INDICATION

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): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.

  • Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.

Limitation of use

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

IMPORTANT SAFETY INFORMATION (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 as JATENZO has not been established for these conditions and there is a risk of increased blood pressure with JATENZO that can increase the risk of MACE.

WARNINGS AND PRECAUTIONS

  • 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. Before initiating JATENZO, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled. Monitor blood pressure approximately 3 weeks after initiating, increasing the dose, and periodically while on JATENZO, and treat any new or exacerbations of hypertension. Re-evaluate benefits and risks of continued treatment with JATENZO in patients who develop cardiovascular risk factors or disease. JATENZO is contraindicated in men with hypogonadal conditions such as “age-related hypogonadism” because the efficacy of JATENZO has not been established for these conditions and the increases in BP can increase the risk of MACE.

  • Polycythemia may require a lower dose or discontinuation of JATENZO. Check hematocrit prior to initiation and every 3 months while a patient is on JATENZO and if hematocrit becomes elevated, stop JATENZO until hematocrit decreases to an acceptable level. If hematocrit increases after JATENZO is restarted, stop permanently.

  • Some studies, but not all, have reported an increased risk of major adverse cardiovascular events (MACE) in association with use of testosterone replacement therapy in men. Long-term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use JATENZO. JATENZO can increase blood pressure, which can increase the risk of MACE.

  • Monitor patients with benign prostatic hyperplasia (BPH) treated with androgens due to an increased risk for worsening signs and symptoms of BPH. Patients treated with androgens may be at increased risk for prostate cancer and should be evaluated prior to initiating and during treatment with androgens. Monitor prostate-specific antigen (PSA) levels periodically.

  • Postmarketing reports of venous thromboembolic events (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone replacement products like JATENZO. Evaluate patients with signs or symptoms consistent with DVT or PE and, if a VTE is suspected, discontinue JATENZO and initiate appropriate workup and management.

  • Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. If abuse is suspected, check testosterone levels to ensure they are in therapeutic range. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.

  • JATENZO is not indicated for use in women.

  • Large doses of androgens can suppress spermatogenesis by feedback inhibition of pituitary FSH. Inform patients of this risk before prescribing JATENZO.

  • Prolonged use of high doses of methyltestosterone has been associated with serious hepatic adverse events. JATENZO is not known to cause these adverse events; however, patients should be instructed to report any signs of hepatic dysfunction and JATENZO should be discontinued while the cause is evaluated.

  • Androgens, including JATENZO, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.

  • Gynecomastia may develop and persist in patients being treated for hypogonadism.

  • The treatment of hypogonadal men with 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. Monitor the lipid profile periodically, particularly after starting testosterone therapy.

  • Use JATENZO with caution in cancer patients at risk of hypercalcemia. Monitor serum calcium concentration regularly during treatment with JATENZO in these patients.

  • Androgens, including JATENZO, may decrease concentrations of thyroxine-binding globulin, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

  • Depression and suicidal ideation have been reported in patients treated with JATENZO in clinical trials. Advise patients and caregivers to seek medical attention for manifestations of new-onset or worsening depression, suicidal ideation or behavior, anxiety, or other mood changes.

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. Androgens may decrease blood glucose and may require a decrease in the dose of antidiabetic medications.

  • Anticoagulant activity may be affected by androgens. More frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking warfarin, especially at initiation and termination of androgen therapy.

  • Use of testosterone and corticosteroids concurrently may increase fluid retention and requires monitoring in patients with cardiac, renal, or hepatic disease.

  • Some prescription and nonprescription analgesic cold medications contain drugs known to increase blood pressure and concomitant use of these medications with JATENZO may lead to additional increases in blood pressure.

USE IN SPECIFIC POPULATIONS

The safety and efficacy of JATENZO in pediatric patients less than 18 years old have not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.

There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing JATENZO to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. There is insufficient long-term safety data in geriatric patients utilizing JATENZO to assess the potentially increased risk of cardiovascular disease and prostate cancer.

Please click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure.

Read More

This Privacy Policy was last updated on April 1, 2019.

Our Policy:
Welcome to the web site (the "Site") of Clarus Therapeutics, Inc. ("Clarus Therapeutics", "we", "us" and/or "our"). This Site is operated by Clarus Therapeutics and has been created to provide information about our company and the products we offer to our Site visitors and users ("you", "your"). This Privacy Policy sets forth our policy with respect to information including personally identifiable data ("Personal Data") and other information that is collected from visitors to the Site.

Information We Collect:
When you interact with us through the Site, we may collect Personal Data and other information from you, as further described below:

            Personal Data That You Provide Through the Site: We collect Personal Data from you when you voluntarily provide such information, such as when you contact us with inquiries.

By voluntarily providing us with Personal Data, you are consenting to our use of it in accordance with this Privacy Policy. If you provide Personal Data to the Site, you acknowledge and agree that such Personal Data may be transferred from your current location to the offices and servers of Clarus Therapeutics and the authorized third parties referred to herein located in the United States.

            Other Information:

                        Non-Identifiable Data: When you interact with Clarus Therapeutics through the Site, we receive and store certain personally non-identifiable information. We may store such information itself or such information may be included in databases owned and maintained by Clarus Therapeutics's affiliates, agents or service providers. The Site may use such information and pool it with other information to track, for example, the total number of visitors to our Site, the number of visitors to each page of our Site, and the domain names of our visitors' Internet service providers. 

            In operating the Site, we may use a technology called "cookies." A cookie is a piece of information that the computer that hosts our Site gives to your browser when you access the Site. Our cookies help provide additional functionality to the Site and help us analyze Site usage more accurately. For instance, our Site may set a cookie on your browser that allows you to access the Site without needing to remember and then enter a password more than once during a visit to the Site. On most web browsers, you will find a "help" section on the toolbar. Please refer to this section for information on how to receive notification when you are receiving a new cookie and how to turn cookies off. We recommend that you leave cookies turned on because they allow you to take advantage of some of the Service features.

                        Aggregated Personal Data: In an ongoing effort to better understand and serve the users of the Site, we often conduct research on its customer demographics, interests and behavior based on the Personal Data and other information provided to us. This research may be compiled and analyzed on an aggregated and/or de-identified basis, and we may share this aggregated and/or de-identified data with its affiliates, agents and business partners. We may also disclose aggregated and/or de-identified user statistics and other metrics related to our Site in order to describe our products or services to current and prospective business partners and to other third parties for other lawful purposes.

                        Analytics and Tracking Technologies:  We may, and we may allow third party service providers to, use cookies (as noted above) or other tracking technologies to collect information about your browsing activities over time and across different websites following your use of the Site. For example, we use Google Analytics, a web analytics service provided by Google, Inc. ("Google"). Google Analytics uses cookies to help us analyze how users use the Site and enhance your experience when you use the Site. For more information on how Google uses this data, go to www.google.com/policies/privacy/partners/. 

Our Site currently does not respond to "Do Not Track" (DNT) signals and operates as described in this Privacy Policy whether or not a DNT signal is received. If we do so in the future, we will describe how we do so in this Privacy Policy.

Our Use of Your Personal Data and Other Information:
We use the Personal Data you provide in a manner that is consistent with this Privacy Policy. If you provide Personal Data for a certain reason, we may use the Personal Data in connection with the reason for which it was provided. For instance, if you contact us by email, we will use the Personal Data you provide to answer your question or resolve your problem. Also, if you provide Personal Data in order to obtain access to the Site, we will use your Personal Data to provide you with access to such services and to monitor your use of such services. Clarus Therapeutics and its subsidiaries and affiliates (the "Related Companies") may also use your Personal Data and other personally non-identifiable information collected through the Site to help us improve the content and functionality of the Site, to better understand our users and to improve the Site and our products and services. Clarus Therapeutics and its affiliates may use this information to contact you in the future to tell you about products and services we believe will be of interest to you. If we do so, each marketing communication we send you will contain instructions permitting you to "opt-out" of receiving future marketing communications. In addition, if at any time you wish not to receive any future marketing communications or you wish to have your name deleted from our mailing lists, please contact us as indicated below. 

Certain other ways we may use your Personal Data are as follows:

  • To allow us to better respond to your requests.

  • To troubleshoot problems with the Site.

  • To enforce our Terms of Use, and to detect and protect against error, fraud and other unauthorized or illegal activities.

  • To provide any legitimate business service or product.

Our Disclosure of Your Personal Data and Other Information:
Clarus Therapeutics is not in the business of selling your Personal Data.  There are, however, certain circumstances in which we may share your Personal Data with certain third parties without further notice to you, as set forth below:

            Business Transfers: As we develop our business, we might sell or buy businesses or assets. In the event of a corporate sale, merger, reorganization, dissolution or similar event, Personal Data may be part of the transferred assets. 

            Related Companies: We may also share your Personal Data with our Related Companies for purposes consistent with this Privacy Policy.

            Agents, Consultants and Related Third Parties: We, like many businesses, sometimes hire other companies to perform certain business-related functions. Examples of such functions include mailing information, maintaining databases and processing payments. When we employ another entity to perform a function of this nature, we generally provide them with the information that they need to perform their specific function.          

            Legal Requirements: We may disclose your Personal Data if required to do so by law or in the good faith belief that such action is necessary to (i) comply with a legal obligation, (ii) protect and defend the rights or property of Clarus Therapeutics, (iii) act in urgent circumstances to protect the personal safety of users of the Site or the public, or (iv) protect against legal liability.

Your Choices:
You can visit the Site without providing any Personal Data. If you choose not to provide any Personal Data, you may not be able to use certain Site features.

Exclusions:
This Privacy Policy does not apply to any Personal Data collected by us other than Personal Data collected through the Site. This Privacy Policy shall not apply to any unsolicited information you provide to us through the Site or through any other means. This includes, but is not limited to, information posted to any public areas of the Site, such as forums, any ideas for new products or modifications to existing products, and other unsolicited submissions (collectively, "Unsolicited Information"). All Unsolicited Information shall be deemed to be non-confidential and we shall be free to reproduce, use, disclose, and distribute such Unsolicited Information to others without limitation or attribution.

Children:
We do not knowingly collect Personal Data from children under the age of 13. If you are under the age of 13, please do not submit any Personal Data through the Site. We encourage parents and legal guardians to monitor their children's Internet usage and to help enforce our Privacy Policy by instructing their children never to provide Personal Data on the Site without their permission. If you have reason to believe that a child under the age of 13 has provided Personal Data to us through the Site, please contact us, and we will endeavor to delete that information from our databases.

Links to Other Web Sites: 
This Privacy Policy applies only to the Site. The Site may contain links to other web sites not operated or controlled by us (the "Third Party Sites"). The policies and procedures we described here do not apply to the Third Party Sites. The links from the Site do not imply that Clarus Therapeutics endorses or has reviewed the Third Party Sites. We suggest contacting those sites directly for information on their privacy policies.

Security:
We take commercially reasonable steps to protect the Personal Data provided via the Site from loss, misuse, and unauthorized access, disclosure, alteration, or destruction. However, no Internet or email transmission is ever fully secure or error free. In particular, email sent to or from the Site may not be secure. Therefore, you should take special care in deciding what information you send to us via email. Please keep this in mind when disclosing any Personal Data to us via the Internet.

Other Terms and Conditions:
Your access to and use of the Site is subject to the Terms of Use and any other definitive agreement between you and Clarus Therapeutics.

Changes to This Privacy Policy:
The Site and our business may change from time to time. As a result, at times it may be necessary for us to make changes to this Privacy Policy. We reserve the right to update or modify this Privacy Policy at any time and from time to time without prior notice. Please review this policy periodically, and especially before you provide any Personal Data. This Privacy Policy was last updated on the date indicated above. Your continued use of the Site after any changes or revisions to this Privacy Policy shall indicate your agreement with the terms of such revised Privacy Policy.

Access to Information; Contacting Us:
Please feel free to contact us if you have any questions about our Privacy Policy or the information practices of the Site.

You may contact us at (847) 562-4300, or at the following address:

Clarus Therapeutics, Inc.
555 Skokie Boulevard
Suite 340
Northbrook, IL 60062

INDICATION

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): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.

  • Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.

Limitation of use

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

IMPORTANT SAFETY INFORMATION (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 as JATENZO has not been established for these conditions and there is a risk of increased blood pressure with JATENZO that can increase the risk of MACE.

WARNINGS AND PRECAUTIONS

  • 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. Before initiating JATENZO, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled. Monitor blood pressure approximately 3 weeks after initiating, increasing the dose, and periodically while on JATENZO, and treat any new or exacerbations of hypertension. Re-evaluate benefits and risks of continued treatment with JATENZO in patients who develop cardiovascular risk factors or disease. JATENZO is contraindicated in men with hypogonadal conditions such as “age-related hypogonadism” because the efficacy of JATENZO has not been established for these conditions and the increases in BP can increase the risk of MACE.

  • Polycythemia may require a lower dose or discontinuation of JATENZO. Check hematocrit prior to initiation and every 3 months while a patient is on JATENZO and if hematocrit becomes elevated, stop JATENZO until hematocrit decreases to an acceptable level. If hematocrit increases after JATENZO is restarted, stop permanently.

  • Some studies, but not all, have reported an increased risk of major adverse cardiovascular events (MACE) in association with use of testosterone replacement therapy in men. Long-term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use JATENZO. JATENZO can increase blood pressure, which can increase the risk of MACE.

  • Monitor patients with benign prostatic hyperplasia (BPH) treated with androgens due to an increased risk for worsening signs and symptoms of BPH. Patients treated with androgens may be at increased risk for prostate cancer and should be evaluated prior to initiating and during treatment with androgens. Monitor prostate-specific antigen (PSA) levels periodically.

  • Postmarketing reports of venous thromboembolic events (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone replacement products like JATENZO. Evaluate patients with signs or symptoms consistent with DVT or PE and, if a VTE is suspected, discontinue JATENZO and initiate appropriate workup and management.

  • Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. If abuse is suspected, check testosterone levels to ensure they are in therapeutic range. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.

  • JATENZO is not indicated for use in women.

  • Large doses of androgens can suppress spermatogenesis by feedback inhibition of pituitary FSH. Inform patients of this risk before prescribing JATENZO.

  • Prolonged use of high doses of methyltestosterone has been associated with serious hepatic adverse events. JATENZO is not known to cause these adverse events; however, patients should be instructed to report any signs of hepatic dysfunction and JATENZO should be discontinued while the cause is evaluated.

  • Androgens, including JATENZO, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.

  • Gynecomastia may develop and persist in patients being treated for hypogonadism.

  • The treatment of hypogonadal men with 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. Monitor the lipid profile periodically, particularly after starting testosterone therapy.

  • Use JATENZO with caution in cancer patients at risk of hypercalcemia. Monitor serum calcium concentration regularly during treatment with JATENZO in these patients.

  • Androgens, including JATENZO, may decrease concentrations of thyroxine-binding globulin, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

  • Depression and suicidal ideation have been reported in patients treated with JATENZO in clinical trials. Advise patients and caregivers to seek medical attention for manifestations of new-onset or worsening depression, suicidal ideation or behavior, anxiety, or other mood changes.

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. Androgens may decrease blood glucose and may require a decrease in the dose of antidiabetic medications.

  • Anticoagulant activity may be affected by androgens. More frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking warfarin, especially at initiation and termination of androgen therapy.

  • Use of testosterone and corticosteroids concurrently may increase fluid retention and requires monitoring in patients with cardiac, renal, or hepatic disease.

  • Some prescription and nonprescription analgesic cold medications contain drugs known to increase blood pressure and concomitant use of these medications with JATENZO may lead to additional increases in blood pressure.

USE IN SPECIFIC POPULATIONS

The safety and efficacy of JATENZO in pediatric patients less than 18 years old have not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.

There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing JATENZO to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. There is insufficient long-term safety data in geriatric patients utilizing JATENZO to assess the potentially increased risk of cardiovascular disease and prostate cancer.

Please click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure.

Read More Read More