Testosterone 50 mg/5g Gel — NDC 66993-955-30 (Billing 66993-0955-30)

1 INDICATIONS AND USAGE Testosterone gel 1% 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 conditions such as 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 ( 1 , 12.3 ). Testosterone gel 1% is indicated for 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 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 Dosage and Administration for testosterone gel 1% differs from testosterone gel 1.62%. For dosage and administration of testosterone gel 1.62% refer to its full prescribing information. ( 2 ) 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.

Dosage and Administration for testosterone gel 1% differs from testosterone gel 1.62%. For dosage and administration of testosterone gel 1.62% refer to its full prescribing information. ( 2 ) 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 ).

Starting dose of testosterone gel 1% is 50 mg of testosterone (4 pump actuations, two 25 mg packets or one 50 mg packet), applied once daily in the morning. ( 2.1 ) Apply to clean, dry, intact skin of shoulders and upper arms and/or abdomen. Do NOT apply testosterone gel 1% to any other parts of the body including the genitals, chest, armpits (axillae), knees, or back.

( 2.2 ) Dose adjustment: testosterone gel 1% can be dose adjusted using 50 mg, 75 mg, or 100 mg of testosterone on the basis of total serum testosterone concentration. The dose should be titrated based on the serum testosterone concentration. Additionally, serum testosterone concentration should be assessed periodically.

( 2.1 ) Patients should wash hands immediately with soap and water after applying testosterone gel 1% and cover the application site(s) with clothing after the 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 )

2.1Dosing and Dose Adjustment The recommended starting dose of testosterone gel 1% is 50 mg of testosterone (4 pump actuations, two 25 mg packets or one 50 mg packet), applied topically once daily in the morning to the shoulders and upper arms and/or abdomen area (preferably at the same time every day). Dose Adjustment To ensure proper dosing, serum testosterone concentrations should be measured at intervals. If the serum testosterone concentration is below the normal range, the daily testosterone gel 1% dose may be increased from 50 mg to 75 mg and from 75 mg to 100 mg for adult males as instructed by the physician.

If the serum testosterone concentration exceeds the normal range, the daily testosterone gel 1% dose may be decreased. If the serum testosterone concentration consistently exceeds the normal range at a daily dose of 50 mg, testosterone gel 1% therapy should be discontinued. In addition, serum testosterone concentrations should be assessed periodically.

The application site and dose of testosterone gel 1% are not interchangeable with other topical testosterone products.

2.2Administration Instructions Testosterone gel 1% should be applied to clean, dry, healthy, intact skin of the right and left upper arms/shoulders and/or right and left abdomen. Area of application should be limited to the area that will be covered by the patient’s short sleeve T-shirt. Do not apply testosterone gel 1% to any other part of the body including the genitals, chest, armpits (axillae), knees, or back.

Testosterone gel 1% should be evenly distributed between the right and left upper arms/shoulders or both sides of the abdomen. The prescribed daily dose of testosterone gel 1% should be applied to the right and left upper arms/shoulders and/or right/left abdomen as shown in the shaded areas in the figure below. Figure 1: Application Locations for Testosterone Gel 1% After applying the gel, the application site should be allowed to dry prior to dressing.

Hands should be washed thoroughly with soap and water… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS Testosterone gel 1% for topical use is available as follows: A metered-dose pump. Each pump actuation delivers 12.5 mg of testosterone in 1.25g of gel. A unit dose packet containing 25 mg of testosterone provided in 2.5 g of gel.

A unit dose packet containing 50 mg of testosterone provided in 5 g of gel. Testosterone gel 1% for topical use is available as follows: Metered-dose pump that delivers 12.5 mg of testosterone per actuation ( 3 ) Packets containing 25 mg of testosterone. ( 3 ) Packets containing 50 mg of testosterone.

( 3 )

17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling (Medication Guide) Patients should be informed of the following:

17.1Use in Men with Known or Suspected Prostate or Breast Cancer Men with known or suspected prostate or breast cancer should not use testosterone gel 1% [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] .

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 [see Warnings and Precautions ( 5.2 )] . 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 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 ( 5.2 ) 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 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.

17.4Patients Should Be Advised of the Following Instructions for Use: Read the Medication Guide before starting testosterone gel 1% therapy and to 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 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 should never share testosterone gel 1% with anyone.

Wait 5 hours before swimming or washing following application of testosterone gel 1%. This will ensure that the greatest amount of testosterone gel 1% is absorbed into their sy… [Excerpted — this section continues on DailyMed.]

MEDICATION GUIDE Testosterone Gel (tes-TOS-teh-rone Jel) CIII 1% for topical use What is the most important information I should know about testosterone gel 1%? 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 applied testosterone gel 1%.

2. 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 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 testosterone gel 1%.

After the gel has dried, cover the application area with clothing. Keep the area covered until you have washed the gel off 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 gel 1% may affect bone growth in children. 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 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 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 testosterone gel 1% with… [Excerpted — this section continues on DailyMed.]

INSTRUCTIONS FOR USE Testosterone Gel (tes-TOS-teh-rone Jel) CIII 1% 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.

Applying testosterone gel 1%: Before applying testosterone gel 1%, make sure that your shoulders, upper arms or stomach are clean, dry, and there is no broken skin. The application sites for testosterone gel 1% are the shoulders, upper arms or stomach area (abdomen) that will be covered by a short sleeve t-shirt (see Figure 1). Do not apply testosterone gel 1% to any other parts of your body such as your penis, scrotum, chest, armpits (axillae), knees, or back.

Figure 1: Application Locations for Testosterone Gel 1% Testosterone gel 1% comes in a pump or in packets. If you are using the testosterone gel 1% pump: Before using a new bottle of testosterone gel 1% for the first time, you will need to prime the pump. To prime the testosterone gel 1% pump, slowly push the pump all the way down 3 times.

Do not use any testosterone gel 1% that came out while priming. Wash it down the sink to avoid accidental exposure to others. Your testosterone gel 1% pump is 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. Apply testosterone gel 1% to the application site.

You may also apply testosterone gel 1% directly to the application site. Wash your hands with soap and water right away. Your healthcare provider will tell you the number of times to press the pump for each dose.

If you are using the testosterone gel 1% packets: Tear open the packet completely at the dotted line. Squeeze from the bottom of the packet to the top. Squeeze all of the testosterone gel 1% out of the packet into the palm of your hand.

Apply testosterone gel 1% to the application site. You may also apply testosterone gel 1% from the packet directly to the application site. Let the application areas dry completely before putting on a t-shirt.

Testosterone gel 1% is flammable until dry. Let 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 5 hours after you apply testosterone gel 1%. How should I store testosterone gel 1%? Store testosterone gel 1% at room temperature between 68ºF to 77ºF (20ºC to 25ºC).

Safely throw away used testosterone gel 1% in the household trash. Be careful to prevent accidental exposure of 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.

Revised: 12/2024 Fig 1