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Long-Term Data of Oral Testosterone Undecanoate (TU)

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2 year analysis of oral TU in hypogonadal men (ages 18-75)1

Patients sustained testosterone levels in the normal eugonadal range for over 2 years1

Total serum testosterone response over duration of studyAt all evaluations, serum T concentrations were in the eugonadal range (300 – 1000 ng/dL)1

Adverse Events Treatment-emergent adverse events in 5% or more of patients at any time over 2 years were prostatomegaly (10.5%), polycythemia (7%), and hypertension (5%).

Limitations of the study include the limited number of patients followed for 2 years and lack of a control or active-treatment group over the second year.

This report describes an extension of a phase 3 clinical trial. Men (N=161) who received open-label, randomized treatment with 316 mg of JATENZO twice daily, with two titration opportunities during 12 months, were offered the option to enroll in a 12-month extension study. The long-term efficacy and safety of JATENZO were evaluated in patients who completed 24 months of uninterrupted JATENZO treatment (n=69).1

Oral TU patients experienced a sustained change from baseline
in symptoms over 2 years1

Psychosexual daily questionnaire (PDQ) scores over duration of study

Changes from baseline for study days 30-730 were analyzed using a repeated measures analysis of covariance model run for each domain.1

*Changes at each study visit were statistically significantly different from Baseline/Day 0 and were p<0.0011 in all cases.

†The PDQ was utilized to evaluate appropriate parameters for patients treated with testosterone therapy. Erectile dysfunction was not evaluated.

‡5 discontinuations due to adverse events in the 12-month follow-up period were observed.

Patients had no clinically significant changes in liver function tests measured as ALT, ALP, AST, and bilirubin.1
A small increase in SBP (3-6 mm Hg) as well as incidence of polycythemia (7%) was observed; 1.2% (n=2) of patients on JATENZO discontinued due to high hematocrit in the initial 1-year period.1§
There were no clinically significant changes in PSA level or in AUA-IPSS scores.1

§One case of cerebral stroke, possibly related to treatment, was observed.

ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; AUA=American Urology Association; IPSS=International Prostate Symptom Score; 
PSA=prostate specific antigen; SBP= systolic blood pressure; T=testosterone; TU=testosterone undecanoate

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IMPORTANT SAFETY INFORMATION FOR JATENZO (testosterone undecanoate)

Indication and Limitations of Use:

JATENZO® (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

  • Primary hypogonadism (congenital or acquired)
  • Hypogonadotropic hypogonadism (congenital or acquired)

Safety and efficacy of JATENZO in men with “age-related hypogonadism” and in males less than 18 years old have not been established.

IMPORTANT SAFETY INFORMATION FOR JATENZO (testosterone undecanoate)

CONTRAINDICATIONS

JATENZO is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate, in women who are pregnant, or in men with a known hypersensitivity to JATENZO or its ingredients.

WARNINGS AND PRECAUTIONS

Increase in hematocrit and polycythemia. High red blood cell counts increase the risk of clots, strokes, and heart attacks.

Venous thromboembolic events (VTE). Deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone replacement products like JATENZO.

Benign prostatic hyperplasia (BPH). Patients may see worsening signs and symptoms of BPH.

Prostate cancer. Patients treated with androgens may be at increased risk for prostate cancer.

Blood pressure increases. JATENZO can increase blood pressure. Monitor blood pressure periodically in men using JATENZO. Not recommended for use with uncontrolled hypertension.

Abuse. Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Testosterone abuse can lead to serious cardiovascular and psychiatric adverse reactions.

Suppression of spermatogenesis. Large doses of androgens, like JATENZO, can suppress spermatogenesis.

Hepatic adverse events. JATENZO is not known to cause liver adverse events; however, patients should be instructed to report any signs of hepatic dysfunction.

Retention of sodium and water.

Gynecomastia.

Sleep apnea. Testosterone may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung disease.

Changes in the serum lipid profile may require dose adjustment of lipid-lowering drugs or discontinuation of testosterone therapy.

Risk of hypercalcemia.

ADVERSE EVENTS

The most common adverse events of JATENZO (incidence ≥2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).

DRUG INTERACTIONS

JATENZO can cause changes in insulin sensitivity or glycemic control and changes in anticoagulant activity. Use of testosterone and corticosteroids concurrently may increase fluid retention. Use of prescription and nonprescription analgesic cold medications with JATENZO have been known to increase blood pressure.

To report suspected adverse reactions contact Tolmar at 1-844-4TOLMAR (486-5627) or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please see full Prescribing Information.

Reference

1. Honig S, Gittelman M, et al. Two-Year Analysis of a New Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men:Efficacy, Impact on Psychosexual Function,and Safety. J Sex Med. 2022;19(12):1750-1758.