AndroGel (testosterone gel) 1%

About AndroGel 1%

A note about AndroGel 1%

For those patients still on AndroGel 1%, you should know that there is a more concentrated version available—AndroGel 1.62%. If you're interested in using less gel, talk to your doctor about AndroGel 1.62% today. If you'd like more information on AndroGel 1%, just read on below and then discuss with your doctor.

AndroGel 1%

AndroGel 1% is a controlled substance (CIII) available by prescription, used to treat adult men with low or no testosterone. It is a daily testosterone replacement therapy (TRT) that can raise low testosterone levels with daily use. The testosterone in AndroGel 1% is the same as the testosterone that your body makes naturally. And, when used daily, it can help you raise your T levels.

AndroGel 1% is clear, odorless, and quick-drying. And it offers packaging options in the form of a metered-dose pump or packets, so you and your doctor can choose what works best for you.

It is important to note:
AndroGel 1% can transfer from your body to others. This can happen if other people come into contact with the area where the AndroGel 1% was applied. Signs of puberty that are not expected have happened in young children who were accidentally exposed to testosterone through skin-to-skin contact with men using topical testosterone products like AndroGel 1%. Women and children should avoid contact with the unwashed or unclothed area where AndroGel 1% has been applied.

So how does AndroGel 1% work?

AndroGel 1% contains testosterone, which is absorbed through the skin after application. The testosterone in AndroGel 1% is the same as the testosterone your body makes naturally. It can help raise testosterone levels to the normal range in most men when used daily.

The most common side effects of AndroGel 1% are acne, skin irritation where the gel is applied, increased cholesterol levels, increased prostate specific antigen (a test used to screen for prostate cancer), increased red blood cell count, and increased liver function tests.

AndroGel 1% clinical study results

In a clinical study, of the 129 hypogonadal men who continued AndroGel 1% therapy for 6 months (with dose adjusted properly), 87% had their T levels restored to normal.

Safety information

AndroGel 1% can cause serious side effects, including worsening symptoms of an enlarged prostate; possible increased risk of prostate cancer; lower sperm count; swelling of ankles, feet, or body; enlarged or painful breasts; problems breathing during sleep; and blood clots in the legs or lungs. Before you use AndroGel, tell your healthcare provider if you have breast cancer; prostate cancer; urinary problems due to enlarged prostate; heart, kidney, or liver problems; problems breathing while you sleep (sleep apnea); and/or have any other medical conditions.

Before you begin

AndroGel 1% is a topical testosterone replacement therapy. Since AndroGel 1% is a gel, there are a few things you should know about packaging and application before you begin treatment.

AndroGel 1% packaging

AndroGel 1% is available in a metered-dose pump and in packets. Our metered-dose pump contains enough gel for many uses. We also have pre-measured packets that contain enough gel for a single application for certain doses.

Your individual dosage may vary, so be sure to follow your doctor's instructions.

AndroGel 1% application instructions

Whether you choose the pump or the packets, it is important that you understand the correct way to apply AndroGel 1%. Read below to find application information for both.

About the AndroGel 1% pump

The AndroGel 1% metered-dose pump gives you the exact amount of medicine that your doctor has prescribed. Two pumps are included in your package of AndroGel 1%. If you are using the starting dose of AndroGel 1% (50 mg of testosterone in 5 grams of gel), this supply will last you 30 days.

Preparing the AndroGel 1% pump

Before using a new bottle of AndroGel 1% for the first time, you will need to prime the pump. To prime the AndroGel 1% pump, slowly push the pump all the way down 3 times. Do not use any AndroGel that came out while priming. Wash it down the sink or throw it in the trash to avoid accidental exposure to others. You do not have to prime your pump every day, only the first time you use it.

It is important that you apply AndroGel 1% exactly as your healthcare provider tells you to. Your doctor will tell you how much AndroGel 1% to apply. You can also check the label on your bottle to see how many times to press the pump for the dose your doctor has prescribed. It is important that you apply AndroGel 1% exactly as your healthcare provider tells you to.

Dosing information for AndroGel 1% pump

Find your dose as prescribed by your physician

Daily dose of testosterone

Number of pump presses

50 mg4 Pump Presses
75 mg6 Pump Presses
100 mg8 Pump Presses

About the AndroGel 1% packets

AndroGel 1% is also available in packets. Each packet contains 25 mg of testosterone in 2.5 g of gel or 50 mg of testosterone in 5 g of gel. After use, throw away the packet in the trash out of the reach of children to avoid accidental exposure.

Applying AndroGel 1%

  1. Apply AndroGel 1% at the same time each morning. AndroGel 1% should be applied after showering or bathing to clean, dry, intact skin.
  2. Your healthcare provider will tell you how much AndroGel 1% to apply. If using the pump, slowly push the pump all the way down to dispense the gel. AndroGel 1% is also available in packets. Each packet contains 25 mg of testosterone in 2.5 g of gel or 50 mg of testosterone in 5 g of gel. If using the packets, you can open them by tearing along the dotted line. Squeeze the contents into the palm of your hand. Squeeze from the bottom of the packet up. AndroGel 1% should be applied right away.
  3. Apply the gel to one or more of the application sites. These areas are your shoulders and upper arms, and/or stomach area (see illustration). Do not apply AndroGel 1% to any other parts of your body, such as your penis, scrotum, chest, or back.
  4. Repeat steps 2 and 3 until you have applied the dose your doctor has prescribed for you.

Your healthcare provider may change your AndroGel 1% dose. Do not change your AndroGel 1% dose without talking to your healthcare provider.

AndroGel 1% is not meant for use in women.

After you apply AndroGel 1%

  • Wash your hands right away with soap and water.
  • Let the application sites dry.
  • Cover the application sites with a short-sleeved T-shirt.

When using AndroGel 1% it is important to note the following.

AndroGel 1% is flammable until dry. Let the gel dry before smoking or going near an open flame.

Avoid showering, swimming, or bathing for at least 5 hours after you apply AndroGel 1%.

Women and children should avoid contact with the unwashed or unclothed area where AndroGel 1% has been applied. If a woman or child makes contact with the AndroGel 1% application area, the contact area on the woman or child should be washed well with soap and water right away. Stop using AndroGel 1% and call your healthcare provider right away if you see any signs and symptoms of puberty in a child, or changes in body hair or increased acne in a woman, that may have occurred through accidental exposure to AndroGel 1%.

Key points

  • AndroGel 1% is a daily testosterone replacement therapy that can help raise low testosterone levels to the normal range.
  • It is very important to understand the correct way to apply AndroGel 1% and the steps to follow after application.

USE: AndroGel® (testosterone gel) 1% and 1.62%

AndroGel® (testosterone gel) 1% and 1.62% are controlled substances, available by prescription, used to treat adult males who have low or no testosterone. It is not known if AndroGel is safe or effective in children younger than 18 years old. Testosterone products that are applied to the skin may have different doses, strengths, or application instructions that may lead to different levels of testosterone in your body.

Important Safety Information

  • AndroGel can transfer from your body to others. This can happen if other people come into contact with the area where AndroGel was applied.
  • Signs of puberty that are not expected have happened in young children who were accidentally exposed to testosterone through skin-to-skin contact with men using topical testosterone products like AndroGel.
  • Women and children should avoid contact with the unwashed or unclothed area where AndroGel has been applied. If a woman or child makes contact with the AndroGel application area, the contact area on the woman or child should be washed well with soap and water right away.
  • To lower the risk of transfer of AndroGel 1.62%, you should apply it only to your shoulders and upper arms, areas that will be covered by a short-sleeve T-shirt. Do not apply AndroGel 1.62% to any other parts of your body, such as your stomach area (abdomen), penis, or scrotum. Wash your hands right away with soap and water after applying. After the gel has dried, cover the application area with clothing until you have washed the application area well or have showered. If you expect another person to have skin-to-skin contact with your shoulders or upper arms, first wash the application area well with soap and water.
  • To lower the risk of transfer of AndroGel 1%, you should apply it only to areas that will be covered by a short-sleeve T-shirt. These areas include shoulders, upper arms, and stomach area. Do not apply AndroGel to your penis or scrotum. Wash your hands right away with soap and water after applying AndroGel. 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.
  • Stop using AndroGel and call your healthcare provider right away if you see any signs and symptoms of puberty in a child, or changes in body hair or increased acne in a woman, that may have occurred through accidental exposure to AndroGel.
  • Do not use AndroGel if you have breast cancer or have or might have prostate cancer.
  • AndroGel is not meant for use in women and must not be used in women who are or may become pregnant or are breastfeeding. AndroGel may harm the unborn or breastfeeding baby. Women who are pregnant or who may become pregnant should avoid contact with the area of skin where AndroGel has been applied.
  • Before you use AndroGel, tell your healthcare provider if you have breast cancer; prostate cancer; urinary problems due to enlarged prostate; heart, kidney, or liver problems; problems breathing while you sleep (sleep apnea); and/or have any other medical conditions.
  • AndroGel can cause serious side effects, including:
    • If you already have enlargement of your prostate gland, your signs and symptoms can get worse while using AndroGel (including changes in urination)
    • Possible increased risk of prostate cancer
    • In large doses, AndroGel 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 your legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling, or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
  • Tell your healthcare provider about all the medicines you take, especially if you take insulin, medicines that decrease blood clotting, or corticosteroids.
  • AndroGel is flammable until dry. Let AndroGel dry before smoking or going near an open flame.
  • The most common side effects of AndroGel 1.62% are increased prostate specific antigen (a test used to screen for prostate cancer), mood swings, high blood pressure, increased red blood cell count, and skin irritation where the gel is applied. The most common side effects of AndroGel 1% are acne, skin irritation where the gel is applied, increased cholesterol levels, increased prostate specific antigen, increased red blood cell count, and increased liver function tests.
  • AndroGel 1% and 1.62% application sites and dosages are not interchangeable with each other, or with other topical testosterone products.
  • This is the most important information to know about AndroGel. For further information, talk with your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.or call 1-800-FDA-1088

If you cannot afford your medication, contact www.pparx.org for assistance.

References: 1. AndroGel 1.62% [package insert]. North Chicago, IL: AbbVie Inc. 2. AndroGel 1% [package insert]. North Chicago, IL: AbbVie Inc.