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How JATENZO
avoids toxicity

The Mode of Absorption bypasses first-pass hepatic metabolism1-3

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Avoids Liver Toxicity Mode of Absorption Clinical Efficacy Results

AVOIDS LIVER TOXICITY

Not your first generation oral1-3,7

The first FDA-approved oral softgel testosterone replacement therapy (TRT)
specifically designed for safe oral delivery of testosterone undecanoate (TU), which:

  • is absorbed via the intestinal lymphatic system,
  • avoids first-pass hepatic metabolism; and
  • in clinical trials there were no liver toxicity-related events observed

Mode of absorption1-3

JATENZO (testosterone undecanoate) avoids first-pass hepatic metabolism

JATENZO is a prodrug formed by adding undecanoate, a fatty acid, to the molecular structure of testosterone.

Designed for absorption in the intestinal lymphatic system2,3,7

JATENZO’s unique formulation is designed to be absorbed and distributed through the intestinal lymphatic system—the pathway responsible for the transport of dietary lipids.

Mode of Absorption avoids first-pass hepatic metabolism1-3,7

The intestinal lymphatic system transports JATENZO to the body’s circulatory system where the fatty acids are cleaved to produce testosterone.

JATENZO offers safe, oral delivery2,3

Once in the body’s systemic circulation, testosterone undecanoate is cleaved to testosterone, avoiding first-pass hepatic metabolism.

JATENZO’s route of administration avoids liver toxicity issues associated with older forms of oral testosterone.

CLINICAL EFFICACY RESULTS

Phase 3 inTUne clinical trial1

The efficacy and safety of JATENZO were evaluated in 166 adult males 
with hypogonadism in a 4-month, open-label study1,6

 

*Normal eugonadal range was defined as 252-90‍7‍ ng‍/‍dL for blood collected in NaF-EDTA tubes.

BID=bi-daily (twice a day); PK=pharmacokinetics.

JATENZO RAISED T LEVELS TO THE NORMAL RANGE IN 87.3% OF MEN1

Primary efficacy endpoint:

Exceeded FDA target of ≥75% of men in eugonadal range3

STEADY STATE BY DAY 78*

JATENZO MAINTAINED NORMAL T LEVELS OVER EACH 12-HOUR DOSING INTERVAL1†

*In a 28-day study, the results suggest that the initial transient effect is resolved by Days 5-7, and that if testosterone administration continues beyond that time, systemic concentrations remain essentially constant from at least Day 7 onward for the remainder of the study period.8

†In a 12-month study, the pharmacokinetics of oral TU were stable over an extended time period (>9 months) of chronic dosing. Steady state exposures for the oral TU treatment subjects did not change between Day 90 (after at least 1 month on the maintenance dose) and Day 365 (after at least 10 months on the maintenance dose).9

‡Normal range according to general thought is 300-1000 ng/dL. Concentrations of NaF-EDTA plasma T measured in patients were converted to approximate serum T equivalents by a conversion factor of 1.21x.1,6

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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 males less than 18 years old have not been established.

IMPORTANT SAFETY INFORMATION FOR JATENZO (testosterone undecanoate)

WARNING: INCREASES IN BLOOD PRESSURE

  • JATENZO can cause blood pressure (BP) increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death.
  • Before initiating JATENZO, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled.
  • Periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension and re-evaluate whether the benefits of JATENZO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment.
  • Due to this risk, use JATENZO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.

CONTRAINDICATIONS

JATENZO is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate, in women who are pregnant, in men with a known hypersensitivity to JATENZO or its ingredients, or in men with hypogonadal conditions that are not associated with structural or genetic etiologies.

WARNINGS AND PRECAUTIONS

Increase blood pressure and Major Adverse Cardiovascular Events. JATENZO can increase blood pressure, which can increase the risk of MACE, with greater risk in patients with established cardiovascular disease or risk factors for cardiovascular disease.

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

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.

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

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.

Please see full Prescribing Information, including BOXED WARNING on increases in 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.

References

1. JATENZO® [prescribing information]. Fort Collins, CO: Tolmar; 2023.

2. Swerdloff RS, Wang C, White WB, et al. A new oral testosterone undecanoate formulation restores testosterone to normal concentrations in hypogonadal men. J Clin Endocrinol Metab. 2020;105(8):2515-2531.

3. Swerdloff RS, Dudley RE. A new oral testosterone undecanoate therapy comes of age for the treatment of hypogonadal men. Ther Adv Urol. 2020;12:1-16.

4. Data on file. The Landmark SERMO survey: The state of TRT in 2024. (conducted February 16-March 1, 2024). Tolmar, Inc.

5. Data on file. The Harris Poll. Hypogonadism Patient Research: Executive Summary (conducted May 6-June 5, 2020). Tolmar, Inc.

6. Data on file. Clinical Study Report: CLAR-15012. Tolmar, Inc.

7. Petrova TV, Koh GY. Organ-specific lymphatic vasculature: From development to pathophysiology. J Exp Med. 2018;215(1):35-49.

8. Data on file. Clinical Study Report: CLAR-09009. Tolmar, Inc.

9. Data on file. Clinical Study Report: CLAR-09007. Tolmar, Inc.

10. Shoskes JJ, Wilson MK, Spinner ML. Pharmacology of testosterone replacement therapy preparations. Transl Androl Urol. 2016;5(6):834-843.