TLANDO is an FDA-approved testosterone replacement therapy that provides the simplicity of a fixed-dose oral combined with an established safety profile for adult males for conditions associated with a deficiency or absence of endogenous testosterone.

Important Safety Information & Indications

TLANDO (testosterone undecanoate) capsules, for oral use, CIII

IMPORTANT SAFETY INFORMATION

WARNING: BLOOD PRESSURE INCREASES

  • TLANDO 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 with greater risk in patients with established cardiovascular disease or risk factors for cardiovascular disease.
  • Before initiating TLANDO, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled.
  • Three weeks after initiating therapy monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension.
  • Re-evaluate whether the benefits of TLANDO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment. Due to this risk, use TLANDO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.

TLANDO INDICATIONS AND USAGE

TLANDO (testosterone undecanoate) is 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 conditions such as
    cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s
    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.

LIMITATIONS OF USE

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

CONTRAINDICATIONS

TLANDO is contraindicated in:

  • Patients with carcinoma of the breast or known or suspected carcinoma of the prostate.
  • Women who are pregnant. Testosterone can cause virilization of the female fetus when administered to a pregnant woman.
  • Known hypersensitivity to testosterone undecanoate or any of TLANDO’s ingredients.
  • Men with hypogonadal conditions, such as “age-related hypogonadism”, that are not associated with structural or genetic etiologies. The efficacy of TLANDO has not been established for these conditions, and TLANDO can increase BP that can increase the risk of MACE.

WARNINGS AND PRECAUTIONS

Increase in Blood Pressure: In Study 18-001, TLANDO increased systolic BP after 4 months of treatment by an average of 4.3 mmHg based on ambulatory blood pressure monitoring (ABPM) and 4.8 mmHg from baseline based on blood pressure cuff measurements [see Adverse Reactions (6.1)].

These BP increases can increase the risk of major adverse cardiovascular events (MACE), with greater risk in patients with established cardiovascular disease or risk factors for cardiovascular disease.

In some patients, the increase in BP with TLANDO may be too small to detect but can still increase the risk for MACE.

Before initiating TLANDO, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled. Check BP approximately 3 weeks after initiating TLANDO and periodically thereafter. Treat new-onset hypertension or exacerbations of pre-existing hypertension. Re-evaluate whether the benefits of continued treatment with TLANDO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease.

Polycythemia: Increases in hematocrit levels, reflective of increases in red blood cell mass, may require discontinuation of TLANDO. Check hematocrit prior to initiating TLANDO. Evaluate hematocrit approximately every 3 months during the first year of treatment, and then every 6 months thereafter while the patient is taking TLANDO. If hematocrit becomes elevated, stop TLANDO until hematocrit decreases to an acceptable concentration. If TLANDO is restarted and again causes hematocrit to become elevated, stop TLANDO permanently. An increase in red blood cell mass may increase the risk of thromboembolic events

Cardiovascular Risk: Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men.

TLANDO can cause BP increases that can increase the risk of MACE. Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO.

Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer: Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms. Patients treated with androgens may be at increased risk for prostate cancer. Evaluate patients for prostate cancer, including measurement of prostate specific antigen (PSA), prior to initiating and during treatment with androgens

Venous Thromboembolism: There have been post marketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone replacement products such as TLANDO. Evaluate patients who report symptoms of pain, edema, warmth, and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue TLANDO and initiate appropriate workup and management

Abuse of Testosterone and Monitoring of Serum Testosterone Concentrations: 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 testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. 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.

Not for Use in Women: Due to lack of controlled studies in women and the potential for virilizing effects, TLANDO is not indicated for use in women. Potential for Adverse Effects on Spermatogenesis: With large doses of exogenous androgens, including TLANDO, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) possibly leading to adverse effects on semen parameters including sperm count. Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO.

Hepatic Adverse Effects: Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas.  TLANDO is not a 17 alpha-alkyl androgen and is not known to produce hepatic adverse effects associated with 17-alpha-alkyl androgens.

Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). If these occur, promptly discontinue TLANDO while the cause is evaluated.

Edema: Androgens, including TLANDO, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease [see Adverse Reactions (6.1)]. In addition to discontinuation of the drug, appropriate work up and management of edema may be required.

Sleep Apnea: The treatment of hypogonadal men with testosterone products may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases.

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

Lipid Changes: Changes in serum lipid profile may require dose adjustment of lipid lowering drugs or discontinuation of testosterone therapy. Monitor the lipid profile periodically after starting testosterone therapy.

Hypercalcemia: Androgens, including TLANDO, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Monitor serum calcium concentrations periodically in these patients.

Decreased Thyroxine-binding Globulin: Androgens, including TLANDO, may decrease concentrations of thyroxin-binding globulins, resulting in decreased total T4 serum concentrations and increased resin uptake of triiodothyronine (T3) and thyroxine (T4). Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Increases in Prolactin: Increases in serum prolactin have been reported in patients treated with TLANDO in clinical trials. Evaluate serum prolactin levels prior to initiating treatment with TLANDO. Re-evaluate serum prolactin levels 3 to 4 months after starting treatment. If serum prolactin remains elevated, discontinue TLANDO.

ADVERSE REACTIONS

The safety of TLANDO was evaluated in 2 clinical studies in a total of 233 men.

Study 18-001: 138 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately 4 months

Study 16-002: 95 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately 24 days.

The most commonly reported adverse reactions (≥ 2%) were: increased blood prolactin, hypertension, increased hematocrit, upper respiratory tract infection, weight increased, headache, and musculoskeletal pain.

DRUG INTERACTIONS

Insulin: Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.

Oral Anticoagulants: Changes in anticoagulant activity may be seen with androgens. Frequent monitoring of INR and prothrombin time may be necessary in patients taking anticoagulants, especially at the initiation and termination of androgen therapy.

Corticosteroids: The concurrent use of testosterone with corticosteroids may result in increased fluid retention and should be monitored cautiously, particularly in patients with cardiac, renal or hepatic disease.

Drugs that May Also Increase Blood Pressure: Some prescription drugs and nonprescription analgesic and cold medications can increase blood pressure. Concomitant administration of these medications with TLANDO may lead to additional increases in blood pressure. .

USE IN SPECIFIC POPULATIONS

Pregnancy: TLANDO is contraindicated in pregnant women and not indicated for use in females. Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies (see Data) and its mechanism of action. Exposure of a female fetus to androgens may result in varying degrees of virilization. In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. These studies did not meet current standards for nonclinical development toxicity studies. Lactation: TLANDO is not indicated for use in females. 

Females and Males of Reproductive Potential: During treatment with large doses of exogenous androgens, including TLANDO, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis. Reduced fertility is observed in some men taking testosterone replacement therapy. The impact on fertility may be irreversible. Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids.

Pediatric Use: The safety and effectiveness of TLANDO 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.

Geriatric Use: There have not been sufficient numbers of geriatric patients in controlled clinical studies with TLANDO to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. Of the 95 patients enrolled in Study 16-002, the 24-day major safety and effectiveness study utilizing TLANDO, 16 (16.8%) were over 65 years of age.  Additionally, there is insufficient long-term safety data in geriatric patients utilizing TLANDO to assess the potentially increased risk of cardiovascular disease and prostate cancer.

Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH and hypertension.

DRUG ABUSE AND DEPENDENCE

TLANDO contains testosterone undecanoate, a Schedule III controlled substance.

Abuse and misuse of testosterone are seen in male and female adults and adolescents. Testosterone, often in combination with other anabolic androgenic steroids may be abused by athletes and bodybuilders.

Serious adverse reactions have been reported in individuals who abuse anabolic androgenic steroids and include cardiac arrest, myocardial infarction, hypertrophic cardiomyopathy, congestive heart failure, cerebrovascular accident, hepatotoxicity, and serious psychiatric manifestations, including major depression, mania, paranoia, psychosis, delusions, hallucinations, hostility and aggression.

The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility.

The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities.

The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty.

Withdrawal symptoms can be experienced upon abrupt discontinuation in patients with addiction. Withdrawal symptoms include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. Drug dependence in individuals using approved doses for approved indications has not been documented.

For more information, call 1-844-VERITY-1 (1-844-837-4891)

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

Verity Pharma

Terms of Use

PLEASE READ THESE TERMS OF USE CAREFULLY!

BY ACCESSING THIS SITE, YOU ACKNOWLEDGE THAT YOU HAVE READ THESE TERMS OF USE, AND UNDERSTAND AND AGREE TO ABIDE BY THEM.

This Terms of Use Agreement (this “Agreement”) describes the terms and conditions applicable to your use of any and all of Antares Pharma, Inc.’s and/or its affiliates (collectively “Antares”) or Antares co-branded websites. If you do not agree to the terms and conditions of this Agreement, please do not use this website. Your use of certain pages or services within this website may be subject to additional terms and conditions. Before being given access to these pages or services, you will be asked to indicate whether you agree to be bound by the additional terms and conditions. If you agree to be bound, you will be given access to the page or service. If you do not agree to be bound, you will not be given access to the page or service.

Antares may at any time revise or modify this Agreement or impose new conditions for use of this website. Such changes, revisions or modifications shall be effective immediately upon notice to you, which may be given by any means including, without limitation, posting on the website or by e-mail. Any use of the website by you after such notice shall be deemed to constitute acceptance of such changes, revisions or modifications. Antares may modify its services at any time.

THIS WEBSITE DOES NOT PROVIDE MEDICAL OR PROFESSIONAL SERVICES ADVICE.

The content on this website is intended to be a general information resource in regard to the subject matter covered, and is provided solely on an “AS IS” and “AS AVAILABLE” basis. You are encouraged to confirm the information contained herein with other sources, and to review the information carefully with your professional health care provider. Antares is not engaged in rendering medical or similar professional services or advice via this website, and the information provided is not intended to replace medical advice offered by a physician. If you desire or need such services or advice, you should consult a professional health care provider. You should not construe Antares’s publication of this content as an endorsement by Antares of the views expressed herein, or any warranty or guarantee of any strategy, recommendation, treatment, action, or application of medication or preparation made by the author of the content.

Scope of Use

Antares invites you to view, use and download a single copy of this website for your informational, personal, non-commercial use. Except as otherwise provided on this page, no part of any content or software on this website may be copied, downloaded or stored in a retrieval system for any other purpose, nor may it be redistributed for any purpose, without the express written permission of Antares. You understand that Antares may discontinue, change, or restrict your use of this website for any reason without notice.

This website is for use by U.S. residents only. By using this website, you represent that you are at least eighteen (18) years old and a United States resident.

No Warranties

ALL CONTENT ON THIS WEBSITE IS PROVIDED TO YOU ON AN “AS IS” “AS AVAILABLE” BASIS WITHOUT WARRANTY OF ANY KIND EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, ACCURACY, AND NON-INFRINGEMENT. ANTARES 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 THE WEBSITE AND THE CONTENT AVAILABLE ON THE WEBSITE IS AT YOUR SOLE RISK. ANTARES MAKES NO REPRESENTATIONS OR WARRANTIES THAT USE OF THE WEBSITE WILL BE UNINTERRUPTED OR ERROR-FREE. YOU ARE RESPONSIBLE FOR TAKING ALL NECESSARY PRECAUTIONS TO ENSURE THAT ANY CONTENT YOU OBTAIN FROM THE WEBSITE IS FREE OF VIRUSES.

The above exclusions may not apply in jurisdictions that do not allow the exclusion of certain implied warranties.

Limitation of Liability

YOUR USE OF THE WEBSITE OR ANY CONTENT ON THE WEBSITE IS AT YOUR OWN RISK. ANTARES SPECIFICALLY DISCLAIMS ANY LIABILITY, WHETHER BASED IN CONTRACT, TORT, STRICT LIABILITY OR OTHERWISE, FOR ANY DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES ARISING OUT OF OR IN ANY WAY CONNECTED WITH ACCESS TO OR USE OF THE WEBSITE, EVEN IF ANTARES HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INCLUDING BUT NOT LIMITED TO RELIANCE BY ANY PARTY ON ANY CONTENT OBTAINED THROUGH THE USE OF THE WEBSITE, OR THAT ARISES IN CONNECTION WITH MISTAKES OR OMISSIONS IN, OR DELAYS IN TRANSMISSION OF, INFORMATION TO OR FROM THE USER, INTERRUPTIONS IN TELECOMMUNICATIONS CONNECTIONS TO THE WEBSITE OR VIRUSES, WHETHER CAUSED IN WHOLE OR IN PART BY NEGLIGENCE, ACTS OF GOD, WAR, TERRORISM, TELECOMMUNICATIONS FAILURE, THEFT OR DESTRUCTION OF, OR UNAUTHORIZED ACCESS TO THE WEBSITE, OR RELATED INFORMATION OR PROGRAMS.

Indemnification

If you violate any terms of this Agreement or if you misuse this website, you agree to defend, indemnify and hold harmless Antares, its officers, directors, employees, agents and licensees from any and all liability including, without limitation, costs, expenses and attorneys’ fees that arise out of or are related to your violation or misuse.

User Submissions

Certain areas of this website enable you to submit e-mails, or otherwise provide feedback or information to Antares.

You agree that by submitting content:

Trademarks

The trademarks, logos, and service marks (collectively, the “Trademarks”) displayed on this website are registered and unregistered Trademarks of Antares and others. Nothing contained in this website should be construed as granting, by implication, estoppel, or otherwise, any license or right in and to the Trademarks. Unauthorized use of any Trademark may be a violation of federal and state trademark laws.

Copyright

This website is protected by United States’ and foreign copyright laws. Except for your informational, personal, non-commercial use as authorized above, you may not modify, reproduce or distribute the design or layout of the website, or individual sections of the design or layout of the website or Antares logos without Antares’s written permission.

Information, News and Press Releases

The website may contain information, news and/or press releases about Antares. While this information was believed to be accurate as of the date it was prepared, Antares disclaims any duty or obligation to update this information, news or any press releases. Information about companies other than Antares contained in the news, press releases or otherwise, should not be relied upon as being provided or endorsed by Antares.

Links

This Antares website may contain links to websites operated by other parties. The linked sites are not under the control of Antares, and Antares is not responsible for the content available on any other Internet sites linked to this website. Such links do not imply Antares’s endorsement of material on any other site and Antares disclaims all liability with regard to your access to such linked websites. Antares provides links to other Internet sites as a convenience to users, and access to any other Internet sites linked to this website is at your own risk.

Unless otherwise set forth in a written agreement between you and Antares, you must adhere to Antares’s linking policy as follows: (i) any link to an Antares website must be a text only link clearly marked “Antares WEBSITE,” (ii) the appearance, position and other aspects of the link may not be such as to damage or dilute the goodwill associated with Antares’s names and trademarks, (iii) the link must “point” to the root domain name of the Antares website and not to other pages within the website, (iv) the appearance, position and other attributes of the link may not create the false appearance that your organization or entity is sponsored by, affiliated with, or associated with Antares, (v) when selected by a user, the link must display the website on full-screen and not within a “frame” on the linking website, and (vi) Antares reserves the right to revoke its consent to the link at any time and in its sole discretion.

Security

This website may require you to register or obtain a password prior to permitting access to the website or certain services available on this site. You are responsible for maintaining the confidentiality of your registration information and password, and for all uses of your password, whether or not authorized by you.

Location, Governing Law and Arbitration

This website is operated by Antares. The law of the State of Delaware shall govern these terms and conditions, without reference to its choice of law rules. Antares makes no representation that the information in the website is appropriate or available for use in other locations, and access to this website from territories where the content of this website may be illegal is prohibited. Those who choose to access this website from other locations do so on their own initiative and are responsible for compliance with applicable local laws.

Any controversy or claim arising under or related to this User Agreement or Antares’s products and/or services shall be settled by binding arbitration in accordance with the commercial rules of arbitration of the American Arbitration Association. Any such controversy or claim shall be arbitrated on an individual basis, and shall not be consolidated in any arbitration with any claim or controversy of any other party. The arbitration shall be conducted in the State of Delaware, and judgment on the arbitration award may be entered by any court of competent jurisdiction. Either you or Antares may seek any interim or preliminary relief from a court of competent jurisdiction in the state of Delaware, necessary to protect the rights or property of you or Antares pending the completion of arbitration.

Violations and Additional Policies

Antares reserves the right to seek all remedies available at law and in equity for violations of these Terms of Use, including the right to block access from a particular Internet address to the website.

Use of Information

Antares reserves the right, and you authorize Antares, to the use and assignment of all information regarding your use of this website and all information provided by you in any manner consistent with this User Agreement and applicable federal law.

Securities Laws

This website may include statements concerning Antares’s operations, prospects, strategies, financial condition, future economic performance and demand for Antares’s products or services, as well as its intentions, plans and objectives, that are forward-looking statements. These statements are based upon a number of assumptions and estimates which are subject to significant uncertainties, many of which are beyond our control. When used on the website, words like “anticipates,” “expects,” “believes,” “estimates,” “seeks,” “plans,” “intends” and similar expressions are intended to identify forward-looking statements designed to fall within securities law safe harbors for forward looking statements. The website and the information contained herein does not constitute an offer or a solicitation of an offer for sale of any securities. None of the information contained herein is intended to be, and shall not be deemed to be, incorporated into any of Antares’s securities-related filings or documents.

Questions

If you have any questions about these Terms of Use, please contact Antares at +1 (609) 359 3020. For all other inquiries, please contact us through the relevant product, support or Antares website.

Privacy Policy

Effective Date: 1/1/2020 Last Updated: 3/23/22

APPLICABILITY

This policy describes Halozyme, Inc.’s information collection and use practices on the places where it appears. These include websites, portals, and other places it is referenced. This policy does not apply to information we collect from employees or contractors.

NOTICE AT COLLECTION

Information We Collect

The type of personal information we collect depends on your relationship with us. It also depends on how you interact with us. California law requires us to tell you if we share categories of information for cross-contextual behavioral advertising. Described below by category is the information we may collect and . To learn how to modify your cross-contextual advertising preferences view our Notice of Right to Opt-out of Sharing for Cross-Contextual Behavioral Advertising.

We do not use or disclose sensitive personal information, as defined by California law, for inferring characteristics or for purposes other than those permitted by law. We keep these categories of personal information as long as necessary or relevant for the purposes for which it was collected. We also keep information as required by law.

We Use Your Information As Described

We use the categories of information for the business and commercial purposes outlined here:

More Information

For more information about our privacy practices, read below for the rest of our privacy policy.

WE COLLECT INFORMATION IN A VARIETY OF WAYS

WE COMBINE INFORMATION

We combine information that we have collected offline with information that we collect online as permitted by law. We combine information we have collected across other third-party sites. We combine information collected across devices, such as computers and mobile devices. We also combine information that we get from a third party with information we already have.

WE MAY DISCLOSE INFORMATION

Below are situations when we may disclose personal information. We have also explained the categories of entities with whom we might disclose your personal information.

We may disclose information for other reasons we may describe to you or as permitted by law.

Additional information for California, Nevada and Virginia residents. California, Nevada, and Virginia law require that we tell you if we sell personal information with a third party for monetary or (in California) other valuable consideration. We do not do this. We also do not sell personal information of minors under the age of 16 for monetary or other valuable consideration.

YOU HAVE CERTAIN CHOICES AND MAY HAVE CERTAIN RIGHTS

You can opt out of certain marketing. To stop receiving our marketing emails please email us at the address noted at the end or follow the instructions in any marketing email message you get from us. If you opt out of marketing emails you will continue to receive emails from us about your relationship with us where permitted by law.

OUR COOKIE AND AD POLICY

Options you make are browser and device specific.

If you live in California or Virginia, or a state with a similar law, you may have certain additional legal rights:

You can exercise those rights by emailing us at verityusa@veritypharma.com In the alternative you can call us at 1-844-855-4256. Those rights are listed below:

  1. Access: to learn the categories of information we collect and use, and for those in California, the categories of sources of collection and disclosure and the business purpose for collection;
  2. Portability: a copy of (Virginia) or specific pieces of (California) personal information collected;
  3. Deletion: to have us delete information we collected from you;
  4. Correction: asking us to fix your information; and
  5. Non-retaliation: not to be discriminated against for exercising a privacy right.

How it works. When you submit your request, we use information you provide to verify your request. We do this by matching the information you provide with information we already have about you. In some situations we may not be able to process your request. This may include if a legal exception applies. If you disagree with our decision you can contact us as described at the end of this policy.

Nevada residents: you may also opt out of the future sale of their information to a third party so that they may license or sell that information by emailing us at noted at the end of this notice.

Third party agents: If you are submitting a request on behalf of an eligible resident, we may ask for additional information to verify your identity. This may include providing proof that you are registered with the Secretary of State to act on someone’s behalf or proof of a power of attorney

OUR SITES ARE NOT INTENDED FOR CHILDREN

Our sites are meant for adults. We do not knowingly collect personally identifiable information from children under 13. If you are a parent or legal guardian and think your child under 13 has given us information, you can contact us at the email or address above. Please mark your inquiries “COPPA Information Request.”

Parents can learn more about how to protect children’s privacy online here.

WE USE REASONABLE SECURITY MEASURES

We use reasonable security measures as required by relevant law. The Internet is not 100% secure. We cannot promise that your use of our sites will be completely safe. We encourage you to use caution when using the Internet.

OUR PLATFORMS ARE BASED IN THE UNITED STATES

Information we collect may be stored and processed in the United States. This site is intended for people who are in the United States. If you live outside of the United States, you understand and agree that we may transfer your information to the United States. The United States may not afford the same level of protection as the laws in your country. By submitting your information you agree to the processing of it in the US as permitted by law.

THIRD PARTY SITES AND SERVICES

We may link to third-party sites. Our sites may also include third party content that collects information. We do not control these third parties. This Policy does not apply to the privacy practices of that website. Please read the privacy policy of other websites carefully. We are not responsible for the practices of these third-party sites.

HOW TO CONTACT US

If you have other questions about this Policy or our privacy practices please email us at verityusa@veritypharma.com.

WE MAY UPDATE THIS POLICY

We may make changes or updates to this Policy. We will notify you of any material changes to this Policy as required by law. Changes will also be posted on our website. Please check our site periodically for updates.