GET STARTED WITH OUR PHARMACY PROVIDER

HAVE A QUESTION? GET IN TOUCH

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 FOR JATENZO (testosterone undecanoate)

Indication and Limitations of Use:

JATENZO®(testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

  • Primary hypogonadism (congenital or acquired)
  • Hypogonadotropic hypogonadism (congenital or acquired)

Safety and efficacy of JATENZO in males less than 18 years old have not been established.

IMPORTANT SAFETY INFORMATION FOR JATENZO (testosterone undecanoate)

WARNING: INCREASES IN BLOOD PRESSURE

  • JATENZO can cause blood pressure (BP) increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death.
  • Before initiating JATENZO, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled.
  • Periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension and re-evaluate whether the benefits of JATENZO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment.
  • Due to this risk, use JATENZO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.

CONTRAINDICATIONS

JATENZO is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate, in women who are pregnant, in men with a known hypersensitivity to JATENZO or its ingredients, or in men with hypogonadal conditions that are not associated with structural or genetic etiologies.

WARNINGS AND PRECAUTIONS

Increase blood pressure and Major Adverse Cardiovascular Events. JATENZO can increase blood pressure, which can increase the risk of MACE, with greater risk in patients with established cardiovascular disease or risk factors for cardiovascular disease.

Increase in hematocrit and polycythemia. High red blood cell counts increase the risk of clots, strokes, and heart attacks.

Benign prostatic hyperplasia (BPH). Patients may see worsening signs and symptoms of BPH.

Prostate cancer. Patients treated with androgens may be at increased risk for prostate cancer.

Venous thromboembolic events (VTE). Deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone replacement products like JATENZO.

Abuse. Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Testosterone abuse can lead to serious cardiovascular and psychiatric adverse reactions.

Suppression of spermatogenesis. Large doses of androgens, like JATENZO, can suppress spermatogenesis.

Hepatic adverse events. JATENZO is not known to cause liver adverse events; however, patients should be instructed to report any signs of hepatic dysfunction.

Retention of sodium and water.

Gynecomastia.

Sleep apnea. Testosterone may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung disease.

Changes in the serum lipid profile may require dose adjustment of lipid-lowering drugs or discontinuation of testosterone therapy.

Risk of hypercalcemia.

ADVERSE EVENTS

The most common adverse events of JATENZO (incidence ≥2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).

DRUG INTERACTIONS

JATENZO can cause changes in insulin sensitivity or glycemic control and changes in anticoagulant activity. Use of testosterone and corticosteroids concurrently may increase fluid retention. Use of prescription and nonprescription analgesic cold medications with JATENZO have been known to increase blood pressure.

Please see full Prescribing Information, including BOXED WARNING on increases in blood pressure.

To report suspected adverse reactions contact Tolmar at 1-844-4TOLMAR (486-5627) or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

References

1. JATENZO® [prescribing information]. Fort Collins, CO: Tolmar; 2023.

2. 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.

3. 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.

4. Data on file. The Landmark SERMO survey: The state of TRT in 2024. (conducted February 16-March 1, 2024). Tolmar, Inc.

5. Data on file. The Harris Poll. Hypogonadism Patient Research: Executive Summary (conducted May 6-June 5, 2020). Tolmar, Inc.

6. Data on file. Clinical Study Report: CLAR-15012. Tolmar, Inc.

7. Petrova TV, Koh GY. Organ-specific lymphatic vasculature: From development to pathophysiology. J Exp Med. 2018;215(1):35-49.

8. Data on file. Clinical Study Report: CLAR-09009. Tolmar, Inc.

9. Data on file. Clinical Study Report: CLAR-09007. Tolmar, Inc.

10. Shoskes JJ, Wilson MK, Spinner ML. Pharmacology of testosterone replacement therapy preparations. Transl Androl Urol. 2016;5(6):834-843.