What is the recommended treatment for adult males with hypogonadism using Jatenzo (testosterone undecanoate)?

Jatenzo (Testosterone Undecanoate) Treatment for Male Hypogonadism

Recommended Starting Regimen

Jatenzo should be initiated at 200 mg orally twice daily (morning and evening) with food, with dose titration based on serum testosterone levels measured 7 days after starting treatment or dose adjustment, 3-5 hours after the morning dose. 1

Diagnostic Requirements Before Initiation

• Confirm hypogonadism with two separate morning total testosterone measurements (8-10 AM) below 300 ng/dL on different days 2, 1
• Measure LH and FSH to distinguish primary from secondary hypogonadism, as this has critical treatment implications for fertility preservation 2
• Document specific symptoms, particularly diminished libido and erectile dysfunction, as these show the most reliable improvement with testosterone therapy (standardized mean difference 0.35) 2
• Assess baseline cardiovascular risk factors and ensure blood pressure is adequately controlled before initiating Jatenzo 1
• Obtain baseline hematocrit/hemoglobin, as hematocrit >54% is an absolute contraindication 2, 1
• Measure PSA in men over 40 years and perform digital rectal examination 2

Dose Titration Algorithm

The FDA-approved titration schedule for Jatenzo is highly specific and differs from other testosterone formulations: 1

• If serum testosterone <300 ng/dL: Increase to next higher dose level
• If serum testosterone 300-460 ng/dL: Increase by one dose level
• If serum testosterone 460-971 ng/dL: No dosage change needed
• If serum testosterone >971 ng/dL: Decrease by one dose level

Available dose levels: 100 mg once daily (minimum), 100 mg twice daily, 200 mg twice daily, 300 mg twice daily, 400 mg twice daily (maximum) 1

Critical Contraindications Specific to Jatenzo

Jatenzo has unique contraindications beyond standard testosterone therapy: 1

• Men with "age-related hypogonadism" or other conditions not associated with structural or genetic etiologies—Jatenzo is FDA-approved ONLY for primary hypogonadism or hypogonadotropic hypogonadism with structural/genetic causes 1
• Active desire for fertility preservation—testosterone causes prolonged azoospermia and is absolutely contraindicated 2, 1
• Breast or prostate cancer 1
• Recent cardiovascular events within 3-6 months 2
• Hematocrit >54% 2, 1
• Pregnancy (for female partners, due to virilization risk) 1

Blood Pressure Monitoring Requirements

Jatenzo carries a boxed warning for blood pressure increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death. 1

• Monitor blood pressure periodically after initiating therapy and treat new-onset hypertension or exacerbations of pre-existing hypertension 1
• Re-evaluate whether benefits outweigh risks in patients who develop cardiovascular risk factors while on treatment 1
• This cardiovascular risk is the primary reason Jatenzo is restricted to structural/genetic hypogonadism rather than age-related testosterone decline 1

Monitoring Schedule

• Measure serum testosterone 7 days after starting or dose adjustment, 3-5 hours after morning dose 1
• Target testosterone levels of 450-600 ng/dL (mid-normal range) 2
• Monitor hematocrit at 2-3 months, then every 6-12 months—withhold treatment if >54% and consider phlebotomy 2
• Monitor PSA in men over 40 years—refer for urologic evaluation if PSA increases >1.0 ng/mL in first 6 months or >0.4 ng/mL per year thereafter 2
• Assess blood pressure at each visit due to Jatenzo's specific cardiovascular risk 1

Expected Treatment Outcomes

• Small but significant improvements in sexual function and libido (standardized mean difference 0.35) 2
• Little to no effect on physical functioning, energy, vitality, depressive symptoms, or cognition 2
• Modest quality of life improvements, primarily in sexual function domains 2
• Potential improvements in insulin resistance, glycemic control, and lipid profile in men with diabetes 2

Advantages of Jatenzo Over Other Formulations

• Oral administration provides convenience compared to injections 3, 4
• More stable testosterone levels throughout the day compared to short-acting injectables 5, 3
• Lower risk of erythrocytosis compared to injectable testosterone cypionate or enanthate 2
• No risk of secondary exposure to women or children (unlike topical gels) 2
• Uses lymphatic absorption via self-emulsifying drug delivery system, avoiding first-pass hepatic metabolism 3

Critical Pitfalls to Avoid

• Never initiate Jatenzo without confirming the patient does not desire fertility—testosterone suppresses spermatogenesis and causes azoospermia; use gonadotropin therapy (hCG plus FSH) instead for men seeking fertility 2, 1
• Never use Jatenzo for "age-related hypogonadism" or functional hypogonadism—it is FDA-approved only for structural/genetic causes due to cardiovascular risk 1
• Never ignore blood pressure monitoring—Jatenzo specifically increases BP and MACE risk, requiring vigilant cardiovascular surveillance 1
• Never continue therapy if hematocrit exceeds 54%—this is an absolute indication to withhold treatment 2, 1
• Never expect meaningful improvements in energy, physical function, or mood—even with confirmed hypogonadism, testosterone provides minimal benefit for these symptoms 2
• Never substitute Jatenzo with other oral testosterone undecanoate products—they are not interchangeable 1

Alternative Treatment Considerations

• For men with secondary hypogonadism desiring fertility: Use gonadotropin therapy (hCG plus FSH) instead of any testosterone formulation 2, 6
• For men with obesity-associated hypogonadism: Attempt weight loss through low-calorie diets and exercise first, as this can improve testosterone levels without medication 2
• For cost-conscious patients: Intramuscular testosterone cypionate/enanthate costs $156 annually versus $2,135 for transdermal formulations 2
• For men with borderline testosterone and fertility concerns: Consider clomiphene citrate 25-50 mg three times weekly off-label, which stimulates endogenous production without suppressing spermatogenesis 6, 7

Reassessment Timeline

• Reevaluate symptoms at 12 months and discontinue Jatenzo if no improvement in sexual function is seen, to prevent unnecessary long-term exposure to cardiovascular risks without benefit 2