Label Changes for:

AndroGel (testosterone gel) 1.62%

September 2012

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

 

September 2012

MEDICATION GUIDE

  • information added on new container closure system

 

November 2011

Medication Guide

What is the most important information I should know about testosterone gel?
  • Signs and symptoms of early puberty in a child may include:
    • enlarged penis or clitoris
    • early development of pubic hair
    • increased erections or sex drive
    • aggressive behavior 

 

March 2011

 

PATIENT COUNSELING INFORMATION

  • To wait 5 hours before showering or swimming. This will ensure that the greatest amount of AndroGel is absorbed into their system.

MEDICATION GUIDE

How should I use AndroGel?

  • To wait 5 hours before showering or swimming. This will ensure that the greatest amount of AndroGel is absorbed into their system.
     

 

September 2009 

 

BOXED WARNING

WARNING: Secondary Exposure to Testosterone
  • Virilization has been reported in children who were secondarily exposed to testosterone gel.
  • Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel.
  • Healthcare providers should advise patients to strictly adhere to recommended instructions for use.

WARNINGS AND PRECAUTIONS

Potential for Secondary Exposure to Testosterone
  • Secondary exposure to testosterone in children and women can occur with testosterone gel use in men...
  • Inappropriate changes in genital size or development of pubic hair or libido in children, or changes in body hair distribution...

ADVERSE REACTIONS

Postmarketing Experience
  • Secondary Exposure to Testosterone in Children
    Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarket surveillance. Signs and symptoms of these reported cases have included enlargement of the clitoris...

PATIENT COUNSELING INFORMATION

(new text added)

  • Secondary exposure to testosterone in children and women can occur with the use of testosterone gel in men. Cases of secondary exposure to testosterone have been reported in children with signs and symptoms including enlargement of the penis or clitoris, premature development of pubic hair, increased erections, and aggressive behavior.

 

 

November 2011

Hide
(web1)