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Prescribing Information Prescribing Information

Favorable Response Rates in Patients with Candidemia and Other Candida Infections*

In a double-blind, randomized clinical trial of patients with candidemia and other Candida infectionsa (n=224), CANCIDAS demonstrated efficacy comparable to amphotericin B.

a
Intraabdominal abscesses, peritonitis, and pleural space infections. CANCIDAS has not been studied in patients with endocarditis, osteomyelitis, or meningitis due to Candida.
b
A favorable response required both symptom or sign resolution or improvement and microbiologic clearance of the Candida infection.
 

Non-albicans Candida species accounted for 61% of candidemia infections.

c
Includes patients with isolates of less common non-albicans species and those infected with multiple species (<3% had C albicans in addition to non-albicans species).6
 

References

  6.
Mora-Duarte J, Betts R, Rotstein C, et al, for the Caspofungin Invasive Candidiasis Study Group. Comparison of caspofungin and amphotericin B for invasive candidiasis. N Engl J Med. 2002;347:2020–2029.

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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.
  • Drug-related clinical adverse events with an incidence of ≥2% reported in patients treated with CANCIDAS (n=114) in the randomized double-blind study of candidemia and other Candida infections were fever (7.0%), chills (5.3%), phlebitis/thrombophlebitis (3.5%), vomiting (3.5%), and diarrhea (2.6%).

    A similar number of patients in the treatment groups receiving CANCIDAS and amphotericin B completed the study (55.3% vs 55.2%, respectively), discontinued the study because of clinical adverse events (34.2% vs 34.4%), and discontinued study therapy due to clinical adverse events (26.3% vs 29.6%).

 

Before prescribing CANCIDAS, please read the Prescribing Information.

CANCIDAS® (caspofungin acetate)

 
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