What is JATENZO® (testosterone undecanoate), capsules, for oral use CIII approved for?

JATENZO is approved by the FDA as a prescription medicine that contains a controlled substance called testosterone. JATENZO is used to treat adult males who have low or no testosterone due to certain medical conditions.

It is not known if JATENZO is safe or effective in children younger than 18 years old. Improper use of JATENZO may affect bone growth in children.

IMPORTANT SAFETY INFORMATION FOR JATENZO (testosterone undecanoate)

What is the most important information I should know about JATENZO?

JATENZO can cause serious side effects, including:

  • JATENZO can increase your blood pressure, which can increase your risk of having a heart attack or stroke and can increase your risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.

  • If your blood pressure increases while on JATENZO, blood pressure medicines may need to be started. If you are taking blood pressure medicines, new blood pressure medicines may need to be added or your current blood pressure medicines may need to be changed to control your blood pressure.

  • If your blood pressure cannot be controlled, JATENZO may need to be stopped.

  • Your healthcare provider will monitor your blood pressure while you are being treated with JATENZO.

What is JATENZO?

JATENZO is a prescription medicine that contains testosterone. JATENZO is used to treat adult men who have low or no testosterone due to certain medical conditions.

JATENZO is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your JATENZO in a safe place to protect it. Never give your JATENZO to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law.

JATENZO is not meant for use by women.

Do not take JATENZO if you:

  • have breast cancer.

  • have or might have prostate cancer.

  • are a woman who is pregnant. JATENZO may harm your unborn baby.

  • are allergic to JATENZO or any ingredients in JATENZO.

  • have low testosterone without certain medical conditions. For example, do not take JATENZO if you have low testosterone due to age.

Before you take JATENZO, tell your healthcare provider about all of your medical conditions, including if you:

  • have high blood pressure or are treated for high blood pressure.

  • have heart problems.

  • have high red blood cell count (hematocrit) or high hemoglobin laboratory value.

  • have urinary problems due to an enlarged prostate.

  • have liver or kidney problems.

  • have a history of mental health illness including suicidal thoughts or actions, depression, anxiety or mood disorder.

  • have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Using JATENZO with certain other medicines can affect each other. Especially, tell your healthcare provider if you take:

  • insulin

  • medicines that decrease blood clotting (blood thinners)

  • corticosteroids

  • medicines that increase blood pressure such as some cold medicines and pain medicines

Know the medicines you take. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take JATENZO?

  • Take JATENZO exactly as your healthcare provider tells you to take it.

  • Take JATENZO by mouth two times daily. Take 1 time in the morning and take 1 time in the evening.

  • Take JATENZO with food.

  • Your healthcare provider may change your JATENZO dose. Do not change your JATENZO dose without talking to your healthcare provider.

What are the possible side effects of JATENZO?

JATENZO may cause serious side effects including:

  • See “What is the most important information I should know about JATENZO?”

  • Increase in blood pressure.

    • JATENZO can increase your blood pressure, which can increase your risk of having a heart attack or stroke and can increase your risk of death due to heart attack or stroke. Your risk may be greater if you already have heart disease or if you have had a heart attack or stroke.

    • You may need to start new medicines or have medicines changed for high blood pressure while on JATENZO.

    • Your healthcare provider should check your blood pressure while you use JATENZO.

  • Increase in red blood cell count (hematocrit) or hemoglobin.

    • JATENZO increases red blood cell counts in some patients. High red blood cell counts increase the risk of blood clots, strokes, and heart attacks.

    • You may need to stop JATENZO if your red blood cell count increases.

    • Your healthcare provider should check your red blood cell count and hemoglobin while you use JATENZO.

  • If you already have an enlarged prostate, your signs and symptoms may worsen while using JATENZO. These may include:

    • increased urination at night

    • trouble starting your urine stream

    • urinating many times during the day

    • urge to go to the bathroom right away

    • a urine accident

    • inability to pass urine or weak urine flow

  • Increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use JATENZO.

  • Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.

  • Abuse. Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects. Your healthcare provider should check you for signs of abuse before and during treatment with JATENZO.

  • In large doses JATENZO may lower your sperm count.

  • Liver problems. Symptoms of liver problems may include:

    • nausea or vomiting

    • yellowing of your skin or whites of your eyes

    • dark urine

    • pain on the right side of your stomach area (abdominal pain)

  • Swelling of your ankles, feet, or body (edema), with or without heart failure.

  • Enlarged or painful breasts.

  • Breathing problems while you sleep (sleep apnea).

  • Changes in mood. Talk to your healthcare provider if you have changes in mood or behavior including, new or worsening depression, or suicidal thoughts.

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effects of JATENZO include:

  • increased red blood cell count

  • burping

  • enlarged prostate gland

  • diarrhea

  • foot, leg, and ankle swelling

  • high blood pressure

  • heart burn

  • nausea

  • headache

Other side effects include more erections than are normal for you or erections that last a long time.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of JATENZO. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.

Keep JATENZO and all medicines out of the reach of children.

Please see the full Prescribing Information, including BOXED WARNING on increases in blood pressure, and Medication Guide for JATENZO.

You are encouraged to report any side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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

What is JATENZO® (testosterone undecanoate), capsules, for oral use CIII approved for?

JATENZO is approved by the FDA as a prescription medicine that contains a controlled substance called testosterone. JATENZO is used to treat adult males who have low or no testosterone due to certain medical conditions.

It is not known if JATENZO is safe or effective in children younger than 18 years old. Improper use of JATENZO may affect bone growth in children.

IMPORTANT SAFETY INFORMATION FOR JATENZO (testosterone undecanoate)

What is the most important information I should know about JATENZO?

JATENZO can cause serious side effects, including:

  • JATENZO can increase your blood pressure, which can increase your risk of having a heart attack or stroke and can increase your risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.

  • If your blood pressure increases while on JATENZO, blood pressure medicines may need to be started. If you are taking blood pressure medicines, new blood pressure medicines may need to be added or your current blood pressure medicines may need to be changed to control your blood pressure.

  • If your blood pressure cannot be controlled, JATENZO may need to be stopped.

  • Your healthcare provider will monitor your blood pressure while you are being treated with JATENZO.

What is JATENZO?

JATENZO is a prescription medicine that contains testosterone. JATENZO is used to treat adult men who have low or no testosterone due to certain medical conditions.

JATENZO is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your JATENZO in a safe place to protect it. Never give your JATENZO to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law.

JATENZO is not meant for use by women.

Do not take JATENZO if you:

  • have breast cancer.

  • have or might have prostate cancer.

  • are a woman who is pregnant. JATENZO may harm your unborn baby.

  • are allergic to JATENZO or any ingredients in JATENZO.

  • have low testosterone without certain medical conditions. For example, do not take JATENZO if you have low testosterone due to age.

Before you take JATENZO, tell your healthcare provider about all of your medical conditions, including if you:

  • have high blood pressure or are treated for high blood pressure.

  • have heart problems.

  • have high red blood cell count (hematocrit) or high hemoglobin laboratory value.

  • have urinary problems due to an enlarged prostate.

  • have liver or kidney problems.

  • have a history of mental health illness including suicidal thoughts or actions, depression, anxiety or mood disorder.

  • have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Using JATENZO with certain other medicines can affect each other. Especially, tell your healthcare provider if you take:

  • insulin

  • medicines that decrease blood clotting (blood thinners)

  • corticosteroids

  • medicines that increase blood pressure such as some cold medicines and pain medicines

Know the medicines you take. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take JATENZO?

  • Take JATENZO exactly as your healthcare provider tells you to take it.

  • Take JATENZO by mouth two times daily. Take 1 time in the morning and take 1 time in the evening.

  • Take JATENZO with food.

  • Your healthcare provider may change your JATENZO dose. Do not change your JATENZO dose without talking to your healthcare provider.

What are the possible side effects of JATENZO?

JATENZO may cause serious side effects including:

  • See “What is the most important information I should know about JATENZO?”

  • Increase in blood pressure.

    • JATENZO can increase your blood pressure, which can increase your risk of having a heart attack or stroke and can increase your risk of death due to heart attack or stroke. Your risk may be greater if you already have heart disease or if you have had a heart attack or stroke.

    • You may need to start new medicines or have medicines changed for high blood pressure while on JATENZO.

    • Your healthcare provider should check your blood pressure while you use JATENZO.

  • Increase in red blood cell count (hematocrit) or hemoglobin.

    • JATENZO increases red blood cell counts in some patients. High red blood cell counts increase the risk of blood clots, strokes, and heart attacks.

    • You may need to stop JATENZO if your red blood cell count increases.

    • Your healthcare provider should check your red blood cell count and hemoglobin while you use JATENZO.

  • If you already have an enlarged prostate, your signs and symptoms may worsen while using JATENZO. These may include:

    • increased urination at night

    • trouble starting your urine stream

    • urinating many times during the day

    • urge to go to the bathroom right away

    • a urine accident

    • inability to pass urine or weak urine flow

  • Increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use JATENZO.

  • Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.

  • Abuse. Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects. Your healthcare provider should check you for signs of abuse before and during treatment with JATENZO.

  • In large doses JATENZO may lower your sperm count.

  • Liver problems. Symptoms of liver problems may include:

    • nausea or vomiting

    • yellowing of your skin or whites of your eyes

    • dark urine

    • pain on the right side of your stomach area (abdominal pain)

  • Swelling of your ankles, feet, or body (edema), with or without heart failure.

  • Enlarged or painful breasts.

  • Breathing problems while you sleep (sleep apnea).

  • Changes in mood. Talk to your healthcare provider if you have changes in mood or behavior including, new or worsening depression, or suicidal thoughts.

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effects of JATENZO include:

  • increased red blood cell count

  • burping

  • enlarged prostate gland

  • diarrhea

  • foot, leg, and ankle swelling

  • high blood pressure

  • heart burn

  • nausea

  • headache

Other side effects include more erections than are normal for you or erections that last a long time.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of JATENZO. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.

Keep JATENZO and all medicines out of the reach of children.

Please see the full Prescribing Information, including BOXED WARNING on increases in blood pressure, and Medication Guide for JATENZO.

You are encouraged to report any side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Read More Read More