Cancidas Side Effects

Hypersensitivity reactions have been reported (see Precautions).
Adult Patients: In clinical studies, 1440 adult individuals received single or multiple doses of CANCIDAS: 564 febrile, neutropenic patients (empirical therapy study), 125 patients with invasive candidiasis, 285 patients with esophageal and/or oropharyngeal candidiasis, 72 patients with invasive aspergillosis and 394 individuals in phase I studies. In the empirical therapy study patients had received chemotherapy for malignancy or had undergone hematopoietic stem cell transplantation. In the studies involving patients with documented Candida infections, the majority of the patients had serious underlying medical conditions (e.g., hematologic or other malignancy, recent major surgery, HIV) requiring multiple concomitant medications. Patients in the noncomparative Aspergillus study often had serious predisposing medical conditions (e.g., bone marrow or peripheral stem cell transplants, hematologic malignancy, solid tumors or organ transplants) requiring multiple concomitant medications.
Reported drug-related clinical and laboratory abnormalities among all adult patients treated with CANCIDAS (total 989) were typically mild and rarely led to discontinuation.
Common (>1/100): General: Fever, headache, abdominal pain, pain, chills.
GI: Nausea, diarrhea, vomiting.
Liver: Elevated liver enzyme levels (AST, ALT, alkaline phosphatase, direct and total bilirubin).
Kidney: Increased serum creatinine.
Blood: Anemia (decreased hemoglobin and hematocrit).
Cardiac: Tachycardia.
Peripheral Vascular: Phlebitis/thrombophlebitis, infused-vein complication, flushing.
Respiratory: Dyspnea.
Skin: Rash, pruritus.
Pediatric Patients: In clinical studies, 171 pediatric patients received single or multiple doses of CANCIDAS: 104 febrile, neutropenic patients; 56 patients with invasive candidiasis; 1 patient with esophageal candidiasis; and 10 patients with invasive aspergillosis. The overall clinical safety profile of CANCIDAS in pediatric patients is comparable to that in adult patients.
Reported drug-related clinical and laboratory abnormalities among all pediatric patients treated with CANCIDAS (total 171) were typically mild and rarely led to discontinuation.
Common (>1/100): General: Fever, headache, chills.
Liver: Elevated liver enzyme levels (AST, ALT).
Cardiac: Tachycardia.
Peripheral Vascular: Catheter site pain, flushing, hypotension.
Skin: Rash, pruritus.
Post-Marketing Experience: The following post-marketing adverse events have been reported: Hepatobiliary: rare cases of hepatic dysfunction.
Skin and subcutaneous tissue disorders: toxic epidermal necrolysis and Stevens-Johnson syndrome.
Cardiovascular: swelling and peripheral edema.
Laboratory abnormalities: hypercalcemia; gamma-glutamyltransferase increased.
Laboratory Test Findings: Adult Patients: Other drug-related laboratory abnormalities reported in adult patients were low albumin, low potassium, hypomagnesemia, decreased white blood cells, increased eosinophils, low platelets, decreased neutrophils, increased urinary red blood cells, increased partial thromboplastin time, decreased total serum protein, increased urinary protein, increased prothrombin time, low sodium, increased urinary white blood cells, and low calcium.
Pediatric Patients: Other drug-related laboratory abnormalities reported in pediatric patients were decreased potassium, hypomagnesemia, increased glucose, decreased phosphorus, increased phosphorus, and increased eosinophils.