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Antares may at any time revise or modify this Agreement or impose new conditions for use of this website. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. Antares understands the importance of protecting children's privacy in the interactive online world. We have multiple internal product development programs, as well as partnerships with industry-leading pharmaceutical companies. Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO. The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. We have put in place procedures to deal with any suspected Personal Information breach and will notify you and any applicable regulator of a breach where we are legally required to do so. To personalize content provided on the website. 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. We are excited with the opportunity to commercialize TLANDO and reinforce our commitment to the TRT market. We have recently expanded our commercial organization to 108 sales representatives and expect to leverage our relationships with urologists and endocrinologists to drive adoption of TLANDO. The information you disclose and provide in interactive services may be linked (pursuant to all applicable laws) with the Personal Information you may choose to provide elsewhere on our site and together this may provide us with Personal Information about your health and health care. 2 0 obj Your exercise of these rights will have no adverse effect on the price and quality of our services. This website is for use by U.S. residents only. Antares Pharma, Inc. EWING, N.J., March 29, 2022 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the Company), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration granted final approval for TLANDO (testosterone undecanoate), an oral treatment for testosterone replacement therapy (TRT) indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke. About Antares Pharma. The drug was also deemed a Schedule III controlled substance, due to risks of abuse and misuse of testosterone. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. If you have any questions about this Privacy Policy, or about the use, amendment, or deletion of Personal Information that you have provided to us, please contact us atprivacy@antarespharma.com. Lipocine And Antares Pharma Enter Into U.S. Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. 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. Antares Pharma, a specialty pharmaceutical company, announced positive results from a Phase I study for an auto-injector for adrenal crisis. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Opens in a new tab or window, Visit us on Instagram. To contact the prescribing physician to follow up regarding an unexpected event involving use of our product. Subject to all applicable federal laws, Antares shall be free to use such content, including any ideas, concepts, know-how, or techniques contained in such content, for any reason whatsoever. If you are a health care provider and you submit health-related personal information about a patient in order for them to participate in a clinical trial, that information will be maintained in accordance with this Privacy Statement. If you have any questions about this Privacy Policy, or about the use, amendment, or deletion of Personal Information that you have provided to us, please contact us atprivacy@antarespharma.com. For more information, go towww.XYOSTED.comor call 1-844-XYOSTED (1-844-996-7833). If a venous thromboembolic event is suspected, discontinue TLANDO and initiate appropriate workup and management. Under the agreement, Antares Pharma will undertake all commercialization, post-marketing obligations, and sourcing of TLANDO in the U.S. "The FDA approval of Tlando brings to market an oral formulation of testosterone that we believe will prove beneficial to physicians and their patients," said Robert F. Apple, president and CEO of Antares Pharma. 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 Antaress written permission. Men with hypogonadal conditions, such as age-related hypogonadism, that are not associated with structural or genetic etiologies. By using this website, you represent that you are at least eighteen (18) years old and a United States resident. Lipocine retains all rights for ex-US territories, and non TRT indications for TLANDO. Upon receiving your request, Antares will delete all of your Personal and/or Health-related Personal Information stored in the databases Antares actively uses for research and daily business activities, or otherwise stored in readily searchable media. Testosterone, often in combination with other anabolic androgenic steroids, may be abused by athletes and bodybuilders. Share on Facebook. Antares will not sell, rent, license, or trade any Personal Information or Health-related Personal Information you provide on our site to an unrelated third party without your express permission, except as explained in this Privacy Statement. Opens in a new tab or window, Visit us on YouTube. dy;rq% We reserve the right to change the terms of this Privacy Statement at any time by posting revisions to our site. <> 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. We also may use a third party verification provider to verify your identity. Interestingly, FDA advisory committees recommended against approval of both Tlando and Jatenzo back in 2018 largely due to cardiovascular concerns. Only some categories of information identify you directly, but each category offers some information about your interests and activities that could be used to make inferences about you. <>>> 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 . @wiaimh;;phJ; 0 Pa0/~REluQ%RF UMA%@uE}{[OD$Hvx Cv\5zg#}K8m)o|yHk8jG\'Q06AIT^x"$*#IB="T*Jysa-%-'MY6{HSExH" This website 2023 Halozyme, Inc.All Rights Reserved MPACP--00138. This Privacy Policy does not address personal information that you provide to us in other contexts (e.g., through a business relationship not handled through the Site). Please note that, while we make reasonable efforts to comply with such requests, deletion of your personal information does not ensure complete and comprehensive removal of that data from all systems. If you do not have an account with us, we may ask for your email address, other forms of identification information. Known hypersensitivity to testosterone undecanoate or any of TLANDOs ingredients. The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products. USE OF THE WEBSITE AND THE CONTENT AVAILABLE ON THE WEBSITE IS AT YOUR SOLE RISK. This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Lipid Changes: Changes in serum lipid profile may require dose adjustment of lipid lowering drugs or discontinuation of testosterone therapy. As an added security precaution, we deploy various methods of protection such as host intrusion prevention and detection systems to maintain the integrity and confidentiality of data. 8ey| +6-!|Ss! Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address . These are not all the possible side effects of XYOSTED. Based out of the New York City office, shes worked at the company since 2015. It is estimated that approximately 35% of men older than 45 years of age and 30-50% of men with obesity or type 2 diabetes have hypogonadism1. Opens in a new tab or window, Visit us on Facebook. Are allergic XYOSTED or to any ingredients in XYOSTED including testosterone or sesame oil. Improper use of XYOSTED may effect bone growth in children. The information you disclose and provide in interactive services may be linked (pursuant to all applicable laws) with the Personal Information you may choose to provide elsewhere on our site and together this may provide us with Personal Information about your health and health care. This Privacy Policy applies solely to the information that we collect through the Site. Antares invites you to view, use and download a single copy of this website for your informational, personal, non-commercial use. For example, do not take XYOSTED if you have low testosterone due to age. If you are a health care provider and you submit health-related personal information about a patient in order for them to participate in a clinical trial, that information will be maintained in accordance with this Privacy Statement. Concomitant administration of these medications with TLANDO may lead to additional increases in blood pressure. Edema: Androgens, including TLANDO, may promote retention of sodium and water. This approval also reinforces the opportunity for Antares to continue to drive share gains in the TRT market with both TLANDO and XYOSTED and support our future growth with an expanded commercial portfolio. 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. by Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address patient needs in . Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. This Privacy Policy describes how we gather and use information about visitors to our Site (Visitors). Improper use of XYOSTED may effect bone growth in children. Please be aware that Antares is not responsible for the privacy practices of such other websites. Because of these concerns, the label for Tlando includes a boxed warning regarding possible blood pressure increases, stating that these "can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death.". Please see the full Prescribing Information, including Boxed Warning, and Medication Guide. The recommended dosage is 225 mg orally twice daily with food. Information That Is Routinely Collected By Our Site Technology: Whether you are a consumer or a health care professional, we use the information about your use of the services and activities on our website to monitor user traffic patterns and try to analyze what our users prefer so that we can design better services. We have implemented appropriate security measures, including encryption practices, to prevent your Personal Information and Health-related Personal Information from being accidentally lost, used or accessed in an unauthorized way, altered or disclosed. Dr. Patel further stated, "Our agreement with Antares Pharma demonstrates our commitment to ensure efficient and effective patient access to TLANDO in the U.S. We are confident in Antares Pharma's capabilities, given its established marketing experience and demonstrated success in the TRT space. 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. Antares Pharma Drug Portfolio. Exogenous administration of androgens may lead to azoospermia (5.8). Testosterone enanthate auto-injection - Antares Pharma - AdisInsight Drug Profile Testosterone enanthate auto-injection - Antares Pharma Alternative Names: QuickShot testosterone; Testosterone enantate - Antares Pharma; TRT - Antares Pharma; Vibex QS T; Vibex QuickShot T; XYOSTED Latest Information Update: 26 May 2022 Price : $50 * Buy Profile While Antares has endeavored to create a secure and reliable website for users, the confidentiality of any communication or material transmitted to/from the Site or via e-mail cannot be guaranteed. This Privacy Policy applies solely to the information that we collect through the Site. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. Under the terms of Agreement Lipocine to receive: Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced it has entered into an exclusive licensing agreement with Antares Pharma, Inc. to commercialize TLANDO in the United States. 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). Treatment-emergent adverse events in the phase III trial occurred in 21.1% of participants, with one person withdrawing due to a serious adverse event. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of cirrhosis. Hypogonadism is a common condition in the male population, with a higher prevalence in older men, obese men, and men with type 2 diabetes. 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