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Important Safety Information

IMPORTANT SAFETY INFORMATION

What is the most important safety information I should know about TLANDO?

Blood Pressure Increases – TLANDO can increase blood pressure, which can increase the 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 you are on TLANDO, blood pressure medicines may need to be started or new medicines may need to be added. If your blood pressure cannot be controlled, TLANDO may need to be stopped. Your healthcare provider should monitor your blood pressure while you are being treated with TLANDO.

What is TLANDO?

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

It is not known if TLANDO is safe and effective for use in children younger than 18 years old. Improper use of TLANDO may effect bone growth in children.

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

TLANDO is not meant for use by women.

Do not use TLANDO if you:

  • Are a man who has breast cancer.
  • Have or might have prostate cancer.
  • Are a woman who is pregnant. TLANDO may harm your unborn baby.
  • Are allergic to TLANDO or to any TLANDO ingredients.
  • Have low testosterone without certain medical conditions. For example, do not take TLANDO if you have low testosterone due to age.

What should I tell my healthcare provider before using TLANDO?

Before you use TLANDO, tell your healthcare provider about all of your medical conditions, including, if you experience any of the following: high blood pressure or heart problems, high red blood cell count, urinary problems due to an enlarged prostate, kidney or liver problems, problems breathing while you sleep (sleep apnea) and enlarged or painful breasts.

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

Using TLANDO with other medicines can affect each other. Especially, tell your healthcare provider if you take insulin, medicines that decrease blood clotting (blood thinners), corticosteroids or medicines for pain and cold. Know the medicines you take. Ask your pharmacist for a list of all your medicines if you are not sure. Show your list to your healthcare provider and pharmacist when you get a new medicine.

How should I use TLANDO?

Use TLANDO exactly as your healthcare provider tells you to take it.

What are the possible side effects of TLANDO?

TLANDO can cause serious side effects including:

  • See “What is the most important information I should know about TLANDO?” above.
  • Blood pressure increases. TLANDO can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase your risk of death due to a heart attack or stroke.
  • Increase in red blood cell count, hematocrit or hemoglobin. High red blood cell counts increase the risk of clots, strokes, and heart attacks. You may need to stop TLANDO if your red blood cell count increases. Your healthcare provider should check your red blood cell count, hematocrit and hemoglobin while you use TLANDO.
  • Cardiovascular risk. Possible increased risk of heart attack, death, or stroke.
  • If you already have an enlarged prostate, your signs and symptoms may get worse while using TLANDO. This can include: increased nighttime urination, trouble starting urination, more frequent urination, feeling an urge to urinate, having a urine accident, and being unable 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 TLANDO.
  • Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg 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.
  • In large doses TLANDO 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 or pain on the right side of your stomach area (abdominal pain).
  • Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney or liver disease.
  • Problems breathing while you sleep (sleep apnea).
  • Enlarged or painful breasts.

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

The most common side effects of TLANDO include: increased blood prolactin, increased blood pressure, red blood cell increase, upper respiratory tract infection, weight increased, headache, and musculoskeletal pain.

For more information, go to www.TLANDO.com or call 1-844-VERITY-1 (1-844-837-4891)

To report side effects to the FDA visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the full Prescribing Information, including Boxed Warning, and Medication Guide.

Verity Pharma

TLANDO TERMS OF USE

VERITY PHARMACEUTICALS, INC.
TERMS OF USE AGREEMENT
Effective February 2024

 

Please read these Terms of Use Carefully Before Using this Website.

 

This Terms of Use Agreement (“Terms”) describes the terms and conditions applicable to your use of the Verity Pharmaceuticals, Inc. (“Verity”) website (“Website”). By accessing or using this Website, you confirm that you have read, understood, and agreed to be bound by these Terms. If you do not agree to all of these Terms, then please do not use the Website.
These Terms provide you with a limited, personal, revocable, nonexclusive, nontransferable license to use this Website and access and view the materials made available on this Website, conditioned on your continued compliance with these Terms.
Verity may modify this Website and the Terms governing its use at any time without prior notice. When these Terms are modified, the date of the latest revision will appear at the top of this page. By continuing to use the Website after the modified Terms are published, you signify your agreement to the modified Terms.

PRIVACY NOTICE

 

On this Website, Verity may collect personal data about you. Verity respects the privacy of its Website users. Please refer to Verity’s Privacy Policy for more information about how Verity handles your personal data.

 

INTENDED AUDIENCE

 

This Website is intended for United States residents over the age of 18. It is not intended for use by children. Verity makes no claim that this Website is appropriate for access or use by individuals outside of the U.S.

 

NO MEDICAL ADVICE

 

This Website is intended for informational and educational purposes. This Website does not provide medical advice, and the information contained herein should not be regarded as a substitute for actual medical care or advice rendered by a physician or any other qualified healthcare professional. Individuals who have specific questions related to their condition or care, or who may require diagnosis or treatment, should always consult with their healthcare provider.

 

THIRD PARTY WEBSITES AND LINKS

 

This Website may contain links or references to other websites operated by third parties that are not under Verity’s control. These links or references are provided for convenience only, and Verity is not responsible for the content available on any other Internet sites linked to this Website. In addition, these links or references are not an endorsement by Verity of any material on any other website, and Verity disclaims all liability with regard to your access to such linked websites or references. Access to any other Internet sites linked to this Website is at your own risk.

 

LIMITATION OF LIABILITY

Verity and its affiliates, officers, directors, employees, agents, suppliers and third party partners (collectively, the “Verity Parties”) make no claims that the material on this Website is appropriate for users outside of the United States. If you access this website from outside of the United States, you do so at your own risk and are responsible for compliance with the laws of your jurisdiction.
YOUR USE OF THIS WEBSITE OR ANY CONTENT ON THIS WEBSITE IS AT YOUR OWN RISK. UNDER NO CIRCUMSTANCES WILL VERITY PARTIES BE LIABLE FOR ANY DAMAGES WHATSOEVER (INCLUDING, WITHOUT LIMITATION, LOSS OF PROFIT, REVENUE, GOODWILL, BUSINESS OPPORTUNITY OR ANTICIPATED SAVINGS OR LOST DATA, OR FOR ANY DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES, WHETHER BASED IN CONTRACT, TORT, STRICT LIABILITY OR OTHERWISE) ARISING OUT OF OR IN ANY WAY CONNECTED WITH THE USE OR INABILITY TO USE THE WEBSITE AND ITS CONTENT, EVEN IF VERITY PARTIES HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INCLUDING BUT NOT LIMITED TO DAMAGES THAT ARISE IN CONNECTION WITH MISTAKES OR OMISSIONS IN, OR DELAYS IN TRANSMISSION OF, INFORMATION TO AND FROM THE USER, INTERRUPTIONS IN TELECOMMUNICATIONS CONNECTIONS TO THE WEBSITE OR VIRUSES, WORMS, TROJAN HORSES AND OTHER THREATS THAT MAY INFECT YOUR COMPUTER EQUIPMENT WHETHER CAUSED IN WHOLE OR IN PART BY NEGLIGENCE, ACTS OF GOD, TELECOMMUNICATIONS FAILURE, THEFT OR DESTRUCTION, OR UNAUTHORIZED ACCESS TO THIS WEBSITE OR RELATED INFORMATION OR PROGRAMS.

DISCLAIMER OF WARRANTIES

 

THIS WEBSITE, INCLUDING ALL CONTENT THEREIN, IS PROVIDED ON AN “AS IS” BASIS. VERITY PARTIES MAKE NO REPRESENTATIONS OR WARRANTIES OF ANY KIND EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF TITLE, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, ACCURACY, AND NON-INFRINGEMENT. VERITY MAKES NO WARRANTY AS TO THE ACCURACY, COMPLETENESS, CURRENCY OR RELIABILITY OF ANY CONTENT AVAILABLE THROUGH THIS WEBSITE. YOU ARE RESPONSIBLE FOR VERIFYING ANY INFORMATION BEFORE RELYING ON IT. USE OF THIS WEBSITE AND THE CONTENT AVAILABLE ON IT IS AT YOUR SOLE RISK.

VERITY PARTIES DO NOT WARRANT THAT THE WEBSITE WILL OPERATE ERROR-FREE OR THAT THIS WEBSITE AND ITS SERVER ARE FREE OF COMPUTER VIRUSES AND OTHER HARMFUL GOODS, INCLUDING MALWARE, WORMS, VIRUSES, AND OTHER EXECUTABLE CODE. IF YOUR USE OF THIS WEBSITE RESULTS IN THE NEED FOR SERVICING OR REPLACING EQUIPMENT OR DATA, VERITY PARTIES ARE NOT RESPONSIBLE FOR THOSE COSTS.

VERITY PARTIES SHALL NOT BE RESPONSIBLE FOR ANY INTERRUPTION, DELAY IN OPERATION OR TRANSMISSION, THEFT OR DESTRUCTION OF, UNAUTHORIZED ACCESS TO, OR ALTERATION OF, ANY CONTENT MADE AVAILABLE VIA THE WEBSITE.
THE ABOVE EXCLUSIONS OF CERTAIN APPLIED WARRANTIES MAY NOT APPLY IN ALL JURISDICTIONS. IN SUCH JURISDICTIONS, THE LIABILITY OF VERITY PARTIES SHALL BE LIMITED TO THE GREATEST EXTENT PERMITTED BY LAW.

 

INDEMNIFICATION

 

YOU AGREE TO INDEMNIFY, DEFEND AND HOLD HARMLESS VERITY PARTIES FROM AND AGAINST ALL LOSSES, LIABILITIES, EXPENSES, DAMAGES AND COSTS, CLAIMS, ACTIONS, AND DEMANDS, INCLUDING REASONABLE ATTORNEYS’ FEES, RESULTING FROM YOUR VIOLATION OF THESE TERMS OR YOUR ACCESS TO, OR USE OR MISUSE OF, THE CONTENT OR WEBSITE.

 

INTELLECTUAL PROPERTY RIGHTS

 

The content of this Website is the property of Verity and its licensors and is protected by U.S. and foreign copyright, trademark, and other intellectual property laws. This Website may also contain or reference patents, proprietary information, technologies, products, processes, or other proprietary rights of Verity and/or other parties. Any company names, trademarks, service marks, trade names, logos, and products displayed on this Website are the property of Verity, its affiliates, licensees, licensors, or collaboration partners, and no use of any of the foregoing may be made without Verity’s prior written consent. Except as expressly provided in these Terms, nothing contained in this Website grants or shall be construed as granting a license or other rights to you under any patent, trademark, copyright, or other intellectual property of Verity or any third party. All rights are reserved by the owners of each trademark, service mark, logo, or other intellectual property, except as otherwise described herein. Unauthorized use of any Verity trademark, service mark, logo, design, page header, icon, or script may be a violation of federal and state trademark laws.

 

GOVERNING LAW

 

This Website is based in Ewing, NJ, USA. The law of the State of New Jersey shall govern these Terms, without reference to its choice of law rules. Any legal action or proceeding based on, arising out of or related to these terms and conditions or your use of this Website (including any information it contains) shall be brought exclusively in a federal or state court of competent jurisdiction sitting in New Jersey, and all parties waive any objection to the personal jurisdiction of and venue in such courts.

   

SEVERABILITY

 

If any provision of these Terms is held invalid or unenforceable by any court of competent jurisdiction, such provision shall be severable without affecting the enforceability of all remaining provisions, which shall remain in full force and effect.

 

TERMINATION

 

In the event that you violate any of these Terms, all rights granted to you under the Terms shall be terminated immediately, with or without notice.

 

QUESTIONS

 

If you have any questions about these Terms, please contact us via
the Contact Us section of the Website.

PRIVACY POLICY

VERITY PHARMACEUTICALS, INC. PRIVACY POLICY Effective May 2020

California residents please see Verity’s Supplemental California Privacy Policy. Verity Pharmaceuticals, Inc. (“Verity”) recognizes the importance of protecting the privacy of information we may collect from you as a result of your visit to our Website, www.veritypharma.com (hereinafter, “Website”). This Privacy Policy describes how Verity, 850 Bear Tavern Road, Suite 108, Ewing, NJ 08628 (hereinafter, “us,” “we,” or “our”) uses and protects the personal information that you provide when using our Website. This Privacy Policy does not apply to our collection of personal information from other sources. This Privacy Policy, together with the Terms and Conditions posted on our Website, set forth the general rules and policies governing your use of our Website.  

WHAT PERSONAL INFORMATION DO WE COLLECT?

  We may collect the following information:

We use “cookies” to enhance your experience and gather information about your visits to our Website. We may also use your personal information to personalize your Website experience and deliver content and product information that we believe reflects your interests. For more information, please see the “How We Use Cookies” section below.  

HOW DO WE USE YOUR INFORMATION?

We may use the personal information we collect from you when you fill in forms or correspond with us by mail, phone, and e-mail, submit questions, purchase products, or consent to receive marketing or promotional communications from Verity. In addition, we may also use your personal information for internal record-keeping purposes, to provide customer service and respond to requests or inquiries, to further develop and improve our products and services, to provide you with newsletters, articles, alerts, announcements, invitations, and other information about products, brands, health topics and disease states or to conduct market research.  

We take measures to ensure that the personal information we collect from you is accurate and up-to-date and that you have the ability to access it and make corrections to it consistent with applicable law (see the “Contact Us” section below to request any amendments to your personal information to which you may be legally entitled).  

DO WE DISCLOSE YOUR INFORMATION TO THIRD PARTIES?

In general, personal information about you that is collected from this Website will not be transferred outside Verity without your prior consent. However, it may be used by our agents, affiliates and third party service providers and business partners for purposes that include assisting us in operating our website, running our business, or providing services to you, provided that they keep your personal information confidential.

We reserve the right to disclose your personal information as required by law when we believe disclosure is necessary or appropriate to comply with a regulatory requirement, judicial proceeding, court order, government request, or legal process service on us, or to protect the safety, rights, or property of our customers, the public, Verity, or others.

We will not sell or rent your personal information without your express consent.  

HOW DO I OPT-OUT/UNSUBSCRIBE?

When you access any service on the Website that collects your personal information, you will be asked to affirmatively choose to provide the requested personal information. You may always choose not to provide the requested personal information or to opt-out of, or unsubscribe from, any communications as appropriate.

You can ask us or third parties to stop sending you communications at any time by following the opt-out links on any message sent to you. Where you opt-out of receiving these communications, this will not apply to personal data provided to us as a result of a product/service purchase, experience or other transaction, warranty, adverse event or product complaint.  

LINKS TO THIRD PARTY WEBSITES

Our Website may contain links to third party websites, content, or services that are not owned or controlled by Verity. Verity is not responsible for how third parties operate or treat your personal information. We recommend that you carefully read the privacy policies and terms of use of any third party websites before providing them with your personal information.

HOW DO WE PROTECT THE SECURITY OF YOUR INFORMATION

We are committed to ensuring the security of your personal information. To prevent unauthorized access or disclosure, we have implemented a variety of security measures, including, but not limited to, securing our networks and utilizing industry standard encryption technology to safeguard your information.  

HOW WE USE COOKIES

A cookie is a small file which requests permission to be placed on your computer’s hard drive. If you agree to accept the cookies, our Website can capture and remember certain information (for example, what items were in your shopping cart). We use cookies to help us understand your preferences based on previous or current site activity and to customize and improve users’ experiences on our Website.

You can choose to accept or decline cookies. While most internet browsers automatically accept cookies, if you do not wish to have cookies on your system, you can set your browser preferences to reject them or to alert you when cookies are being sent. The “Help” section of your browser may tell you how to prevent your browser from accepting cookies. If your browser is set to reject cookies, websites that are cookie-enabled will not recognize you when you return to the website, and some website functionality may be lost.  

“Do Not Track” Signals

Verity does not track its customers to provide targeted advertising and therefore does not respond to “Do Not Track” (DNT) signals. However, some third party sites do keep track of your browsing activities when they provide content, which enables them to tailor what they present to you. Please note that some browsers allow you to set the DNT signal on your browser so that third parties (particularly advertisers) know you do not want to be tracked.  

Children’s Privacy

The Site is not directed to individuals under the age of thirteen (13), and we do not knowingly collect personal data from children under the age of thirteen.  

Privacy Policy Updates

From time to time, we may update this Privacy Policy. Any changes will be effective when we post the revised Privacy Policy. This Privacy Policy was last updated as of the effective date listed above. If the Privacy Policy changes in a way that significantly affects how we handle personal information, we will not use the personal information we previously gathered in the manner described in the new policy without providing notice and/or obtaining your consent, as appropriate. We encourage you to periodically review this page for the latest information.

Contact Us

If you have questions about this Privacy Policy or how we use your personal information, please contact us by emailing verityusa@veritypharma.com or by writing to us at the following address:

850 Bear Tavern Road Suite 108, Ewing, NJ 08628
VERITY PHARMACEUTICALS, INC.
SUPPLEMENTAL CALIFORNIA PRIVACY POLICY
Effective May 2020

If you reside in California, please read this section for additional disclosures about how we collect, use, and disclose information about you as well as your rights under the California Consumer Privacy Act (“CCPA”) (California Civil Code Section 1798.100 et seq.).

INFORMATION WE COLLECT

We may collect information that identifies, relates to, describes, references, is capable of being associated with, or could reasonably be linked, directly or indirectly, with a particular person or device (“Personal Information”). Personal Information does not include:

We have not collected any of the following categories of Personal Information within the last twelve (12) months; however in the future, Verity may collect:

SOURCES OF PERSONAL INFORMATION

We may obtain the Personal Information from the following categories of sources:

USE OF PERSONAL INFORMATION

We may use or disclose the personal information we collect for one or more of the business purposes described in the “How Do We Use Your Information” Section of Verity’s Privacy Policy.

HOW WE SHARE YOUR PERSONAL INFORMATION

Verity will not sell or rent your Personal Information without your express consent. We may, however, share your Personal Information with other parties for business purposes as described in the “Do We Disclose Your Personal Information to Third Parties?” Section of Verity’s Privacy Policy.

In the last 12 months, we have not disclosed any categories of your Personal Information identified under “Information We Collect” for a business purpose.

YOUR CALIFORNIA PRIVACY RIGHTS

  The California Consumer Privacy Act (“CCPA”) provides consumers (i.e., California residents) with specific rights (listed below and subsequently referred to as “California Privacy Rights”), subject to some limitations and the verification of their identity, regarding their Personal Information:

In order for Verity to process a request for you to exercise your California Privacy Rights, Verity will first verify certain personal information that you provide, depending on the nature of the information you require, which we will attempt to match with information we maintain about you to verify your identity. Information to identify and verify your agent can be submitted through the same mechanism and at the same time that you submit information to verify your identity. Please submit your requests by contacting us at this toll-free number: 877-433-8068 or by using the “Exercise Your California Privacy Rights” interactive web form, available here: Contact Us

You may designate an authorized agent to exercise your California Privacy Rights on your behalf in accordance with the CCPA. Verity may require that you provide the authorized agent with written permission to act on your behalf and that the authorized agent verify his or her identity directly with us. Information to identify and verify your agent can be submitted through the same mechanism and at the same time that you submit information to verify your identity. We do not charge a fee to process or respond to your verifiable request unless it is excessive, repetitive, or manifestly unfounded. If we determine that the request warrants a fee, we will tell you why we made that decision and provide you with a cost estimate before completing your request. When you submit a request to exercise your California Privacy Rights, Verity will do its best to respond to your request as soon as possible, and, in any event, no later than 45 days after receiving your request. You may only make a request twice within a 12-month calendar year.