Testosterone Gel

Included as part of the "PRECAUTIONS" Section

FORTESTA®
(FOR-tes -ta)
(testosterone) Gel

Read this Medication Guide before you start using FORTESTA and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about FORTESTA?

1. Early signs and symptoms of puberty have happened in young children who were accidentally exposed to testosterone through contact with men using topical testosterone products like FORTESTA.

Signs and symptoms of early puberty in a child may include:

• enlarged penis or clitoris
• early development of pubic hair
• increased erections or sex drive
• aggressive behavior
2. FORTESTA can transfer from your body to others. Women and children should avoid contact with the unwashed or unclothed area where FORTESTA has been applied to your skin.

Stop using FORTESTA and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have occurred through accidental exposure to FORTESTA.

Signs and symptoms of exposure to FORTESTA in a child may include:

• enlarged penis or clitoris
• early development of pubic hair
• increased erections or sex drive
• aggressive behavior

Signs and symptoms of exposure to FORTESTA in women may include:

• changes in body hair
• a large increase in acne

To lower the risk of transfer of FORTESTA from your body to others, you should follow these important instructions:

• Apply FORTESTA only to the front and inside area of your thighs that will be covered by clothing.
• Wash your hands right away with soap and water after applying FORTESTA.
• After the FORTESTA 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 another person to have skin-to-skin contact with your thighs, first wash the application area well with soap and water.
• If a woman or child makes contact with the FORTESTA application area, that area on the woman or child should be washed well with soap and water right away.

What is FORTESTA?

FORTESTA is a prescription medicine that contains testosterone. FORTESTA is used to treat adult males who have low or no testosterone due to certain medical conditions.

Your healthcare provider will test your blood before you start taking and while you are taking FORTESTA.

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

It is not known if FORTESTA is safe or effective in children younger than 18 years old. Improper use of FORTESTA may affect bone growth in children.

FORTESTA is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your FORTESTA in a safe place to protect it. Never give FORTESTA to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law.

FORTESTA is not meant for use in women.

Who should not use FORTESTA?

Do not use FORTESTA if you:

• have breast cancer
• have or might have prostate cancer
• are pregnant or may become pregnant or breast-feeding. FORTESTA may harm your unborn or breast-feeding baby.

Women who are pregnant or who may become pregnant should avoid contact with the area of skin where FORTESTA has been applied.

Talk to your healthcare provider before taking this medicine if you have any of the above conditions.

What should I tell my healthcare provider before using FORTESTA?

Before you use FORTESTA, tell your healthcare provider if you:

• have breast cancer
• have or might have prostate cancer
• have urinary problems due to an enlarged prostate
• have heart problems
• have liver or kidney problems
• have problems breathing while you sleep (sleep apnea)
• have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Using FORTESTA with certain other medicines can affect each other. Especially, tell your healthcare provider if you take:

• insulin
• medicines that decrease blood clotting
• corticosteroids

Know the medicines you take. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I use FORTESTA?

• It is important that you apply FORTESTA exactly as your healthcare provider tells you to.
• Your healthcare provider will tell you how much FORTESTA to apply and when to apply it.
• Your healthcare provider may change your FORTESTA dose. Do not change your FORTESTA dose without talking to your healthcare provider.
• FORTESTA should be applied to the front and inner part of your thighs only. Do not apply FORTESTA to any other parts of your body such as your stomach area (abdomen), penis, scrotum, shoulders or upper arms.
• Apply FORTESTA in the morning. If you shower or bathe, FORTESTA should be applied afterwards.
• Avoid swimming, showering, or bathing for at least 2 hours after you apply FORTESTA.
• FORTESTA is flammable until dry. Let FORTESTA dry before smoking or going near an open flame.
• Apply FORTESTA only to areas that will be covered by shorts or pants .
• Wash your hands with soap and water right after you apply FORTESTA.

Applying FORTESTA:

• Before using a new canister of FORTESTA for the first time, you will need to prime the pump. To prime the FORTESTA pump, gently push down on the pump 8 times. Do not use any FORTESTA that comes out while priming. Wash it down the sink or throw it in the trash to avoid accidental exposure to others. Your FORTESTA pump is now ready to use.
• Use FORTESTA exactly as your healthcare provider tells you to use it. Your healthcare provider will tell you the dose of FORTESTA that is right for you.
• 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 FORTESTA evenly onto the front and inner part of each thigh.
• Let the application site dry completely before putting on shorts or pants.
• Wash your hands right away with soap and water.

What are the possible side effects of FORTESTA?

See “What is the most important information I should know about FORTESTA?”

FORTESTA can cause serious side effects including:

• If you already have enlargement of your prostate gland your signs and symptoms can get worse while using FORTESTA. This can include:
  • increased urination at night
  • trouble starting your urine stream
  • having to pass urine many times during the day
  • having an urge that you have to go to the bathroom right away
  • having a urine accident
  • being unable to pass urine or weak urine flow
• Possible increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use FORTESTA.
• 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 FORTESTA may lower your sperm count.
• Swelling of your ankles, feet, or body, with or without heart failure.
• Enlarged or painful breasts .
• Have problems breathing while you sleep (sleep apnea).
• Increased red blood cell count

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effects of FORTESTA include:

• skin redness or irritation where FORTESTA is applied
• increased in blood level of Prostate Specific Antigen (a test used to screen for prostate cancer)
• abnormal dreams

Other side effects include more erections than are normal for you or erections that last a long time.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of FORTESTA. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088.

How should I store FORTESTA?

• Store FORTESTA at 15°C to 30°C (59°F to 86°F).
• When it is time to throw away the canister, safely throw away used FORTESTA in household trash. Be careful to prevent accidental exposure of children or pets.
• Keep FORTESTA away from fire.
• Do not freeze FORTESTA.

Keep FORTESTA and all medicines out of the reach of children.

General information about FORTESTA

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FORTESTA for a condition for which it was not prescribed. Do not give FORTESTA to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about FORTESTA. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about FORTESTA that is written for health professionals.

For more information, go to www.fortestagel.com or call 1-800-462-3636.

What are the ingredients in FORTESTA?

Active ingredient: testosterone

Inactive ingredients : propylene glycol, purified water, ethanol, 2-propanol, oleic acid, carbomer 1382, triethanolamine and butylated hydroxytoluene.

This Medication Guide has been approved by the U.S. Food and Drug Administration

Testim® is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

• Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
• Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.

Limitations Of Use

• Safety and efficacy of Testim in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
• Safety and efficacy of Testim in males less than 18 years old have not been established [see Use in Specific Populations].
• Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].

This medication 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 testosterone topical gel, or with a man's skin areas where a testosterone topical patch has been worn or 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 the medication. 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.

The testosterone transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

Do not apply AndroGel or Testim testosterone gel to your penis or your scrotum. Testim gel should also not be applied to your stomach area.

Avoid swimming, bathing, or showering for at least 5 hours after applying AndroGel testosterone gel, or 2 hours after applying Testim testosterone gel.

Avoid using lotions, oils, or other skin products on the area where you will apply the skin patch. The patch may not stick properly to the skin.

If your doctor recommends a topical steroid medicine such as hydrocortisone to treat skin irritation caused by wearing a testosterone skin patch, avoid using an ointment form of the steroid.

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

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In a controlled clinical study, 304 patients were treated with testosterone gel 50 mg or 100 mg or placebo gel for up to 90 days. Two hundred-five (205) patients received testosterone gel 50 mg or 100 mg daily and 99 patients received placebo. Subjects could be counted in both testosterone gel treatment groups if they received both 50 mg and 100 mg at different points in the study and experienced an adverse reaction at both dose levels. Adverse reactions reported by ≥ 1% of the testosterone gel patients and greater than placebo are listed in Table 3.

Table 3: Incidence of Adverse Reactions (Reported by ≥ 1% of the Testosterone Gel Patients and Greater than Placebo) in the Controlled Clinical Trial Through 90 Days

The following adverse reactions occurred in fewer than 1% of patients but were greater in testosterone gel groups compared to the placebo group: activated partial thromboplastin time prolonged, blood creatinine increased, prothrombin time prolonged, appetite increased, sensitive nipples, and acne.

In this clinical trial of testosterone gel, six patients had adverse events that led to their discontinuation. These events included: depression with suicidal ideation, urinary tract infection, mood swings and hypertension. No testosterone gel patients discontinued due to skin reaction. In one foreign Phase 3 trial, one subject discontinued due to a skin-related adverse event.

In the pivotal U.S. and European Phase 3 trials combined, at the 50 mg dosage strength, the percentage of subjects reporting clinically notable increases in hematocrit or hemoglobin were similar to placebo. However, in the 100 mg dose group, 2.3% and 2.8% of patients had a clinically notable increase in hemoglobin ( ≥ 19 g/dL) or hematocrit ( ≥ 58%), respectively, compared to 1.0% and 1.5% of patients in the placebo group, respectively.

In the combined U.S. and European open label extension studies, approximately 140 patients received testosterone gel for at least 6 months. The results from these studies are consistent with those reported for the U.S. controlled clinical trial.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of testosterone gel products. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarketing surveillance of testosterone gel products. Signs and symptoms of these reported cases have included enlargement of the clitoris (with surgical intervention) or of the penis, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases with a reported outcome, these signs and symptoms were reported to have regressed with removal of the testosterone gel exposure. In a few cases, however, enlarged genitalia did not fully return to age-appropriate normal size, and bone age remained modestly greater than chronological age. In some of the cases, direct contact with the sites of application on the skin of men using testosterone gel was reported. In at least one reported case, the reporter considered the possibility of secondary exposure from items such as the testosterone gel user's shirts and/or other fabrics, such as towels and sheets [see WARNINGS AND PRECAUTIONS].

Myocardial infarction, stroke [see WARNINGS AND PRECAUTIONS]

Venous thromboembolism [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Vogelxo (Testosterone Gel)

• It is used to treat low testosterone levels.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time testosterone gel is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take testosterone gel or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to testosterone gel. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

6.1 Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In a controlled multicenter, open label, non-comparative 90-day clinical study, 149 hypogonadal patients were treated with Testosterone Gel [see Clinical Studies (14.1)]. Adverse reactions occurred in 22.8% (34/149) of patients. The most common adverse reaction reported in this study was skin reactions associated with the site of application (16.1%; 24/149) of which 79% (19/24) were mild, and the remainder were moderate (21%; 5/24) (Table 3).

During the 90 day trial 5 patients (3.4%) discontinued treatment because of adverse reactions. These reactions were: 1 patient with contact dermatitis (considered probably related to Testosterone Gel application), 1 with application site reaction (considered probably related to Testosterone Gel application), 1 with gastrointestinal hypomotility (considered possibly related to Testosterone Gel application), 1 with severe dyspnea (considered not related to Testosterone Gel application), and 1 with moderate contusion (considered not related to Testosterone Gel application).

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of Testosterone Gel. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure (Table 4).

Secondary Exposure to Testosterone in Children
Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarketing surveillance of Testosterone Gel products. Signs and symptoms of these reported cases have included enlargement of the clitoris (with surgical intervention) or the penis, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases with a reported outcome, these signs and symptoms were reported to have regressed with removal of the Testosterone Gel exposure. In a few cases, however, enlarged genitalia did not fully return to age appropriate normal size, and bone age remained modestly greater than chronological age. In some of the cases, direct contact with the sites of application on the skin of men using Testosterone Gel was reported. In at least one reported case, the reporter considered the possibility of secondary exposure from items such as the Testosterone Gel user’s shirts and/or other fabric, such as towels and sheets [see Warnings and Precautions (5.2)].

See FDA-approved Medication Guide.

Patients should be informed of the following information:

17.1 Use in Men with Known or Suspected Prostate or Breast Cancer

Men with known or suspected prostate or breast cancer should not use Testosterone Gel [see Contraindications (4) and Warnings and Precautions (5.1)].

17.2 Potential for Secondary Exposure to Testosterone and Steps to Prevent Secondary Exposure

Secondary exposure to testosterone in children and women can occur with the use of Testosterone Gel in men. Cases of secondary exposure to testosterone in children have been reported.

Physicians should advise patients of the reported signs and symptoms of secondary exposure which may include the following:

• In children; unexpected sexual development including inappropriate enlargement of the penis or clitoris, premature development of pubic hair, increased erections, and aggressive behavior.
• In women; changes in hair distribution, increase in acne, or other signs of testosterone effects.
• The possibility of secondary exposure to Testosterone Gel should be brought to the attention of a healthcare provider.
• Testosterone Gel should be promptly discontinued until the cause of virilization is identified.

Strict adherence to the following precautions is advised to minimize the potential for secondary exposure to testosterone from Testosterone Gel in men [see Medication Guide]:

• Children and women should avoid contact with unwashed or unclothed application site(s) of men using Testosterone Gel.
• Patients using Testosterone Gel should apply the product as directed and strictly adhere to the following:
  • Wash hands with soap and water after application.
  • Cover the application site(s) with clothing after the gel has dried.
  • Wash the application site(s) thoroughly with soap and water prior to any situation where skin-to-skin contact of the application site with another person is anticipated.
• In the event that unwashed or unclothed skin to which Testosterone Gel has been applied comes in contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible [see Dosage and Administration (2.2), Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)].

17.3 Potential Adverse Reactions with Androgens

Patients should be informed that treatment with androgens may lead to adverse reactions which include:

• Changes in urinary habits such as increased urination at night, trouble starting your urine stream, passing urine many times during the day, having an urge that you have to go to the bathroom right away, having a urine accident, being unable to pass urine and weak urine flow.
• Breathing disturbances, including those associated with sleep, or excessive daytime sleepiness.
• Too frequent or persistent erections of the penis.
• Nausea, vomiting, changes in skin color, or ankle swelling.

17.4 Patients Should Be Advised of the Following Instructions for Use

• Read the Medication Guide before starting Testosterone Gel therapy and reread it each time the prescription is renewed.
• Testosterone Gel should be applied and used appropriately to maximize the benefits and to minimize the risk of secondary exposure in children and women.
• Keep Testosterone Gel out of the reach of children.
• Testosterone Gel is an alcohol based product and is flammable; therefore avoid fire, flame or smoking until the gel has dried.
• It is important to adhere to all recommended monitoring.
• Report any changes in their state of health, such as changes in urinary habits, breathing, sleep, and mood.
• Testosterone Gel is prescribed to meet the patient’s specific needs, therefore, the patient should never share Testosterone Gel with anyone.
• Wait 2 hours before swimming or washing following application of Testosterone Gel. This will ensure that the greatest amount of Testosterone Gel is absorbed into their system.

Manufactured by:
Pharbil Waltrop GmbH
Waltrop, Germany

Distributed by:
Par Pharmaceutical
Chestnut Ridge, NY 10977

118315

MEDICATION GUIDE

Testosterone Gel CIII

Read this Medication Guide before you start using Testosterone Gel and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Testosterone Gel?

1.      Early signs and symptoms of puberty have happened in young children who were accidentally exposed to testosterone through contact with men using topical testosterone products like Testosterone Gel.

Signs and symptoms of early puberty in a child may include:

• enlarged penis or clitoris
• early development of pubic hair
• increased erections or sex drive
• aggressive behavior

2.      Testosterone Gel can transfer from your body to others.  Women and children should avoid contact with the unwashed or unclothed area where Testosterone Gel has been applied to your skin.

Stop using Testosterone Gel and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have occurred through accidental exposure to Testosterone Gel.

Signs and symptoms of exposure to Testosterone Gel in a child may include:

• enlarged penis or clitoris
• early development of pubic hair
• increased erections or sex drive
• aggressive behavior

Signs and symptoms of exposure to Testosterone Gel in women may include:

• changes in body hair
• a large increase in acne

To lower the risk of transfer of Testosterone Gel from your body to others, you should follow these important instructions:

• Apply Testosterone Gel only to the front and inside area of your thighs that will be covered by clothing.
• Wash your hands right away with soap and water after applying Testosterone Gel.
• After the Testosterone 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 another person to have skin-to-skin contact with your thighs, first wash the application area well with soap and water. 
• If a woman or child makes contact with the Testosterone Gel application area, that area on the woman or child should be washed well with soap and water right away.

What is Testosterone Gel?

Testosterone Gel is a prescription medicine that contains testosterone. Testosterone Gel is used to treat adult males who have low or no testosterone due to certain medical conditions.

Your healthcare provider will test your blood before you start taking and while you are taking Testosterone Gel.

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

It is not known if Testosterone Gel is safe or effective in children younger than 18 years old. Improper use of Testosterone Gel may affect bone growth in children.

Testosterone Gel is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your Testosterone Gel in a safe place to protect it. Never give Testosterone Gel to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law.

Testosterone Gel is not meant for use in women.

Who should not use Testosterone Gel ?

Do not use Testosterone Gel if you:

• have breast cancer
• have or might have prostate cancer
• are pregnant or may become pregnant or breast-feeding. Testosterone Gel may harm your unborn or breast-feeding baby.

Women who are pregnant or who may become pregnant should avoid contact with the area of skin where Testosterone Gel has been applied.

Talk to your healthcare provider before taking this medicine if you have any of the above conditions.

What should I tell my healthcare provider before using Testosterone Gel?

Before you use Testosterone Gel, tell your healthcare provider if you:

• have breast cancer
• have or might have prostate cancer
• have urinary problems due to an enlarged prostate
• have heart problems
• have liver or kidney problems
• have problems breathing while you sleep (sleep apnea)
• have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Using Testosterone Gel with certain other medicines can affect each other.  Especially, tell your healthcare provider if you take:

• insulin
• medicines that decrease blood clotting
• corticosteroids

Know the medicines you take. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I use Testosterone Gel?

• It is important that you apply Testosterone Gel exactly as your healthcare provider tells you to.
• Your healthcare provider will tell you how much Testosterone Gel to apply and when to apply it.
• Your healthcare provider may change your Testosterone Gel dose. Do not change your Testosterone Gel dose without talking to your healthcare provider.
• Testosterone Gel should be applied to the front and inner part of your thighs only. Do not apply Testosterone Gel to any other parts of your body such as your stomach area (abdomen), penis, scrotum, shoulders or upper arms.
• Apply Testosterone Gel in the morning. If you shower or bathe, Testosterone Gel should be applied afterwards.
• Avoid swimming, showering, or bathing for at least 2 hours after you apply Testosterone Gel.
• Testosterone Gel is flammable until dry. Let Testosterone Gel dry before smoking or going near an open flame.
• Apply Testosterone Gel only to areas that will be covered by shorts or pants.
• Wash your hands with soap and water right after you apply Testosterone Gel.

Applying Testosterone Gel:

• Before using a new canister of Testosterone Gel for the first time, you will need to prime the pump. To prime the Testosterone Gel pump, gently push down on the pump 8 times. Do not use any Testosterone Gel that comes out while priming. Wash it down the sink or throw it in the trash to avoid accidental exposure to others. Your Testosterone Gel pump is now ready to use.
• Use Testosterone Gel exactly as your healthcare provider tells you to use it. Your healthcare provider will tell you the dose of Testosterone Gel that is right for you.
• 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 Testosterone Gel evenly onto the front and inner part of each thigh.

• Let the application site dry completely before putting on shorts or pants.
• Wash your hands right away with soap and water.

What are the possible side effects of Testosterone Gel?

See “What is the most important information I should know about Testosterone Gel?”

Testosterone Gel can cause serious side effects including:

• If you already have enlargement of your prostate gland your signs and symptoms can get worse while using Testosterone Gel. This can include:
  • increased urination at night
  • trouble starting your urine stream
  • having to pass urine many times during the day
  • having an urge that you have to go to the bathroom right away
  • having a urine accident
  • being unable to pass urine or weak urine flow
• Possible increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use Testosterone Gel.
• 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 Testosterone Gel may lower your sperm count.
• Swelling of your ankles, feet, or body, with or without heart failure.
• Enlarged or painful breasts.
• Have problems breathing while you sleep (sleep apnea).
• Increased red blood cell count

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effects of Testosterone Gel include:

• skin redness or irritation where Testosterone Gel is applied
• increased in blood level of Prostate Specific Antigen (a test used to screen for prostate cancer)
• abnormal dreams

Other side effects include more erections than are normal for you or erections that last a long time.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Testosterone Gel. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Testosterone Gel?

• Store Testosterone Gel at 15°C to 30°C (59°F to 86°F).
• When it is time to throw away the canister, safely throw away used Testosterone Gel in household trash. Be careful to prevent accidental exposure of children or pets.
• Keep Testosterone Gel away from fire.
• Do not freeze Testosterone Gel.

Keep Testosterone Gel and all medicines out of the reach of children.

General information about Testosterone Gel

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Testosterone Gel for a condition for which it was not prescribed. Do not give Testosterone Gel to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about Testosterone Gel. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Testosterone Gel that is written for health professionals.

For more information call 1-800-444-4011.

What are the ingredients in Testosterone Gel?

Active ingredient: testosterone

Inactive ingredients: propylene glycol, purified water, ethanol, 2-propanol, oleic acid, carbomer 1382, triethanolamine and butylated hydroxytoluene.

This Medication Guide has been approved by the U.S. Food and Drug Administration

Manufactured by:
Pharbil Waltrop GmbH
Waltrop, Germany

Distributed by:
Par Pharmaceutical
Chestnut Ridge, NY  10977

Revised:  07/2017

118314

Package Label – Principle Display Panel – 60 g Canister Label