The proportion of patients who experienced an infusion-related adverse reaction3 was significantly lower in the group treated with CANCIDAS (35.1%) than in the group treated with AmBisome (51.6%).

To eva luate the effect of CANCIDAS and AmBisome on renal function, nephrotoxicity was defined as doubling of serum creatinine relative to baseline or an increase of ≥1 mg/dL in serum creatinine if baseline serum creatinine was above the upper limit of the normal range. Among patients whose baseline creatinine clearance was >30 mL/min, the incidence of nephrotoxicity was significantly lower in the group treated with CANCIDAS (2.6%) than in the group treated with AmBisome (11.5%). Clinical renal events, regardless of causality, were similar between CANCIDAS (75/564, 13.3%) and AmBisome (85/547, 15.5%).

Candidemia and Other Candida Infections [see Clinical Studies (14.2)]

In the randomized, double-blinded invasive candidiasis study, patients received either CANCIDAS 50 mg/day (following a 70-mg loading dose) or amphotericin B 0.6 to 1.0 mg/kg/day. Adverse reactions occurring in ≥10% of the patients in either treatment group are presented in Table 3.

TABLE 3: Adverse Reactions Among Patients with Candidemia or other Candida Infections * , † — Incidence ≥10% for at Least One Treatment Group by System Organ Class or Preferred Term  Adverse Reaction
(MedDRA v10.1 System Organ Class and Preferred Term) CANCIDAS
50 mg‡ N=114
(percent) Amphotericin B
N=125 (percent)
Within any system organ class, individuals may experience more than 1 adverse reaction.
*
Intra-abdominal abscesses, peritonitis and pleural space infections.
†
Regardless of causality
‡
Patients received CANCIDAS 70 mg on Day 1, then 50 mg daily for the remainder of their treatment. 
All Systems, Any Adverse Reaction 95.6 99.2
Blood and Lymphatic System Disorders  14.9 12.8
   Anemia 10.5 8.8
Cardiac Disorders 26.3 33.6
   Tachycardia 7.9 12.0
Gastrointestinal Disorders 49.1 52.8
   Diarrhea 14.0 10.4
   Nausea 8.8 16.8
   Vomiting 16.7 16.0
General Disorders and Administration Site Conditions  46.5 63.2
   Chills 8.8 29.6
   Edema Peripheral 10.5 12.0
   Pyrexia 13.2 32.8
Infections and Infestations  48.2 53.6
   Pneumonia 4.4 10.4
   Septic Shock 10.5 8.8
Investigations  66.7 81.6
   Alanine Aminotransferase Increased 15.8 15.2
   Aspartate Aminotransferase Increased 15.8 14.4
   Bilirubin Conjugated Increased 7.9 13.6
   Blood Alkaline Phosphatase Increased 21.1 32.0
   Blood Bilirubin Increased 13.2 16.8
   Blood Creatinine Increased 11.4 28.0
   Blood Potassium Decreased 22.8 32.0
   Blood Urea Increased 8.8 23.2
   Hematocrit Decreased 13.2 18.4
   Hemoglobin Decreased 18.4 23.2
   Red Blood Cells Urine Positive 9.6 10.4
Respiratory, Thoracic and Mediastinal Disorders  39.5 53.6
   Pleural Effusion 8.8 14.4
   Respiratory Failure 10.5 12.0
   Tachypnea 0.9 11.2
Skin and Subcutaneous Tissue Disorders 25.4 28.0