AndroGel Topical Gel

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.

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.

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.

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.

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.

• Androgens may decrease blood glucose and therefore may decrease insulin requirements in diabetic patients
• Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of International Normalized Ratio (INR) and prothrombin time is recommended
• Use of AndroGel with adrenocorticotrophic hormone (ACTH) or corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease

• Men with carcinoma of the breast or known or suspected prostate cancer
• Women who are pregnant. Testosterone may cause fetal harm

The most common adverse reaction (incidence ≥5%) is an increase in prostate specific antigen (PSA).

Testosterone 1.62% gel is contraindicated in pregnant women. Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action. Testosterone 1.62% gel is not indicated for use in women.

• Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH.
• Avoid unintentional exposure of women or children to AndroGel gel 1.62%. Secondary exposure to AndroGel can produce signs of virilization. AndroGel gel 1.62% should be discontinued until the cause of virilization is identified.
• Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using AndroGel products. Evaluate patients with signs or symptoms consistent with DVT or PE.
• Some postmarketing studies have shown an increased risk of myocardial infarction and stroke associated with use of AndroGel replacement therapy.
• Exogenous administration of androgens may lead to azoospermia Edema with or without congestive heart failure (CHF) may be a complication in patients with preexisting cardiac, renal, or hepatic disease
• Sleep apnea may occur in those with risk factors (5.12)
• Monitor serum AndroGel, prostate specific antigen (PSA), hemoglobin, hematocrit, liver function tests and lipid concentrations periodically
• AndroGel gel 1.62% is flammable until dry

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.