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FREQUENTLY ASKED QUESTIONS

I am new to JATENZO

How do I get JATENZO?

You need a prescription from a doctor for JATENZO.

What is JATENZO?

JATENZO (testosterone undecanoate) is a testosterone replacement therapy (TRT) designed to get men into the normal testosterone zone through individualized dosing options. JATENZO delivers testosterone safely to your blood stream without going through your liver first1-3

Who can currently take JATENZO?

Men 18 years and over who have low or no testosterone due to certain medical conditions. JATENZO is not indicated for use in women or men with breast cancer or known or suspected prostate cancer.2,3

Is JATENZO as safe as other testosterone replacement therapies?

Unlike older forms of oral testosterone replacement therapy, Jatenzo avoids direct circulation to the liver by delivering testosterone to your blood stream. In clinical trials, no liver toxicity events were observed.3,7 Because there are no studies that directly compare all treatment options, it’s important for you to find the one that works best for you and your needs. Talk to your doctor to help find the best treatment for you.

Is JATENZO as effective as other testosterone replacement therapies?

In clinical trials, JATENZO raised T levels to the normal range in 87.3% of men.3,10 Steady state T levels were also reached as early as Day 7 for men in the clinical study.3 However, because there are no studies that directly compare all treatment options, it’s important for you to talk to your doctor to find the option that works best for you.

I am a JATENZO patient

How do I store JATENZO?

JATENZO is designed to be taken on the go. Store JATENZO in a dry place at room temperature between 68 °F to 77 °F (20 °C to 25 °C). Keep JATENZO and all medicines out of the reach of children.2

How do I take JATENZO?

Take JATENZO twice a day with food—in the AM and then again in the PM—to help keep your testosterone levels right where they should be.1

What do I do if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take 2 doses at one time.

What results could I see with JATENZO?

In a clinical study, JATENZO raised testosterone levels to the normal range in 87.3% (n=145/166) of adult men at 4 months.3,10

What are potential side effects of JATENZO?

JATENZO may cause serious side effects, including increase in blood pressure; increase in red blood cell count or hemoglobin; worsening signs and symptoms of pre-existing enlarged prostate; increased risk of prostate cancer; or blood clots in the legs or lungs. In large doses, JATENZO may lower sperm count; cause liver problems; cause swelling of ankles, feet, or body, with or without heart failure; cause enlarged or painful breasts; or cause breathing problems while you sleep and changes in mood. These are not all the possible side effects of JATENZO. For more information, ask your healthcare provider or pharmacist.2

In the inTUne study, the most common side effects with JATENZO (incidence ≥2%) were headache (5%), increased red blood cell count (5%), hypertension (4%), decreased HDL (“good”) cholesterol (3%), and nausea (2%).1

How much does JATENZO cost?

With the JATENZO Savings Card, eligible patients with commercial insurance may pay as little as $0 for JATENZO*. See Terms, Conditions and Restrictions for more information.

What do the different capsule doses look like?1


Capsules are not actual size.

RESOURCES

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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.