Eraxis IV Infusion

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.

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]

Cyclosporine: Administration of multiple doses of Eraxis and cyclosporine to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug. No dosage adjustment of cyclosporine or Eraxis is needed when the two drugs are co-administered.

Voriconazole: Administration of multiple doses of Eraxis and voriconazole to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug. No dosage adjustment of voriconazole or Eraxis is needed when the two drugs are co-administered.

Tacrolimus: Administration of multiple doses of Eraxis 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 Eraxis is needed when the two drugs are co-administered.

Rifampin: Administration of multiple doses of Eraxis and rifampin to patients resulted in no significant alteration in the steady state pharmacokinetics of Eraxis. No dosage adjustment of Eraxis is needed when it is co administered with rifampin.

Amphotericin B Liposome for Injection: Administration of multiple doses of Eraxis and liposomal amphotericin B to patients resulted in no significant alteration in the steady state pharmacokinetics of Eraxis. No dosage adjustment of Eraxis is needed when it is co-administered with liposomal amphotericin B.

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

Hereditary Fructose Intolerance (HFI): Eraxis 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 Eraxis 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 Eraxis 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)

Eraxis is not dialyzable. The maximum non-lethal dose of Eraxis 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

Eraxis vials: Eraxis vials should be stored in a refrigerator at 2°C-8°C. Do not freeze. Excursions for 96 hours up to 25ºC are permitted, and the vial can be returned to storage at 2°C-8°C.

Reconstituted solution: Eraxis reconstituted solution can be stored at up to 25°C for up to 24 hours.

Infusion Solution: Eraxis infusion solution can be stored at temperatures up to 25°C for up to 48 hours. Do not freeze.