AndroGel Geriatric (65+) Caregiver Administration Guidance

Where the gel goes, and where it must not

The label is specific about placement. It directs application to clean, dry, intact skin of the upper arms and shoulders, and says the application area should be limited to the skin a short-sleeve t-shirt would cover [1]. It says not to apply the gel to the abdomen, genitals, chest, armpits or knees [1].

The 1.62% and 1% gels are not interchangeable: the 1.62% label states that its dosing and administration differ from those of the 1% gel and points to that product's own prescribing information [1]. A caregiver needs to know which strength the patient has, because the label states that the application site and dose of the 1.62% gel are not substitutable with other topical testosterone products [1].

How the label describes application

The label describes using the palm of the hand to spread the gel across the maximum surface area of the application site, letting it dry, covering the site with clothing, and washing hands thoroughly with soap and water [1]. It states that the gel is flammable until dry and that fire, flames and smoking should be avoided until the gel has dried [1].

Secondary exposure: the boxed warning in practice

The gel's boxed warning is about secondary exposure. It states that virilization has been reported in children who were secondarily exposed to testosterone gel, that children should avoid contact with unwashed or unclothed application sites, and that health care providers should advise patients to adhere strictly to the instructions for use [1]. The warnings section adds that children and women should avoid contact with unwashed or unclothed application sites [1].

The label lists what secondary exposure has looked like in reported cases: enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age [1]. In most cases these signs and symptoms regressed once the exposure was removed, but in a few cases enlarged genitalia did not fully return to age-appropriate normal size and bone age remained modestly greater than chronological age [1]. The label notes that the risk of transfer was increased in some of these cases by not adhering to the precautions for appropriate use [1].

The label also states that the gel is contraindicated in women who are pregnant, that it can cause virilization of the female fetus, and that pregnant women need to be aware of the potential for transfer of testosterone from men treated with the gel [1].

What the label says about men over 65

The label carries a limitation of use: safety and efficacy in men with age-related hypogonadism (also called late-onset hypogonadism) have not been established [1]. In June 2026 FDA requested that this limitation be removed and that prostate cancer and benign prostatic hyperplasia safety information be revised, so the label text on this point is in transition [2].

The label also states that geriatric patients treated with androgens may be at risk for worsening of signs and symptoms of benign prostatic hyperplasia [1].

Dose and titration for a man over 65

The approved starting dose of the 1.62% gel is 40.5 mg of testosterone, as two pump actuations or one 40.5 mg packet, applied once daily in the morning [1]. The dose can be adjusted between a minimum of 20.25 mg and a maximum of 81 mg of testosterone daily [1]. Titration is based on a pre-dose morning total serum testosterone:

• Greater than 750 ng/dL: the label says to decrease the daily dose by 20.25 mg [1]
• 350 to 750 ng/dL: no change [1]
• Less than 350 ng/dL: the label says to increase the daily dose by 20.25 mg [1]

Before treatment starts, the label says hypogonadism should be confirmed with morning serum testosterone measured on at least two separate days, both below the normal range [1].

For older men, the 2018 Endocrine Society guideline recommends against starting testosterone therapy in men with an elevated hematocrit, untreated severe sleep apnea, uncontrolled heart failure, or a heart attack or stroke within the previous 6 months, among other conditions, and recommends monitoring symptoms, serum testosterone, hematocrit and prostate cancer risk during the first year [3].

What the label says to monitor

Hematocrit. The label says to check hematocrit before starting treatment, re-evaluate it 3 to 6 months after starting, and then check it annually. It says that if hematocrit becomes elevated, therapy is stopped until hematocrit decreases to an acceptable concentration, and it notes that an increase in red blood cell mass may increase the risk of thromboembolic events [1]. For scale, a network meta-analysis of 29 placebo-controlled trials in 3,393 men found that gels raised mean hematocrit by 3.0 percent versus placebo, against 4.0 percent for intramuscular enanthate or cypionate [4].

Blood pressure. In an ambulatory blood pressure study, the 1.62% gel raised mean systolic and diastolic pressure by 1.9 and 1.3 mm Hg from baseline after 16 weeks; in men with hypertension on antihypertensive therapy, the rise was 3.0 and 2.2 mm Hg [1]. The label says to monitor blood pressure periodically, especially in men with hypertension, and that the gel is not recommended for patients with uncontrolled hypertension [1].

Cardiovascular events. TRAVERSE randomized 5,246 men aged 45 to 80 with hypogonadism and existing or high cardiovascular risk to daily 1.62% testosterone gel or placebo gel. A major adverse cardiovascular event occurred in 7.0 percent on testosterone and 7.3 percent on placebo, with a hazard ratio of 0.96 [5]. Mean systolic pressure rose 1.0 mm Hg on testosterone against a 0.5 mm Hg fall on placebo at 36 months [1]. Venous thromboembolism was numerically higher on gel, 1.7 percent versus 1.2 percent, and the label says to evaluate leg pain, swelling, warmth and redness for deep vein thrombosis and acute shortness of breath for pulmonary embolism, and to discontinue the gel if such an event is suspected [1].

PSA and prostate. Increased PSA was the most common adverse reaction in the 182-day double-blind period, reported in 11.1 percent of men on the 1.62% gel and none on placebo [1]. The label says to evaluate patients for prostate cancer before and during treatment, to monitor PSA periodically, and to monitor men with benign prostatic hyperplasia for worsening signs and symptoms [1].

Other label warnings. The label lists edema, with or without congestive heart failure, in men with preexisting cardiac, renal or hepatic disease, and sleep apnea in those with risk factors [1]. Application site reactions were reported in 2 of 234 patients (0.9 percent) during the double-blind period, and both resolved [1].

Interactions that matter in an older household

The 1.62% gel label lists three interaction areas [1]:

• Insulin and diabetes medicines. The label states that androgens may decrease blood glucose and therefore may decrease insulin requirements in diabetic patients [1].
• Oral anticoagulants. The label states that changes in anticoagulant activity may be seen with androgens, and that more frequent monitoring of INR and prothrombin time is recommended, especially at the start and end of androgen therapy [1].
• Corticosteroids and ACTH. The label states that concurrent use may result in increased fluid retention and requires careful monitoring, particularly in patients with cardiac, renal or hepatic disease [1].