Anidula 100 mg/vial (IV Infusion)

Indications

• 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

Pharmacology

Anidulafungin inhibits glucan synthase, an enzyme present in fungal, but not mammalian cells, resulting in inhibition of the formation of 1,3-β-D-glucan, an essential component of the fungal cell wall.

Dosage & Administration

• Duration of treatment: Insufficient data to support the 100 mg dose for longer than 35 days of treatment
• Special populations:
  • No dosing adjustments required for patients with mild, moderate, or severe hepatic impairment
  • No dosing adjustments required for patients with any degree of renal insufficiency, including those on dialysis
  • No dosing adjustments required for adult patients based on gender, weight, ethnicity, HIV positivity, or elderly
• 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 (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:
  • 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
• 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.

Interaction

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.

Contraindications

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

Side Effects

• Hypokalemia
• Nausea
• Vomiting
• Diarrhea
• Dyspepsia
• Abdominal pain
• Pyrexia
• Insomnia
• Hypotension
• Headache
• Anemia
• Thrombocytopenia

Pregnancy & Lactation

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

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: 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.

Overdose Effects

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

Therapeutic Class

• Candida infections
• Echinocandins

Reconstitution

Anidula must be reconstituted with water for injection and subsequently diluted with only 5% Dextrose, 0.9% Sodium chloride or normal saline.

Storage Conditions

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.

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