What are the monitoring recommendations for a patient taking 100 mg of testosterone gel?

From the Guidelines

Patients taking 100 mg of testosterone gel should have their testosterone levels monitored 2-4 weeks after starting therapy, then every 3-6 months during the first year, and annually thereafter. This monitoring schedule is based on the most recent and highest quality study available, which prioritizes the patient's morbidity, mortality, and quality of life as the primary outcome 1. The monitoring recommendations include:

• Complete blood count and liver function tests checked at baseline, 3-6 months, and then annually
• Prostate-specific antigen (PSA) measured at baseline, 3-6 months, then according to prostate cancer screening guidelines
• Blood pressure, lipid profile, and hemoglobin A1c monitored periodically
• Clinical assessment for symptom improvement, side effects, and signs of polycythemia at each visit
• Testosterone levels measured in the morning, ideally 2-8 hours after gel application, with target levels in the mid-normal range (400-700 ng/dL) This schedule helps ensure treatment efficacy while detecting potential adverse effects like erythrocytosis, liver dysfunction, worsening sleep apnea, or prostate issues, as highlighted in previous studies 1. Key considerations for monitoring and management include:
• Avoiding transference to others, particularly women and children, who are at high risk for adverse events
• Using commercially manufactured testosterone products instead of compounded testosterone, when possible, to ensure consistency and quality
• Considering alternative therapies, such as selective estrogen receptor modulators, human chorionic gonadotropin, or aromatase inhibitors, for men with testosterone deficiency who desire to maintain fertility.

From the FDA Drug Label

Dose adjustment: testosterone gel 1.62% can be dose adjusted between a minimum of 20.25 mg of testosterone (1 pump actuation or a single 20. 25 mg packet) and a maximum of 81 mg of testosterone (4 pump actuations or two 40.5 mg packets). The dose should be titrated based on the pre-dose morning serum testosterone concentration at approximately 14 days and 28 days after starting treatment or following dose adjustment. Additionally, serum testosterone concentration should be assessed periodically thereafter.

The monitoring recommendations for a patient taking 100 mg of testosterone gel are to titrate the dose based on the pre-dose morning serum testosterone concentration at approximately 14 days and 28 days after starting treatment or following dose adjustment. Additionally, serum testosterone concentration should be assessed periodically thereafter.

• Key monitoring parameters: serum testosterone concentration, prostate specific antigen (PSA), hemoglobin, hematocrit, liver function tests, and lipid concentrations.
• Frequency of monitoring: periodically, with specific timing depending on individual patient needs and response to treatment 2.

From the Research

Monitoring Recommendations for 100 mg Testosterone Gel

• The monitoring recommendations for a patient taking 100 mg of testosterone gel are not explicitly stated in the provided studies, but we can look at the effects of testosterone gel on various parameters to inform monitoring decisions 3.
• A study on the effects of transdermal testosterone gel on hypogonadal men found that the gel improved sexual function, mood, muscle strength, and body composition parameters, with minimal adverse effects 3.
• The study used a dose of 50 or 100 mg/day of 1% testosterone gel, and the dose was adjusted up or down to 75 mg/day based on serum testosterone concentrations 3.
• Monitoring of serum testosterone levels, hematocrit, and hemoglobin is recommended for patients taking testosterone gel, as increases in these parameters were observed in the study 3.
• Lipid profiles should also be monitored, as changes in lipid parameters were observed in some studies, although the effects were variable and inconsistent 4, 5, 6.
• Prostate-specific antigen (PSA) levels should be monitored, as increases in PSA were observed in some studies, although these increases were within the normal range 4, 3.

Parameters to Monitor

• Serum testosterone levels
• Hematocrit
• Hemoglobin
• Lipid profiles (including total cholesterol, HDL, LDL, and triglycerides)
• Prostate-specific antigen (PSA) levels
• Erythrocytosis (Hct > 50%) should be monitored, especially in patients taking injectable testosterone, as it was more common in this group than in those taking testosterone gel or pellets 4.

Frequency of Monitoring

• The frequency of monitoring will depend on individual patient factors, such as the presence of underlying medical conditions or the development of adverse effects.
• Regular monitoring of lipid levels is likely to be beneficial for patients taking testosterone gel, although the optimal frequency of monitoring is not clear 7.
• Monitoring of PSA levels and hematocrit should be performed regularly, especially in patients with a history of prostate cancer or erythrocytosis 4, 3.