Jane S. Ricciuti, RPh, MS


October 23, 2002

In This Article

Antifungal Agents

(caspofungin acetate) for Injection

Manufacturer: Merck Research Laboratories

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 9/20/02)

New Indication: This supplemental new drug application provides for the use of Cancidas (caspofungin acetate) for Injection for the treatment of esophageal candidiasis.

Cancidas previously was only indicated for the treatment of invasive aspergillosis in patients intolerant to other therapies.

Dosing: For the treatment of esophageal candidiasis, Cancidas 50 mg daily should be administered by slow intravenous infusion over approximately 1 hour. Because of the risk of relapse of oropharyngeal candidiasis in patients with HIV infections, suppressive oral therapy could be considered. A 70-mg loading dose has not been studied with this indication.

Clinical Summary: Cancidas was studied in 166 patients with culture-confirmed esophageal candidiasis in a randomized, double-blind, controlled, noninferiority clinical trial. Patients were treated for a period of 7-21 days (average 9 days) with Cancidas 50 mg/day vs fluconazole 200 mg/day. The primary end point was a favorable overall response at 5-7 days following discontinuation of study therapy. The overall response for the primary end point was comparable for Cancidas (81.5%) and fluconazole (85.1%)

Pharmacokinetics: A drug-interaction study with rifampin has shown a 30% decrease on caspofungin trough concentrations. It is recommended that patients on rifampin receive 70 mg of Cancidas daily.

Patient pharmacokinetic data suggest that coadministration of other inducers of drug clearance (carbamazepine, dexamethasone, efavirenz, nevirapine, phenytoin) with Cancidas may result in clinically meaningful reductions in caspofungin concentrations. It is recommended that a 70-mg daily dose be administered in patients receiving carbamazepine, dexamethasone, efavirenz, nevirapine, or phenytoin.

Cancidas (caspofungin acetate) for injection labeling.


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