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Trade Names:
Eraxis
- Powder for injection, lyophilized 50 mg

Mechanism of Action

Pharmacology

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 84%.

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; t _½ is 43.2 to 50.3 h. Approximately 30% excreted in feces over 9 days and less than 1% excreted in urine.

Special Populations

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

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

Dosage adjustments not necessary for elderly patients.

Dosage adjustments not necessary based on gender.

Dosage adjustments not necessary based on race.

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

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.

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

General Advice

• For IV infusion, not for IV bolus injection.
• Only reconstitute with companion diluent (20% [w/w] dehydrated alcohol in water for injection) and subsequently dilute only with dextrose 5% injection or sodium chloride 0.9% injection.
• Reconstitute each 50 mg vial with 15 mL of companion diluent to a concentration of 3.33 mg/mL.
• Aseptically transfer the contents of the reconstituted vial(s) into an IV bag (or bottle) containing dextrose 5% injection or sodium chloride 0.9% injection (normal saline) to provide an infusion solution concentration of 0.5 mg/mL.
• Rate of infusion should not exceed 1.1 mg/min.
• Do not administer if particulate matter or discoloration noted.

Storage/Stability

Store unreconstituted vials and companion vials at 77°F; excursions permitted to 59° to 86°F. Do not freeze.

Store reconstituted solution at 77°F; excursions permitted to 59° to 86°F. Do not freeze. The reconstituted solution must be further diluted to an infusion solution and administered within 24 h.

Store the infusion solution at 77°F; excursions permitted to 59° to 86°F.

Drug Interactions

Anidulafungin AUC may be slightly increased.

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

Headache (1%); convulsions, dizziness (less than 2%).

Dermatologic

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

EENT

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

GI

Diarrhea (3%); constipation, diarrhea NOS, dyspepsia, fecal incontinence, upper abdominal pain (less than 2%); nausea, vomiting (1%).

Hematologic-Lymphatic

Deep vein thrombosis, leukopenia, neutropenia (1%); coagulopathy, thrombocytopenia (less than 2%).

Hepatic

Cholestasis, hepatic necrosis (less than 2%).

Lab Tests

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

Local

Infusion-related reaction, peripheral edema, rigors (less than 2%).

Metabolic-Nutritional

Hyperglycemia (less than 2%).

Musculoskeletal

Back pain (less than 2%).

Respiratory

Cough (less than 2%).

Miscellaneous

Candidiasis, clostridial infection, fungemia, oral candidiasis (less than 2%).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Hepatic Function

Monitor patients developing abnormal LFTs during use of anidulafungin for worsening hepatic function and evaluate for continued therapy.

Overdosage

Symptoms

Generally well tolerated. Transient, asymptomatic transaminase elevations have been reported.