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JATENZO® is Safe & Effective

Designed to offer safe oral delivery
of testosterone1,3

How JATENZO works

JATENZO is testosterone replacement therapy that offers safe, oral delivery.1,3

Designed to work differently

JATENZO is a newer 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

JATENZO is testosterone undecanoate that avoids direct circulation to the liver

Unlike older forms of oral testosterone… JATENZO does not initially go through or build up in the liver.7

Avoiding a direct route to the liver means avoiding liver safety issues and having more available testosterone

JATENZO offers safe, oral delivery by avoiding the liver toxicity issues associated with older forms of oral TRT and consistently having more testosterone available for the body.3,7

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Jatenzo raised T levels to the normal range in 87% of men3

T=testosterone

Men reached normal testosterone levels within 7 days and maintained them over time8-9*†

*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).

TU=testosterone undecanoate

Men taking oral JATENZO reported improvements as a result of increased testosterone levels

Psychosexual Daily Questionnaire (PDQ)3,7,12

Positive Sexual Mood

increase

Sexual Desire

increase

Sexual Enjoyment With Partner

increase

Sexual Enjoyment Without Partner

increase

Weekly Sexual Activity

increase

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.

Men taking oral JATENZO also reported improvements in lean body mass and fat loss7

Lean Body Mass

increase

Fat Mass

decrease

Feel confident with an established safety profile1

Table listing side effects of JATENZO with corresponding percentage of patients affected (N=166)

HDL=high-density lipoprotein.

Among the 569 patients who received JATENZO in all Phase 2 and 3 trials combined, the following adverse reactions were reported in >2% of patients: polycythemia, diarrhea, dyspepsia, eructation, peripheral edema, nausea, increased hematocrit, headache, prostatomegaly, and hypertension.

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).

If your current TRT doesn’t fit your routine
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.

*These common side effects were reported in ≥2% of men who received JATENZO in the 4-month study.

If your current TRT doesn’t fit your routine

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.
Let Your Doctor Know

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

What is JATENZO?

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.

What important safety information is there for JATENZO?

  • JATENZO might raise your blood pressure, which could cause serious heart problems like heart attacks, strokes, or even death related to heart conditions.
  • Before taking JATENZO, your doctor should check your blood pressure and consider your risk for heart problems. Your doctor should also periodically monitor new-onset and pre-existing high blood pressure.
  • Due to this risk, JATENZO should only be used for treatment of men who have a deficiency or absence of natural testosterone due to structural or genetic causes.

Who should not take JATENZO?

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.

What side effects should I be aware of before starting JATENZO?

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.

What are the most common side effects with JATENZO?

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.

What medications should I tell my doctor that I am taking before starting JATENZO?

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.

12. 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.