Testim
testosterone · Gel · Transdermal
Uses
1 INDICATIONS AND USAGE TESTIM is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Limitations of Use: Safety and efficacy of TESTIM in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. Safety and efficacy of TESTIM in males less than 18 years old have not been established [see Use in Specific Populations ( 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 )] . TESTIM 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 TESTIM in men with “age-related hypogonadism” have not been established. ( 1 ) Safety and efficacy of TESTIM 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
Prior to initiating TESTIM, 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 TESTIM, 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 TESTIM 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 TESTIM 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 ) TESTIM is not substitutable with other topical testosterone products. ( 2.1 ) 2.1 Dosing and Dose Adjustment The recommended starting dose of TESTIM 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 TESTIM dose may be increased from 50 mg testosterone (one tube) to 100 mg testosterone (two tubes) once daily. The maximum recommended dose of TESTIM is 100 mg once daily. The application site and dose of TESTIM are not substitutable with other topical testosterone products. 2.2 Administration 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 TESTIM 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 TESTIM has been applied. Avoid fire, flame or smoking during the application of TESTIM until the TESTIM 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 TESTIM-treated skin: Children and women should avoid contact with unwashed or unclothed application site(s) of men using TESTIM. TESTIM 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. Patients should wash their hands with soap and water immediately after applying TESTIM. Patients should cover the application site(s) with clothing (e.g., a T-shirt) after the gel has dried. Prior to situations in which direct skin-to-skin contact is anticipated, patients should wash the application site(s) thoroughly with soap and water to remove any testosterone residue. In the event that unwashed or unclothed skin to which TESTIM has been applied comes in direct 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. Figure A
Dosage forms and strengths
(testosterone gel) for topical use 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 )
Contraindications
4 CONTRAINDICATIONS TESTIM is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions ( 5.4 )] . TESTIM is contraindicated in women who are pregnant. Testosterone can cause virilization of the female fetus when administered to a pregnant woman [see Use in Specific Populations ( 8.1 , 8.2 )] . Men with known carcinoma of the breast or known or suspected carcinoma of the prostate. ( 4 , 5.4 ) Women who are pregnant. Testosterone may cause fetal harm. ( 4 , 5.7 , 8.1 , 8.2 )
Warnings and precautions
Potential for Secondary Exposure to Testosterone: Avoid unintentional exposure of women or children to TESTIM. Secondary exposure to testosterone can produce signs of virilization. TESTIM should be discontinued until the cause of virilization is identified. ( 5.1 ) Venous thromboembolism (VTE): 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. ( 5.3 ) Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer: Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH. ( 5.4 ) Blood Pressure Increases: Testosterone can increase blood pressure, which can increase cardiovascular risk over time. Measure blood pressure periodically. Not recommended for use in men with uncontrolled hypertension ( 5.5 ) Abuse of Testosterone: Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids ( 5.6 ). Potential for Adverse Effects on Spermatogenesis Exogenous administration of androgens may lead to azoospermia. ( 5.8 ) Edema: Edema, with or without congestive heart failure, may be a complication in patients with preexisting cardiac, renal, or hepatic disease. ( 5.10 , 6.2 ) Sleep apnea: Sleep apnea may occur in those with risk factors. ( 5.12 ) Monitor prostate specific antigen (PSA), hematocrit, and lipid concentrations periodically. ( 5.2 , 5.4 , 5.13 ) TESTIM is flammable until dry. ( 5.16 ) 5.1 Potential 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 TESTIM [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. 5.2 Polycythemia 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. 5.3 Venous Thromboembolism (VTE) 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 TESTIM. In the Testosterone Replacement therapy for Assessment of long-term Vascular Events and efficacy ResponSE in hypogonadal men (TRAVERSE) Study, a randomized, double-blind, placebo-controlled, cardiovascular (CV) outcomes study, compared to placebo, topical testosterone gel was associated with a numerically higher incidence of VTE (1.7% vs 1.2%) which included DVT (0.6% vs 0.5%) and PE events (0.9% vs 0.5%) [see Adverse Reactions ( 6.1 )]. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with TESTIM and initiate appropriate workup and management [see Adverse Reactions ( 6.2 )] . 5.4 Worsening 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 )] . 5.5 Blood Pressure Increases TESTIM can increase blood pressure. In an ambulatory blood pressure monitoring (ABPM) study, TESTIM increased the mean systolic/diastolic blood pressure by 2.7/1.1 mm Hg from baseline after 16 weeks of treatment. In patients with hypertension on antihypertensive therapy, TESTIM increased the mean systolic/diastolic BP by 1.9/0.3 mm Hg from baseline. Blood pressure increases can increase cardiovascular (CV) risk over time. The CV risk associated with topical testosterone gel was evaluated in TRAVERSE, a randomized, double-blind, placebo-controlled, CV outcomes study in men with a history of CV disease or multiple CV risk factors. In TRAVERSE, topical testosterone gel increased mean systolic blood pressure by 1.0 mm Hg from baseline to 36 months, whereas a mean decrease from baseline of 0.5 mm Hg was observed in the placebo group at this timepoint, for a mean between-group difference of 1.5 mm Hg.
Side effects
Most common adverse reactions (incidence ≥ 2% of the TESTIM patients and greater than placebo) are application site reaction and increased hematocrit. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Endo at 1-800-462-3636 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a controlled clinical study, 304 patients were treated with TESTIM 50 mg or 100 mg or placebo gel for up to 90 days. Two hundred five (205) patients received TESTIM 50 mg or 100 mg daily and 99 patients received placebo. Subjects could be counted in both TESTIM treatment groups if they received both 50 mg and 100 mg at different points in the study and experienced an adverse reaction at both dose levels. Adverse reactions reported by ≥ 1% of the TESTIM patients and greater than placebo are listed in Table 1. Table 1: Incidence of Adverse Reactions (Reported by ≥ 1% of the TESTIM Patients and Greater than Placebo) in the Controlled Clinical Trial Through 90 Days Event TESTIM 50 mg (n=103) TESTIM 100 mg (n=149) Placebo (n=99) Application Site Reactions 2% 4% 3% Blood Pressure Increased 1% 1% 0% Gynecomastia 1% 0% 0% Headache 1% 1% 0% Hematocrit / hemoglobin Increased 1% 2% 0% Hot Flushes 1% 0% 0% Insomnia 1% 0% 0% Mood Swings 1% 0% 0% Smell Disorder 1% 0% 0% Spontaneous Penile Erection 1% 0% 0% Taste Disorder 1% 1% 0% The following adverse reactions occurred in fewer than 1% of patients but were greater in TESTIM groups compared to the placebo group: activated partial thromboplastin time prolonged, blood creatinine increased, prothrombin time prolonged, appetite increased, sensitive nipples, and acne. In this clinical trial of TESTIM, 6 patients had adverse reactions that led to their discontinuation. These events included: depression with suicidal ideation, urinary tract infection, mood swings and hypertension. No TESTIM patients discontinued due to skin reaction. In one foreign Phase 3 trial, one subject discontinued due to a skin-related adverse reaction. In the pivotal US and European Phase 3 trials combined, at the 50-mg dosage strength, the percentage of subjects reporting clinically notable increases in hematocrit or hemoglobin were similar to placebo. However, in the 100-mg dose group, 2.3% and 2.8% of patients had a clinically notable increase in hemoglobin (≥ 19 g/dL) or hematocrit (≥ 58%), respectively, compared to 1.0% and 1.5% of patients in the placebo group, respectively. In the combined US and European open-label extension studies, approximately 140 patients received TESTIM for at least 6 months. The results from these studies are consistent with those reported for the US controlled clinical trial. Blood Pressure Increases In a 4-month clinical study, 24-hour ambulatory blood pressure monitoring (ABPM) was conducted on 225 patients. ABPM was conducted at baseline and at Week 16 of TESTIM therapy. A total of 113 patients had acceptable ABPM recordings at both baseline and Week 16 and were at least 85% compliant with study drug. In that group, the mean change in 24-hour systolic blood pressure (BP) and diastolic BP from baseline to end-of-treatment at Week 16 (n=113) was 2.7 mm Hg (95% CI 0.7, 4.8) and 1.1 mm Hg (95% CI -0.1, 2.3), respectively. In patients with a history of hypertension who were receiving antihypertensive therapy, the mean ABPM systolic and diastolic BP increased by 1.9 mm Hg [95% CI -1.4, 5.2] and 0.3 mm Hg [95% CI -1.6, 2.2], respectively [n=55]). In patients with no history of hypertension, the mean systolic and diastolic blood pressure increased by 2.2 mm Hg [95% CI -0.4, 4.9] and 1.1 mm Hg [95% CI -0.4, 2.7], respectively [n=56]. 3 patients (2.7%) on TESTIM, all of whom were receiving antihypertensive medications at baseline, either started new antihypertensive medications (n=3) or had their antihypertensive medication regimen adjusted (n=0) during the ABPM study. Of the 225 patients in the ABPM study who used TESTIM, 6 patients (2.7%) were reported to have either an adverse reaction of hypertension (6 patients, 2.7%) or increased blood pressure (0 patients, 0.0%). Cardiovascular Outcomes TRAVERSE was a randomized, double-blind, cardiovascular outcomes study to assess the cardiovascular (CV) safety of topical testosterone gel compared to placebo in 5198 hypogonadal men aged 45 to 80 years with a history of CV disease or with multiple CV risk factors. The primary outcome was the incidence of the composite endpoint of major adverse cardiovascular events (MACE), consisting of CV death, non-fatal myocardial infarction (MI), and non-fatal stroke. The mean duration of therapy was approximately 22 months. The mean duration of follow-up was 33 months. Approximately 61% of all patients discontinued topical testosterone gel or placebo therapy. The mean patient age (±SD) was 63.3 (7.9) years, with 2452 patients aged 65 years or more (47%); 2847 (about 55%) patients had pre-existing cardiovascular disease, whereas 2357 patients (about 45%) had an elevated cardiovascular risk at baseline, and mean BMI was 35kg/m 2 . Approximately 80% of patients were White, 17% were Black, and 3% were of other races or ethnic groups. Approximately 69%, 84%, and 93% had diabetes mellitus, hyperlipidemia, and hypertension, respectively. The mean serum testosterone concentration at baseline in patients receiving topical testosterone gel was 220.4 ng/dL (n=2596). The mean serum testosterone concentrations at 12 months, 24 months, 36 months, and 48 months in patients receiving topical testosterone gel were 440.5 ng/dL (n=1683), 420.9 ng/dl (n=1125), 428.7 ng/dL (n=731), and 365.2 ng/dL (n=220), respectively.
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 international normalized ratio (INR) and prothrombin time is recommended in patients taking warfarin. ( 7.2 ) Use of testosterone with corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease. ( 7.3 ) 7.1 Insulin 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 necessitate a decrease in the dose of anti-diabetic medication. 7.2 Oral 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 warfarin, especially at the initiation and termination of androgen therapy. 7.3 Corticosteroids The concurrent use of testosterone with corticosteroids may result in increased fluid retention and requires careful monitoring particularly in patients with cardiac, renal or hepatic disease.
Use in specific populations
Geriatric Patients: There are insufficient long-term safety data to assess the potential risks of cardiovascular disease and prostate cancer. ( 8.5 ) 8.1 Pregnancy Risk Summary TESTIM is contraindicated in pregnant women. Testosterone is teratogenic and may cause fetal harm 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 development 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 anogenital 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. 8.2 Lactation Risk Summary TESTIM is not indicated for use in females. 8.3 Females and Males of Reproductive Potential Infertility During treatment with large doses of exogenous androgens, including TESTIM, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis [see Warnings and Precautions ( 5.8 )] , possible leading to adverse effects on semen parameters including sperm count. 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. 8.4 Pediatric Use The safety and effectiveness of TESTIM in pediatric patients less than 18 years old have not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses. 8.5 Geriatric Use There is insufficient long-term safety data in geriatric patients to assess the potentially increased risks of cardiovascular disease and prostate cancer [see Warnings and Precautions ( 5.4 )] . 8.6 Renal Impairment No studies were conducted in patients with renal impairment. 8.7 Hepatic Impairment No studies were conducted in patients with hepatic impairment.
Pregnancy
8.1 Pregnancy Risk Summary TESTIM is contraindicated in pregnant women. Testosterone is teratogenic and may cause fetal harm 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 development 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 anogenital 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
8.4 Pediatric Use The safety and effectiveness of TESTIM in pediatric patients less than 18 years old have not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.
Geriatric use
8.5 Geriatric Use There is insufficient long-term safety data in geriatric patients to assess the potentially increased risks of cardiovascular disease and prostate cancer [see Warnings and Precautions ( 5.4 )] .
Overdosage
There were no reports of overdose in the TESTIM clinical trials. There is a single report in the literature of acute overdosage after injection of testosterone enanthate. This subject had serum testosterone concentrations of up to 11,400 ng/dL, which were implicated in a cerebrovascular accident. Treatment of overdosage would consist of discontinuation of TESTIM, washing the application site with soap and water, and appropriate symptomatic and supportive care.
Description
(testosterone gel) is a clear to translucent hydroalcoholic topical gel containing testosterone, an androgen. TESTIM provides continuous transdermal delivery of testosterone for 24 hours, following a single application to intact, clean, dry skin of the shoulders and/or upper arms. One 5-g or two 5-g tubes of TESTIM contains 50 mg or 100 mg of testosterone, respectively, to be applied daily to the skin’s surface. Approximately 10% of the applied testosterone dose is absorbed across skin of average permeability during a 24-hour period. The active pharmacological ingredient in TESTIM is testosterone. Testosterone USP is a white to practically white crystalline powder chemically described as 17-β hydroxyandrost-4-en-3-one. The structural formula is shown in the following figure: Testim may have an alcoholic/musk odor. Inactive ingredients in TESTIM are purified water, pentadecalactone, carbopol, acrylates, propylene glycol, glycerin, polyethylene glycol, ethanol (74%), and tromethamine. Chemical Structure of testosterone
Mechanism of action
12.1 Mechanism 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; and 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 2 main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's syndrome or Leydig cell aplasia, while secondary hypogonadism (hypogonadotropic hypogonadism) is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).
How supplied
16 HOW SUPPLIED/STORAGE AND HANDLING TESTIM is supplied in unit-dose tubes in cartons of 30. Each tube contains 50 mg testosterone in 5 g of gel, and is supplied as follows: NDC Number Package Size 66887-001-05 30 tubes: 50 mg testosterone in 5 g of gel per tube Store at 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Discard used TESTIM tubes in household trash in a manner that prevents accidental exposure of women, children, or pets [see Boxed Warning and Warnings and Precautions ( 5.1 )]. Contents are flammable [see Warnings and Precautions ( 5.16 )].
Storage
Store at 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Discard used TESTIM tubes in household trash in a manner that prevents accidental exposure of women, children, or pets [see Boxed Warning and Warnings and Precautions ( 5.1 )]. Contents are flammable [see Warnings and Precautions ( 5.16 )].
Patient information
Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Advise patients of the following : 17.1 Men with Known or Suspected Carcinoma of the Breast or Prostate Men with known or suspected prostate or breast cancer should not use TESTIM [see Contraindications ( 4 ) and Warnings and Precautions ( 5.4 )]. 17.2 Potential for Secondary Exposure to Testosterone and Steps to Prevent Secondary Exposure Secondary exposure to testosterone in children and women can occur with the use of testosterone gel in men. Cases of secondary exposure to testosterone 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 TESTIM should be brought to the attention of a healthcare provider TESTIM 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 TESTIM in men [see Medication Guide ] : Children and women should avoid contact with unwashed or unclothed application site(s) of men using TESTIM. Patients using TESTIM 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 TESTIM 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 )]. 17.3 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 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. 17.4 Patients Should Be Advised of the Following Instructions for Use Read the Medication Guide before starting TESTIM therapy and reread it each time the prescription is renewed. TESTIM should be applied and used appropriately to maximize the benefits and to minimize the risk of secondary exposure in children and women. Keep TESTIM out of the reach of children. The package is not child resistant. TESTIM 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. TESTIM is prescribed to meet the patient’s specific needs; therefore, the patient should never share TESTIM with anyone. TESTIM should be applied once daily at approximately the same time each day to clean dry skin of the shoulders and/or upper arms. TESTIM should not be applied to the scrotum, penis, or abdomen. Wait 2 hours before swimming or washing following application of TESTIM. This will ensure that the greatest amount of TESTIM is absorbed into their system. Manufactured for: Endo USA Malvern, PA 19355 Manufactured by: DPT Laboratories, Ltd. San Antonio, TX 78215 or Contract Pharmaceuticals Limited Mississauga, ON, Canada L5N 6R8 US Patent Nos. 7,320,968; 7,608,605; 7,608,606; 7,608,607; 7,608,608; 7,608,609; 7,608,610; 7,935,690; 8,063,029; 8,178,518 © 2025 Endo, Inc. or one of its affiliates. Revised: 07/2025
Label text from the FDA structured product label by Endo USA, Inc. (revised Jul 15, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Testosterone in 1 product
Testim NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 66887-001 | Testosterone 50 mg/5g Gel | Endo USA, Inc. | NDA · DEA CIII |
Frequently asked questions
What is Testim used for?
1 INDICATIONS AND USAGE TESTIM is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from…
What are the side effects of Testim?
Most common adverse reactions (incidence ≥ 2% of the TESTIM patients and greater than placebo) are application site reaction and increased hematocrit. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Endo at 1-800-462-3636 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction… See the full label for the complete list.
Who makes Testim?
Testim is listed by 1 labeler in the FDA NDC directory, including Endo USA, Inc..