What is the recommended dosing for testosterone cypionate in adult males with hypogonadism?

Testosterone Cypionate Dosing for Adult Males with Hypogonadism

For replacement therapy in hypogonadal adult males, testosterone cypionate should be administered at 50-400 mg intramuscularly every 2-4 weeks, with most effective regimens being 100-200 mg every 2 weeks. 1

Dosing Recommendations

• The FDA-approved dosing range for testosterone cypionate in hypogonadal males is 50-400 mg administered intramuscularly every 2-4 weeks 1
• The most effective dosing regimens appear to be:
  • 100 mg weekly, or
  • 200 mg every 2 weeks 2, 3
• These regimens effectively suppress elevated LH and FSH levels to normal range while maintaining serum testosterone within physiologic levels 3
• Dosage should be adjusted based on the patient's response and the appearance of adverse reactions 1

Administration Route

• Testosterone cypionate is for intramuscular use only and should be administered deep in the gluteal muscle 1
• Intramuscular injections should not be given intravenously 1
• Subcutaneous administration is an emerging alternative that has shown effectiveness and may be preferred by some patients due to less discomfort 4, 5

Monitoring Parameters

• Target testosterone levels should be in the mid-normal range (450-600 ng/dL) 6
• Serum testosterone levels should be measured:
  • 3-6 months after treatment initiation
  • Then annually to ensure levels remain in the target range 6
• Regular monitoring of hematocrit/hemoglobin is essential as testosterone therapy commonly causes erythrocytosis, particularly with injectable formulations 7
• If hematocrit rises above the reference range, consider temporarily withholding therapy, reducing the dose, or performing phlebotomy 7
• Prostate monitoring through digital rectal examination and PSA measurement is recommended before initiating therapy, with regular PSA monitoring during treatment 7

Clinical Considerations

• Diagnosis of hypogonadism requires both low testosterone levels (<300 ng/dL) and symptoms/signs of testosterone deficiency 6
• Diagnosis should be confirmed with a second morning total testosterone measurement before initiating treatment 6
• Injectable testosterone formulations may be associated with greater fluctuations in serum testosterone levels compared to transdermal preparations 2
• Subcutaneous testosterone enanthate may be associated with lower post-therapy estradiol and hematocrit levels compared to intramuscular testosterone cypionate 5

Safety Considerations

• Injectable testosterone may be associated with a greater risk of cardiovascular events compared to gels, possibly due to increased time spent in both supratherapeutic and subtherapeutic ranges 2
• Testosterone therapy is contraindicated in men seeking fertility 2
• Active or treated male breast cancer remains an absolute contraindication for testosterone therapy 2
• Testosterone therapy should be avoided in patients with recent cardiovascular events (within past 3-6 months) 6

Practical Application

• Warming and shaking the vial should redissolve any crystals that may have formed during storage 1
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration 1
• For patients with erectile dysfunction, combination therapy with testosterone replacement and PDE5 inhibitors may be more effective than testosterone alone in more severe forms of ED 2, 8