Testosterone 12.5 mg Gel, Metered — NDC 0832-1121-42 (Billing 00832-1121-42)

1 INDICATIONS AND USAGE Testosterone gel is indicated for 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 levels 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 levels but have gonadotropins in the normal or low range. Limitations of Use: Safety and efficacy of testosterone gel in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established.

Safety and efficacy of testosterone gel 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 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 (congenital or acquired). ( 1 ) Limitations of Use: Safety and efficacy of testosterone gel in men with age-related hypogonadism have not been established ( 1 ) Safety and efficacy of testosterone gel 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, 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, 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 or one packet or 4 pump actuations) applied topically once daily at approximately the same time each day. ( 2.1 ) Apply to clean, dry, intact skin of the shoulders and/or upper arms. Do not apply testosterone gel to the genitals or abdomen.

( 2.1 , 2.2 ) If morning pre-dose serum testosterone concentration is below the 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 and cover application site(s) with clothing after gel has dried.

Wash the application sites 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 )

2.1Dosing and Dose Adjustment The recommended starting dose of testosterone gel is 50 mg of testosterone (one tube, one packet, or 4 pump actuations) applied topically once daily at approximately the same time each day 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 dose may be increased from 50 mg testosterone (one tube, one packet, or 4 pump actuations) to 100 mg of testosterone (two tubes, two packets, or 8 pump actuations) once daily. The maximum recommended dose of testosterone gel is 100 mg once daily.

2.2Administration Instructions Unit-Dose Tube or Packet Upon opening the tube or packet 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 ]). Table 1 has specific dosing guidelines for when the unit-dose tubes or packets are used. Table 1: Specific Dosing Guideline for Using the Unit-Dose Tubes or Packets Prescribed Daily Dose Number of Unit-Dose Tubes or Packets Application Method 50 mg testosterone One unit-dose tube or packet (once daily) Apply one unit-dose tube or packet to one upper arm and shoulder.

100 mg testosterone Two unit-dose tubes or packets (once daily) Apply one unit-dose tube or packet to one upper arm and shoulder and then apply one unit-dose tube or packet to the opposite upper arm and shoulder. Multi-Dose Metered Pump Patients should be instructed to prime the pump before using it for the first time by fully depressing the pump mechanism (actuation) 3 times and discard this portion of the product to assure precise dose delivery. After the priming procedure, patients should completely depress the pump one time (actuation) for every 12.5 mg of testosterone required to achieve the daily prescribed dosage.

Table 2 has specific dosing guidelines for when the metered pump is used. Table 2: Specific Dosing Guidelines for Using the Multi-Dose Pump Prescribed Daily Dose Number of Pump Actuations Application Method 50 mg testosterone 4 (once daily) Apply 4 pump actuations to one upper arm and shoulder 100 mg testosterone 8 (once daily) A… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS Testosterone gel is a clear to translucent hydroalcoholic topical gel for topical use available in unit-dose tubes, unit-dose packets, and multiple-dose metered pumps. Each tube or packet provides 50 mg testosterone in 5 g of gel. One pump actuation delivers 12.5 mg testosterone in 1.25 g of gel (4 actuations = 50 mg testosterone).

Topical Gel available as: 50 mg of testosterone in a unit-dose tube. ( 3 ) 50 mg of testosterone in a unit-dose packet. ( 3 ) 12.5 mg of testosterone per one pump actuation in a metered-dose pump.

( 3 )

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Men with Known or Suspected Carcinoma of the Breast or Prostate Men with known or suspected prostate or breast cancer should not use testosterone gel [see Contraindications (4) and Warnings and Precautions (5.1) ] . 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 products 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 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 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 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) ] .

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 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 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. The package is not child resistant.

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. Testosterone gel should be applied topically once daily at approximately the same time each day to clean dry skin of the shoulders and/or upper arms. Testosterone gel should not be applied to the scrotum, penis, or abdomen.

Wait 2 hours before washi… [Excerpted — this section continues on DailyMed.]

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised 5/2020 MEDICATION GUIDE Testosterone (tes-TOS-te-rōn) Gel, CIII for topical use What is the most important information I should know about testosterone gel?

Testosterone gel 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 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.

Children Signs and symptoms of early puberty in a child when they come in direct contact with Testosterone gel 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 may include: changes in body hair. an abnormal increase in pimples (acne).

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 happened through accidental touching of the area where you have applied testosterone gel. To lower the risk of transfer of testosterone gel from your body to others, follow these important instructions: Apply testosterone gel 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.

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, that area on the child or woman 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 and while you are using 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 your testosterone gel 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 is not meant for use in women. Do not use testosterone gel if you: have breast cancer. have or might have prostate cancer. are a woman who is pregnant. Testosterone gel may harm your unborn baby.

Women who are pregnant or who may become pregnant should avoid contact with the area of skin where testosterone gel has been applied. Before using testosterone gel, 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 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 testostero… [Excerpted — this section continues on DailyMed.]

INSTRUCTIONS FOR USE Testosterone (tes-TOS-te-rōn) Gel, CIII for topical use Read this Instructions for Use for testosterone gel 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.

Applying Testosterone gel: Testosterone gel comes in tubes, packets, or in a pump. Before applying testosterone gel, make sure that your shoulders and upper arms are clean, dry, and there is no broken skin. The application sites for testosterone gel are the shoulders and the upper arms that will be covered by a short sleeve t-shirt (See Figure A ).

Do not apply testosterone gel to any other parts of your body such as your penis, scrotum, or stomach area (abdomen). If you are using testosterone gel tubes: Remove the cap from the tube and use the top of the cap to puncture the metal seal on the top of the tube. Squeeze from the bottom of the tube to the top.

Squeeze all of the testosterone gel out of the tube into the palm of your hand. Testosterone gel is to be applied only to the areas of your shoulders and upper arms that will be covered by a short sleeve t-shirt. Apply testosterone gel to the application site.

Rub the gel onto your skin for several seconds. Testosterone gel is flammable until dry. Let testosterone gel dry before smoking or going near an open flame.

Let the application site dry for a few minutes before putting on a t-shirt. Wash your hands with soap and water right away after applying testosterone gel. Put the cap back on the tube.

Avoid showering, swimming, or bathing for at least 2 hours after you apply testosterone gel. If you are using testosterone gel packets: Tear open the packet completely at the notch on the top edge. Squeeze from the bottom of the packet to the top.

Squeeze all of the testosterone gel out of the packet into the palm of your hand. Apply testosterone gel 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. Wash your hands with soap and water right away after applying testosterone gel . If you are using the testosterone gel pump: Before using a new bottle of testosterone gel for the first time, you will need to prime the pump.

To prime the testosterone gel pump, remove the cap and slowly push the pump all the way down 3 times. Do not use any testosterone gel that came out while priming. Wash it down the sink to avoid accidental exposure to others.

Your testosterone gel pump is now ready to use. Remove the cap from the pump. Then position the nozzle over the palm of your hand and slowly push the pump all the way down.

Your healthcare provider will tell you the number of times to press the pump for each dose. Apply testosterone gel 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. Wash your hands with soap and water right away. Put the cap back on the pump.

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

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

This Instructions for Use has been approved by the U.S. Food and Drug Administration Revised: Revised 5/2020 Figure A