Testosterone Gel, 1% 10 mg/g Gel
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Androgen class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Testosterone topical is used to treat low or no testosterone levels in men. Testosterone is in a class of medications called androgenic hormones. Testosterone is a male sex hormone responsible for development and functioning of male sexual organs and typical male characteristics. Testosterone topical works by replacing the testosterone that is normally produced by the body.
Read the full MedlinePlus article ↗- Testosterone replacement is specifically for men whose bodies aren't making enough testosterone because of a medical condition — like a problem with the testes themselves (primary...
- What exactly is testosterone replacement therapy for — do I really need it?
- Yes, this is a serious concern. Children who accidentally touch the gel on your skin or clothing can absorb testosterone and develop early puberty signs — things like pubic hair gr...
- I use the gel — do I really need to worry about my kids or partner being exposed to it?
Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII 4Q93RCW27E
A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
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UNII 0RE8K4LNJS
Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
5 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.405 | $60.80 / 150 g |
| Medicaid paysCMS SDUD · 12 mo | $0.6728 | $100.92 / 150 g |
| Medicare drug plans payPart D · Q2 2026 | $0.8214 | $123.21 / 150 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Testosterone Gel, 1% 10 mg/gthis 21922-0019-02 | Encube | 30 packets | $0.405 | AB1 | Availability likely | — |
| Testosterone Gel, 1% 10 mg/g 72162-1274-03 | Bryant | 30 packets | — | AB1 | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 21922-0019-02 You're viewing this | 30 PACKET in 1 CARTON (21922-019-02) / 5 g in 1 PACKET | $0.4053 / g | $60.79 | 2021-11-19 | Active |
| 21922-0019-47 | 2 CONTAINER in 1 CARTON (21922-019-47) / 75 g in 1 CONTAINER | $0.7197 / g | $107.96 | 2024-02-14 | Active |
| 21922-0019-52 | 30 PACKET in 1 CARTON (21922-019-52) / 25 g in 1 PACKET | $1.14 / g | $853.02 | 2024-08-12 | Active |
This pack has the lowest per-g cost of the 3 priced pack sizes ($0.4053 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 56% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 21922-0019-02?
What NDC number is used to bill for this package of Testosterone Gel, 1% 10 mg/g Gel?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE Virilization has been reported in children who were secondarily exposed to testosterone gel [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 )] . Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel [see Dosage and Administration ( 2.2) and Warnings and Precautions ( 5.2 )] . Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.2 ) and Patient Counseling Information ( 17 )] .
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE See full prescribing information for complete boxed warning. Virilization has been reported in children who were secondarily exposed to testosterone gel. ( 5.2 , 6.2 ) Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel.
( 2.2 , 5.2 ) Healthcare providers should advise patients to strictly adhere to recommended instructions for use. ( 2.2 , 5.2 , 17 )
🎯 Indications and Usage ▾
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 )
⏱️ Dosage and Administration ▾
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 (see Table 1, Dosing Information for testosterone gel 1%).
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. After applying the gel, the application site should be allowed to dry prior to dressing.
Hands should be washed thorough…
💊 Dosage Forms and Strengths ▾
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 1.25 g 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 12.5mg of testosterone per actuation. ( 3 ) Packets containing 25 mg of testosterone.
( 3 ) Packets containing 50 mg of testosterone. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Testosterone gel, 1% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 ), and Nonclinical Toxicology ( 13.1 )] . Testosterone gel, 1% is contraindicated in women who are pregnant. Testosterone gel, 1% can cause virilization of the female fetus when administered to a pregnant woman.
Pregnant women need to be aware of the potential for transfer of testosterone from men treated with testosterone gel, 1%. If a pregnant woman is exposed to testosterone gel, 1%, she should be apprised of the potential hazard to the fetus [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.1 )] . Men with carcinoma of the breast or known or suspected prostate cancer.
( 4 , 5.1 ) Women who are pregnant. Testosterone may cause fetal harm. ( 4 , 8.1 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH. ( 5.1 ) Avoid unintentional exposure of women or children to testosterone gel, 1%. Secondary exposure to testosterone can produce signs of virilization.
Testosterone gel, 1% should be discontinued until the cause of virilization is identified. ( 5.2 ) Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products. Evaluate patients with signs or symptoms consistent with DVT or PE.
( 5.4 ) Some postmarketing studies have shown an increased risk of myocardial infarction and stroke associated with use of testosterone replacement therapy. ( 5.5 ) Exogenous administration of androgens may lead to azoospermia. ( 5.8 ) Edema, with or without congestive heart failure (CHF), may be a complication in patients with preexisting cardiac, renal, or hepatic disease.
( 5.10 , 6.2 ) Sleep apnea may occur in those with risk factors. ( 5.12 ) Monitor serum testosterone, prostate specific antigen (PSA), hemoglobin, hematocrit, liver function tests, and lipid concentrations periodically. ( 5.1 , 5.3 , 5.9 , 5.13 ) Testosterone gel, 1% is flammable until dry.
( 5.16 )
5.1Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms. Patients treated with androgens may be at increased risk for prostate cancer.
Evaluate patients for prostate cancer prior to initiating and during treatment with androgens [see Contraindications ( 4 ), Adverse Reactions ( 6.1 ) and Nonclinical Toxicology ( 13.1 )] .
5.2Potential for Secondary Exposure to Testosterone Cases of secondary exposure resulting in virilization of children have been reported in postmarketing surveillance. Signs and symptoms have included enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases, these signs and symptoms regressed with removal of the exposure to testosterone gel.
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. The risk of transfer was increased in some of these cases by not adhering to precautions for the appropriate use of the topical testosterone product. Children and women should avoid contact with unwashed or unclothed application sites in men using testosterone gel, 1% [see Dosage and Administration ( 2.2 ), Use in Specific Populations ( 8.1 ) and Clinical Pharmacology ( 12.3 )].
Inappropriate changes in genital size or development of pubic hair or libido in children, or changes in body hair distribution, significant increase in acne, or other signs of virilization in adult women should be brought to the attention of a physician and the possibility of secondary exposure to testosterone gel should also be brought to the attention of a physician. Testosterone gel should be promptly discontinued until the cause of virilization has been identified.
5.3Polycythemia Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. Check hematocrit prior to initiating treatment. It would also be appropriate to re-evaluate the hematocrit 3 to 6 months after starting treatment, and then annually.
If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable concentration. An increase in red blood cell mass may increase the risk of thromboembolic events.
5.4Venous Thromboembolism There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products such as testosterone gel, 1%…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions (incidence greater than or equal to 5%) are acne, application site reaction, abnormal lab tests, and prostatic disorders. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical 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. Clinical Trials in Hypogonadal Men Table 2 shows the incidence of all adverse events judged by the investigator to be at least possibly related to treatment with testosterone gel, 1% and reported by greater than 1% of patients in a 180 Day, Phase 3 study.
Table 2: Adverse Events Possibly, Probably or Definitely Related to Use of Testosterone Gel, 1% in the 180-Day Controlled Clinical Trial Adv erse Event Dose of Testosterone Gel, 1% 50 mg 75 mg 100 mg N = 77 N = 40 N = 78 Acne 1% 3% 8% Alopecia 1% 0% 1% Application Site Reaction 5% 3% 4% Asthenia 0% 3% 1% Depression 1% 0% 1% Emotional Lability 0% 3% 3% Gynecomastia 1% 0% 3% Headache 4% 3% 0% Hypertension 3% 0% 3% Lab Test Abnormal* 6% 5% 3% Libido Decreased 0% 3% 1% Nervousness 0% 3% 1% Pain Breast 1% 3% 1% Prostate Disorder** 3% 3% 5% Testis Disorder*** 3% 0% 0% * Lab test abnormal occurred in nine patients with one or more of the following events reported: elevated hemoglobin or hematocrit, hyperlipidemia, elevated triglycerides, hypokalemia, decreased HDL, elevated glucose, elevated creatinine, elevated total bilirubin.** Prostate disorders included five patients with enlarged prostate, one with BPH, and one with elevated PSA results. *** Testis disorders were reported in two patients: one with left varicocele and one with slight sensitivity of left testis.
Other less common adverse reactions, reported in fewer than 1% of patients included: amnesia,anxiety, discolored hair, dizziness, dry skin, hirsutism, hostility, impaired urination, paresthesia, penis disorder, peripheral edema, sweating, and vasodilation. In this 180 day clinical trial, skin reactions at the site of application were reported with testosterone gel, 1%, but none was severe enough to require treatment or discontinuation of drug. Six patients (4%) in this trial had adverse events that led to discontinuation of testosterone gel, 1%.
These events included: cerebral hemorrhage, convulsion (neither of which were considered related to testosterone gel, 1% administration), depression, sadness, memory loss, elevated prostate specific antigen, and hypertension. No testosterone gel, 1% patient discontinued due to skin reactions. In a separate uncontrolled pharmacokinetic study of 10 patients, two had adverse events associated with testosterone gel, 1%; these were asthenia and depression in one patient and increased libido and hyperkinesia in the other.
In a 3 year, flexible dose, extension study, the incidence of all adverse events judged by the investigator to be at least possibly related to treatment with testosterone gel, 1% and reported by greater than 1% of patients is shown in Table 3. Table 3: Adverse Events Possibly, Probably or Definitely Related to Use of Testosterone Gel, 1% in the 3 Year, Flexible Dose, Extension Study Adverse Event Percent of Subjects (N = 162) Lab Test Abnormal+
9.3 Skin dry
1.9 Application Site Reaction
5.6 Acne
3.1 Pruritus
1.9 Enlarged Prostate
11.7 Carcinoma of Prostate
1.2 Urinary Symptoms*
3.7 Testis Disorder**
1.9 Gynecomastia
2.5Anemia 2.5 + Lab test abnormal occurred in 15 patients with one or more of the following events reported: elevated AST, elevated ALT, elevated testosterone, elevated hemoglobin or hematocrit, elevated cholesterol, elevated cholesterol/LDL ratio, elevated triglycerides, elevated HDL, elevated serum creatinine. * Urinary symptoms included noctu…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Androgens may decrease blood glucose and therefore may decrease insulin requirements in diabetic patients. ( 7.1 ) Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of INR and prothrombin time is recommended.
( 7.2 ) Use of testosterone with adrenocorticotrophic hormone (ACTH) or corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease. ( 7.3 )
7.1Insulin Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease insulin requirements.
7.2Oral Anticoagulants Changes in anticoagulant activity may be seen with androgens, therefore more frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking anticoagulants, especially at the initiation and termination of androgen therapy.
7.3Corticosteroids The concurrent use of testosterone with adrenocorticotropic hormone (ACTH) or corticosteroids may result in increased fluid retention and requires careful monitoring particularly in patients with cardiac, renal or hepatic disease.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS There are insufficient long-term safety data in geriatric patients using testosterone gel, 1% to assess the potential risks of cardiovascular disease and prostate cancer. ( 8.5 ) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 07/2024
8.1Pregnancy Risk Summary Testosterone gel, 1% is contraindicated in pregnant women. Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action [see Contraindications ( 4 ) and Clinical Pharmacology ( 12.1 )] . Exposure of a female fetus to androgens may result in varying degrees of virilization.
In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. These studies did not meet current standards for nonclinical development toxicity studies. Data Animal Data In developmental studies conducted in rats, rabbits, pigs, sheep and rhesus monkeys, pregnant animals received intramuscular injection of testosterone during the period of organogenesis.
Testosterone treatment at doses that were comparable to those used for testosterone replacement therapy resulted in structural impairments in both female and male offspring. Structural impairments observed in females included increased ano-genital distance, phallus development, empty scrotum, no external vagina, intrauterine growth retardation, reduced ovarian reserve, and increased ovarian follicular recruitment. Structural impairments seen in male offspring included increased testicular weight, larger seminal tubular lumen diameter, and higher frequency of occluded tubule lumen.
Increased pituitary weight was seen in both sexes. Testosterone exposure in utero also resulted in hormonal and behavioral changes in offspring. Hypertension was observed in pregnant female rats and their offspring exposed to doses approximately twice those used for testosterone replacement therapy.
8.2Lactation Risk Summary Testosterone gel, 1% is not indicated for use in women.
8.3Females and Males of Reproductive Potential Infertility Testis disorder, testicular atrophy, and oligospermia have been identified during use of Testosterone gel, 1% [see Adverse Reactions ( 6.1 , 6.2 )] . During treatment with large doses of exogenous androgens, including testosterone gel, 1%, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis [see Warnings and Precautions ( 5.8 )] . Reduced fertility is observed in some men taking testosterone replacement therapy.
Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids [see Drug Abuse and Dependence ( 9.2 )] . With either type of use, the impact on fertility may be irreversible.
8.4Pediatric Use The safety and efficacy of testosterone gel, 1% in pediatric patients less than 18 years old has not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.
8.5Geriatric Use There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing testosterone gel, 1% to determine whether efficacy in those over 65 years of age differs from younger subjects. Additionally, there is insufficient long-term safety data in geriatric patients to assess the potential risks of cardiovascular disease and prostate cancer. Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH.
8.6Renal Impairment No studies were conducted in patients with renal impairment.
8.7Hepatic Impairment No studies were conducted in patients with hepatic impairment.
8.7Hepatic Impairment No studies were conducted in patients with hepatic impairment.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Testosterone gel, 1% is contraindicated in pregnant women. Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action [see Contraindications ( 4 ) and Clinical Pharmacology ( 12.1 )] . Exposure of a female fetus to androgens may result in varying degrees of virilization.
In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. These studies did not meet current standards for nonclinical development toxicity studies. Data Animal Data In developmental studies conducted in rats, rabbits, pigs, sheep and rhesus monkeys, pregnant animals received intramuscular injection of testosterone during the period of organogenesis.
Testosterone treatment at doses that were comparable to those used for testosterone replacement therapy resulted in structural impairments in both female and male offspring. Structural impairments observed in females included increased ano-genital distance, phallus development, empty scrotum, no external vagina, intrauterine growth retardation, reduced ovarian reserve, and increased ovarian follicular recruitment. Structural impairments seen in male offspring included increased testicular weight, larger seminal tubular lumen diameter, and higher frequency of occluded tubule lumen.
Increased pituitary weight was seen in both sexes. Testosterone exposure in utero also resulted in hormonal and behavioral changes in offspring. Hypertension was observed in pregnant female rats and their offspring exposed to doses approximately twice those used for testosterone replacement therapy.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and efficacy of testosterone gel, 1% in pediatric patients less than 18 years old has not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.
🧓 Geriatric Use ▾
8.5Geriatric Use There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing testosterone gel, 1% to determine whether efficacy in those over 65 years of age differs from younger subjects. Additionally, there is insufficient long-term safety data in geriatric patients to assess the potential risks of cardiovascular disease and prostate cancer. Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH.
🆘 Overdosage ▾
10 OVERDOSAGE There is one report of acute overdosage with use of an approved injectable testosterone product: this subject had serum testosterone concentrations of up to 11,400 ng/dL with a cerebrovascular accident. Treatment of overdosage would consist of discontinuation of testosterone gel, 1%, washing the application site with soap and water, and appropriate symptomatic and supportive care.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution. Testosterone and DHT are necessary for the normal development of secondary sex characteristics.
Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter’s syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).
12.2Pharmacodynamics No specific pharmacodynamic studies were conducted using testosterone gel, 1%.
12.3Pharmacokinetics Absorption Testosterone gel, 1% delivers physiologic amounts of testosterone, producing circulating testosterone concentrations that approximate normal concentrations (298 to 1043 ng/dL) seen in healthy men. Testosterone gel, 1% provides continuous transdermal delivery of testosterone for 24 hours following a single application to intact, clean, dry skin of the shoulders, upper arms and/or abdomen. Testosterone gel, 1% is a hydroalcoholic formulation that dries quickly when applied to the skin surface.
The skin serves as a reservoir for the sustained release of testosterone into the systemic circulation. Approximately 10% of the testosterone dose applied on the skin surface from testosterone gel is absorbed into systemic circulation. In a study with testosterone gel, 1% 100 mg, all patients showed an increase in serum testosterone within 30 minutes, and eight of nine patients had a serum testosterone concentration within normal range by 4 hours after the initial application.
Absorption of testosterone into the blood continues for the entire 24-hour dosing interval. Serum concentrations approximate the steady-state concentration by the end of the first 24 hours and are at steady state by the second or third day of dosing. With single daily applications of testosterone gel, 1%, follow-up measurements 30, 90 and 180 days after starting treatment have confirmed that serum testosterone concentrations are generally maintained within the eugonadal range.
Figure 1 summarizes the 24-hour pharmacokinetic profiles of testosterone for hypogonadal men (less than 300 ng/dL) maintained on testosterone gel, 1% 50 mg or 100 mg for 30 days. The average (± SD) daily testosterone concentration produced by testosterone gel, 1% 100 mg on Day 30 was 792 (± 294) ng/dL and by testosterone gel, 1% 50 mg 566 (± 262) ng/dL. Figure 1 : Mean (± SD) Steady-State Serum Testosterone Concentrations on Day 30 in Patients Applying Testosterone Gel, 1% Once Daily Distribution Circulating testosterone is primarily bound in the serum to sex hormone-binding globulin (SHBG) and albumin.
Approximately 40% of testosterone in plasma is bound to SHBG, 2% remains unbound (free) and the rest is bound to albumin and other proteins. Metabolism Testosterone is metabolized to various 17-keto steroids through two different pathways. The major active metabolites of testosterone are estradiol and dihydrotestosterone (DHT).
DHT concentrations increased in parallel with testosterone concentrations during testosterone gel, 1% treatment. The mean steady-state DHT/T ratio during 180 days of testosterone gel treatment ranged from 0.23 to 0.29 (50 mg of testosterone gel, 1%/day) and from 0.27 to 0.33 (100 mg of testosterone gel, 1%/day). Excretion There is considerable variation in the half-life of testosterone concentration as reported in the literature, ranging from 10 to 100 minute…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution. Testosterone and DHT are necessary for the normal development of secondary sex characteristics.
Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter’s syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Testosterone gel 1% is supplied in non-aerosol, metered-dose pumps that deliver 12.5 mg of testosterone per complete pump actuation. The pumps are composed of plastic and stainless steel and an LDPE/aluminum foil inner liner encased in rigid plastic with a polypropylene cap. Each 88 g metered- dose pump is capable of dispensing 75 g of gel or 60-metered pump actuations; each pump actuation dispenses 1.25 g of gel.
NDC Number Package Size 21922-019-47 2 x 75 g pumps per carton (each pump dispenses 60 metered pump actuations with each pump actuation containing 12.5 mg of testosterone in 1.25 g of gel) Testosterone gel, 1% is supplied in unit-dose aluminum foil packets in cartons of 30. Each packet of 2.5 g or 5 g gel contains 25 mg or 50 mg testosterone, USP, respectively. NDC Number Package Size 21922-019-52 30 packets (a unit dose packet containing 25 mg of testosterone provide in 2.5 g of gel) 21922-019-02 30 packets (a unit dose packet containing 50 mg of testosterone provided in 5 g of gel) Keep testosterone gel out of the reach of children.
Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Disposal Used testosterone gel 1% pump or used testosterone gel 1% packets should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.
📋 Description ▾
11 DESCRIPTION Testosterone gel, 1% is a clear, colorless to yellowish hydroalcoholic gel containing testosterone, USP. The active pharmacologic ingredient in testosterone gel 1% is testosterone, USP an androgen. Testosterone, USP is a white to practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3-one.
The structural formula is: Pharmacologically inactive ingredients in testosterone gel, 1% are carbomer 980, ethyl alcohol 67.0%, isopropyl myristate, purified water, and sodium hydroxide. These ingredients are not pharmacologically active. structure.jpg
💬 Information for Patients ▾
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…
💬 Medication Guide ▾
MEDICATION GUIDE Testosterone Gel, 1% (tes TOS ter one Jel) CIII 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. Us…