Professional Information

Anidulafungin

Pronunciation: (ay-NID-ue-la-FUN-jin)
Class: Antifungal

Trade Names:
Eraxis
- Injection, lyophilized powder for solution 50 mg
- Injection, lyophilized powder for solution 100 mg

Pharmacology

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Inhibits formation of an essential component of fungal cell walls by inhibiting glucan synthase, an enzyme present in fungal cells.

Pharmacokinetics

Absorption

C _max ranges from 3.55 to 10.9 mg/L; AUC ranges from 42.3 to 168.9 mg•h/L.

Distribution

Vd is 30 to 50 L. Protein binding is greater than 99%.

Metabolism

Undergoes slow chemical degradation at physiologic temperature and pH. Anidulafungin is not a substrate, inducer, or inhibitor of CYP isozymes.

Elimination

Cl is 0.84 to 0.78 L/h; elimination half-life is 43.2 to 50.3 h. Approximately 30% excreted in feces over 9 days and less than 1% excreted in urine.

Special Populations

Renal Function Impairment

Dosage adjustments are not necessary based on degree of renal insufficiency, including hemodialysis.

Hepatic Function Impairment

Dosage adjustment not necessary based on mild, moderate, or severe hepatic insufficiency.

Elderly

Dosage adjustments not necessary for elderly patients.

Gender

Dosage adjustments not necessary based on gender.

Race

Dosage adjustments not necessary based on race.

HIV status

Dosage adjustments not necessary based on HIV status, including coadministration of antiretroviral therapy.

Indications and Usage

Treatment of esophageal candidiasis, candidemia, and other forms of Candida infections.

Contraindications

Hypersensitivity to echinocandins or any component of the product.

Dosage and Administration

Candidemia or Other Candida Infections
Adults

IV Single 200 mg loading dose on day 1 followed by 100 mg/day thereafter, generally for at least 14 days after the last positive culture.

Esophageal Candidiasis
Adults

IV Single 100 mg loading dose on day 1 followed by 50 mg/day thereafter for a minimum of 14 days and at least 7 days following resolution of symptoms.

General Advice

For IV infusion, not for IV bolus injection.
Rate of infusion should not exceed 1.1 mg/min.
Do not administer if particulate matter or discoloration is noted.

Storage/Stability

Store unreconstituted vials and companion vials at 59° to 86°F. Do not freeze.

Store reconstituted solution at 59° to 86°F. Do not refrigerate or freeze. The reconstituted solution must be further diluted to an infusion solution and administered within 24 h.

Store the infusion solution at 59° to 86°F. Do not refrigerate or freeze.

Drug Interactions

Cyclosporine

Anidulafungin AUC may be slightly increased. No dosage adjustment is needed.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Atrial fibrillation, hypertension, hypotension, right bundle branch block, sinus arrhythmia, superficial thrombophlebitis, ventricular extrasystoles (less than 2%).

CNS

Convulsions, dizziness (less than 2%); headache (1%).

Dermatologic

Angioneurotic edema, erythema, flushing, increased sweating, pruritus, urticaria (less than 2%); rash (1%).

EENT

Blurred vision, eye pain, visual disturbance (less than 2%).

GI

Diarrhea (3%); constipation, dyspepsia, fecal incontinence, nausea, upper abdominal pain, vomiting (less than 2%).

Hematologic-Lymphatic

Coagulopathy, thrombocytopenia (less than 2%); deep vein thrombosis, leukopenia, neutropenia (1%).

Hepatic

Cholestasis, hepatic necrosis (less than 2%).

Lab Tests

Decreased potassium (3%); increased alkaline phosphatase, increased ALT, increased hepatic enzyme (2%); decreased magnesium and platelet count; increased amylase, bilirubin, calcium, CPK, creatinine, lipase, magnesium, platelet count, potassium, sodium, and urea; PT prolongation, QT prolongation (less than 2%); increased AST, increased gamma-glutamyl transferase (1%).