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anidulafungin (Eraxis)

 

Classes: Antifungals, Systemic; Antifungals, Echinocandin

Dosing and uses of Eraxis (anidulafungin)

 

Adult dosage forms and strengths

powder for injection

  • 50mg

 

Candidemia, Candidal Peritonitis, Intra-Abdominal Abscess

Day 1: 200 mg IV infusion, THEn

Day 2 Onwards: 100 mg/day IV

Generally continue 14 days after last positive culture

 

Esophageal Candidiasis

Day 1: 100 mg IV infusion, THEn

Day 2 Onwards: 50 mg/day IV

Minimum 14 day treatment, at least 7 days following resolution of symptoms

 

Pediatric dosage forms and strengths

Safety and efficacy not established; limited data suggest off-label dose of 3 mg/m²/dose IV loading dose, then 1.5 mg/m²/dose IV once daily

 

Eraxis (anidulafungin) adverse (side) effects

1-10%

Candidemia treatment

  • Diarrhea (3%)
  • Hypokalemia (3%)
  • Abnl LFTs (2%)

Esophageal Candidiasis treatment

  • Headache (1%)
  • Nausea (1%)
  • Neutropenia (1%)
  • Rash (1%)

 

Frequency not defined

Possible histamine-mediated symptoms reported including rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, and hypotension; infrequent when infusion rate does not exceed 1.1 mg/minute.

 

Warnings

Contraindications

Hypersensitivity to any component or other echinocandins

 

Cautions

Abnormal LFTs observed; monitor for potential hepatic problems

May cause bronchospasm

Not studied for Candida-caused endocarditis, osteomyelitis or meningitis

Not for bolus administration

 

Pregnancy and lactation

Pregnancy category: C

Lactation: not known if distributed in breast milk, use caution

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Eraxis (anidulafungin)

Vd: 30-50 L

Half-Life, distribution: 30 min-1 hr

Half-Life, terminal elim: 40-50 hr

Protein Bound: 84%

Peak Plasma: 8.6 mg/L (on 200 mg/100 mg dosing regimen)

Clearance: 1 L/hr

Metabolism: not hepatically, not a CYP3A4 substrate

Excretion: feces 30%, very low in urine

 

Mechanism of action

Echinocandin - inhibits synthesis of 1,3-beta-D-glucan, an essential component of fungal cell walls

 

Administration

IV Preparation

Aseptically reconstitute each 50 mg vial with 15 mL supplied diluent to obtain a 3.33 mg/mL solution

May store at 25°C (77°F) - do not freeze

Administer within 24 hr post-reconstitution

Dilute further by transferring aseptically in a bag or bottle containing D5W or NS to provide an infusion solution of 0.5 mg/mL

Discard if particulate matter or discoloration appears

 

IV Administration

Infuse at NMT 1.1 mg/min

Do not give bolus

 

Storage

Unopened vials, reconstituted vials & diluted solution may be stored at 25°C (77°F) - do not freeze