AndroGel

AndroGel^® is a prescription topical testosterone gel approved by the United States Food and Drug Administration (FDA) for hormone replacement therapy in adult men with hypogonadism, the medical term for a testosterone deficiency that causes symptoms. AndroGel aims to restore normal testosterone levels and ease symptoms of low testosterone, including fatigue, reduced libido, depression, and decreased muscle mass. 

AndroGel is applied once daily to clean, dry skin on the shoulders and upper arms or abdomen. Healthcare providers monitor how a person responds to AndroGel treatment through periodic blood tests to ensure testosterone levels remain within a normal range. Based on these tests, the provider may adjust the dose and/or strength (1.0 percent or 1.62 percent) of AndroGel as needed. 

Some common side effects include skin irritation at the application site, increased red blood cell count, headache, acne, and mood changes. AndroGel may also trigger more serious adverse effects, such as elevated red blood cell count (polycythemia) or worsening of underlying prostate conditions.

AndroGel (testosterone gel) 1.62% is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:

• Primary hypogonadism (congenital or acquired)

• Hypogonadotropic hypogonadism (congenital or acquired)

Androgen

The most common adverse reaction (incidence ≥5%) is:

• An increase in prostate specific antigen (PSA)

The price of AndroGel may vary depending on factors such as quantity, dosage, insurance plan, and where you buy it.

The average retail price of AndroGel is about $788 for one to four doses of the higher-strength (1.62 percent) gel, but coupons and discount cards may be available to lower the price. Generic AndroGel (testosterone gel) is typically less expensive, at about $450 for a month’s supply, with coupons available to bring down the price to as low as about $90.

Health insurance may cover all or some of the cost of this medication.

• Men with carcinoma of the breast or known or suspected prostate cancer

• Women who are pregnant. Testosterone may cause fetal harm

• Drug interactions: Androgens may decrease blood glucose and therefore may decrease insulin requirements in diabetic patients, changes in anticoagulant activity may be seen with androgens, use of testosterone with adrenocorticotrophic hormone (ACTH) or corticosteroids may result in increased fluid retention

• Worsening of benign prostatic hyperplasia (BPH) and potential risk of prostate cancer: Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH

• Potential for secondary exposure to testosterone: Avoid unintentional exposure of women or children to AndroGel 1.62%

• Venous thromboembolism (VTE)

• Blood pressure increases

• Potential for adverse effects on spermatogenesis

• Edema

• Sleep apnea: Sleep apnea may occur in those with risk factors

• Monitor serum testosterone, prostate specific antigen (PSA), hemoglobin, hematocrit, liver function tests and lipid concentrations periodically

• Flammability: AndroGel 1.62% is flammable until dry

WARNING: SECONDARY EXPOSURE TO TESTOSTERONE

Virilization has been reported in children who were secondarily exposed to testosterone gel.

Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel.

Healthcare providers should advise patients to strictly adhere to recommended instructions for use.

*This information is from the label for brand name AndroGel^®. See the Full Prescribing Information for more complete information. Testosterone gel, the active ingredient in AndroGel, may also be the active ingredient in other medications, and this information may not be accurate for all medications that include the active ingredient testosterone gel.