What is the proper protocol for writing an order for AndroGel (testosterone gel) for an adult male patient with hypogonadism or low testosterone levels?

How to Write an Order for AndroGel

For adult males with confirmed hypogonadism (two morning testosterone levels <300 ng/dL with symptoms), prescribe AndroGel 1.62% starting at 40.5 mg (2 pump actuations or one 40.5 mg packet) applied once daily to the shoulders and upper arms, with dose titration based on testosterone levels checked at 14 and 28 days targeting 350-750 ng/dL. 1, 2

Diagnostic Confirmation Required Before Prescribing

• Measure morning total testosterone (8-10 AM) on two separate occasions, with both values <300 ng/dL required to establish hypogonadism 1, 2, 3
• Document specific symptoms of testosterone deficiency, particularly diminished libido and erectile dysfunction 1, 3
• Measure LH and FSH to distinguish primary from secondary hypogonadism, as this has critical fertility implications 1, 3
• Absolutely confirm the patient does not desire fertility within the next year, as testosterone suppresses spermatogenesis and causes azoospermia 1, 4

The Prescription Order

Write the order as follows:

• Medication: AndroGel (testosterone gel) 1.62%
• Dose: 40.5 mg (2 pump actuations OR one 40.5 mg packet)
• Route: Topical to shoulders and upper arms only
• Frequency: Once daily in the morning
• Quantity: 30-day supply (60 pump actuations OR 30 packets of 40.5 mg)
• Refills: 2-3 refills initially (to cover monitoring period)
• Special instructions: "Apply to clean, dry, intact skin of shoulders and upper arms. Allow to dry completely, then cover with clothing. Wash hands immediately with soap and water after application." 2

Critical Application Instructions to Provide Patient

• Apply only to shoulders and upper arms—never to abdomen, genitals, chest, armpits, or knees 2
• Limit application area to what would be covered by a short-sleeve t-shirt 2
• Allow gel to dry completely, then cover with clothing before any skin-to-skin contact 2
• Wash hands immediately with soap and water after application 2
• Avoid swimming, showering, or washing application site for minimum 2 hours after application 2
• Wash application sites thoroughly with soap and water before any anticipated skin contact with women or children to prevent secondary exposure 2

Dose Titration Protocol

• Check testosterone level at 14 days and 28 days after starting treatment (pre-dose morning level) 2
• Target range: 350-750 ng/dL 2
• Adjust dose based on the following algorithm 2:
  • If testosterone >750 ng/dL: Decrease by 20.25 mg (1 pump actuation)
  • If testosterone 350-750 ng/dL: Continue current dose
  • If testosterone <350 ng/dL: Increase by 20.25 mg (1 pump actuation)
• Minimum dose: 20.25 mg daily (1 pump actuation) 2
• Maximum dose: 81 mg daily (4 pump actuations or two 40.5 mg packets) 2

Mandatory Baseline Testing Before First Prescription

• Baseline hematocrit or hemoglobin (hematocrit >54% is absolute contraindication) 1, 4
• PSA and digital rectal exam in men over 40 years (PSA >4.0 ng/mL requires urology evaluation first) 1, 4
• Morning testosterone on two occasions to confirm diagnosis 1, 2
• LH and FSH to distinguish primary vs. secondary hypogonadism 1, 4

Ongoing Monitoring Schedule

• Testosterone levels at 2-3 months after any dose change, then every 6-12 months once stable 1, 4
• Hematocrit at each visit—withhold treatment if >54% and consider phlebotomy 1, 4
• PSA monitoring in men over 40—refer to urology if increase >1.0 ng/mL in first 6 months or >0.4 ng/mL per year thereafter 1, 4
• Assess symptomatic response, particularly sexual function, at 12 months—discontinue if no improvement 1, 4

Absolute Contraindications (Do Not Prescribe If Present)

• Active desire for fertility preservation (use gonadotropins instead) 1, 4
• Active or treated male breast cancer 1, 2
• Known or suspected prostate cancer 2
• Hematocrit >54% 1, 4
• Pregnancy in female partners (risk of virilization of female fetus through transfer) 2

Cost Considerations and Alternative Formulations

• AndroGel 1.62% costs approximately $2,135 annually vs. $156 for intramuscular testosterone 1, 4
• If cost is prohibitive, consider switching to testosterone cypionate 100-200 mg IM every 2 weeks or 50-100 mg weekly 1, 5, 6
• Transdermal formulations have significantly lower risk of erythrocytosis (15.4%) compared to injectable testosterone (43.8%) 1
• Transdermal provides more stable day-to-day testosterone levels, while injectable causes fluctuations with peaks at 2-5 days and return to baseline by 10-14 days 1, 4

Common Prescribing Pitfalls to Avoid

• Never prescribe without confirming fertility status—testosterone causes prolonged azoospermia 1, 4
• Never prescribe based on symptoms alone without two documented low morning testosterone levels 1, 3
• Never prescribe to eugonadal men (normal testosterone) even if symptomatic—this violates evidence-based guidelines 1, 4
• Never forget to counsel about transfer risk to women and children through skin contact 2
• Never assume AndroGel 1% and 1.62% are interchangeable—they have different dosing and are not equivalent 1, 2

Expected Treatment Outcomes to Discuss

• Small but significant improvements in sexual function and libido (standardized mean difference 0.35) 7, 1, 4
• Little to no effect on physical functioning, energy, vitality, or cognition 7, 1
• Modest improvements in quality of life, primarily in sexual function domains 7, 1
• Potential improvements in bone mineral density and body composition (increased lean mass, decreased fat mass) 8