AndroGel

AndroGel 1.62% is a topical testosterone gel indicated for replacement therapy in adult males with conditions associated with a deficiency or absence of endogenous testosterone, including primary and hypogonadotropic hypogonadism. The gel is applied once daily to the shoulders and upper arms and requires dose titration based on serum testosterone levels. Use in men with age-related hypogonadism and in boys under 18 years has not been established.

AndroGel 1.62% is indicated for replacement therapy in adult males with conditions of testosterone deficiency or absence, including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

Testosterone

The recommended starting dose is 40.5 mg of testosterone (2 pump actuations or one 40.5 mg packet) applied topically once daily in the morning on the clean, dry, intact skin of the shoulders and upper arms. Dose may be adjusted between 20.25 mg (1 pump actuation or 20.25 mg packet) and 81 mg (4 pump actuations or two 40.5 mg packets) based on pre-dose morning serum testosterone concentrations measured approximately 14 and 28 days after starting or adjusting therapy. Subsequent doses are applied to the right and left upper arms and shoulders as per dosing tables provided. Patients should wash hands immediately after application, cover the site with clothing once dried, and avoid swimming or washing the application site for at least 2 hours. Pump priming is needed before first use, discarding initial three actuations. Strict adherence to precautions to minimize secondary exposure is advised.

Men with carcinoma of the breast or known or suspected carcinoma of the prostate; women who are pregnant due to risk of fetal harm.

AndroGel 1.62% carries a boxed warning for risk of secondary exposure to testosterone, which can cause virilization in children. Children and women should avoid contact with unwashed or unclothed application sites. AndroGel 1.62% is contraindicated in men with carcinoma of the breast or known/suspected prostate cancer, and in pregnant women due to potential fetal harm. Monitor for worsening of benign prostatic hyperplasia (BPH) and potential prostate cancer risk. Venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism, has been reported. AndroGel 1.62% can increase blood pressure; it is not recommended for patients with uncontrolled hypertension. Use caution in patients at risk for edema, sleep apnea, and monitor laboratory parameters periodically. Avoid fire, flames, or smoking near application site until gel is dry due to flammability.

AndroGel 1.62% is contraindicated in women who are pregnant as it may cause virilization of the female fetus. Pregnant women should avoid exposure to the gel. If exposed, they should be apprised of potential fetal hazards.