The proportion of patients who experienced an infusion-related adverse reaction4 was significantly lower in the group treated with CANCIDAS (20.2%) than in the group treated with amphotericin B (48.8%).

To eva luate the effect of CANCIDAS and amphotericin B 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. In a subgroup of patients whose baseline creatinine clearance was >30 mL/min, the incidence of nephrotoxicity was significantly lower in the group treated with CANCIDAS than in the group treated with amphotericin B.

Esophageal Candidiasis and Oropharyngeal Candidiasis

Adverse reactions occurring in ≥10% of patients with esophageal and/or oropharyngeal candidiasis are presented in Table 4.

TABLE 4: Adverse Reactions Among Patients with Esophageal and/or Oropharyngeal Candidiasis * — 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=83
(percent) Fluconazole IV
200 mg†
N=94
(percent)
Within any system organ class, individuals may experience more than 1 adverse reaction.
*
Regardless of causality
†
Derived from a Phase III comparator-controlled clinical study. 
All Systems, Any Adverse Reaction 90.4 92.6
Gastrointestinal Disorders 57.8 50.0
   Diarrhea 26.5 18.1
   Nausea 14.5 14.9
General Disorders and Administration Site Conditions 31.3 36.2
   Pyrexia 20.5 21.3
Investigations  53.0 60.6
   Alanine Aminotransferase Increased 12.0 17.0
   Aspartate Aminotransferase Increased 13.3 19.1
   Blood Alkaline Phosphatase Increased 13.3 17.0
   Hematocrit Decreased 18.1 16.0
   Hemoglobin Decreased 20.5 16.0
   White Blood Cell Count Decreased 12.0 19.1
Nervous System Disorders  18.1 17.0
   Headache 14.5 8.5
Vascular Disorders 19.3 14.9
   Phlebitis 18.1 10.6

Invasive Aspergillosis

In an open-label, noncomparative aspergillosis study, in which 69 patients received CANCIDAS (70-mg loading dose on Day 1 followed by 50 mg daily), the following treatment-emergent adverse reactions were observed with an incidence of ≥12.5%: blood alkaline phosphatase increased (21.7%), hypotension (20.3%), respiratory failure (20.3%), pyrexia (17.4%), diarrhea (14.5%), nausea (14.5%), headache (14.5%), rash (13.0%), aspergillosis (13.0%), alanine aminotransferase increased (13.0%), aspartate aminotransferase increased (13.0%), blood bilirubin increased (13.0%), and blood potassium decreased (13.0%). Also reported infrequently in this patient population were pulmonary edema, ARDS, and radiographic infiltrates.

Concomitant Therapy

In one clinical study, 3 of 4 adult subjects who received CANCIDAS 70 mg daily on Days 1 through 10, and also received two 3 mg/kg doses of cyclosporine 12 hours apart on Day 10, developed transient elevations of ALT on Day 11 that were 2 to 3 times the upper limit of normal (ULN). In a separate panel of