Anidula IV Infusion

Anidula is indicated for the invasive fungal infection as follows:

• 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

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.

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

Patients with 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.

Other special population: No dosing adjustments are required for adult patients based on gender, weight, ethnicity, HIV positivity, or elderly.

Adults	Pediatric (1 Month of Age and Older)
Candidemia and other forms of Candida infections
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	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
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	Not approved

Method of Administration: For intravenous use only. Anidulafungin should be reconstituted with water for injection to a concentration of 3.33 mg/mL and subsequently diluted to a concentration of 0.77 mg/mL. It is recommended that Anidulafungin be administered at a rate of infusion that does not exceed 1.1 mg/min (equivalent to 1.4 mL/min when reconstituted and diluted per instructions). Anidulafungin must not be administered as a bolus injection.

Administration of multiple doses of Anidula with Cyclosporine, Tacrolimus, Rifampin, Voriconazole, and Amphotericin B to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of Anidula. No dosage adjustment of Anidula is needed when the mentioned drugs are co-administered.

Anidulafungin is contraindicated in patients with known hypersensitivity to any component of Anidulafungin, or other Echinocandins.

Most common adverse reactions are hypokalemia, nausea, vomiting, diarrhea, dyspepsia, abdominal pain, pyrexia, insomnia, hypotension, headache, anemia and thrombocytopenia.

There are no available human data on the use of Anidulafungin in pregnant women to inform a drug-associated risk of adverse developmental outcomes. There are no data on the presence of Anidulafungin in human milk, the effects on the breastfed infant or the effects on milk production.

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: Anidula 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. Anidula is not approved in pediatric patients younger than 1 month of age.

Hereditary Fructose Intolerance (HFI): Anidula 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 Anidula administration.

During clinical trials a single 400 mg dose of Anidula was inadvertently administered as a loading dose. No clinical adverse events were reported.

Candida infections, Echinocandins

Anidula must be reconstituted with water for injection and subsequently diluted with only 5% Dextrose, 0.9% Sodium chloride or normal saline. Aseptically transfer the contents of the reconstituted vial(s) into an intravenous bag (or bottle) containing either 5% Dextrose, 0.9% Sodium chloride or normal saline obtaining an Anidula concentration of 0.77 mg/mL.

For (unreconstituted) vial: Store in a refrigerator (2-8°C). Do not freeze.
For reconstituted solution in vial: Store at up to 25°C for up to 24 hours. Do not freeze.
For infusion solution: Store at up to 25°C for up to 48 hours. Do not freeze.