TLANDO Dosing & Features

Due to its TITRATION-FREE oral dosing, TLANDO may require fewer office visits in order to optimize dosing.

TLANDO offers the convenience of oral dosing, avoiding intramuscular (IM) needle pain as well as the mess, skin irritation and risk of transference associated with topicals. 

TLANDO 2 Capsules

2 capsules. Twice daily along with meals. 

When TLANDO is taken as directed, patients may be capable of achieving normal range T levels, regardless of meal content. 

The efficacy and safety of each TRT has not been adequately compared in randomized, controlled clinical studies. For full information, see the full Prescribing Information for each TRT product.

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

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.