HOW TO APPLY

AndroGel 1.62%

Applying AndroGel 1.62%

PUMP

Whether you are using pump or packet, make sure your shoulders and upper arms are clean and dry and that there is no broken skin. If you are using a pump and your bottle is already primed, press down firmly to dispense the gel, either into the palm of your hand or directly onto the application site. If you are using packets, open the packet and dispense the gel into the palm of your hand or directly onto the application site.

APPLY

Rub the gel onto upper arms and shoulders – areas that are normally 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, scrotum, chest, armpits (axillae), or knees.

WASH

Wash your hands with soap and water immediately after the application process.

COVER

Wait a few minutes until the gel has completely dried on your skin, and then cover up the application site with a T-shirt.

What you should know about AndroGel 1.62%

AndroGel 1.62% is a topical testosterone replacement therapy gel available in a metered-dose pump or travel-ready packets. Before you begin treatment, there are a few things you should know about application. No matter which packaging option you choose, you should apply AndroGel 1.62% at the same time each morning after showering or bathing.

The AndroGel 1.62% Pump

Before using a new bottle of AndroGel 1.62% for the first time, you will need to prime the pump. To prime the AndroGel 1.62% pump, slowly push the pump all the way down 3 times. Do not use any AndroGel 1.62% that comes out while priming. Wash it down the sink to avoid accidental exposure to others. Your AndroGel 1.62% pump is now ready to use. You do not have to prime your pump every day, only the first time you use it.

It is important that you apply AndroGel 1.62% exactly as your doctor tells you to. Your doctor will tell you how much AndroGel 1.62% to apply and when to apply it.

When using AndroGel 1.62%, it is important to note the following:

Your doctor may change your AndroGel 1.62% dose. Do not change your dose without talking to your doctor.
Never apply AndroGel 1.62% to the following areas: stomach area (abdomen), penis, scrotum, chest, armpits (axillae), or knees.
AndroGel 1.62% is not meant for use in women.
AndroGel 1.62% is flammable until dry. Let the gel dry before smoking or going near an open flame.
Avoid showering, swimming, or bathing for at least 2 hours after you apply AndroGel 1.62%.

Women and children should avoid contact with the unwashed or unclothed area where AndroGel 1.62% has been applied to your skin. If a woman or child makes contact with the AndroGel 1.62% application area, the contact area on the woman or child should be washed well with soap and water right away. Stop using AndroGel 1.62% 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 1.62%.

In This Section

USE AND IMPORTANT SAFETY INFORMATION

AndroGel^® (testosterone gel) 1% and 1.62% are controlled substances, available by prescription, used to treat adult males who have low or no testosterone due to certain medical conditions.

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

It is not known if AndroGel is safe or effective in children younger than 18 years old.

AndroGel is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep it in a safe place to protect it and never give it to anyone else. Selling or giving away this medicine may harm others and is against the law.

AndroGel is not meant for use in women.

IMPORTANT SAFETY INFORMATION^1,2

AndroGel^® (testosterone gel) 1% and 1.62% are controlled substances, available by prescription, used to treat adult males who have low or no testosterone due to certain medical conditions.

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

It is not known if AndroGel is safe or effective in children younger than 18 years old.

AndroGel is not meant for use in women.

IMPORTANT SAFETY INFORMATION^1,2

AndroGel can transfer from your body to others, including children and women. This can happen if other people come into contact with the area where the AndroGel was applied. Children and women should avoid contact with the unwashed or not covered (unclothed) areas where AndroGel has been applied to your skin.
Early signs and symptoms of puberty have occurred in young children who have come in direct contact with testosterone by touching areas where men have used AndroGel.
Signs and symptoms of early puberty in a child who has come in direct contact with AndroGel may include:
- Abnormal sexual changes:
  - Enlarged penis or clitoris.
  - Early growth of hair near the vagina or around the penis (pubic hair).
  - Erections or acting out sexual urges (sex drive).
- Behavior problems, including acting aggressively or behaving in an angry or violent way.
Signs and symptoms in a woman who has come in direct contact with AndroGel may include:
- Changes in body hair.
- An abnormal increase in pimples (acne).
To lower the risk of transfer of AndroGel from your body to others, you should follow these important instructions:
- Apply AndroGel 1.62% only to your shoulders and upper arms that will be covered by a short-sleeve t-shirt.
- Apply AndroGel 1% only to areas of your shoulders, upper arms, or stomach area (abdomen) that will be covered by a short-sleeve t-shirt.
- Wash your hands right away with soap and water after applying AndroGel.
- After the gel has dried, cover the application area with clothing. Keep the area covered until you have washed the application area well or have showered.
- If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water.
- If a child or woman touches the area where you have applied AndroGel, that area on the child or woman should be washed well with soap and water right away.
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 happened through accidental touching of the area where you have applied AndroGel.
Do not use AndroGel if you:
- Have breast cancer or have or might have prostate cancer.
- Are pregnant. AndroGel may harm your unborn baby. Women who are pregnant should avoid contact with the area of skin where AndroGel has been applied.
Before using AndroGel, tell your healthcare provider about all of your medical conditions, including if you have breast cancer; prostate cancer; urinary problems due to enlarged prostate; heart, kidney, or liver problems; or problems breathing while you sleep (sleep apnea).
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take insulin, medicines that decrease blood clotting (blood thinners), or corticosteroids.
AndroGel can cause serious side effects, including:
- If you already have an 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.
- Blood clots in the 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.
- Possible increased risk of heart attack or stroke.
- 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).
The most common side effects of AndroGel 1.62% include 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% include acne, skin irritation where AndroGel 1% is applied, lab test changes, and increased prostate specific antigen.
This is the most important information to know about AndroGel. For further information, talk with your healthcare provider. You may report side effects to ASCEND Therapeutics® US, LLC at 1-877-204-1013.

Please see the full Prescribing Information, including BOXED WARNING, and Medication Guide for AndroGel 1% and please see the full Prescribing Information, including BOXED WARNING, and Medication Guide for AndroGel 1.62%.

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.

The information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made by a healthcare provider considering the unique characteristics of the patient. This site is intended for US residents only. Use of and access to this site are subject to the Terms of Use and Privacy Statement.

USE AND IMPORTANT SAFETY INFORMATION

AndroGel^® (testosterone gel) 1% and 1.62% are controlled substances, available by prescription, used to treat adult males who have low or no testosterone due to certain medical conditions.

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

It is not known if AndroGel is safe or effective in children younger than 18 years old.

AndroGel is not meant for use in women.

IMPORTANT SAFETY INFORMATION^1,2

AndroGel^® (testosterone gel) 1% and 1.62% are controlled substances, available by prescription, used to treat adult males who have low or no testosterone due to certain medical conditions.

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

It is not known if AndroGel is safe or effective in children younger than 18 years old.

AndroGel is not meant for use in women.

IMPORTANT SAFETY INFORMATION^1,2

AndroGel can transfer from your body to others, including children and women. This can happen if other people come into contact with the area where the AndroGel was applied. Children and women should avoid contact with the unwashed or not covered (unclothed) areas where AndroGel has been applied to your skin.
Early signs and symptoms of puberty have occurred in young children who have come in direct contact with testosterone by touching areas where men have used AndroGel.
Signs and symptoms of early puberty in a child who has come in direct contact with AndroGel may include:
- Abnormal sexual changes:
  - Enlarged penis or clitoris.
  - Early growth of hair near the vagina or around the penis (pubic hair).
  - Erections or acting out sexual urges (sex drive).
- Behavior problems, including acting aggressively or behaving in an angry or violent way.
Signs and symptoms in a woman who has come in direct contact with AndroGel may include:
- Changes in body hair.
- An abnormal increase in pimples (acne).
To lower the risk of transfer of AndroGel from your body to others, you should follow these important instructions:
- Apply AndroGel 1.62% only to your shoulders and upper arms that will be covered by a short-sleeve t-shirt.
- Apply AndroGel 1% only to areas of your shoulders, upper arms, or stomach area (abdomen) that will be covered by a short-sleeve t-shirt.
- Wash your hands right away with soap and water after applying AndroGel.
- After the gel has dried, cover the application area with clothing. Keep the area covered until you have washed the application area well or have showered.
- If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water.
- If a child or woman touches the area where you have applied AndroGel, that area on the child or woman should be washed well with soap and water right away.
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 happened through accidental touching of the area where you have applied AndroGel.
Do not use AndroGel if you:
- Have breast cancer or have or might have prostate cancer.
- Are pregnant. AndroGel may harm your unborn baby. Women who are pregnant should avoid contact with the area of skin where AndroGel has been applied.
Before using AndroGel, tell your healthcare provider about all of your medical conditions, including if you have breast cancer; prostate cancer; urinary problems due to enlarged prostate; heart, kidney, or liver problems; or problems breathing while you sleep (sleep apnea).
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take insulin, medicines that decrease blood clotting (blood thinners), or corticosteroids.
AndroGel can cause serious side effects, including:
- If you already have an 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.
- Blood clots in the 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.
- Possible increased risk of heart attack or stroke.
- 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).
The most common side effects of AndroGel 1.62% include 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% include acne, skin irritation where AndroGel 1% is applied, lab test changes, and increased prostate specific antigen.
This is the most important information to know about AndroGel. For further information, talk with your healthcare provider. You may report side effects to ASCEND Therapeutics® US, LLC at 1-877-204-1013.

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.

HOW TO APPLY

AndroGel 1.62%

Applying AndroGel 1.62%

PUMP

APPLY

WASH

COVER

What you should know about AndroGel 1.62%

The AndroGel 1.62% Pump

When using AndroGel 1.62%, it is important to note the following:

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