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FAQs & Resources

Check the info below for FAQs, resources, links, and other useful details

FREQUENTLY ASKED QUESTIONS

I am new to JATENZO®

Are testosterone “pills” and “capsules” the same thing?

While many people commonly use the terms “pills” and “capsules” interchangeably, no, they are not the same thing. Both formulations are taken orally, but there are important differences to keep in mind. Capsules, unlike pills, can not be cut in half or crushed.

How do I get JATENZO?

You need a prescription from a doctor for JATENZO. Be sure to talk to your doctor about your testosterone replacement therapy (TRT) needs.

What is JATENZO?

JATENZO is prescribed to adult men for testosterone replacement therapy who have a deficiency or absence of their natural testosterone due to structural or genetic causes. Oral JATENZO softgel “capsules” are a form of testosterone undecanoate that is suspended in a special type of liquid (emulsion) that allows it to be safely absorbed in your bloodstream without going through your liver first.1,3,7

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?

JATENZO is an oral formulation of testosterone undecanoate that is absorbed via the intestinal lymphatic system, therefore initially bypassing the liver. In clinical trials, no liver toxicity events were observed.1,3,7 Because there are no studies that directly compare 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 Steady state T levels (the time which the concentration of the drug in the body stays consistent) were also reached as early as Day 7 for men in the clinical study.8 However, because there are no studies that directly compare 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.1

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.2

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

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.1 For more information, ask your healthcare provider or pharmacist.

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%).1,3

How much does JATENZO cost?

It feels good to save money. With the JATENZO Copay Card, you may pay as little as $0 for JATENZO. Restrictions may apply. A maximum benefit per calendar year will be applied. Patients without insurance or those who choose to pay cash can get JATENZO for $185 per month.

What do the different capsule doses look like?


Capsules are not actual size.

RESOURCES

Patient Education
Brochure

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Folleto de educación
al paciente en español

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Answers 
to
FAQs

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Copay
Card

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Doctor
Discussion Guide

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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 men with low testosterone due to age and 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.

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, or in men who are over-sensitive to JATENZO or its ingredients.

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

Elevated red blood cell counts. This may increase the risk of blood clots, strokes, and heart attacks.

Blood clots. Blood clots in the legs that may travel to the lungs have been reported in patients using testosterone replacement products.

Enlarged prostate. If you already have an enlarged prostate, your signs and symptoms may worsen.

Prostate cancer. Patients taking testosterone may be at increased risk for prostate cancer.

Increase in blood pressure. JATENZO can increase blood pressure. JATENZO may need to be stopped if your blood pressure cannot be controlled. Your healthcare provider should monitor your blood pressure while you are being treated with JATENZO.

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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information, including Medication Guide.

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.