Safety

Cancidas (caspofungin acetate) for injection

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

October 2014

Summary View

6 ADVERSE REACTIONS

6.4 Postmarketing Experience
  • add the term “gamma-glutamyl transferase increased”  

 

January 2013

Summary View

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity
  • Anaphylaxis has been reported during administration of CANCIDAS. If this occurs, CANCIDAS should be discontinued and appropriate treatment administered. Possible histamine-mediated adverse reactions, including rash, facial swelling, angioedema, pruritus, sensation of warmth or bronchospasm have been reported and may require discontinuation and/or administration of appropriate treatment.

6 ADVERSE REACTIONS

The following serious adverse reactions are discussed in detail in another section of the labeling:

  • Hypersensitivity [see Warnings and Precautions (5.1)]

17 PATIENT COUNSELING INFORMATION

17.1 Hypersensitivity
  • Inform patients that anaphylactic reactions have been reported...

 

October 2010 

Summary View 

ADVERSE REACTIONS

  • angioedema

 

January 2010 

Summary View 

WARNINGS AND PRECAUTIONS

Hepatic effects
  • ...in healthy volunteers and in adult and pediatric patients...In some adult and pediatric patients...

USE IN SPECIFIC POPULATION

Pediatric Use
  • Postmarketing hepatobiliary adverse events have been reported in pediatric patients with serious underlying medical conditions

 

Page Last Updated: 11/17/2014
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