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General

Possible histamine-mediated symptoms have been reported with ERAXIS (anidulafungin) , including rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, and hypotension. These events are infrequent when the rate of ERAXIS (anidulafungin) infusion does not exceed 1.1 mg/minute.

Overall ERAXIS (anidulafungin) Safety Experience

The safety of ERAXIS (anidulafungin) for Injection was assessed in 929 individuals, including 672 patients in Clinical Studies and 257 individuals in Phase 1 studies. A total of 633 patients received ERAXIS (anidulafungin) at daily doses of either 50 or 100 mg. A total of 481 patients received ERAXIS (anidulafungin) for ≥ 14 days.

Candidemia/other Candida Infections

Three studies (one comparative vs. fluconazole, two non-comparative) assessed the efficacy and safety of ERAXIS (anidulafungin) (100 mg) in patients with candidemia and other Candida infections. Table 8 presents treatment-related adverse events that were reported in ≥ 2.0% of subjects receiving ERAXIS (anidulafungin) or fluconazole therapy in the comparative candidemia study.

Table 8: Treatment-related^a adverse events reported in ≥ 2.0% of subjects receiving ERAXIS (anidulafungin) or fluconazole therapy for candidemia/other Candida infections

Esophageal Candidiasis

A single phase 3, randomized, double-blind study compared the efficacy and safety of ERAXIS (anidulafungin) to that of fluconazole in patients with esophageal candidiasis. Table 9 presents treatment-related adverse events that were reported in > 1.0% of subjects receiving ERAXIS (anidulafungin) therapy. (No adverse events were reported at a frequency of 2% or greater in patients with esophageal candidiasis).

Table 9: Treatment-related ^a adverse events reported in ≥ 1.0% of subjects receiving ERAXIS (anidulafungin) or fluconazole therapy for esophageal candidiasis

The following events occurred in either < 2% of patients treated for candidemia/other Candida infections, or in < 1% of patients treated for esophageal candidiasis and were judged by investigators to be at least possibly related to ERAXIS (anidulafungin) :

Blood and Lymphatic: coagulopathy, thrombocytopenia

Cardiac: atrial fibrillation, bundle branch block (right), sinus arrhythmia, ventricular extrasystoles

Eye: eye pain, vision blurred, visual disturbance

Gastrointestinal: abdominal pain upper, constipation, diarrhea NOS, dyspepsia, fecal incontinence, nausea, vomiting

General and Administration Site: infusion related reaction, peripheral edema, rigors

Hepatobiliary: abnormal liver function tests NOS, cholestasis, hepatic necrosis

Infections: candidiasis, clostridial infection, fungemia, oral candidiasis

Investigations: amylase ↑, bilirubin ↑, CPK ↑, creatinine ↑, electrocardiogram QT prolonged, electrocardiogram early transition, gamma-glutamyl transferase ↑, lipase ↑, magnesium ↓, platelet count ↑, platelet count ↓, potassium ↓, prothrombin time prolonged, urea ↑

Metabolism and Nutrition: hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypomagnesemia

Musculoskeletal and Connective Tissue: back pain

Nervous System: convulsion, dizziness, headache

Respiratory, Thoracic and Mediastinal: cough

Skin and Subcutaneous Tissue: angioneurotic edema, erythema, pruritus, pruritus generalized, sweating increased, urticaria, urticaria NOS Vascular: flushing, hot flushes, hypertension, hypotension, thrombophlebitis superficial

Pre-clinical in vitro and in vivo and Clinical Studies demonstrated that anidulafungin is not a clinically relevant substrate, inducer, or inhibitor of cytochrome P450 isoenzymes. Anidulafungin has negligible renal clearance. Minimal interactions are expected from the concomitant medications (see CLINICAL PHARMACOLOGY –Drug Interaction Studies).

Drug interaction studies were performed with anidulafungin and other drugs likely to be coadministered. When used in therapeutic doses, no dosage adjustment of either drug is recommended when anidulafungin is co-administered with voriconazole or tacrolimus, and no dosage adjustment for anidulafungin is recommended when co-administered with amphotericin B or rifampin (see CLINICAL PHARMACOLOGY –Drug Interaction Studies).

Co-administration with cyclosporine slightly increased the steady state AUC of anidulafungin by 22%. A separate in vitro study showed that anidulafungin has no effect on the metabolism of cyclosporine. Adverse events observed in the study were consistent with adverse events observed from other studies with the administration of anidulafungin alone. No dosage adjustment of either drug is warranted for patients on concomitant cyclosporine (see CLINICAL PHARMACOLOGY –Drug Interaction Studies).

Last reviewed on RxList: 12/9/2010
This monograph has been modified to include the generic and brand name in many instances.