
• Esophageal candidiasis: Most common adverse reactions (≥5%) are diarrhea, pyrexia, anemia, headache, vomiting, nausea, dyspepsia, oral candidiasis, and hypokalemia. 

Pediatric Patients (1 month and older): Candidemia and other forms of Candida infections: Most common adverse reactions (≥ 5%): diarrhea, vomiting, pyrexia, abdominal pain, anemia, thrombocytopenia, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) increased, hypoglycemia, epistaxis, and rash.

Pregnancy & Lactation

Pregnancy: Based on findings from animal studies, Anidulafungin can cause fetal harm when administered to a pregnant woman. There are no available human data on the use of Anidulafungin in pregnant women to inform a drug-associated risk of adverse developmental outcomes. In animal reproduction studies fetal toxicity was observed in the presence of maternal toxicity when anidulafungin was administered to pregnant rabbits during organogenesis at 4 times the proposed therapeutic maintenance dose of 100 mg/day on the basis of relative body surface area. Inform pregnant woman of the risk to the fetus.

Lactation: There are no data on the presence of anidulafungin in human milk, the effects on the breastfed infant or the effects on milk production. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Anidulafungin was found in the milk of lactating rats. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Anidulafungin and any potential adverse effects on the breastfed child from Anidulafungin or from the underlying maternal condition.

Precautions & Warnings

Hepatic Effects: Risk of abnormal liver tests, hepatitis, hepatic failure; monitor hepatic function during therapy.

Hypersensitivity: Anaphylaxis, including shock has been reported. Risk of infusion-related adverse reactions, possibly histamine-mediated, including rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, and hypotension; to reduce occurrence, do not exceed a rate of infusion of 1.1 mg/minute.

Risk of Neonatal Toxicity Associated with Polysorbates: Anidulafungin contains polysorbate 80, an inactive ingredient. Thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension and metabolic acidosis haves been reported in low-birth weight infants receiving high doses of polysorbate. Anidulafungin is not approved in pediatric patients younger than 1 month of age.

Hereditary Fructose Intolerance (HFI): Anidulafungin contains fructose. Risk of metabolic crisis with life-threatening hypoglycemia, hypophosphatemia, lactic acidosis, and hepatic failure. Obtain history of HFI symptoms in pediatric patients before Anidulafungin administration.

Use in Special Populations

Pediatric Use: The safety and effectiveness in patients younger than 1 month of age has not been established.

Geriatric Use: Dosage adjustments are not required for geriatric patients.

Hepatic Insufficiency: No dosing adjustments are required for patients with any degree of hepatic insufficiency.

Renal Insufficiency: Dosage adjustments are not required for patients with any degree of renal insufficiency including those on hemodialysis.