In an open-label, noncomparative study in patients with definite or probable aspergillosisa who were refractory to or intolerant of standard therapies, CANCIDAS demonstrated efficacy in salvage therapy.
CANCIDAS has not been studied as initial therapy for invasive aspergillosis.
Favorable response=complete resolution (complete response) or clinically meaningful improvement (partial response) of all signs and symptoms and attributable radiographic findings.
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The definitions were modeled after the Mycoses Study Group Criteria, as published in Denning DW, Lee JY, Hostetler JS, et al. NIAID Mycoses Study Group multicenter trial of oral itraconazole therapy for invasive aspergillosis. Am J Med. 1994;97:135–144. All patients had documented disease confirmed by positive tissue histopathology or positive tissue culture obtained by invasive procedure (definite) or positive radiographic or computed tomographic evidence with supporting culture from bronchoalveolar lavage or sputum, galactomannan enzyme-linked immunosorbent assay, and/or polymerase chain reaction (probable). Patients with extrapulmonary disease had to have definite invasive aspergillosis.
- 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.
- Drug-related clinical adverse events with an incidence of ≥2% reported in patients treated with CANCIDAS (n=69) in the noncomparative aspergillosis study were flushing (2.9%), fever (2.9%), nausea (2.9%), vomiting (2.9%), and infused-vein complications (2.9%).
Before prescribing CANCIDAS, please read the Prescribing Information.
