Label Changes for:

Cancidas (caspofungin acetate) 50mg/vial and 70 mg/vial for Injection

June 2009

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2009

WARNINGS AND PRECAUTIONS 

  • Hepatic Effects: Can cause abnormalities 
Concomitant Use with Cyclosporine 
  • In another clinical study, 2 of 8 healthy men developed transient ALT elevations of less than 2X ULN. In this study, cyclosporine (4 mg/kg) was administered on Days 1 and 12, and CANCIDAS was administered (70 mg) daily on Days 3 through 13. In one subject, the ALT elevation occurred on Days 7 and 9 and, in the other subject, the ALT elevation occurred on Day 19. These elevations returned to normal by Day 27. In all groups, elevations in AST paralleled ALT elevations but were of lesser magnitude. In these clinical studies, cyclosporine (one 4 mg/kg dose or two 3 mg/kg doses) increased the AUC of caspofungin by approximately 35%. 

USE IN SPECIFIC POPULATIONS 

  • Pregnancy – Based on animal 
  • Hepatic impairment: No data are available in adults with severe impairment of in pediatric patients with any degree of impairment 

ADVERSE REACTIONS 

  • Anaphylaxis has been reported during administration of Cancidas 
  • 6.1 Clinical Trials Experience in Adults/Empirical Therapy, Table 2 revised 
  • 6.1 Clinical Trials Experience in Adults/Candidemia and Other Candida Infections, Table 3 revised 
  • In a second randomized, double-blinded invasive candidiasis study, patients received either Cancidas 50 mg/day (following a 70-mg loading dose) or Cancidas 150 mg/day. The proportion of patients who experienced any adverse reaction was similar in the 2 treatment groups; however, this study was not large enough to detect differences in rare or unexpected adverse events. Adverse reactions occurring in ≥5% of the patients in either treatment group are presented in Table 4. 
  • New information regarding the 150 mg CANCIDAS dose and a new Table 4 are added
  • Revisions in Table 6 & Table 7
  • 6.3 Overall Safety Experience of Cancidas in Clinical Trials: ...overall safety in 2036 individuals (including 1642 adult or pediatric...) from 34 clinical studies...safety data is available from 1951 individuals. [numeric changes]
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