Label Changes for:

Cancidas (caspofungin acetate) for Injection (Intravenous Use Only)

July 2008

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


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

Sections Modified

USE IN SPECIFIC POPULATIONS

  • Pregnancy
    • ...In offspring born to pregnant rats treated with caspofungin at doses comparable to the human dose based on body surface area comparisons, there was incomplete ossification of the skull and torso and increased incidences of cervical rib.
  • Pediatric Use

ADVERSE REACTIONS

  • Clinical Trials Experience in Pediatric Patients (3 months to 17 years of age)
    • Table 5
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