Label Changes for:

Cancidas (caspofungin acetate)

January 2013

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)

 

January 2013

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 

 

ADVERSE REACTIONS

  • angioedema

 

January 2010 

 

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

 

Hide
(web5)