Testosterone 50 mg/5g Gel — NDC 0591-3524-30 (Billing 00591-3524-30)

1 INDICATIONS AND USAGE Testosterone gel 1% 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 testosterone gel 1% in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

Safety and efficacy of testosterone gel 1% in males less than 18 years old have not been established [see Use in Specific Populations ( 8.4 )] . Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure [see Dosage and Administration ( 2 ) and Clinical Pharmacology ( 12.3 )] . Testosterone gel 1% is an androgen indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary Hypogonadism (Congenital or Acquired) ( 1 ) Hypogonadotropic Hypogonadism ( 1 ) Limitations of Use : Safety and efficacy of testosterone gel 1% in men with “age-related hypogonadism” have not been established.

( 1 ) Safety and efficacy of testosterone gel 1% in males less than 18 years old have not been established. ( 8.4 ) Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure. ( 1 , 12.3 )

2 DOSAGE AND ADMINISTRATION Prior to initiating testosterone gel 1%, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range. Prior to initiating testosterone gel 1%, confirm the diagnosis of hypogonadism by ensuring that serum testosterone has been measured in the morning on at least two separate days and that these concentrations are below the normal range.

( 2 ) Recommended starting dose for adult males: 50 mg of testosterone (one tube) applied topically once daily. ( 2.1 ) Apply to clean, dry, intact skin of the shoulders and/or upper arms. Do NOT apply testosterone gel 1% to the genitals or abdomen.

( 2.1 , 2.2 ) If morning pre-dose serum testosterone concentration is below normal range, increase dose to 100 mg. ( 2.1 ) Pre-dose serum testosterone concentration should be assessed periodically. ( 2.1 ) Patients should wash hands with soap and water immediately after applying testosterone gel 1% and cover application site(s) with clothing after gel has dried.

Wash the application site thoroughly with soap and water prior to any situation where skin-to-skin contact of the application site with another person is anticipated. ( 2.2 ) Testosterone gel 1% is not substitutable with other topical testosterone products. ( 2.1 )

2.1Dosing and Dose Adjustment The recommended starting dose of testosterone gel 1% is 50 mg of testosterone (one tube) applied once daily (preferably in the morning) to clean, dry intact skin of the shoulders and/or upper arms. Dose Adjustment To ensure proper dosing, serum testosterone concentrations should be measured. Morning, pre-dose serum testosterone concentrations should be measured approximately 14 days after initiation of therapy to ensure proper serum testosterone concentrations are achieved.

If the serum testosterone concentration is below the normal range (300 ng/dL to 1,000 ng/dL), the daily testosterone gel 1% dose may be increased from 50 mg testosterone (one tube) to 100 mg testosterone (two tubes) once daily. The maximum recommended dose of testosterone gel 1% is 100 mg once daily. The application site and dose of testosterone gel 1% are not substitutable with other topical testosterone products.

2.2Administration Instructions Upon opening the tube the entire contents should be squeezed into the palm of the hand and immediately applied to the shoulders and/or upper arms (area of application should be limited to the area that will be covered by the patient’s short sleeve T-shirt ( see figure below ). Do not apply testosterone gel 1% to the genitals or to the abdomen. Application sites should be allowed to dry for a few minutes prior to dressing.

Hands should be washed thoroughly with soap and water after testosterone gel 1% has been applied. Avoid fire, flame or smoking during the application of testosterone gel 1% until the testosterone gel 1% has dried [see Warnings and Precautions ( 5.1 , 5.16) ] . In order to prevent transfer to another person, wear clothing to cover the application sites.

If direct skin-to-skin contact with another person is anticipated, the application sites must be washed thoroughly with soap and water [see Warnings and Precautions ( 5.1 ) and Clinical Pharmacology ( 12.3 )] . The patient should avoid swimming or showering or washing the administration site for a minimum of 2 hours after application [see Clinical Pharmacology ( 12.3) ] . Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from testosterone-treated skin: Children and women should avoid contact with unwashed or unclothed application site(s) of men using testosterone gel 1%.

Testosterone gel 1% should only be applied to the upper arms and shoulders. The area of application should be limited to the area that will be covered by a short sleeve T-shirt. Patie… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS Testosterone gel 1% is a clear to translucent hydroalcoholic gel, for topical use and is available in a unit-dose tube. Each tube contains 50 mg testosterone in 5 g of gel. Topical gel: 50 mg of testosterone in a unit-dose tube ( 3 )

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Advise patients of the following :

17.1Men with Known or Suspected Carcinoma of the Breast or Prostate Men with known or suspected prostate or breast cancer should not use testosterone gel 1% [see Contraindications ( 4 ) and Warnings and Precautions ( 5.4 )] .

17.2Potential 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 have been reported in children. 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 1% 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 1% should apply the product as directed and strictly adhere to the following: - Wash hands with soap and water immediately 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 1% 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 ( 5.1 ), and Clinical Pharmacology ( 12.3 )] .

17.3Potential 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 the urine stream, passing urine many times during the day, having an urge to go the bathroom right away, having a urine accident, or being unable to pass urine or 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 Venous thromboembolism, the signs and symptoms of which may include lower limb pain, edema, or erythema; dyspnea; or chest pain.

Increased blood pressure that can increase cardiovascular risk over time.

17.4Patients Should Be Advised of the Following Instructions for Use Read the Medication Guide before starting testosterone gel 1% therapy and reread it each time the prescription is renewed. Testosterone gel 1% 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 1% out of the reach of children.

The package is not child resistant. Testosterone gel 1% 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 1% is prescribed to meet the patient’s specific needs; therefore, the patient… [Excerpted — this section continues on DailyMed.]

MEDICATION GUIDE Testosterone (tes tos ' ter one) Gel 1% , CIII for topical use What is the most important information I should know about testosterone gel 1%? Testosterone gel 1% can transfer from your body to others including, children and women. Children and women should avoid contact with the unwashed or not covered (unclothed) areas where testosterone gel 1% 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 testosterone gel 1%. Children Signs and symptoms of early puberty in a child when they come in direct contact with testosterone gel 1% 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: acting aggressively, behaving in an angry or violent way.

Women Signs and symptoms in women when they come in direct contact with testosterone gel 1% may include: changes in body hair. an abnormal increase in pimples (acne). Stop using testosterone gel 1% and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have happened through accidental touching of the area where you have placed testosterone gel 1%. To lower the risk of transfer of testosterone gel 1% from your body to others, follow these important instructions: Apply testosterone gel 1% only to the areas of your shoulders and upper arms that will be covered by a short sleeve t-shirt.

Wash your hands right away with soap and water after applying testosterone gel 1%. 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 testosterone gel 1%, that area on the child or woman should be washed well with soap and water right away. What is testosterone gel 1%?

Testosterone gel 1% is a prescription medicine that contains testosterone. Testosterone gel 1% 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 and while you are using testosterone gel 1%.

It is not known if testosterone gel 1% is safe or effective to treat men who have low testosterone due to aging. It is not known if testosterone gel 1% is safe or effective in children younger than 18 years old. Improper use of testosterone in children may affect bone growth.

Testosterone gel 1% is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your testosterone gel 1% in a safe place to protect it. Never give your testosterone gel 1% to anyone else, even if they have the same symptoms you have.

Selling or giving away this medicine may harm others and it is against the law. Testosterone gel 1% is not meant for use in women. Do not use testosterone gel 1% if you: have breast cancer. have or might have prostate cancer. are pregnant.

Testosterone gel 1% may harm your unborn baby. Women who are pregnant should avoid contact with the area of skin where testosterone gel 1% has been applied. Before using testosterone gel 1%, tell your healthcare provider about all of your medical conditions including if you: have breast cancer. have or might have prostate cancer. have urinary problems due to an enlarged prostate. have high blood pressure or are being treated for high blood pressure have heart problems. have liver or kidney problems. have 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. Using… [Excerpted — this section continues on DailyMed.]

INSTRUCTIONS FOR USE Testosterone (tes tos' ter one) Gel 1%, CIII for topical use Read this Instructions for Use for testosterone gel 1% before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

Important Information about Testosterone gel 1%: Children and women should avoid contact with the unwashed or not covered (unclothed) areas where testosterone gel 1% has been applied to your skin. If a child or woman touches the area where you have applied testosterone gel 1%, that area on the child or woman should be washed well with soap and water right away. If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water.

Testosterone gel 1% is flammable until dry. Let the testosterone gel 1% dry before smoking or going near an open flame. Before applying testosterone gel 1%, make sure that your shoulders and upper arms are clean, dry, and there is no broken skin.

The application sites for testosterone gel 1% are the shoulders and upper arms that will be covered by a short sleeve t-shirt (see Figure A). Do not apply testosterone gel 1% to any other parts of your body such as your stomach area (abdomen), penis, or scrotum. Applying Testosterone gel 1%: Remove the cap from the tube and use the top of the cap to pierce the metal seal on the top of the tube by pushing or screwing the cap in.

Testosterone gel 1% may have an alcoholic or musk odor. Squeeze all of the testosterone gel 1% out of the tube by pushing or screwing the cap in. Apply all of the testosterone gel 1% to the application site.

Rub the gel onto your skin for several seconds. Let the application site dry for a few minutes before putting on a t-shirt. Testosterone gel 1% is flammable until dry.

Let the testosterone gel 1% dry before smoking or going near an open flame. Wash your hands with soap and water right away after applying testosterone gel 1% . Avoid showering, swimming, or bathing for at least 2 hours after you apply testosterone gel 1%.

How should I store testosterone gel 1%? Store testosterone gel 1% at room temperature between 68° to 77°F (20° to 25°C). Safely throw away used testosterone gel 1% in the household trash.

Be careful to prevent accidental exposure of women, children or pets. Keep testosterone gel 1% away from fire. Keep testosterone gel 1% and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev.

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