These highlights do not include all the information needed to use ANDROGEL 1.62% safely and effectively. See full prescribing information for ANDROGEL 1.62%.
AndroGel ® (testosterone gel) 1.62% for topical use CIII
Initial U.S. Approval: 1953
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
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Virilization has been reported in children who were secondarily exposed to testosterone gel (5.2, 6.2).
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Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel (2.2, 5.2).
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Healthcare providers should advise patients to strictly adhere to recommended instructions for use (2.2, 5.2, 17).
RECENT MAJOR CHANGES
Indications and Usage. (1) 09/2012
INDICATIONS AND USAGE
AndroGel 1.62% is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
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Primary hypogonadism (congenital or acquired) (1)
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Hypogonadotropic hypogonadism (congenital or acquired) (1)
Important limitations of use:
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Safety and efficacy of AndroGel 1.62% in males less than 18 years old have not been established. (1, 8.4)
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Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure. (1, 12.3)
DOSAGE AND ADMINISTRATION
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Dosage and Administration for AndroGel 1.62% differs from AndroGel 1%. For dosage and administration of AndroGel 1% refer to its full prescribing information. (2)
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Starting dose of AndroGel 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)
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Apply to clean, dry, intact skin of the shoulders and upper arms. Do not apply AndroGel 1.62% to any other parts of the body including the abdomen or genitals. (2.2, 12.3)
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Dose adjustment: AndroGel 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)
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Patients should wash hands immediately with soap and water after applying AndroGel 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)
DOSAGE FORMS AND STRENGTHS
AndroGel (testosterone gel) 1.62% for topical use is available as follows:
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a metered-dose pump that delivers 20.25 mg testosterone per actuation. (3)
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packets containing 20.25 mg testosterone. (3)
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packets containing 40.5 mg testosterone. (3)
CONTRAINDICATIONS
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Men with carcinoma of the breast or known or suspected prostate cancer (4, 5.1)
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Pregnant or breast-feeding women. Testosterone may cause fetal harm (4, 8.1, 8.3)
WARNINGS AND PRECAUTIONS
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Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH (5.1)
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Avoid unintentional exposure of women or children to AndroGel 1.62%. Secondary exposure to testosterone can produce signs of virilization. AndroGel 1.62% should be discontinued until the cause of virilization is identified (5.2)
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Exogenous administration of androgens may lead to azoospermia (5.5)
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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 (5.7)
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Sleep apnea may occur in those with risk factors (5.9)
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Monitor serum testosterone, prostate specific antigen (PSA), hemoglobin, hematocrit, liver function tests and lipid concentrations periodically (5.1, 5.3, 5.6, 5.10)
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AndroGel 1.62% is flammable until dry (5.13)
ADVERSE REACTIONS
The most common adverse reaction (incidence ≥ 5%) is an increase in prostate specific antigen (PSA). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Abbott Laboratories at 1-800-241-1643 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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Androgens may decrease blood glucose and therefore may decrease insulin requirements in diabetic patients (7.1)
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Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of International Normalized Ratio (INR) and prothrombin time is recommended (7.2)
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Use of testosterone with adrenocorticotrophic hormone (ACTH) or corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease (7.3)
USE IN SPECIFIC POPULATIONS
There are insufficient long-term safety data in geriatric patients using AndroGel 1.62% to assess the potential risks of cardiovascular disease and prostate cancer. (8.5)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 3/2013
