Label Changes for:

Fortesta (testosterone gel)

September 2013

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

 

September 2013

MEDICATION GUIDE

What is the most important information I should know about FORTESTA? 

1. Early signs and symptoms of puberty have happened in young children who were accidentally exposed to testosterone through contact with men using topical testosterone products like FORTESTA.

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

2. FORTESTA can transfer from your body to others. Women and children should avoid contact with the unwashed or unclothed area where FORTESTA has been applied to your skin. Stop using FORTESTA and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have occurred through accidental exposure to FORTESTA.

Signs and symptoms of exposure to FORTESTA in a child may include:

  • enlarged penis or clitoris
  • early development of pubic hair
  • increased erections or sex drive
  • aggressive behavior

Signs and symptoms of exposure to FORTESTA in women may include:

  • changes in body hair
  • a large increase in acne

To lower the risk of transfer of FORTESTA from your body to others, you should follow these important instructions:

  • Apply FORTESTA only to the front and inside area of your thighs that will be covered by clothing.
  • Wash your hands right away with soap and water after applying FORTESTA.
  • After the FORTESTA gel has dried, cover the application area with clothing. Keep the area covered until you have washed the application area well or have showered.

If you expect another person to have skin-to-skin contact with your thighs, first wash the application area well with soap and water.

If a woman or child makes contact with the FORTESTA application area, that area on the woman or child should be washed well with soap and water right away.

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