AndroGel Non-Responder Profile: Who Doesn't Get Results and Why

What the label provides

The prescribing information for Testosterone Gel, 1.62% states that its dosing differs from 1% gel [1]. The label starts the dose at 40.5 mg once daily in the morning and allows adjustment down to a minimum of 20.25 mg per day [1]. It directs application to clean, dry, intact skin of the shoulders and upper arms and says not to apply the gel to the abdomen, genitals, chest, armpits or knees [1].

In TRAVERSE, the daily 1.62% gel dose was adjusted to keep testosterone between 350 and 750 ng/dL [2]. That trial tested cardiovascular safety. It does not identify who will fail to respond to AndroGel.

Low level versus persistent symptoms

These are two different situations.

• A low measured level on gel. The label calls for periodic monitoring of serum testosterone, and the dose is adjustable [1].
• Symptoms that persist with an in-range level. The Endocrine Society recommends diagnosing hypogonadism only in men with symptoms and signs of testosterone deficiency plus unequivocally and consistently low serum testosterone. It recommends confirming the diagnosis with a repeat fasting morning total testosterone [3]. Those criteria apply to the original diagnosis. A level brought into range by gel does not undo that diagnosis, and a level in range does not by itself explain why symptoms persist.

During treatment, the guideline recommends monitoring symptoms, serum testosterone, hematocrit and prostate cancer risk in the first year [3].

Monitoring named in the gel label

The label calls for periodic monitoring of serum testosterone, PSA, hemoglobin, hematocrit, liver function tests and lipids [1]. It says to check hematocrit before starting, re-evaluate 3 to 6 months after starting, and then check annually [1]. In the 182-day controlled trial, increased PSA was the most common adverse reaction, reported in 26 of 234 treated men (11.1%) [1].