Testosterone Topical

IMPORTANT WARNING:

Testosterone topical products may cause harmful effects to people who touch your skin in the area where you applied the gel or solution. Women and children are especially likely to be affected if they touch skin that has been covered with testosterone topical products. If a woman who is pregnant, may become pregnant, or is breastfeeding touches skin that has been covered with testosterone topical products, her baby may be harmed. Women should not use this medication, especially if they are or may become pregnant or are breastfeeding. Testosterone may harm the baby.

You must take precautions to be sure that others will not come into contact with testosterone gel or solution that is on your skin. After you apply testosterone gel or solution, you should allow the medication to dry for a few minutes and then put on clothing that completely covers the area so that no one will touch your bare skin. When you have finished applying the medication, you must wash your hands with soap and water to remove any medication that may be left on your hands.

Do not let anyone touch your skin in the area where you applied testosterone gel or solution. If you expect that you may have skin-to-skin contact with another person, you should wash the area very well with soap and water. If anyone touches skin that has been covered with testosterone gel or solution and has not been washed, that person should wash his or her skin with soap and water as soon as possible. You should also tell others to be careful when handling your clothing, bed linens, or other items that may have testosterone gel or solution on them.

If women or children touch skin that has been treated with testosterone products, they may develop certain symptoms. If a woman who may have come into contact with testosterone develops either of the following symptoms, she should call her doctor immediately: growth of hair in new places on the body or acne. If a child who may have come into contact with testosterone develops any of the following system, you should call the child's doctor immediately: enlarged genitals, growth of pubic hair, increased erections, increased sexual desire, or aggressive behavior. Most of these symptoms can be expected to go away after the child stops coming into contact with testosterone, but in some cases, genitals may remain larger than normal.

Testosterone topical may cause the bones to mature more quickly than normal in children who come into contact with the medication. This means that the children may stop growing sooner than expected and may have a shorter than expected adult height. Even if these children no longer come into contact with testosterone topical products, their bones may remain more mature than normal.

WHY is this medicine prescribed?

Testosterone topical is used to treat the symptoms of low testosterone in adult men who have hypogonadism (a condition in which the body does not produce enough natural testosterone). Testosterone is used only for men with low testosterone levels caused by certain medical conditions, including disorders of the testicles, pituitary gland (a small gland in the brain), or hypothalamus (a part of the brain) that cause hypogonadism. Your doctor will order certain tests to check your testosterone levels to see if they are low before you begin to use testosterone topical. Testosterone should not be used to treat the symptoms of low testosterone in men who have low testosterone due to aging ('age related hypogonadism'). Testosterone is in a class of medications called androgenic hormones. Testosterone is a hormone produced by the body that contributes to the growth, development, and functioning of the male sexual organs and typical male characteristics. Testosterone topical works by replacing the testosterone that is normally produced by the body.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Topical testosterone comes as a gel and solution to apply to the skin. It is usually applied once a day. It is best to apply testosterone gel or solution in the morning. To help you remember to apply testosterone topical, apply it at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use testosterone topical exactly as directed. Do not apply more or less of it or apply it more often than prescribed by your doctor.

Testosterone topical products are manufactured differently and are used in slightly different ways. Be sure that you know which topical brand you are using and how and where you should apply it. Read the manufacturer's patient information that came with your topical testosterone product carefully.

If you usually take a bath or shower in the morning, be sure to take your bath or shower before you apply testosterone topical products. Read the manufacturer's patient information about your topical testosterone product for information about when you can wash, shower, bath, or swim after you apply the medication.

You should not apply any testosterone topical products to your penis or scrotum or to skin that has sores, cuts, or irritation.

Be careful not to get testosterone topical in your eyes. If you do get testosterone topical in your eyes, wash them right away with warm, clean water. Call a doctor if your eyes become irritated.

Testosterone topical comes in single use tubes, packets, and a multiple-use pump. The pump releases a specific amount of testosterone each time the top is pressed. Your doctor or pharmacist will tell you how many times to press the pump for each dose, and how many doses your pump contains. Dispose of the pump after you have used that number of doses even if it is not empty.

Testosterone gel and solution may catch fire. Stay away from open flames and do not smoke while you are applying testosterone topical and until the gel or solution has dried completely.

Your doctor may adjust your dose of testosterone depending on the amount of testosterone in your blood during your treatment.

Testosterone topical may control your symptoms but will not cure your condition. Continue to use testosterone topical even if you feel well. Do not stop using testosterone topical without talking to your doctor. If you stop using testosterone topical, your symptoms may return.

To use testosterone topical products, follow these steps:

1. Be sure that the skin in the place where you plan to apply testosterone topical is clean and completely dry.
2. Open your testosterone topical container. If you are using a packet, fold the top edge at the perforation and tear across the packet along the perforation. If you are using a tube, unscrew the cap. If you are using an Androgel^® or Volgelxo^® pump for the first time, press down on the top of the pump three times. If you are using a Fortesta^® pump for the first time, press down on the top of the pump eight times. Always discard the extra medication that comes out after priming the pump down a drain or in a trash can that is safe from children and pets.
3. Squeeze the packet or tube or press down on the top of the pump the right number of times to place the medication on the palm of your hand. It may be easier to apply testosterone gel if you squeeze the medication onto your palm and apply it to your skin in small portions.
4. Apply the medication to the area you have chosen.
5. Dispose of the empty packet or tube in a trash can safely, out of the reach of children and pets.
6. Wash your hands with soap and water right away.
7. Allow the medication to dry for a few minutes before you cover the area with clothing.

What SPECIAL PRECAUTIONS should I follow?

Before using testosterone gel,

• tell your doctor and pharmacist if you are allergic to testosterone, any other medications, or any of the ingredients in topical testosterone products. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants (blood thinners) such as warfarin (Coumadin, Jantoven); insulin (Apridra, Humalog, Humulin, others); and oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have breast cancer or have or may have prostate cancer. Your doctor will probably tell you that you should not use testosterone topical.

• tell your doctor if you have or have ever had sleep apnea (breathing stops for short periods of time during sleep), benign prostate hyperplasia (BPH; an enlarged prostate); high blood levels of calcium; diabetes; or heart, kidney, liver, or lung disease.

• talk to your doctor about the risks and benefits of using topical testosterone if you are 65 years of age or older. Older men should not usually use topical testosterone, unless they have hypogonadism.

• you should know that there have been reports of serious side effects in people who use testosterone at higher doses, along with other male sex hormone products, or in ways other than directed by a doctor. These side effects may include a heart attack, heart failure, or other heart problems; stroke and mini-stroke; liver disease; seizures; or mental health changes such as depression, mania (frenzied, abnormally excited mood), aggressive or unfriendly behavior, hallucinations (seeing things or hearing voices that do not exist), or delusions (having strange thoughts or beliefs that have no basis in reality). People who use higher doses of testosterone than recommended by a doctor may also experience withdrawal symptoms such as depression, extreme tiredness, craving, irritability, restlessness, loss of appetite, inability to fall asleep or stay asleep, or a decreased sex drive, if they suddenly stop using testosterone topical. Be sure to use testosterone topical exactly as directed by your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply a double dose to make up for a missed dose.

What SIDE EFFECTS can this medicine cause?

Testosterone topical may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• breast enlargement and/or pain
• decreased sexual desire
• acne
• depression
• mood changes
• headache
• teary eyes
• dry or itchy skin
• diarrhea
• skin redness or irritation

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

• lower leg pain, swelling, warmth, or redness
• shortness of breath
• swelling of the hands, feet, ankles, or lower legs
• nausea or vomiting
• slow or difficult speech
• dizziness or faintness
• weakness or numbness of an arm or leg
• chest pain
• difficulty breathing, especially during sleep
• erections that happen too often or that last too long
• difficulty urinating, weak urine flow, frequent urination, sudden need to urinate right away
• yellowing of the skin or eyes

Testosterone topical may cause a decrease in the number of sperm (male reproductive cells) produced, especially if it is used at high doses. Talk to your doctor about the risks of using this medication if you are a man and would like to have children.

Testosterone may increase the risk of developing prostate cancer. Talk to your doctor about the risks of using this medication.

Testosterone topical may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Store testosterone topical products in a safe place so that no one else can use it accidentally or on purpose. Keep track of how much medication is left so you will know if any is missing.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to testosterone.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using testosterone topical.

Do not let anyone else use your medication. Testosterone topical is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.