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

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

   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. Testim can transfer from your body to others. Women and children should avoid contact with the unwashed or unclothed area where Testim has been applied to your skin.
   
   Stop using Testim and call your doctor right away if you see any signs and symptoms in a child or a woman that may have occurred through accidental exposure to Testim.
   
   
   • Signs and symptoms of exposure to Testim 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 Testim in women may include: changes in body hair; a large increase in acne.

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

• Apply Testim only to the areas of your shoulders and upper arms that a short sleeve T-shirt would cover.
• Wash your hands right away with soap and water after applying Testim.
• After the gel has dried, cover the application area with clothing.
• If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water.
• If a woman or child comes in contact with the Testim application area, the contact area on the woman or child should be washed well with soap and water right away.

Do not use Testim if you: have breast cancer; have or might have prostate cancer; or are allergic to testosterone or any of the ingredients in Testim, including soy.

Testim is not meant for use in women. Do not use Testim if you are pregnant or may become pregnant or are breast-feeding. Testim may harm your unborn or breast-feeding baby. Women who are pregnant or who may become pregnant should avoid contact with the area of skin where Testim has been applied.

Before you use Testim, tell your doctor if you: have breast cancer or prostate cancer, have urinary problems due to an enlarged prostate, have heart problems, have liver or kidney problems, have problems breathing while you sleep (sleep apnea), or have any other medical conditions.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Testim and certain other medicines you take can affect each other. Especially, tell your doctor if you take insulin, propranolol or corticosteroids.

It is important that you apply Testim exactly as prescribed by your doctor. Your doctor will tell you how much Testim to apply and when to apply it. Do not change your Testim dose without talking to your doctor. Testim is for skin use only. Apply Testim only to the areas of your shoulders and upper arms that will be covered by a short sleeve T-shirt. Apply Testim at the same time each day. Do not apply Testim to your penis, scrotum or abdomen.

Testim is flammable until dry. Let the gel dry before smoking or going near an open flame.

Testim can cause serious side effects including:

• If you already have enlargement of your prostate gland, your signs and symptoms can get worse while using Testim. This can include increased urination at night, trouble starting your urine stream, having to pass urine many times during the day, having an urge that you have to go to the bathroom right away, having a urine accident, or being unable to pass urine or weak urine flow.
• Possible increased risk of prostate cancer. Your doctor should check you for prostate cancer or any other prostate problems before you start and while you use Testim.
• In large doses, Testim may lower your sperm count.
• Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney or liver disease.
• Enlarged or painful breasts.
• Having problems breathing while you sleep (sleep apnea).
• Blood clots in the legs. This can include pain, swelling or redness of your legs.
  
  

Call your doctor right away if you have any of these serious side effects.

The most common side effects of Testim include: skin irritation where Testim is applied, increased red blood cell count, headache and increased blood pressure. Other side effects include more erections than are normal for you or erections that last a long time. Tell your doctor if you have any side effect that bothers you or that does not go away.

It is not known if Testim is safe or effective in children younger than 18 years old. Exposure of children to testosterone may affect bone growth.

Testim is a controlled substance because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your Testim in a safe place to protect it. Do not give Testim to other people, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and it is against the law.