For Healthcare Professionals

IMPORTANT RISK INFORMATION

Who should not use ANDRODERM? Do not use ANDRODERM if you:

• are a man who has breast cancer
• have or might have prostate cancer
• are pregnant. ANDRODERM may harm your unborn baby

INDICATION

ANDRODERM is a prescription medicine that contains testosterone. ANDRODERM is used to treat adult males who have low or no testosterone due certain medical conditions.

Your healthcare provider will test your blood for testosterone before you start and while you are taking ANDRODERM.

It is not known if ANDRODERM is safe and effective to treat men who have low testosterone due to aging.

It is not known if ANDRODERM is safe and effective in children younger than 18 years old. Improper use of ANDRODERM may affect bone growth in children.

ANDRODERM is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your ANDRODERM in a safe place to protect it. Never give your ANDRODERM to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and it is against the law.

ANDRODERM is not meant for use by women.

IMPORTANT RISK INFORMATION (cont’d)

What should I tell my healthcare provider before using ANDRODERM? Before you use ANDRODERM, tell your healthcare provider if you:

• have breast cancer
• have or might have prostate cancer
• have urinary problems due to an enlarged prostate
• have heart problems
• have kidney or liver problems
• have problems breathing while you sleep (sleep apnea)
• have diabetes
• have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Using ANDRODERM with other medicines can affect how ANDRODERM works and how other medicines work. Especially, tell your healthcare provider if you take:

• insulin
• medicines that decrease blood clotting
• corticosteroids

What are the possible side effects of ANDRODERM? ANDRODERM can cause serious side effects including:

• If you already have an enlargement of your prostate gland your signs and symptoms may get worse while using ANDRODERM. 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
  • being unable to pass urine or weak urine flow
• Possible increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use ANDRODERM.
• Blood clots in the legs or lungs. Signs and symptoms can include leg pain, swelling or redness of your legs, difficulty breathing or chest pain.
• Possible increased risk of heart attack or stroke.
• In large doses ANDRODERM may lower your sperm count.
• Swelling of your ankles, feet, or body, with or without heart failure.
• Enlarged or painful breasts.
• Problems breathing while you sleep (sleep apnea).

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effects of ANDRODERM include:

• skin redness, irritation, burning, or blisters where ANDRODERM is applied
• back pain
• depression
• headache
• prostate abnormalities

Other side effects include more erections than are normal for you or erections that last a long time.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ANDRODERM.

Please see full Prescribing Information.