Terms & Conditions
Please carefully review the following terms and conditions of use (“Terms and Conditions”), which apply to everyone who visits this UroNova* website. By accessing and using this website, you are agreeing to abide by, and be bound by, the following Terms and Conditions and any amendments in effect at the time of your visit. UroNova may modify these Terms and Conditions at any time without notice by updating these legal notices, and we encourage you to review the Terms and Conditions because any such modifications will be binding on you.
Copyright/Trademark Notice
Trademarks and service marks on this UroNova website, including but not limited to product names, are registered and unregistered trademarks of UroNova and others. The contents of this UroNova website (including, without limitation, the arrangement and layout of the websites; names and logos; and text, illustrations and artwork) are the copyrighted and/or trademarked property of UroNova (or the original creator of the material) and are protected under applicable copyright and trademark laws. Nothing contained on the websites should be construed as granting any license or right to use any such marks or copyrighted material without the written permission of UroNova or such other party who may own such mark(s) or copyrighted material. Any unauthorized use of the trademarks, copyrights or other contents of this UroNova website may violate civil or criminal laws.
Product Catalog
The product catalog on the UroNova website has been designed as a quick reference for UroNova products. Some products-either brand or generic-may no longer be available on the market due to discontinuations from product portfolios. This product catalog may not represent our complete product portfolio due to additional product launches or product discontinuations. The products displayed on this website are intended as a reference source only and not for prescribing or dispensing purposes.
Patients should always obtain complete medical information about their prescription medicines (beneficial medical uses and possible adverse effects) from the product’s approved package insert and/or by discussing the appropriate use of any medicine(s) directly with their prescribing physician. Consumers should not construe any information herein as medical advice. UroNova and its affiliates are not responsible for any reliance on or use of any information included herein.
No Advice
Nothing contained in UroNova’s website should be construed as medical, legal, investment, financial or other advice. Without limitation, nothing contained in the sites should replace medical advice, medical visits or recommendations from health care providers. Patients should always consult with a doctor or other health care provider for medical advice.
Links
UroNova’s website contains links to third-party websites, which are provided as a convenience to users of our site. UroNova makes no claim or warranty of, and is not responsible for, any information found in a linked website. We encourage you to check the disclaimers and other legal notices provided on such linked sites.
No Representation or Warranty
While UroNova uses reasonable efforts to include up-to-date and accurate information on its website, UroNova does not make, and expressly disclaims, any representations or warranties of any kind, either express or implied (including without limitation any implied warranties of merchantability, fitness for a particular purpose or non-infringement) with regard to any such information, its accuracy or completeness or the frequency that it is updated. Everything on UroNova’s website is provided “AS IS.” UroNova assumes no liability or responsibility for any errors or omissions in the content of its websites.
Limitation of Liability
Your use of UroNova’s website is at your own risk. In no event shall UroNova or any of its officers, directors, employees or affiliates, be liable, directly or indirectly, for any damages of any kind or nature, including, without limitation, direct, incidental, punitive or consequential, or any claims or losses, resulting from or in connection with the creation or use of, or reliance on, this site or any information contained herein, any other UroNova website or any linked website contained in any such sites, or any of the information accessed through any such site or from the inability to use any such site. This limitation includes damage to your computer equipment or any viruses that may infect your computer equipment or other property.
Governing Law
These Terms and Conditions of use and your use of this website shall be governed by the laws of the State of Colorado without regard to conflict of laws principles. Any legal action or proceeding related to the Terms and Conditions or your use of this website shall be brought exclusively in the courts of the State of Colorado or the United States District Court for the District of Colorado.
* UroNova refers to UroNova Pharmaceuticals, Inc
Important Safety Information
Vabrinty™ (leuprolide acetate) for injectable suspension is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer.
Vabrinty is contraindicated in patients with hypersensitivity to GnRH, GnRH agonists, or any of the components of Vabrinty.Anaphylactic reactions to synthetic GnRH or GnRH agonists have been reported in the literature. Transient increase in serum levels of testosterone during treatment may result in worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, hematuria, bladder outlet obstruction, ureteral obstruction, or spinal cord compression. Monitor patients at risk closely and manage as appropriate.
Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Monitor blood glucose level and manage according to current clinical practice. Increased risk of myocardial infarction, sudden cardiac death and stroke has also been reported with use of GnRH agonists in men. Monitor for cardiovascular disease and manage according to current clinical practice. Androgen deprivation therapy may prolong the QT/QTc interval. Consider risks and benefits.
Convulsions have been observed in patients taking leuprolide acetate with or without a history of predisposing factors. Manage convulsions according to current clinical practice. Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis, and erythema multiforme, occurred in patients receiving Vabrinty. Monitor for and advise patients of the signs and symptoms of SCARs. May cause fetal harm.
Vabrinty may impair fertility in males of reproductive potential.
The most common injection site adverse events are transient burning and stinging, pain, bruising, and erythema. The most common systemic adverse events include mild to severe hot flashes/sweats, malaise and fatigue, weakness, myalgia, dizziness, clamminess, testicular atrophy, and gynecomastia. As with other GnRH agonists, other adverse reactions, including decreased bone density and rare cases of pituitary apoplexy have been reported.
See full Prescribing Information.
To report suspected adverse reactions, contact UroNova at 877-712-4575 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch