Description

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.

Cyclosporine: Administration of multiple doses of anidulafungin and cyclosporine to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug. No dosage adjustment of cyclosporine or anidulafungin is needed when the two drugs are co-administered. Voriconazole: Administration of multiple doses of anidulafungin and voriconazole to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug. No dosage adjustment of voriconazole or anidulafungin is needed when the two drugs are co-administered. Tacrolimus: Administration of multiple doses of anidulafungin and a single-dose of tacrolimus to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug. No dosage adjustment of tacrolimus or anidulafungin is needed when the two drugs are co-administered. Rifampin: Administration of multiple doses of anidulafungin and rifampin to patients resulted in no significant alteration in the steady state pharmacokinetics of anidulafungin. No dosage adjustment of anidulafungin is needed when it is co administered with rifampin. Amphotericin B Liposome for Injection: Administration of multiple doses of anidulafungin and liposomal amphotericin B to patients resulted in no significant alteration in the steady state pharmacokinetics of anidulafungin. No dosage adjustment of anidulafungin is needed when it is co-administered with liposomal amphotericin B.

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: 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.

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.

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.

During clinical trials a single 400 mg dose of Anidulafungin was inadvertently administered as a loading dose. No clinical adverse events were reported. In a study of 10 healthy subjects administered a loading dose of 260 mg followed by 130 mg daily; 3 of the 10 subjects experienced transient, asymptomatic transaminase elevations (≤3 x ULN) Anidulafungin is not dialyzable. The maximum non-lethal dose of anidulafungin in rats was 50 mg/kg, a dose which is equivalent to 10 times the recommended daily dose for esophageal candidiasis (50 mg/day) or equivalent to 5 times the recommended daily dose for candidemia and other Candida infections (100 mg/day), based on relative body surface area comparisons.

Candida infections, Echinocandins