What is the proper protocol for prescribing AndroGel (testosterone gel)?

Proper Protocol for Prescribing AndroGel (Testosterone Gel)

When prescribing AndroGel (testosterone gel), follow the FDA-approved dosing regimen of 50-100 mg/day for AndroGel 1% or 20.25-81 mg/day for AndroGel 1.62%, applied to the upper arms and shoulders, with careful monitoring of testosterone levels and potential side effects. 1, 2

Dosing and Administration Guidelines

Initial Dosing

• For AndroGel 1%, start with 50-100 mg/day (5-10 g of gel) applied to the skin of the back, abdomen, upper thighs, and upper arms 1
• For AndroGel 1.62%, start with 40.5 mg/day (2.5 g of gel) applied to the skin of the upper arms and shoulders only 2
• Titrate dose based on pre-dose morning total serum testosterone concentration measured 2-3 months after treatment initiation 1, 2

Dose Adjustment

• If testosterone level is >750 ng/dL: Decrease daily dose by 20.25 mg (for 1.62% gel) 2
• If testosterone level is 350-750 ng/dL: No change in dose 2
• If testosterone level is <350 ng/dL: Increase daily dose by 20.25 mg (for 1.62% gel) 2
• Target mid-normal testosterone values (500-600 ng/dL) 1

Application Instructions

• Apply to clean, dry, intact skin of the upper arms and shoulders only for AndroGel 1.62% 2
• Limit application area to what will be covered by a short-sleeve t-shirt 2
• Use palm of hand to spread gel across maximum surface area 2
• Allow gel to dry completely before dressing 2
• Wash hands thoroughly with soap and water immediately after application 2
• Avoid swimming or showering for at least 2 hours after application 2

Monitoring Protocol

• Measure testosterone levels 2-3 months after initiating treatment and after any dose change 1
• Once stable levels are confirmed, monitor every 6-12 months 1
• For transdermal preparations, levels can be measured at any time, understanding that testosterone concentrations can vary with gel use 1
• Monitor for signs of secondary exposure in women and children 2
• Assess prostate health with PSA and digital rectal examination before and during treatment 2
• Monitor hematocrit and hemoglobin for potential erythrocytosis 3

Safety Precautions

Secondary Exposure Prevention

• Advise patients to cover application site with clothing after gel has dried 2
• Warn patients about potential transfer to women and children through skin contact 2
• Instruct patients to wash application sites thoroughly before anticipated skin-to-skin contact 2
• If unwashed or unclothed skin with applied gel contacts another person, advise washing the contact area with soap and water immediately 2

Contraindications

• Men with known or suspected prostate or breast cancer 2
• Pregnant women due to risk of fetal virilization 2

Warnings and Precautions

• Risk of worsening benign prostatic hyperplasia (BPH) symptoms 2
• Potential increased risk of prostate cancer 2
• Possible increased risk of cardiovascular events, though evidence is conflicting 1
• Flammability of alcohol-based gel; avoid fire, flames, or smoking until gel has dried 2

Clinical Considerations

• Transdermal testosterone preparations are preferred over injections due to more stable day-to-day testosterone levels 1
• Gel preparations offer easy application and good skin tolerability compared to patches 1
• Gel preparations may have less cardiovascular risk compared to injectable testosterone 1
• Disadvantages include potential for transfer to others and higher cost than injectable formulations 1
• Treatment efficacy should be assessed through improvements in symptoms of hypogonadism, including sexual function, mood, lean body mass, and bone mineral density 3

By following these guidelines, clinicians can appropriately prescribe AndroGel to maximize therapeutic benefits while minimizing risks to patients and those who may come in contact with them.