Fortesta gel is a prescription medicine that contains testosterone.

Testosterone is a naturally occurring male hormone necessary for many processes in the body.

Fortesta gel is used to treat conditions in men that result from a lack of natural testosterone.

Fortesta will not enhance athletic performance and should not be used for this purpose.

Fortesta gel should not be used by a woman. Testosterone can cause birth defects in an unborn baby. A pregnant woman should avoid coming into contact with Fortesta gel, or with a man's skin areas where the gel has been applied. If contact does occur, wash with soap and water right away.

Topical testosterone is absorbed through the skin and can cause side effects or symptoms of male features in a child or woman who comes into contact with Fortesta. Call your doctor if a person who has close contact with you develops enlarged genitals, premature pubic hair, increased libido, aggressive behavior, male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any signs of male characteristics.

Misuse of Fortesta can cause dangerous or irreversible effects. Never use more than your prescribed dose. Do not share this medicine with another person.

Before using this medicine

You should not use Fortesta if you are allergic to testosterone patches or gels, or if you have;

• prostate cancer; or

• male breast cancer.

To make sure Fortesta is safe for you, tell your doctor if you have ever had:

• breast cancer or prostate cancer;

• enlarged prostate, urination problems;

• heart problems;

• a heart attack, stroke, or blood clot;

• sleep apnea (breathing stops during sleep); or

• liver or kidney disease.

Using Fortesta may increase your risk of developing prostate cancer. Ask your doctor about this risk.<

Testosterone can lower your sperm count and may affect fertility (your ability to have children).

Fortesta gel should not be used by a woman. Testosterone may harm an unborn baby. A pregnant woman should avoid coming into contact with testosterone gels, or with a man's skin areas where gel has been applied. If contact does occur, wash with soap and water right away.

Do not use Fortesta gel on anyone younger than 18 years old.

Use Fortesta gel exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than prescribed.

This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Misuse of testosterone can cause dangerous or irreversible effects, such as enlarged breasts, small testicles, infertility, high blood pressure, heart attack, stroke, liver disease, bone growth problems, addiction, and mental effects such as aggression and violence.

Do not share this medicine with another person.

• Before using a new canister of Fortesta for the first time, you will need to prime the pump. To prime the pump, gently push down on the pump 8 times. Do not use any Fortesta gel that comes out while priming. Wash it down the sink or throw it in the trash to avoid accidental exposure to others. Your pump is now ready to use.

• Depress the pump to apply the medicine directly on clean, dry, intact skin of the front and inner part of your thighs. Use one finger to gently rub the gel evenly onto the front and inner part of each thigh.

• Apply Fortesta gel in the morning. If you shower or bathe, the gel should be applied afterwards.

• Apply the gel only to areas that will be covered by shorts or pants.

• Let the application site dry completely before putting on shorts or pants.

• Wash your hands right away with soap and water.

Avoid swimming, showering, or bathing for at least 2 hours after you apply the gel.

Fortesta gel is flammable. Do not use near high heat or open flame. Do not smoke until the gel has completely dried on your skin.

Cover treated skin areas with clothing to keep from getting this medicine on other people. If someone else does come into contact with a treated skin area, they must wash the contact area right away with soap and water.

While using Fortesta, you may need frequent blood tests.

Use Fortesta regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat.

You should not use Fortesta if you are allergic to testosterone patches or gels, or if you have;

• prostate cancer; or

• male breast cancer.

To make sure Fortesta is safe for you, tell your doctor if you have ever had:

• breast cancer or prostate cancer;

• enlarged prostate, urination problems;

• heart problems;

• a heart attack, stroke, or blood clot;

• sleep apnea (breathing stops during sleep); or

• liver or kidney disease.

Using Fortesta may increase your risk of developing prostate cancer. Ask your doctor about this risk.<

Testosterone can lower your sperm count and may affect fertility (your ability to have children).

Fortesta gel should not be used by a woman. Testosterone may harm an unborn baby. A pregnant woman should avoid coming into contact with testosterone gels, or with a man's skin areas where gel has been applied. If contact does occur, wash with soap and water right away.

Do not use Fortesta gel on anyone younger than 18 years old.

Apply the gel as soon as you remember. Skip the missed dose if it is almost time to apply your next dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not apply this medicine to your penis or your scrotum.

Avoid swimming, bathing, or showering for 2 to 5 hours after applying Fortesta gel. Follow the directions provided with your specific brand.

Fortesta gel may be flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.

Get emergency medical help if you have any signs of an allergic reaction to Fortesta gel: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Fortesta and call your doctor at once if you have:

• increased urination (many times per day), loss of bladder control;

• painful or difficult urination;

• breast pain or swelling;

• painful or bothersome erections;

• swelling, rapid weight gain, shortness of breath during sleep;

• chest pain or pressure, pain spreading to your jaw or shoulder;

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• signs of a blood clot deep in the body - swelling, warmth, or redness in an arm or leg.

Topical testosterone is absorbed through the skin and can cause side effects or symptoms of male features in a child or woman who comes into contact with this medicine. Call your doctor if a person who has close contact with you develops enlarged genitals, premature pubic hair, increased libido, aggressive behavior, male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any signs of male characteristics.

Common Fortesta side effects may include:

• redness, itching, burning, hardened skin or other irritation where the medicine was applied or where the skin patch was worn;

• increased red blood cells (may cause dizziness, itching, redness in your face, or muscle pain);

• increased prostate-specific antigen;

• increased blood pressure;

• headache;

• mood changes, strange dreams;

• frequent or prolonged erections;

• nausea, vomiting; or

• swelling in your lower legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines and those you start or stop using during your treatment with Fortesta, especially:

• insulin;

• a blood thinner - (warfarin, Coumadin, Jantoven); or

• a steroid medicine - methylprednisolone (Medrol), prednisone (Sterapred), and others.

This list is not complete. Other drugs may interact with testosterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.