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JATENZO® is used for testosterone replacement therapy in adult men with testosterone deficiency due to structural or genetic causes. Inform your healthcare provider if you have high blood pressure, heart problems, prostate issues, or a history of blood clots. Also, disclose any medications you are taking, including over-the-counter drugs, vitamins, and supplements.

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? <ul> <li>JATENZO might raise your blood pressure, which could cause serious heart problems like heart attacks, strokes, or even death related to heart conditions. </li> <li>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.</li> <li>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.</li> </ul> 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 <a href="https://jatenzo.com/wp-content/uploads/jatenzo-prescribing-information-2023.pdf" target="_blank">full Prescribing Information</a>, including boxed warning on increases in blood pressure, and <a href="https://jatenzo.com/wp-content/uploads/jatenzo-medication-guide-2023.pdf" target="_blank">Medication Guide</a>. 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.

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