Testosterone Gel, Topical

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KEY POINTS

• This medicine is put on the skin to increase levels of testosterone. Use it exactly as directed.
• Pregnant women and children must avoid skin contact with this medicine. To protect others from skin to skin contact with this medicine, cover the area where you apply it with clothing.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: androgen; male hormone

Generic and brand names: testosterone gel, topical; AndroGel 1%; Fortesta; Testim Gel 1%; Vogelxo

What is this medicine used for?

This medicine is applied to the skin to increase levels of testosterone (male hormone).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Men should not use this medicine if they have breast cancer or prostate cancer.

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or hormone, or to soy products
• A stroke or transient ischemic attack (TIA)
• Blood clots in your legs, lungs, brain, or eyes
• Diabetes
• Heart disease or a heart attack
• High cholesterol
• Liver or kidney disease
• Lung or breathing problems such as asthma, COPD, or sleep apnea
• Trouble urinating or an enlarged prostate gland

Females of childbearing age: This medicine MUST NOT be used by women who are pregnant, or may become pregnant, or those who are breast-feeding because it may harm the baby. Avoid contact with this medicine.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Use this medicine exactly as your healthcare provider prescribes. Do not use more or less or use it longer than prescribed. Your healthcare provider will tell you how much medicine to apply, when to apply it, and where to apply it. Carefully follow the instructions included in the medicine package for using this medicine. Apply this medicine to clean, dry, and unbroken skin. Certain products must be placed on certain areas of your body. Be sure you know where you are to apply this medicine and how to apply it. Do not apply the gel to your sex organs or abdomen. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Check with your healthcare provider before using this medicine in children under age 18 years.

This medicine may come in packets, a tube, or in a pump. If you are using the pump, you need to prime the pump before using it for the first time. Follow the instructions included in the medicine package for how to prime the pump.

Use the gel only where it will be covered by clothes. Do not put the gel on any other parts of your body.

Allow the treated areas to dry before you get dressed. Use the gel once each day. It is best to use it in the morning.

Wash your hands with lots of soap and water after applying this medicine.

After applying this medicine, you will need to wait a certain period of time before showering, bathing, or swimming. Be sure you know how long you need to wait. Follow the instructions included in the medicine package carefully. If you take a bath or shower in the morning, apply the medicine after your bath or shower.

This medicine is flammable. Do not apply the medicine near high heat or open flames. If you smoke, do not smoke until the medicine is completely dry. Dispose of the empty packet or tube safely away from children or pets.

What if I miss a dose?

If you miss a dose, apply it as soon as you remember unless it is within 12 hours of the next dose. In that case, skip the missed dose and apply the next one as directed. Do not apply double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine can transfer from your body to others. This can happen if other people come into contact with the area where the medicine was applied. Signs of puberty that are not expected (such as pubic hair) have happened in young children who were accidentally exposed to testosterone from skin to skin contact. Women and children must avoid contact with the skin where this medicine has been applied. If a woman or child makes contact with skin where medicine has been applied, wash the contact area on the woman or child with soap and water right away.

If a child or woman has symptoms that may have been caused by contact with this medicine, they should be seen by a healthcare provider right away.

Signs and symptoms in children may include:

• Enlarged penis or clitoris
• Early development of pubic hair
• Increased erections or sex drive
• Aggressive behavior

Signs and symptoms in women may include:

• Changes in body hair
• A large increase in acne

Pregnant women must avoid skin contact with this medicine. It can harm the infant. If a pregnant woman does come in contact with the gel in any way, wash the area with lots of soap and water.

To protect others from skin to skin contact with this medicine, cover the area where you apply it with clothing. If you expect another person to have skin-to-skin contact with the area where you applied the medicine, first wash the area well with soap and water. If another person comes in contact with this medicine, they should wash with lots of soap and water as soon as possible.

This medicine may:

• Raise your cholesterol.
• Increase your risk for prostate cancer or an enlarged prostate.
• Make breast cancer worse.
• Increase your risk for blood clots.
• Worsen heart failure symptoms by causing you to retain fluid.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

You may need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine is a controlled substance. It is illegal for you to give it to anyone else.

This medicine may lower the sperm count in men. Talk with your healthcare provider about this.

Rarely, this medicine may cause a painful erection of the penis that will not return to normal. If this happens, contact your healthcare provider or get medical care right away. It can lead to permanent erectile dysfunction if not treated.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Too frequent erections or erections that last more than 4 hours; trouble urinating; increased or decreased urination; unexplained nausea or vomiting; changes in skin color; yellowing of your skin or eyes; dark urine; light-colored bowel movements; redness, warmth, or swelling in your lower legs, ankles or feet; sudden shortness of breath; chest pain; tender or enlarged breasts; breathing problems, especially while sleeping; extreme drowsiness; loss of appetite; dizziness; fainting; unusual mood changes; unusual bruising or bleeding.

Other: Anxiety, mood swings, abnormal dreams, discolored hair, dry skin, acne, sweating, change in sense of taste, headache, redness or irritation where you apply the medicine.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Diabetes medicines such as glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)
• Saw palmetto
• Warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Protect it from heat, high humidity, and bright light. Dispose of empty packets and tubes safely away from children and pets.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.