testosterone
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . TESTOSTERONE gel, for topical use CIIIInitial U.S. Approval: 1953
54fcdcb9-fb0e-4164-9e51-f2a5feae3217
HUMAN PRESCRIPTION DRUG LABEL
Oct 1, 2022
Padagis Israel Pharmaceuticals Ltd
DUNS: 600093611
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
testosterone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
testosterone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
testosterone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Drug Labeling Information
WARNINGS AND PRECAUTIONS SECTION
5 WARNINGS AND PRECAUTIONS
5.1 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. Evaluation of patients for prostate cancer prior to initiating and during treatment with androgens is appropriate [see Contraindications (4)].
5.2 Potential for Secondary Exposure to Testosterone
Cases of secondary exposure resulting in virilization of children have been reported in postmarketing surveillance of testosterone gel products. 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, 1.62% [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.
5.3 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.
5.4 Venous 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, 1.62%. 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 Testosterone Gel, 1.62% and initiate appropriate workup and management [see Adverse Reactions (6.2)].
5.5 Cardiovascular Risk
Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men.
Patients should be informed of this possible risk when deciding whether to use or to continue to use Testosterone Gel, 1.62%.
5.6 Abuse of Testosterone and Monitoring of Serum Testosterone
Concentrations
Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions [see Drug Abuse and Dependence (9)].
If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.
5.7 Use in Women
Due to the lack of controlled evaluations in women and potential virilizing effects, Testosterone Gel, 1.62% is not indicated for use in women [see Contraindications (4) and Use in Specific Populations (8.1, 8.2)].
5.8 Potential for Adverse Effects on Spermatogenesis
With large doses of exogenous androgens, including Testosterone Gel, 1.62%, spermatogenesis may be suppressed through feedback inhibition of pituitary FSH possibly leading to adverse effects on semen parameters including sperm count.
5.9 Hepatic Adverse Effects
Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. Testosterone Gel, 1.62% is not known to cause these adverse effects.
5.10 Edema
Androgens, including Testosterone Gel, 1.62%, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease [see Adverse Reactions (6.2)].
5.11 Gynecomastia
Gynecomastia may develop and persist in patients being treated with androgens, including Testosterone Gel, 1.62%, for hypogonadism.
5.12 Sleep Apnea
The treatment of hypogonadal men with testosterone may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases.
5.13 Lipids
Changes in serum lipid profile may require dose adjustment or discontinuation of testosterone therapy.
5.14 Hypercalcemia
Androgens, including Testosterone Gel, 1.62%, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is recommended in these patients.
5.15 Decreased Thyroxine-binding Globulin
Androgens, including Testosterone Gel, 1.62%, may decrease concentrations of thyroxin-binding globulins, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
5.16 Flammability
Alcohol based products, including Testosterone Gel, 1.62%, are flammable; therefore, patients should be advised to avoid fire, flame or smoking until the Testosterone Gel, 1.62% has dried.
•
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, 1.62%. Secondary exposure to testosterone can produce signs of virilization. Testosterone Gel, 1.62% 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)
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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)
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Edema with or without congestive heart failure (CHF) may be a complication in patients with preexisting cardiac, renal, or hepatic disease (5.10)
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Sleep apnea may occur in those with risk factors (5.12)
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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, 1.62% is flammable until dry (5.16)
DRUG INTERACTIONS SECTION
7 DRUG INTERACTIONS
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 decrease insulin requirements.
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 anticoagulants, especially at the initiation and termination of androgen therapy.
7.3 Corticosteroids
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.
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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 (7.2)
•
Use of testosterone with adrenocorticotropic hormone (ACTH) or corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease (7.3)
DRUG ABUSE AND DEPENDENCE SECTION
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
Testosterone Gel, 1.62% contains testosterone, a Schedule III controlled substance in the Controlled Substances Act.
9.2 Abuse
Drug abuse is intentional non-therapeutic use of a drug, even once, for its rewarding psychological and physiological effects. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids (AAS), and not obtained by prescription through a pharmacy, may be abused by athletes and bodybuilders. There have been reports of misuse by men taking higher doses of legally obtained testosterone than prescribed and continuing testosterone despite adverse events or against medical advice.
Abuse-Related Adverse Reactions
Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression.
The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility.
The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities.
The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty.
Because these reactions are reported voluntarily from a population of uncertain size and may include abuse of other agents, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
9.3 Dependence
Behaviors Associated with Addiction
Continued abuse of testosterone and other anabolic steroids, leading to addiction is characterized by the following behaviors:
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Taking greater dosages than prescribed
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Continued drug use despite medical and social problems due to drug use
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Spending significant time to obtain the drug when supplies of the drug are interrupted
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Giving a higher priority to drug use than other obligations
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Having difficulty in discontinuing the drug despite desires and attempts to do so
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Experiencing withdrawal symptoms upon abrupt discontinuation of use
Physical dependence is characterized by withdrawal symptoms after abrupt drug discontinuation or a significant dose reduction of a drug. Individuals taking supratherapeutic doses of testosterone may experience withdrawal symptoms lasting for weeks or months which include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido and hypogonadotropic hypogonadism.
Drug dependence in individuals using approved doses of testosterone for approved indications has not been documented.
CLINICAL PHARMACOLOGY SECTION
12 CLINICAL PHARMACOLOGY
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 chord 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 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).
12.2 Pharmacodynamics
No specific pharmacodynamic studies were conducted using testosterone gel, 1.62%.
12.3 Pharmacokinetics
Absorption
Testosterone gel, 1.62% delivers physiologic amounts of testosterone, producing circulating testosterone concentrations that approximate normal levels (300 – 1000 ng/dL) seen in healthy men. Testosterone gel, 1.62% provides continuous transdermal delivery of testosterone for 24 hours following once daily application to clean, dry, intact skin of the shoulders and upper arms. Average serum testosterone concentrations over 24 hours (Cavg) observed when testosterone gel, 1.62% was applied to the upper arms/shoulders were comparable to average serum testosterone concentrations (Cavg) when testosterone gel, 1.62% was applied using a rotation method utilizing the abdomen and upper arms/shoulders. The rotation of abdomen and upper arms/shoulders was a method used in the pivotal clinical trial [see Clinical Studies (14.1)].
Figure 2: Mean (±SD) Serum Total Testosterone Concentrations on Day 7 in Patients Following Testosterone Gel, 1.62% Once-Daily Application of 81 mg of Testosterone (N=33) for 7 Days
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 loosely 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 DHT.
Excretion
There is considerable variation in the half-life of testosterone concentration as reported in the literature, ranging from 10 to 100 minutes. About 90% of a dose of testosterone given intramuscularly is excreted in the urine as glucuronic acid and sulfuric acid conjugates of testosterone and its metabolites. About 6% of a dose is excreted in the feces, mostly in the unconjugated form. Inactivation of testosterone occurs primarily in the liver.
When testosterone gel, 1.62% treatment is discontinued, serum testosterone concentrations return to approximately baseline concentrations within 48-72 hours after administration of the last dose.
Potential for testosterone transfer
The potential for testosterone transfer following administration of testosterone gel, 1.62% when it was applied only to upper arms/shoulders was evaluated in two clinical studies of males dosed with testosterone gel, 1.62% and their untreated female partners. In one study, 8 male subjects applied a single dose of testosterone gel, 1.62% 81 mg to their shoulders and upper arms. Two (2) hours after application, female subjects rubbed their hands, wrists, arms, and shoulders to the application site of the male subjects for 15 minutes. Serum concentrations of testosterone were monitored in female subjects for 24 hours after contact occurred. After direct skin-to-skin contact with the site of application, mean testosterone Cavg and Cmax in female subjects increased by 280% and 267%, respectively, compared to mean baseline testosterone concentrations. In a second study evaluating transfer of testosterone, 12 male subjects applied a single dose of testosterone gel, 1.62% 81 mg to their shoulders and upper arms. Two (2) hours after application, female subjects rubbed their hands, wrists, arms, and shoulders to the application site of the male subjects for 15 minutes while the site of application was covered by a t-shirt. When a t-shirt was used to cover the site of application, mean testosterone Cavg and Cmax in female subjects increased by 6% and 11%, respectively, compared to mean baseline testosterone concentrations.
A separate study was conducted to evaluate the potential for testosterone transfer from 16 males dosed with testosterone gel, 1.62% 81 mg when it was applied to abdomen only for 7 days, a site of application not approved for testosterone gel, 1.62%. Two (2) hours after application to the males on each day, the female subjects rubbed their abdomens for 15 minutes to the abdomen of the males. The males had covered the application area with a T-shirt. The mean testosterone Cavg and Cmax in female subjects on day 1 increased by 43% and 47%, respectively, compared to mean baseline testosterone concentrations. The mean testosterone Cavg and Cmax in female subjects on day 7 increased by 60% and 58%, respectively, compared to mean baseline testosterone concentrations.
Effect of showering
In a randomized, 3-way (3 treatment periods without washout period) crossover study in 24 hypogonadal men, the effect of showering on testosterone exposure was assessed after once daily application of testosterone gel, 1.62% 81 mg to upper arms/shoulders for 7 days in each treatment period. On the 7th day of each treatment period, hypogonadal men took a shower with soap and water at either 2, 6, or 10 hours after drug application. The effect of showering at 2 or 6 hours post-dose on Day 7 resulted in 13% and 12% decreases in mean Cavg, respectively, compared to Day 6 when no shower was taken after drug application. Showering at 10 hours after drug application had no effect on bioavailability. The amount of testosterone remaining in the outer layers of the skin at the application site on the 7th day was assessed using a tape stripping procedure and was reduced by at least 80% after showering 2-10 hours post-dose compared to on the 6th day when no shower was taken after drug application.
Effect of hand washing
In a randomized, open-label, single-dose, 2-way crossover study in 16 healthy male subjects, the effect of hand washing on the amount of residual testosterone on the hands was evaluated. Subjects used their hands to apply the maximum dose (81 mg testosterone) of testosterone gel, 1.62% to their upper arms and shoulders. Within 1 minute of applying the gel, subjects either washed or did not wash their hands prior to study personnel wiping the subjects’ hands with ethanol dampened gauze pads. The gauze pads were then analyzed for residual testosterone content. A mean (SD) of 0.1 (0.04) mg of residual testosterone (0.12% of the actual applied dose of testosterone, and a 96% reduction compared to when hands were not washed) was recovered after washing hands with water and soap.
Effect of sunscreen or moisturizing lotion on absorption of testosterone
In a randomized, 3-way (3 treatment periods without washout period) crossover study in 18 hypogonadal males, the effect of applying a moisturizing lotion or a sunscreen on the absorption of testosterone was evaluated with the upper arms/shoulders as application sites. For 7 days, moisturizing lotion or sunscreen (SPF 50) was applied daily to the testosterone gel, 1.62% application site 1 hour after the application of testosterone gel, 1.62% 40.5 mg. Application of moisturizing lotion increased mean testosterone Cavg and Cmax by 14% and 17%, respectively, compared to testosterone gel, 1.62% administered alone. Application of sunscreen increased mean testosterone Cavg and Cmax by 8% and 13%, respectively, compared to testosterone gel, 1.62% applied alone.
NONCLINICAL TOXICOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis
Testosterone has been tested by subcutaneous injection and implantation in mice and rats. In mice, the implant induced cervical-uterine tumors which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats.
Mutagenesis
Testosterone was negative in the in vitro Ames and in the in vivo mouse micronucleus assays.
Impairment of Fertility
The administration of exogenous testosterone has been reported to suppress spermatogenesis in rats, dogs, and non-human primates, which was reversible on cessation of the treatment.
HOW SUPPLIED SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
Testosterone Gel, 1.62% is supplied in non-aerosol, metered-dose pumps that deliver 20.25 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.
Testosterone Gel, 1.62% is also supplied in unit-dose aluminum foil packets in cartons of 30. Each packet of 1.25 g or 2.5 g gel contains 20.25 mg or 40.5 mg testosterone, respectively.
NDC 45802-754-01 |
88 g pump (each pump dispenses 60 metered pump actuations with each pump actuation containing 20.25 mg of testosterone in 1.25 g of gel) |
NDC 45802-281-03 |
Each unit dose packet contains 20.25 mg of testosterone provided in 1.25 g of gel |
NDC 45802-281-39 |
30 packets (each unit dose packet contains 20.25 mg of testosterone provided in 1.25 g of gel) |
NDC 45802-366-02 |
Each unit dose packet contains 40.5 mg of testosterone provided in 2.5 g of gel |
NDC 45802-366-65 |
30 packets (each unit dose packet contains 40.5 mg of testosterone provided in 2.5 g of gel) |
Store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°- 30°C (59°- 86°F) [see USP Controlled Room Temperature].
Used Testosterone Gel, 1.62% pumps or used Testosterone Gel, 1.62% packets should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.
INFORMATION FOR PATIENTS SECTION
17 PATIENT COUNSELING INFORMATION
See FDA-Approved Medication Guide
Patients should be informed of the following:
17.1 Use in Men with Known or Suspected Prostate or Breast Cancer
Men with known or suspected prostate or breast cancer should not use Testosterone Gel, 1.62% [see Contraindications (4) and Warnings and Precautions (5.1)].
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 [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:
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In children: unexpected sexual development including inappropriate enlargement of the penis or clitoris, premature development of pubic hair, increased erections, and aggressive behavior.
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In women: changes in hair distribution, increase in acne, or other signs of testosterone effects.
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The possibility of secondary exposure to testosterone gel should be brought to the attention of a healthcare provider.
•
Testosterone Gel, 1.62% 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, 1.62% in men [see Medication Guide]:
•
**Children and women should avoid contact with unwashed or unclothed application site(s)**of men using Testosterone Gel, 1.62%.
•
Patients using Testosterone Gel, 1.62% should apply the product as directed and strictly adhere to the following:
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**Wash hands**with soap and water immediately after application.
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**Cover the application site(s)**with clothing after the gel has dried.
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**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.
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In the event that unwashed or unclothed skin to which Testosterone Gel, 1.62% 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)].
17.3 Potential Adverse Reactions with Androgens
Patients should be informed that treatment with androgens may lead to adverse reactions which include:
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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 to the bathroom right away, having a urine accident, being unable to pass urine and weak urine flow.
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Breathing disturbances, including those associated with sleep, or excessive daytime sleepiness.
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Too frequent or persistent erections of the penis.
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Nausea, vomiting, changes in skin color, or ankle swelling.
17.4 Patients Should Be Advised of the Following Instructions for Use
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**Read the Medication Guide before starting Testosterone Gel, 1.62% therapy and to reread it each time the prescription is renewed.**
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**Testosterone Gel, 1.62% should be applied and used appropriately to maximize the benefits and to minimize the risk of secondary exposure in children and women.**
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Keep Testosterone Gel, 1.62% out of the reach of children.
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**Testosterone Gel, 1.62% is an alcohol based product and is flammable; therefore avoid fire, flame or smoking until the gel has dried.**
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It is important to adhere to all recommended monitoring.
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Report any changes in their state of health, such as changes in urinary habits, breathing, sleep, and mood.
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Testosterone Gel, 1.62% is prescribed to meet the patient’s specific needs; therefore, the patient should never share Testosterone Gel, 1.62% with anyone.
•
Wait 2 hours before swimming or washing following application of Testosterone Gel, 1.62%. This will ensure that the greatest amount of Testosterone Gel, 1.62% is absorbed into their system.
Manufactured By Padagis
Yeruham, Israel
Distributed By Padagis
Allegan, MI 49010
www.padagis.com
Rev 10-22
6M300 RC J3
INSTRUCTIONS FOR USE SECTION
INSTRUCTIONS FOR USE
Testosterone (tes-TOS-te-rone) Gel, 1.62% CIII
for topical use
Read this Instructions for Use for Testosterone Gel, 1.62% 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, 1.62%:
•
**Testosterone Gel, 1.62% comes in a pump or in packets.**
•
**Before applying Testosterone Gel, 1.62% make sure that your shoulders and upper arms are clean, dry, and that there is no broken skin.**
•
**Testosterone Gel, 1.62% is to be applied to the area of your shoulders and upper arms that will be covered by a short sleeve t-shirt (See Figure A). Do not**apply Testosterone Gel, 1.62% to any other parts of your body such as your stomach area (abdomen), penis, scrotum, chest, armpits (axillae), or knees.
If you are using Testosterone Gel, 1.62% pump:
•
Before using a new bottle of Testosterone Gel, 1.62% for the first time, you will need to remove the cap and then prime the pump. To prime the Testosterone Gel, 1.62% pump, slowly push the pump all the way down 3 times, over the sink drain.
Do notuse any Testosterone Gel, 1.62% that came out while priming. Wash it down the sink to avoid accidental exposure to others. Your Testosterone Gel, 1.62% pump is now ready to use.
•
Remove the cap from the pump. Then, put the spout opening at the top of the pump where the medicine comes out over the palm of your hand and slowly push the pump all the way down. Apply Testosterone Gel, 1.62% to the application site. You may also apply Testosterone Gel, 1.62% directly to the application site.**Your healthcare provider will tell you the number of times to press the pump for each dose.**
•
**Wash your hands with soap and water right away.**
Find Your Dose as Prescribed by Your Healthcare Provider |
Application Method | |
1 pump |
20.25 mg |
Apply 1 pump of Testosterone Gel, 1.62% to 1 upper arm and shoulder. |
2 pumps |
40.5 mg |
Apply 1 pump of Testosterone Gel, 1.62% to 1 upper arm and shoulder and then apply 1 pump of Testosterone Gel, 1.62% to the opposite upper arm and shoulder. |
3 pumps |
60.75 mg |
Apply 2 pumps of Testosterone Gel, 1.62% to 1 upper arm and shoulder and then apply 1 pump of Testosterone Gel, 1.62% to the opposite upper arm and shoulder. |
4 pumps |
81 mg |
Apply 2 pumps of Testosterone Gel, 1.62% to 1 upper arm and shoulder and then apply 2 pumps of Testosterone Gel, 1.62% to the opposite upper arm and shoulder. |
If you are using Testosterone Gel, 1.62% 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, 1.62% out of the packet into the palm of your hand.
•
Apply Testosterone Gel, 1.62% to the application site. You may also apply Testosterone Gel, 1.62% directly to the application site.
•
Let the application site dry completely before putting on a t-shirt.
•
**Testosterone Gel, 1.62% is flammable until dry.**Let Testosterone Gel, 1.62% dry before smoking or going near an open flame.
•
Avoid showering, swimming or bathing for at least 2 hours after you apply Testosterone Gel, 1.62%.
•
**Wash your hands right away**with soap and water after applying Testosterone Gel, 1.62%.
Find Your Dose as Prescribed by Your Healthcare Provider |
Application Method | |
One 20.25 mg packet |
20.25 mg |
Apply 1 packet of Testosterone Gel, 1.62% to 1 upper arm and shoulder. |
One 40.5 mg packet |
40.5 mg |
Apply half of the 40.5 mg packet of Testosterone Gel, 1.62% to 1 upper arm and shoulder and then apply the remaining packet contents to the opposite upper arm and shoulder. |
One 40.5 mg packet and one 20.25 mg packet |
60.75 mg |
Apply one 40.5 mg packet of Testosterone Gel, 1.62% to 1 upper arm and shoulder and then apply one 20.25 mg packet of Testosterone Gel, 1.62% to the opposite upper arm and shoulder. |
Two 40.5 mg packets |
81 mg |
Apply one 40.5 mg packet of Testosterone Gel, 1.62% to 1 upper arm and shoulder and then apply one 40.5 mg packet of Testosterone Gel, 1.62% to the opposite upper arm and shoulder. |
How should I store Testosterone Gel, 1.62%?
•
Store Testosterone Gel, 1.62% at room temperature between 68°F to 77°F (20°C to 25°C).
•
When it is time to throw away the pump or packets, safely throw away used Testosterone Gel, 1.62% in the household trash. Be careful to prevent accidental exposure of children or pets.
•
Keep Testosterone Gel, 1.62% away from fire.
Keep Testosterone Gel, 1.62% and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured By Padagis
Yeruham, Israel
Distributed By Padagis
Allegan, MI 49010
www.padagis.com
Revised: 10/2022
DOSAGE & ADMINISTRATION SECTION
2 DOSAGE AND ADMINISTRATION
Dosage and Administration for Testosterone Gel, 1.62% differs from Testosterone Gel, 1%. For dosage and administration of Testosterone Gel, 1% refer to its full prescribing information. (2)
Prior to initiating Testosterone Gel, 1.62%, 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.
2.1 Dosing and Dose Adjustment
The recommended starting dose of Testosterone Gel, 1.62% is 40.5 mg of testosterone (2 pump actuations or a single 40.5 mg packet) applied topically once daily in the morning to the shoulders and upper arms.
The dose can be adjusted between a minimum of 20.25 mg of testosterone (1 pump actuation or a single 20.25 mg packet) and a maximum of 81 mg of testosterone (4 pump actuations or two 40.5 mg packets). To ensure proper dosing, the dose should be titrated based on the pre-dose morning serum testosterone concentration from a single blood draw at approximately 14 days and 28 days after starting treatment or following dose adjustment. In addition, serum testosterone concentration should be assessed periodically thereafter. Table 1 describes the dose adjustments required at each titration step.
Table 1: Dose Adjustment Criteria
Pre-Dose Morning Total Serum Testosterone Concentration |
Dose Titration |
Greater than 750 ng/dL |
Decrease daily dose by 20.25 mg (1 pump actuation or the equivalent of one 20.25 mg packet) |
Equal to or greater than 350 and equal to or less than 750 ng/dL |
No change: continue on current dose |
Less than 350 ng/dL |
Increase daily dose by 20.25 mg (1 pump actuation or the equivalent of one 20.25 mg packet) |
The application site and dose of Testosterone Gel, 1.62% are not interchangeable with other topical testosterone products.
2.2 Administration Instructions
Testosterone Gel, 1.62% should be applied to clean, dry, intact skin of the upper arms and shoulders. Do not apply Testosterone Gel, 1.62% to any other parts of the body, including the abdomen, genitals, chest, armpits (axillae), or knees [see Clinical Pharmacology (12.3)]. Area of application should be limited to the area that will be covered by the patient’s short sleeve t-shirt. Patients should be instructed to use the palm of the hand to apply Testosterone Gel, 1.62% and spread across the maximum surface area as directed in Table 2 (for pump) and Table 3 (for packets) and in Figure 1.
Table 2: Application Sites for Testosterone Gel, 1.62%, Pump
Total Dose of Testosterone |
Total Pump Actuations |
Pump Actuations Per Upper Arm and Shoulder | |
Upper Arm and Shoulder #1 |
Upper Arm and Shoulder #2 | ||
20.25 mg |
1 |
1 |
0 |
40.5 mg |
2 |
1 |
1 |
60.75 mg |
3 |
2 |
1 |
81 mg |
4 |
2 |
2 |
Table 3: Application Sites for Testosterone Gel, 1.62%, Packets
Total Dose of Testosterone |
Total packets |
Gel Applications Per Upper Arm and Shoulder | |
Upper Arm and Shoulder #1 |
Upper Arm and Shoulder #2 | ||
20.25 mg |
One 20.25 mg packet |
One 20.25 mg packet |
0 |
40.5 mg |
One 40.5 mg packet |
Half of contents of One 40.5 mg packet |
Half of contents of One 40.5 mg packet |
60.75 mg |
One 20.25 mg packet AND One 40.5 mg packet |
One 40.5 mg packet |
One 20.25 mg packet |
81 mg |
Two 40.5 mg packets |
One 40.5 mg packet |
One 40.5 mg packet |
The prescribed daily dose of Testosterone Gel, 1.62% should be applied to the right and left upper arms and shoulders as shown in the shaded areas in Figure 1.
Figure 1. Application Sites for Testosterone Gel, 1.62%
Once the application site is dry, the site should be covered with clothing [see Clinical Pharmacology (12.3)]. Wash hands thoroughly with soap and water. Avoid fire, flames or smoking until the gel has dried since alcohol based products, including Testosterone Gel, 1.62%, are flammable.
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)].
To obtain a full first dose, it is necessary to prime the canister pump. To do so, with the canister in the upright position, slowly and fully depress the actuator three times. Safely discard the gel from the first three actuations. It is only necessary to prime the pump before the first dose.
After the priming procedure, fully depress the actuator once for every 20.25 mg of Testosterone Gel, 1.62%. Testosterone Gel, 1.62% should be delivered directly into the palm of the hand and then applied to the application sites.
When using packets, the entire contents should be squeezed into the palm of the hand and immediately applied to the application sites. When 40.5 mg packets need to be split between the left and right shoulder, patients may squeeze a portion of the gel from the packet into the palm of the hand and apply to application sites. Repeat until entire contents have been applied. Alternatively, Testosterone Gel, 1.62% can be applied directly to the application sites from the pump or packets.
Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from Testosterone Gel, 1.62%-treated skin:
•
Children and women should avoid contact with unwashed or unclothed application site(s) of men using Testosterone Gel, 1.62%.
•
Testosterone Gel, 1.62% 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 Testosterone Gel, 1.62%.
•
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 Testosterone Gel, 1.62% 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.
•
**Dosage and Administration for Testosterone Gel, 1.62% differs from Testosterone Gel, 1%. For dosage and administration of Testosterone Gel, 1% refer to its full prescribing information. (****2****)**
•
Prior to initiating Testosterone Gel, 1.62%, 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, 1.62% is 40.5 mg of testosterone (2 pump actuations or a single 40.5 mg packet), applied topically once daily in the morning. (2.1)
•
Apply to clean, dry, intact skin of the shoulders and upper arms. Do not apply Testosterone Gel, 1.62% to any other parts of the body including the abdomen, genitals, chest, armpits (axillae), or knees. (2.2, 12.3)
•
Dose adjustment: Testosterone Gel, 1.62% can be dose adjusted between a minimum of 20.25 mg of testosterone (1 pump actuation or a single 20.25 mg packet) and a maximum of 81 mg of testosterone (4 pump actuations or two 40.5 mg packets). The dose should be titrated based on the pre-dose morning serum testosterone concentration at approximately 14 days and 28 days after starting treatment or following dose adjustment. Additionally, serum testosterone concentration should be assessed periodically thereafter. (2.1)
•
Patients should wash hands immediately with soap and water after applying Testosterone Gel, 1.62% 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)