AndroGel Dosing in Hepatic Impairment: What Clinicians and Patients Need to Know

What the label says about liver disease

The hepatic-impairment section of the testosterone gel 1% label is one sentence: no studies were conducted in these patients [1].

The label also says inactivation of testosterone occurs primarily in the liver [1]. The other liver-related statement sits in the edema warning: edema, with or without congestive heart failure, may be a complication in patients with preexisting cardiac, renal, or hepatic disease [1]. Liver function tests are also named among the parameters to check periodically [1].

Dosing described in the 1% gel label

The label says to confirm low testosterone first, with morning serum testosterone measured on at least two separate days and found below the normal range [1].

The starting dose is 50 mg of testosterone once daily in the morning, applied to clean, dry, intact skin of the shoulders and upper arms and/or abdomen [1]. The dose can then be adjusted to 50, 75 or 100 mg on the basis of total serum testosterone [1]. The label states that dosing for the 1% gel differs from the 1.62% gel and refers to that product's own prescribing information [1].

Monitoring the label asks for

• Serum testosterone, PSA, hemoglobin, hematocrit, liver function tests and lipid concentrations, checked periodically [1].
• The testosterone gel 1% label calls for a hematocrit check before treatment, another check after 3 to 6 months, and annual checks thereafter [1]. If hematocrit becomes elevated, the label says to stop therapy until it decreases to an acceptable concentration [1].
• The label asks for periodic blood pressure checks [1]. In a 4-month ambulatory monitoring study, mean 24-hour systolic/diastolic pressure rose 1.9/1.3 mm Hg by week 16 in the 169 men with usable recordings; in men with hypertension already on antihypertensive treatment the rise was 3.0/2.2 mm Hg, and the label says the gel is not recommended for men with uncontrolled hypertension [1].
• The 2018 Endocrine Society guideline recommends monitoring symptoms, serum testosterone, hematocrit and prostate cancer risk during the first year of therapy [2].

Other interactions the label lists

Oral anticoagulants: changes in anticoagulant activity may be seen with androgens, and the label recommends more frequent INR and prothrombin time monitoring, especially when testosterone therapy is started or stopped [1].

Corticosteroids or ACTH: increased fluid retention, with caution advised particularly in patients with cardiac, renal or hepatic disease [1].

Insulin: androgens may decrease blood glucose and therefore insulin requirements in diabetic patients [1].