What is the dosage and treatment protocol for Cernos (testosterone undecanoate) tablets in patients with hypogonadism?

Testosterone Undecanoate (Cernos) Dosage Protocol for Hypogonadism

For patients with hypogonadism, testosterone undecanoate (Cernos) tablets should be administered with a target dose to achieve serum testosterone levels between 450-600 ng/dL, with monitoring every 4-6 weeks initially and dose adjustments of 50 mg based on measured testosterone levels. 1

Dosing Protocol

• Initial Dosing:

  • Start with manufacturer's recommended dose
  • Take with meals containing fat to improve absorption
  • Typically administered 2-3 times daily due to short half-life

• Dose Adjustment:

  • Check testosterone levels 4-6 weeks after treatment initiation 1
  • Increase dose by 50 mg if testosterone levels remain below 300 ng/dL 1
  • Decrease dose by 50 mg if testosterone levels exceed 600 ng/dL 1
  • Target serum testosterone range: 450-600 ng/dL 1

Monitoring Schedule

• Initial phase: Check testosterone levels 4-6 weeks after starting treatment 1
• Maintenance phase: Monitor every 3-6 months 1
• Safety monitoring:
  • Hematocrit/hemoglobin: Every 3-6 months 1
  • Prostate-specific antigen (PSA): Baseline and follow-up
  • Liver function tests: Periodically with oral formulations

Special Considerations

• Fertility concerns: Testosterone undecanoate suppresses spermatogenesis. For men wishing to preserve fertility, consider alternative treatments such as:

  • Clomiphene citrate
  • Human chorionic gonadotropin (hCG)
  • Selective estrogen receptor modulators (SERMs) 1, 2

• Contraindications:

  • Prostate cancer
  • Male breast cancer
  • Desire for fertility in near future
  • Severe obstructive sleep apnea
  • Uncontrolled congestive heart failure
  • Hematocrit >54% 1

Safety Precautions

• Hematocrit management:

  • If hematocrit exceeds 54%, reduce dose or consider therapeutic phlebotomy 1
  • Consider switching to transdermal formulation if erythrocytosis persists 1

• Potential side effects:

  • Suppression of spermatogenesis
  • Polycythemia
  • Peripheral edema
  • Emotional lability
  • Cardiovascular effects 1

Clinical Pearls and Pitfalls

• Common pitfalls to avoid:

  • Diagnosing hypogonadism based on a single testosterone measurement
  • Failing to measure free testosterone in obese patients
  • Overlooking secondary causes of hypogonadism
  • Initiating therapy without proper baseline evaluation
  • Not monitoring for adverse effects, particularly hematocrit elevation 1

• Advantages of oral testosterone undecanoate:

  • Non-invasive administration compared to injections
  • Allows for more frequent dose adjustments if needed 3

• Disadvantages:

  • Requires multiple daily doses
  • Variable absorption pattern
  • Daily fluctuations in serum testosterone levels 3
  • Less consistent testosterone levels compared to newer formulations like gels or long-acting injectables 4, 3

Oral testosterone undecanoate represents one of several treatment options for hypogonadism. While newer formulations like transdermal gels and long-acting injectables are increasingly preferred due to more stable testosterone levels 3, oral formulations remain a viable option for some patients, particularly when other delivery methods are not suitable or available.