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VERITY PHARMACEUTICALS, INC.
TERMS OF USE AGREEMENT
Effective May 2020
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.
INDICATION AND USAGE
TRELSTAR® (triptorelin pamoate for injectable suspension) is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Hypersensitivity: TRELSTAR® is contraindicated in individuals with a known hypersensitivity to triptorelin or any other component of the product, or other GnRH agonists or GnRH.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Anaphylactic shock, hypersensitivity, and angioedema related to triptorelin administration have been reported. In the event of a hypersensitivity reaction, therapy with TRELSTAR® should be discontinued immediately and the appropriate supportive and symptomatic care should be administered.
Transient Increase in Serum Testosterone: Initially, triptorelin, like other GnRH agonists, causes a transient increase in serum testosterone levels. As a result, isolated cases of worsening of signs and symptoms of prostate cancer during the first weeks of treatment have been reported with GnRH agonists. Patients may experience worsening of symptoms or onset of new symptoms, including bone pain, neuropathy, hematuria, or urethral or bladder outlet obstruction .
Metastatic Vertebral Lesions and Urinary Tract Obstruction: Cases of spinal cord compression, which may contribute to weakness or paralysis with or without fatal complications, have been reported with GnRH agonists. If spinal cord compression or renal impairment develops, standard treatment should be instituted, and in extreme cases an immediate orchiectomy considered. Patients with metastatic vertebral lesions and/or with upper or lower urinary tract obstruction should be closely observed during the first few weeks of therapy.
Effect on QT/QTc Interval: Androgen deprivation therapy may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.
Hyperglycemia and Diabetes: Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Hyperglycemia may represent development of diabetes mellitus or worsening of glycemic control in patients with diabetes. Monitor blood glucose and/or glycosylated hemoglobin (HbA1c) periodically in patients receiving a GnRH agonist and manage with current practice for treatment of hyperglycemia or diabetes.
Cardiovascular Diseases: Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists in men. The risk appears low based on the reported odds ratios, and should be evaluated carefully along with cardiovascular risk factors when determining a treatment for patients with prostate cancer. Patients receiving a GnRH agonist should be monitored for symptoms and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice.
Laboratory Tests: Response to TRELSTAR® should be monitored by measuring serum levels of testosterone periodically or as indicated.
Laboratory Test Interactions: Chronic or continuous administration of triptorelin in therapeutic doses results in suppression of pituitary-gonadal axis. Diagnostic tests of the pituitary-gonadal function conducted during treatment and after cessation of therapy may therefore be misleading..
Embryo-Fetal Toxicity: Based on findings from animal studies and mechanism of action, TRELSTAR® can cause fetal harm when administered to a pregnant woman. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus.should be discontinued immediately and the appropriate supportive and symptomatic care should be administered. can cause fetal harm when administered to a pregnant woman. In animal developmental and reproductive toxicology studies, daily administration of triptorelin to pregnant rats during the period of organogenesis caused maternal toxicity and embryo-fetal toxicities, including loss of pregnancy, at doses as low as 0.2, 0.8, and 8 times the estimated human daily dose based on body surface area. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus.
MOST COMMON ADVERSE REACTIONS
• TRELSTAR® 3.75 mg: Most common adverse reactions (≥ 5%) included hot flushes, skeletal pain, impotence, and headache.
• TRELSTAR® 11.25 mg: Most common adverse reactions (≥ 5%) included hot flushes, skeletal pain, headache, edema in the legs, and leg pain.
• TRELSTAR® 22.5 mg: Most common adverse reactions (≥ 5%) included hot flushes, erectile dysfunction, and testicular atrophy.
SPECIFIC POPULATIONS
Pregnancy: Based on findings in animal studies and mechanism of action, TRELSTAR® can cause fetal harm when administered to a pregnant woman. Expected hormonal changes that occur with TRELSTAR® treatment increase the risk for pregnancy loss. In animal developmental and reproductive toxicology studies, daily administration of triptorelin to pregnant rats during the period of organogenesis caused maternal toxicity and embryo-fetal toxicities, including loss of pregnancy, at doses as low as 0.2, 0.8, and 8 times the estimated human daily dose based on body surface area. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus.
Lactation: The safety and efficacy of TRELSTAR® have not been established in females. There are no data on the presence of triptorelin in human milk, the effects of the drug on milk production, or the effects of the drug on the breastfed child. Because of the potential for serious adverse reactions in a breastfed child from TRELSTAR®, a decision should be made to either discontinue breastfeeding, or discontinue the drug taking into account the importance of the drug to the mother.
Females and Males of Reproductive Potential: Based on mechanism of action, TRELSTAR® may impair fertility in males of reproductive potential.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Prostate cancer occurs primarily in an older population. Clinical studies with TRELSTAR® have been conducted primarily in patients ≥ 65 years.
Renal Impairment: Subjects with renal impairment had higher exposure than young healthy males.
Hepatic Impairment: Subjects with hepatic impairment had higher exposure than young healthy males.
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.
For more information, visit www.Trelstar.com, or call 1-844-837-4891.
Please see the accompanying full Prescribing Information.
Trelstar® and its designs are licensed trademarks of Verity Pharmaceuticals, Inc.
MIXJECT® is a registered trademark of West Pharma. Services IL, Ltd.
Verity Pharmaceuticals, Verity Pharma, and their designs are trademarks of Verity Pharmaceuticals, Inc.
© 2023 Verity Pharmaceuticals, Inc. All rights reserved.
TSR-072 March 2023
TRELSTAR can be ordered directly from our national specialty distributor,
CuraScriptSD®, which provides next business day delivery and other convenient
benefits. Call CuraScriptSD® at 877.599.7748.
If you already have a TRELSTAR account with CuraScriptSD®, please click here or register at www.curascriptsd.com.
TRELSTAR can be ordered directly from our national specialty distributor, AndaMEDS, which provides next business day delivery and other convenient benefits. Call AndaMEDS at 1.855.468.5649, ext.74453.
If you already have a TRELSTAR account with AndaMEDS®, please click here or register at www.andameds.com.
The information contained in this website is intended for US Healthcare professionals only.