What is the maximum dose of Jatenzo (testosterone) for an adult male with hypogonadism?

Maximum Dose of Jatenzo

The maximum dose of Jatenzo (oral testosterone undecanoate) is 396 mg twice daily (792 mg total daily dose). 1

FDA-Approved Dosing Parameters

• Starting dose: 237 mg (3 capsules of 79 mg) taken twice daily with food 1
• Dose range: Can be adjusted between 158 mg (2 capsules) and 396 mg (5 capsules) twice daily 1
• Maximum single dose: 396 mg (5 capsules of 79 mg each) 1
• Maximum total daily dose: 792 mg per day (396 mg twice daily) 1

Dose Titration Strategy

Jatenzo requires food-dependent dosing and must be taken with meals to ensure adequate absorption through the lymphatic system. 2, 3

Titration Timeline and Targets

• Measure serum testosterone levels 4-6 hours after the morning dose at approximately 14 days after starting treatment or dose adjustment 1
• Target testosterone levels should be in the mid-normal range (450-600 ng/dL) 4, 5
• If testosterone levels are below 300 ng/dL, increase the dose by one capsule (79 mg) per administration 1
• If testosterone levels exceed 750 ng/dL, decrease the dose by one capsule (79 mg) per administration 1
• Continue monitoring every 3-6 months once stable levels are achieved 5, 6

Clinical Efficacy at Maximum Dosing

In phase III trials, oral testosterone undecanoate achieved eugonadal testosterone levels in 84-87% of patients, with mean serum testosterone concentrations of approximately 489-628 ng/dL. 2

• Significant improvements in sexual function parameters (p <0.0001) were observed across all dosing ranges 2
• Lean body mass increased by 3.2 ± 2.7 kg and fat mass decreased by 2.4 ± 3.6 kg after 365 days (both p <0.0001) 2
• Bone mineral density improved in both hip and spine after one year of therapy (both p <0.0001) 2

Safety Considerations at Higher Doses

Cardiovascular Monitoring

Oral testosterone undecanoate is associated with a mean increase in systolic blood pressure of 3-5 mmHg, which requires monitoring. 2

• Blood pressure should be assessed at baseline and monitored periodically during treatment 2
• Patients with uncontrolled hypertension should have blood pressure optimized before initiating therapy 2
• The formulation did not elevate cardiovascular biomarkers (high-sensitivity C-reactive protein or lipoprotein-associated phospholipase A2) after 365 days 2

Hematologic Monitoring

• Monitor hematocrit at baseline, 3-6 months after initiation, and then annually 5, 6
• Withhold treatment if hematocrit exceeds 54% 4, 5
• Consider phlebotomy in high-risk cases with persistent erythrocytosis 5, 6

Gastrointestinal Effects

Oral testosterone undecanoate is associated with a greater frequency of mild gastrointestinal adverse effects compared to other testosterone formulations, though these are typically mild. 2

• Common GI effects include nausea, diarrhea, and abdominal discomfort 2
• These effects are generally transient and resolve with continued therapy 2
• Taking the medication with food as directed minimizes GI symptoms 2, 3

Critical Contraindications

Jatenzo is absolutely contraindicated in men actively seeking fertility, as exogenous testosterone suppresses spermatogenesis and causes azoospermia. 4, 5

• Active or treated male breast cancer is an absolute contraindication 4, 5
• Hematocrit >54% requires withholding therapy 4, 5
• Recent cardiovascular events within the past 3-6 months warrant delaying initiation 4, 7

Advantages of Oral Formulation

The oral route provides physiologic testosterone levels without the risk of secondary transfer to women and children, which is a significant concern with topical formulations. 1, 3

• No risk of virilization in household contacts through skin-to-skin contact 1, 3
• Avoids the supraphysiologic peaks and subtherapeutic troughs seen with injectable testosterone 5, 3
• Does not cause hepatotoxicity despite oral administration, due to lymphatic absorption bypassing first-pass hepatic metabolism 2, 3
• More convenient than injections or daily topical applications for some patients 3

Common Pitfall to Avoid

Never prescribe Jatenzo without confirming the patient takes it with food—absorption is critically dependent on fat content in meals, and fasting administration results in inadequate testosterone levels. 2, 3 The self-emulsifying drug delivery system requires dietary fat for optimal lymphatic absorption, distinguishing it from older oral testosterone formulations that caused liver toxicity 2, 3.