AndroGel Seasonal Use Considerations: A Clinical Guide

What does the label say about swimming, showering and clothing?

The label advises avoiding swimming or showering for at least 5 hours after the application of AndroGel 1%, and its counseling section says waiting 5 hours before swimming or washing ensures that the greatest amount of AndroGel 1% is absorbed [1]. The patient instructions say to apply AndroGel 1% at the same time each morning, after showering or bathing, and to avoid showering, swimming or bathing for at least 5 hours afterward [1].

The label limits the application area to the area that will be covered by the patient's short-sleeve T-shirt, and says the site should be allowed to dry before dressing [1]. The patient instructions say that after the gel has dried, the application area should be covered with clothing and kept covered until the gel has been washed off well or the person has showered [1]. If skin-to-skin contact with another person is expected, they say to wash the application area well with soap and water first [1]. The label's study of 38 couples found that when a shirt covered the application sites, transfer of testosterone from the men to their female partners was completely prevented [1].

What year-round precautions apply?

FDA reports that ambulatory blood pressure studies confirmed a blood pressure increase with all testosterone products, class-wide [2]. The AndroGel 1% label says AndroGel 1% can increase blood pressure [1].

Testosterone therapy raises hematocrit. In a network meta-analysis of 29 placebo-controlled trials in 3,393 men, gels raised mean hematocrit by 3.0% (95% CI 1.8 to 4.3) versus placebo [3]. The label says to check hematocrit before starting, that it would be appropriate to re-evaluate it 3 to 6 months after starting and then annually, and to stop therapy if hematocrit becomes elevated until it falls [1].

Secondary exposure is a year-round warning. The label carries a boxed warning that virilization has been reported in children secondarily exposed to testosterone gel, with signs including enlargement of the penis or clitoris, pubic hair, increased erections and libido, aggressive behavior and advanced bone age [1]. The label says children and women should avoid contact with unwashed or unclothed application sites [1].

The label also says alcohol-based products, including AndroGel 1%, are flammable, and to avoid fire, flames or smoking until the gel has dried [1].