Label Changes for:
Cancidas (caspofungin acetate)
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)
5 WARNINGS AND PRECAUTIONS
- 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
- Inform patients that anaphylactic reactions have been reported...
WARNINGS AND PRECAUTIONS
- ...in healthy volunteers and in adult and pediatric patients...In some adult and pediatric patients...
USE IN SPECIFIC POPULATION
- Postmarketing hepatobiliary adverse events have been reported in pediatric patients with serious underlying medical conditions