AndroGel Pre-Surgery Hold Window: What Patients and Prescribers Need to Know

Does the label give a pre-surgery hold window?

The AndroGel 1% label does not mention surgery or a hold before it [1]. AndroGel 1.62% has its own prescribing information, which this page does not cover [1]. What the 1% label does address is reported venous thromboembolism, the thromboembolic risk that comes with increased red blood cell mass, and blood pressure [1].

Venous thromboembolism

The label says VTE, including DVT and PE, has been reported in patients using testosterone products such as AndroGel 1% [1]. It reports that in TRAVERSE, a randomized, double-blind, placebo-controlled cardiovascular outcomes study that compared AndroGel 1.62% with placebo gel in 5,246 men with hypogonadism and preexisting or high cardiovascular risk [4][5], AndroGel 1.62% was associated with a numerically higher incidence of VTE: 1.7% versus 1.2% on placebo, with DVT 0.6% vs 0.5% and PE 0.9% vs 0.5% [1]. The label says to evaluate pain, edema, warmth and erythema in the lower extremity for DVT and acute shortness of breath for PE, and to discontinue AndroGel 1% and begin workup if a VTE is suspected [1].

Hematocrit

The label says increases in hematocrit reflect increases in red blood cell mass and may require lowering the dose or discontinuing testosterone [1]. It directs that hematocrit be checked before starting, re-evaluated 3 to 6 months after starting and then annually, and that therapy be stopped if hematocrit becomes elevated, until it falls to an acceptable concentration [1]. It adds that an increase in red blood cell mass may increase the risk of thromboembolic events [1].

In a network meta-analysis of 29 placebo-controlled randomized trials in 3,393 men, gel raised mean hematocrit by 3.0% versus placebo (95% CI 1.8 to 4.3) [6]. A retrospective single-center review of 178 hypogonadal men followed for 3 years reported erythrocytosis (hematocrit above 50%) in 66.7% of men using injectable testosterone; the injection group was younger (mean 42.5 vs about 54 years) and had a higher baseline hematocrit than the gel group, and the review was not randomized [7].

Blood pressure

The label says AndroGel 1% can increase blood pressure, which can increase cardiovascular risk over time [1]. It reports an ambulatory blood pressure study in which mean 24-hour systolic/diastolic pressure rose 1.9/1.3 mm Hg from baseline at week 16, and 3.0/2.2 mm Hg in men with hypertension already on antihypertensive treatment; the blood pressure section says AndroGel 1.62% is not recommended for patients with uncontrolled hypertension [1]. FDA's February 2025 labeling action said ambulatory studies confirmed a blood pressure increase with all testosterone products, class-wide [8].

What a guideline says before starting

The 2018 Endocrine Society guideline recommends against starting testosterone therapy in men with elevated hematocrit, untreated severe obstructive sleep apnea, uncontrolled heart failure, or a myocardial infarction or stroke within 6 months, and recommends monitoring symptoms, serum testosterone, hematocrit and prostate cancer risk in the first year [2]. The society's 2010 guideline put the hematocrit cutoff at greater than 50% [3].