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

Does kidney disease change the dose?

The AndroGel 1% label has a renal impairment section that says only that no studies were conducted in patients with renal impairment [1]. It contains no renal dosing table and no renal-specific starting dose.

The label also says topical testosterone products may have different doses, strengths, or application instructions that produce different systemic exposure, and it refers to the separate 1.62% prescribing information for that product's dosing [1].

What the label says about kidney disease

Edema. Edema, with or without congestive heart failure, may be a complication in patients with preexisting cardiac, renal, or hepatic disease [1].

Corticosteroids. Testosterone with ACTH or corticosteroids may increase fluid retention, and the label calls for careful monitoring, particularly in patients with cardiac, renal, or hepatic disease [1].

Blood pressure. The label says AndroGel 1% can increase blood pressure. It reports an ambulatory blood pressure monitoring study in which 169 men had usable recordings at both baseline and week 16, with a mean 24-hour systolic/diastolic rise of 1.9/1.3 mm Hg; in men with hypertension already on antihypertensive therapy, the rise was 3.0/2.2 mm Hg [1]. The blood pressure section says AndroGel 1.62% is not recommended for patients with uncontrolled hypertension [1].

Standard dosing in the AndroGel 1% label

The label says to confirm hypogonadism before starting, with morning serum testosterone measured on at least two separate days and both values below the normal range [1].

The label's starting dose is 50 mg once daily in the morning (two 25 mg packets or one 50 mg packet), applied to clean, dry, intact skin of the shoulders and upper arms and/or abdomen, not the genitals, chest, armpits, knees, or back [1]. The dose may be increased to 75 mg and then 100 mg if serum testosterone is below the normal range, and decreased if it exceeds the normal range [1].

The label says the gel is flammable until dry. Children and women should avoid contact with unwashed or unclothed application sites, and virilization has been reported in children exposed secondhand [1].

Low testosterone is common in men with kidney failure

A cross-sectional study of 48 men with chronic renal failure, from mild to end stage, defined hypogonadism as a low (below 10 nmol/L) or low-normal (10 to 14 nmol/L) total testosterone and found it in 22 of them (46%) [2]. Gonadotropins were normal in 21 of those 22 men, hyperprolactinemia was present in 6, and type 2 diabetes and diabetic nephropathy were the only risk factors identified [2]. It is one small study, but it is a reason testosterone gets checked in this group.

What the label says to monitor

Hematocrit. The label calls for hematocrit before treatment, again at 3 to 6 months, then annually, and says to stop therapy if hematocrit becomes elevated until it falls to an acceptable concentration [1].

PSA. The label says to evaluate for prostate cancer before and during treatment [1]. In the initial 6-month study, mean PSA rose 0.26 ng/mL [1]. In a 3-year extension study of 162 men, 29 (18%) met the protocol criterion for a PSA increase (more than twice baseline or any single value above 6 ng/mL), and most did so by doubling from a low baseline [1].

Clots. Venous thromboembolism, including deep vein thrombosis and pulmonary embolism, has been reported with testosterone products; the label says to evaluate symptoms and to discontinue if VTE is suspected [1]. It reports that in TRAVERSE, VTE occurred in 1.7% of men on testosterone gel versus 1.2% on placebo [1].

Interactions listed in the label

• Corticosteroids or ACTH: increased fluid retention; careful monitoring, especially with cardiac, renal, or hepatic disease [1].
• Insulin or diabetes medicines: androgens may lower blood glucose and reduce insulin requirements [1].
• Oral anticoagulants: changes in anticoagulant activity may occur; more frequent INR and prothrombin time monitoring, especially at initiation and termination [1].