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