What are the guidelines for refilling testosterone replacement therapy?

Guidelines for Testosterone Replacement Therapy Refills

Testosterone replacement therapy refills should follow a structured monitoring protocol with specific timing for laboratory tests, clinical evaluations, and dose adjustments to ensure safety and efficacy.

Monitoring Timeline

• Initial follow-up should occur at 1-2 months after starting testosterone therapy to assess treatment efficacy and consider dose adjustments 1
• Testosterone levels should be formally tested 2-3 months after treatment initiation or after any dose change 1
• Subsequent monitoring visits should be performed at 3-6 month intervals for the first year, then yearly thereafter if stable 1, 2

Laboratory Parameters to Monitor

• Serum testosterone levels should be measured at the appropriate time based on formulation:

  • For injectable testosterone (cypionate/enanthate): measure levels midway between injections (typically day 5-7 for weekly injections) 1
  • Target testosterone levels should be in the mid-to-upper normal range for optimal treatment response 1

• Hematocrit/hemoglobin should be measured:

  • At baseline before initiating testosterone therapy
  • At 1-2 months after initiation
  • Every 3-6 months during the first year
  • Annually thereafter if stable 2

• PSA levels should be monitored to detect potential prostate-related issues 1

Intervention Thresholds

• If hematocrit exceeds 54%, interventions are required to reduce cardiovascular and thromboembolic risk 2:

  • Therapeutic phlebotomy is recommended as first-line intervention 2
  • Temporarily withholding testosterone therapy or reducing dosage may also be considered 2

• If baseline hematocrit exceeds 50%, consider withholding testosterone therapy until the etiology is formally investigated 2

Formulation-Specific Considerations

• Injectable testosterone formulations carry a higher risk of erythrocytosis (43.8%) compared to transdermal preparations (15.4%) 2
• For replacement in the hypogonadal male, 50 to 400 mg should be administered every two to four weeks for injectable formulations 3
• Testosterone gel preparations show a dose-dependent relationship with erythrocytosis, with incidence rates increasing at higher doses 2

Clinical Response Assessment

• At each follow-up visit, assess:
  • Symptomatic response to treatment
  • Voiding symptoms
  • Sleep apnea
  • Physical examination, including digital rectal examination 1

Risk Factors Requiring Closer Monitoring

• Patients using injectable testosterone formulations require closer monitoring due to higher erythrocytosis risk 2
• Patients with concurrent conditions that may independently increase hematocrit (e.g., chronic obstructive pulmonary disease) require more vigilant monitoring 2
• Elderly patients or those with vascular disease may be at higher risk from TRT-associated erythrocytosis due to increased blood viscosity 2

Practical Refill Algorithm

1. Verify appropriate laboratory monitoring has been completed within recommended timeframes
2. Confirm hematocrit is <54% (if ≥54%, implement interventions before refilling)
3. Review PSA levels for significant changes
4. Assess clinical response and side effects
5. Adjust dosage if needed based on testosterone levels and clinical response
6. Schedule next monitoring appointment according to the established timeline
7. Provide refill with appropriate quantity to last until next scheduled evaluation