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

Overall ERAXIS Safety Experience
The safety of ERAXIS 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 at daily doses of either 50 or 100 mg. A total of 481 patients received ERAXIS for ≥14 days.

Candidemia/other Candida Infections
Three studies (one comparative vs. fluconazole, two non-comparative) assessed the efficacy and safety of ERAXIS (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 or fluconazole therapy in the comparative candidemia study.

Table 8. Treatment-related^a adverse events reported in ≥2.0% of subjects receiving ERAXIS 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 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 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 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:

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

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