What are the key counseling points for testosterone (hypogonadism treatment) gel pump?

From the Guidelines

When counseling patients about testosterone gel pump, it's essential to emphasize proper application technique and safety precautions to minimize the risk of adverse effects and ensure optimal treatment outcomes. The most important counseling points for testosterone gel pump include applying the prescribed number of pump actuations to clean, dry, intact skin of the shoulders, upper arms, or abdomen once daily, typically in the morning, as recommended by 1. Wash hands thoroughly with soap and water immediately after application, and allow the gel to dry completely before dressing and avoid washing the application site for at least 2 hours. To prevent testosterone transfer to others, cover the application site with clothing and avoid skin-to-skin contact, especially with women and children, as noted in 1. If contact occurs, the exposed person should wash the area immediately with soap and water. Some key points to consider when counseling patients about testosterone gel pump include:

• Potential side effects, such as skin irritation, acne, increased PSA levels, and cardiovascular risks, as mentioned in 1
• Regular monitoring of testosterone levels, PSA, hematocrit, and lipid profile is necessary, as recommended by 1
• Inform patients that results may take several weeks to become noticeable, and they should continue regular follow-up appointments to assess efficacy and monitor for adverse effects, as suggested by 1
• Testosterone gel is a controlled substance that should not be shared with others, as emphasized in 1. It is also important to note that the method of testosterone replacement should be individualized for each patient, and transdermal testosterone preparations, such as gel pumps, are often preferred due to their convenience and ability to produce normal serum testosterone concentrations, as discussed in 1. Overall, proper counseling and education on the use of testosterone gel pump are crucial to ensure safe and effective treatment, and to minimize the risk of adverse effects, as highlighted in 1 and 1.

From the FDA Drug Label

To ensure proper dosing, the dose should be titrated based on the pre-dose morning serum testosterone concentration from a single blood draw at approximately 14 days and 28 days after starting treatment or following dose adjustment In addition, serum testosterone concentration should be assessed periodically thereafter. Testosterone gel, 1. 62% should be applied to clean, dry, intact skin of the upper arms and shoulders. Do not apply testosterone gel, 1.62% to any other parts of the body, including the abdomen, genitals, chest, armpits (axillae), or knees [see Clinical Pharmacology (12. 3)]. Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from testosterone gel, 1. 62%-treated skin: Children and women should avoid contact with unwashed or unclothed application site(s) of men using testosterone gel, 1.62%. Patients should wash their hands with soap and water immediately after applying testosterone gel, 1.62%. Patients should cover the application site(s) with clothing (e.g., a t-shirt) after the gel has dried. Prior to situations in which direct skin-to-skin contact is anticipated, patients should wash the application site(s) thoroughly with soap and water to remove any testosterone residue.

The most important counseling points for testosterone gel pump are:

• Proper application: Apply to clean, dry, intact skin of the upper arms and shoulders.
• Dose titration: Monitor serum testosterone concentration at 14 and 28 days after starting treatment and adjust dose accordingly.
• Precautions to minimize secondary exposure: Avoid contact with children and women, wash hands after application, cover application site with clothing, and wash application site before direct skin-to-skin contact.
• Contraindications: Inform patients about the risks of worsening benign prostatic hyperplasia (BPH) and potential risk of prostate cancer 2.

From the Research

Important Counseling Points for Testosterone Gel Pump

• The use of testosterone gel pump may have various effects on the prostate, including an increase in prostate volume, but not necessarily an increase in adenoma volume 3.
• Serum testosterone levels have been found to be significantly associated with prostatic volume increase among benign prostatic hyperplasia (BPH) patients, although the effect is weak 4.
• Testosterone therapy may improve markers of prostatitis in men with BPH, but it does not necessarily improve urinary symptoms 3.
• The exact mechanism of the improvement in lower urinary tract symptoms (LUTS) with testosterone therapy is still debated, but it may be related to metabolic syndrome 5, 6.
• Low testosterone levels, rather than high levels, may favor prostate inflammation and contribute to the development of BPH 6.
• Testosterone levels may be an independent predictor of disease and can enhance the predictive accuracy for BPH and prostate cancer when combined with prostate-specific antigen (PSA) levels 7.
• Patients should be informed about the potential risks and benefits of testosterone gel pump, including the possibility of worsening LUTS or urinary retention, although the evidence suggests that testosterone may not be detrimental to the prostate 5, 6.