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

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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.

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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

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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. 
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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.

IMPORTANT SAFETY INFORMATION & INDICATIONS

IMPORTANT SAFETY INFORMATION & INDICATIONS

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

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.
  • Safety and efficacy of TLANDO in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

IMPORTANT SAFETY INFORMATION

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.

WARNINGS AND PRECAUTIONS

Polycythemia: Check hematocrit prior to initiating TLANDO and evaluate 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 hematocrit increases again after TLANDO is restarted, stop treatment permanently.

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.

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

Blood Pressure Increases: TLANDO can increase blood pressure which can increase cardiovascular risk over time. Monitor BP periodically in men using TLANDO, especially men with hypertension. TLANDO is not recommended for use in patients with uncontrolled hypertension.

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. If abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids.

Not for Use in Women: TLANDO is not indicated for use in women.

Potential for Adverse Effects on Spermatogenesis: Large doses of androgens like TLANDO can suppress spermatogenesis. Inform patients of this risk before prescribing TLANDO.

Hepatic Adverse Effects: Prolonged use of high doses of alpha-alkyl androgen has been associated with serious hepatic adverse effects, however TLANDO is not this type of compound and therefore is not known to cause serious hepatic adverse effects. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction. If these occur, promptly discontinue TLANDO while the cause is evaluated.

Edema: Edema may occur in patients with or without congestive heart failure and with preexisting cardiac, renal or hepatic disease. In addition to discontinuing TLANDO, appropriate workup and management of edema may be required.

Sleep Apnea: TLANDO may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases.

Lipid Changes: TLANDO may affect serum lipid profile. Monitor patient lipid concentrations periodically; if necessary, adjust dosage of lipid lowering drug(s) or discontinue TLANDO.

Increases in Prolactin: Increases in serum prolactin have been reported in patients treated with TLANDO in clinical trials. Monitor serum prolactin levels prior to initiation of TLANDO and 3 to 4 months after starting TLANDO. Discontinue TLANDO if serum prolactin levels remain elevated.

Other warnings to consider: gynecomastia; hypercalcemia in cancer patients; and decreased thyroxine-binding globulin.

ADVERSE REACTIONS

The most commonly reported adverse reactions (≥ 2%) were: increased blood prolactin (6%), hypertension (5%), increased hematocrit (4%), upper respiratory tract infection (4%), weight increased (2%), headache (2%), and musculoskeletal pain (2%).

DRUG INTERACTIONS

Insulin: TLANDO can cause changes in insulin sensitivity or glycemic control. Androgens may decrease blood glucose requiring a decrease in the dose of anti-diabetic medication.

Oral Anticoagulants: Anticoagulant activity may be seen with androgens. Frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking anticoagulants, especially at initiation and termination of androgen therapy.

Corticosteroids: Concurrent use of testosterone with corticosteroids may increase fluid retention and requires careful monitoring, particularly in patients with cardiac, renal, or hepatic disease.

Medications that May Also Increase Blood Pressure: Concomitant administration of medications or drugs known to increase BP with TLANDO may lead to additional BP increases.

DOSAGE AND ADMINISTRATION

TLANDO is not substitutable with other oral testosterone undecanoate products.

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

Please note that this information is not comprehensive. Please click here for full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Verity Pharma at 1-844-837-4891 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.