Indications

• 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: intra-abdominal abscesses, peritonitis, and pleural space infections. CANCIDAS has not been studied in endocarditis, osteomyelitis, and meningitis due to Candida.
• Treatment of esophageal candidiasis.
• Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies (eg, amphotericin B, lipid formulations of amphotericin B, 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 (eg, anaphylaxis) 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. Patients who develop abnormal liver function tests during concomitant therapy should be monitored and the risk/benefit of continuing therapy should be evaluated.

• Laboratory abnormalities in liver function tests have been seen in healthy volunteers and in adult and pediatric patients treated with CANCIDAS. In some adult and pediatric patients with serious underlying conditions who were receiving multiple concomitant medications with CANCIDAS, isolated cases of clinically significant hepatic dysfunction, hepatitis, and hepatic failure have been reported; 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.

• Adult patients on rifampin should receive 70 mg of CANCIDAS daily. When CANCIDAS is co-administered to adult patients with inducers of drug clearance, such as efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine, use of a daily dose of 70 mg of CANCIDAS should be considered.

• 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.

• Adult patients on rifampin should receive 70 mg of CANCIDAS daily. When CANCIDAS is co-administered to adult patients with inducers of drug clearance, such as efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine, use of a daily dose of 70 mg of CANCIDAS should be considered. Pediatric patients receiving these same concomitant medications may also require an increase in dose to 70 mg/m² once daily (not to exceed an actual daily dose of 70 mg).

• Although limited pharmacokinetic data were collected in neonates and infants below 3 months of age, these data are insufficient to establish a safe and effective dose of caspofungin in the treatment of neonatal candidiasis. Invasive candidiasis in neonates has a higher rate of central nervous system and multi-organ involvement than in older patients; the ability of CANCIDAS to penetrate the blood-brain barrier and to treat patients with meningitis and endocarditis is unknown.

• Anaphylaxis has been reported during administration of CANCIDAS. Possible histamine-mediated symptoms have been reported including reports of rash, facial swelling, angioedema, pruritus, sensation of warmth, or bronchospasm.

• The most common adverse reactions (≥10%) in adult patients treated with CANCIDAS, regardless of causality, were: diarrhea, pyrexia, alanine aminotransferase (ALT)/aspartate aminotransferase (AST) increased, blood alkaline phosphatase increased, and blood potassium decreased.

• The most common adverse reactions (≥10%) in pediatric patients treated with CANCIDAS, regardless of causality, were: pyrexia (29%), blood potassium decreased (15%), diarrhea (14%), increased AST (12%), rash (12%), increased ALT (11%), hypotension (11%), and chills (11%).

• Before prescribing CANCIDAS, please read the accompanying Prescribing Information.

• For additional copies of the Prescribing Information, please call 1-800-672-6372, visit cancidas.com, or contact your Merck representative.