JATENZO’s route of administration is built to reduce liver toxicity issues associated with older forms of testosterone.1,3,6
MODE OF ABSORPTION
JATENZO is a form of oral testosterone specifically designed to be safely delivered to your blood stream without going through your liver first.3,7
JATENZO should be taken with meals as food helps it work better.1,2
Unlike older forms of oral testosterone replacement therapy, JATENZO avoids direct circulation to the liver.7
JATENZO offers safe, oral delivery by avoiding the liver toxicity issues associated with older forms of oral TRT.3,7
Primary endpoint
FDA target ≥75%
87.3% of JATENZO patients were in normal testosterone ranges
OTHER CLINICAL STUDIES
STEADY STATE BY DAY 78*†
Optimal testosterone levels were achieved in 7 days* and remained stable over an extended period (>9 months)† in other studies8,9
*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.
†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).
GET THE RESULTS YOU WANT
The PDQ was an exploratory assessment of each participant’s view of his psychosexual satisfaction, evaluated by self-report. Sexual desire, sexual enjoyment, positive mood, and negative mood, were evaluated on a 7-point scale.
Weekly sexual activity was determined using a count of the activities experienced over the complete weekly period.
The PDQ was an exploratory assessment of each participant’s view of his psychosexual satisfaction, evaluated by self-report. Sexual desire, sexual enjoyment, positive mood, and negative mood, were evaluated on a 7-point scale. Weekly sexual activity was determined using a count of the activities experienced over the complete weekly period.
JATENZO PATIENTS EXPERIENCED SIGNIFICANT IMPROVEMENTS IN LEAN BODY MASS AND FAT LOSS7
Effect of 6- and 12-month oral TU therapy on mean (±) change from baseline (lbs) in lean body mass and fat mass in trial 1. Data was converted from kilograms (kg) to pounds (lb) with the conversion factor of 2.20.7
TU = testosterone undecanoate.
HDL=high-density lipoprotein.
No clinically significant changes in liver function tests were observed with JATENZO.*
The most common side effects reported with JATENZO in clinical studies included headache, increased red blood cell count, high blood pressure, enlarged prostate gland, diarrhea, heartburn, foot, leg, and ankle swelling, burping, and nausea.
A serious side effect reported with JATENZO is that it can increase blood pressure. This can increase your risk of having a heart attack or stroke. It can also increase your risk of death due to a heart attack or stroke. Your doctor should monitor your blood pressure while you are being treated with JATENZO. You may also need to start new medicines or have medicines changed for high blood pressure.
Three patients (1.8% of 166) had adverse reactions that led to premature discontinuation from the study, including rash (n=1) and headache (n=2).
This does not represent all the possible side effects related to JATENZO. Please be sure to talk to your doctor about any side effect you experience while on JATENZO.
*These common side effects were reported in ≥2% of men who received JATENZO in the 4-month study.
Be prepared to talk to your doctor if you feel you are experiencing any problems or burdens associated with injections or topical applications. Because your TRT should help you feel better. That’s it.
JATENZO® (testosterone undecanoate) capsules are prescribed to adult men for testosterone replacement therapy when they have a deficiency or absence of their natural testosterone due to structural or genetic causes.
Safety and efficacy of JATENZO in boys less than 18 years old have not been established. JATENZO is a controlled substance, CIII, due to risk for physical and psychological dependence and abuse.
JATENZO should not be used in men with breast cancer or known or suspected prostate cancer, in women who are pregnant, in men who are over-sensitive to JATENZO or its ingredients, or in men with low testosterone that is not associated with structural or genetic factors.
Increase blood pressure. JATENZO can increase blood pressure, which can increase the risk of serious heart problems, especially in with established risk factors for heart disease.
Elevated red blood cell counts. This may increase the risk of blood clots, strokes, and heart attacks.
Benign prostatic hyperplasia (BPH). If you have been previously diagnosed with BPH, signs and symptoms may worsen.
Prostate cancer. Patients taking testosterone may be at increased risk for prostate cancer.
Blood clots. Blood clots in the legs that may travel to the lungs have been reported in patients using testosterone replacement products.
Abuse. Testosterone has been subject to abuse, typically at doses higher than recommended. Testosterone abuse can lead to serious cardiovascular and psychiatric side effects, including depression and suicidal ideas.
Low sperm count. Large doses of testosterone products may suppress sperm production.
Liver problems. JATENZO is not known to cause liver side effects; however, report any signs of liver problems to your doctor.
Swelling of your ankles, feet, or body (edema).
Enlarged or painful breasts.
Sleep apnea. Testosterone may worsen sleep apnea, especially with risk factors such as excess body fat or chronic lung conditions.
Changes in lipid levels. Lipid changes may require dose adjustment of your cholesterol medication or stopping testosterone treatment.
Changes in mood. Talk to your healthcare provider if you have changes in mood or behavior including, new or worsening depression, or suicidal thoughts.
The most common side effects of JATENZO are increased red blood cell count, diarrhea, indigestion, burping, swelling of the leg or foot, nausea, enlarged prostate gland, high blood pressure, and headache.
Tell your healthcare provider about all medications that you are taking prior to starting JATENZO, including prescription, over the counter medicines, vitamins, and supplements. Ensure that you notify your provider if you take insulin, blood-thinning medications, corticosteroids, or common pain or cold medicines.
Please see full Prescribing Information, including boxed warning on increases in blood pressure, and Medication Guide.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
References
1. JATENZO® [prescribing information]. Fort Collins, CO: Tolmar; 2023.
2. JATENZO® [medication guide]. Fort Collins, CO: Tolmar; 2023.
3. 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.
4. Data on file. The Harris Poll. Hypogonadism Patient Research: Executive Summary (conducted May 6-June 5, 2020). Tolmar, Inc.
5. Data on file. The Landmark SERMO survey: The state of TRT in 2024. (conducted February 16-March 1, 2024). Tolmar, Inc.
6. Petrova TV, Koh GY. Organ-specific lymphatic vasculature: From development to pathophysiology. J Exp Med. 2018;215(1):35-49.
7. 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.
8. Data on file. Clinical Study Report: CLAR-09009. Tolmar, Inc.
9. Data on file. Clinical Study Report: CLAR-09007. Tolmar, Inc.
10. Data on file. Clinical Study Report: CLAR-15012. Tolmar, Inc.
11. Shoskes JJ, Wilson MK, Spinner ML. Pharmacology of testosterone replacement therapy preparations. Transl Androl Urol. 2016;5(6):834-843.
