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Terms and Conditions

Please carefully review the following terms and conditions of use (“Terms and Conditions”), which apply to everyone who visits this Tolmar* website. By accessing and using this website, you are agreeing to abide by, and be bound by, the following Terms and Conditions and any amendments in effect at the time of your visit. Tolmar may modify these Terms and Conditions at any time without notice by updating these legal notices, and we encourage you to review the Terms and Conditions because any such modifications will be binding on you.

Copyright/Trademark Notice

Trademarks and service marks on this Tolmar website, including but not limited to product names, are registered and unregistered trademarks of Tolmar and others. The contents of this Tolmar website (including, without limitation, the arrangement and layout of the websites; names and logos; and text, illustrations and artwork) are the copyrighted and/or trademarked property of Tolmar (or the original creator of the material) and are protected under applicable copyright and trademark laws. Nothing contained on the websites should be construed as granting any license or right to use any such marks or copyrighted material without the written permission of Tolmar or such other party who may own such mark(s) or copyrighted material. Any unauthorized use of the trademarks, copyrights or other contents of this Tolmar website may violate civil or criminal laws.

Product Catalog

The product catalog on the Tolmar website has been designed as a quick reference for Tolmar products. Some products-either brand or generic-may no longer be available on the market due to discontinuations from product portfolios. This product catalog may not represent our complete product portfolio due to additional product launches or product discontinuations. The products displayed on this website are intended as a reference source only and not for prescribing or dispensing purposes.

Patients should always obtain complete medical information about their prescription medicines (beneficial medical uses and possible adverse effects) from the product’s approved package insert and/or by discussing the appropriate use of any medicine(s) directly with their prescribing physician. Consumers should not construe any information herein as medical advice. Tolmar and its affiliates are not responsible for any reliance on or use of any information included herein.

No Advice

Nothing contained in Tolmar’s website should be construed as medical, legal, investment, financial or other advice. Without limitation, nothing contained in the sites should replace medical advice, medical visits or recommendations from health care providers. Patients should always consult with a doctor or other health care provider for medical advice.

Links

Tolmar’s website contains links to third-party websites, which are provided as a convenience to users of our site. Tolmar makes no claim or warranty of, and is not responsible for, any information found in a linked website. We encourage you to check the disclaimers and other legal notices provided on such linked sites.

No Representation or Warranty

While Tolmar uses reasonable efforts to include up-to-date and accurate information on its website, Tolmar does not make, and expressly disclaims, any representations or warranties of any kind, either express or implied (including without limitation any implied warranties of merchantability, fitness for a particular purpose or non-infringement) with regard to any such information, its accuracy or completeness or the frequency that it is updated. Everything on Tolmar’s website is provided “AS IS.” Tolmar assumes no liability or responsibility for any errors or omissions in the content of its websites.

Limitation of Liability

Your use of Tolmar’s website is at your own risk. In no event shall Tolmar or any of its officers, directors, employees or affiliates, be liable, directly or indirectly, for any damages of any kind or nature, including, without limitation, direct, incidental, punitive or consequential, or any claims or losses, resulting from or in connection with the creation or use of, or reliance on, this site or any information contained herein, any other Tolmar website or any linked website contained in any such sites, or any of the information accessed through any such site or from the inability to use any such site. This limitation includes damage to your computer equipment or any viruses that may infect your computer equipment or other property.

Governing Law

These Terms and Conditions of use and your use of this website shall be governed by the laws of the State of Colorado without regard to conflict of laws principles. Any legal action or proceeding related to the Terms and Conditions or your use of this website shall be brought exclusively in the courts of the State of Colorado or the United States District Court for the District of Colorado.

*Tolmar refers to Tolmar Holdings, Inc. and its wholly owned operating subsidiaries, Tolmar, Inc. (product development and manufacturing), Tolmar Therapeutics, Inc. (licensing), and Tolmar Pharmaceuticals, Inc. (sales and marketing).

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.