Testosterone: Package Insert and Label Information

TESTOSTERONE- testosterone gel, metered
Xiromed, LLC

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 )].

1 INDICATIONS AND USAGE

Testosterone gel, 1.62% 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, 1.62% in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
  • Safety and efficacy of testosterone gel, 1.62% 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 Indications and Usage ( 1), and Clinical Pharmacology ( 12.3 )].

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) 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) and a maximum of 81 mg of testosterone (4 pump actuations). 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)
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)

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 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 110
40.5 mg 211
60.75 mg 321
81 mg422

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-application-sites
(click image for full-size original)

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.

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.
figure-application-sites

3 DOSAGE FORMS AND STRENGTHS

Testosterone gel, 1.62% for topical use only, is available as follows:

  • A metered-dose pump. Each pump actuation delivers 20.25 mg of testosterone in 1.25 g of gel.

4 CONTRAINDICATIONS

  • Testosterone gel, 1.62% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )].
  • Testosterone gel, 1.62% is contraindicated in women who are pregnant. Testosterone gel, 1.62% 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, 1.62%. If a pregnant woman is exposed to testosterone gel, 1.62%, she should be apprised of the potential hazard to the fetus [see Warnings and Precautions ( 5.2) and Use in Specific Populations ( 8.1)] .

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)] .

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.