CANCIDAS is indicated in adults and pediatric patients (3 months and older) for:

• Empirical therapy for presumed fungal infections in febrile neutropenic patients.
• Treatment of candidemia and the following Candida infections: intraabdominal abscesses, peritonitis, and pleural space infections. CANCIDAS has not been studied in endocarditis, osteomyelitis, or meningitis due to Candida.
• Treatment of esophageal candidiasis.
• Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies (ie, amphotericin B, lipid formulations of amphotericin B, and/or itraconazole). CANCIDAS has not been studied as initial therapy for invasive aspergillosis.

The efficacy and safety of CANCIDAS has not been adequately studied in prospective clinical trials involving neonates and infants under 3 months of age.

Selected Important Risk Information

• CANCIDAS is contraindicated in patients with hypersensitivity to any component of this product.
• Concomitant use of CANCIDAS with cyclosporine should be limited to patients for whom the potential benefit outweighs the potential risk of increased hepatic enzyme abnormalities. See the Warning in the Prescribing Information.
• Laboratory abnormalities in liver function tests have been seen in healthy volunteers and patients treated with CANCIDAS. In some patients with serious underlying conditions who were receiving multiple concomitant medications along with CANCIDAS, clinical hepatic abnormalities have also occurred. Isolated cases of significant hepatic dysfunction, hepatitis, or worsening hepatic failure have been reported in patients; a causal relationship to CANCIDAS has not been established. Patients who develop abnormal liver function tests during therapy with CANCIDAS should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing therapy with CANCIDAS.
• For patients receiving CANCIDAS and tacrolimus, standard monitoring of tacrolimus blood concentrations and appropriate tacrolimus dosage adjustments are recommended.
• Patients receiving rifampin should receive 70 mg of CANCIDAS daily. Patients receiving nevirapine, efavirenz, carbamazepine, dexamethasone, or phenytoin may require an increase in dose to 70 mg of CANCIDAS daily.
• When CANCIDAS is co-administered to pediatric patients with inducers of drug clearance, such as rifampin, efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine, a dose of 70 mg/m2 daily (not to exceed an actual daily dose of 70 mg) should be considered.
• Possible histamine-mediated symptoms have been reported, including rash, facial swelling, pruritus, sensation of warmth, and bronchospasm. Anaphylaxis has been reported during administration of CANCIDAS.
• The most common adverse reactions in adult patients treated with CANCIDAS (>10%), regardless of causality, are: diarrhea, pyrexia, chills, ALT/AST increase, blood alkaline phosphatase increase, and decrease of blood potassium.
• The most common adverse reactions in pediatric patients treated with CANCIDAS, regardless of causality, were pyrexia (29.2%), blood potassium decreased (15.2%), diarrhea (14%), increased aspartate aminotransferase (11.7%), rash (11.7%), increased alanine aminotransferase (11.1%), hypotension (11.1%), and chills (11.1%).
• There is no clinical experience in adult patients with severe hepatic insufficiency (Child Pugh score >9) and in pediatric patients with any degree of hepatic insufficiency.
• Administer by slow intravenous infusion (IV) over approximately 1 hour. Not for IV bolus administration.