3 0 obj To send you an e-mail confirming your registration with our site and to respond to questions from you. Antares will not sell your Personal Information or Health-related Personal Information. 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. Personal Information. Prescribing Information, including Boxed Warning. It also has . If you agree to be bound, you will be given access to the page or service. Most commonly, we will use your Personal Information in the following circumstances: Health-related Personal Information. Exposure of a female fetus to androgens may result in varying degrees of virilization. Upon exercise of the TLANDO XR option, Lipocine is entitled to receive an additional $4.0 million in license fees, clinical and regulatory milestone payments of up to an aggregate of $35.0 million, and tiered royalties on net sales at rates ranging from the mid-teens to up to 20%. Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH and hypertension. If we allow a third party contractor to have access to your Personal Information or health-related personal information, we will not authorize them to take it or use it for any purpose that is not consistent with this Privacy Statement. Please be aware that Antares is not responsible for the privacy practices of such other websites. Kristen Monaco, Staff Writer, MedPage Today Concomitant administration of these medications with TLANDO may lead to additional increases in blood pressure. The most common side effects of XYOSTED include:red blood cell increase, prostatic specific antigen (PSA) increase (a blood test for prostate cancer), increased blood pressure, and injection site reactions including bruising, bleeding, redness and headache. 2 0 obj Your continued use of the Site following the posting of changes to these terms will mean that you accept those changes. Get Dragon Pharma Steroids 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. The Site is not designed for, or intentionally targeted at, children under 13 years of age. The linked sites are not under the control of Antares, and Antares is not responsible for the content available on any other Internet sites linked to this website. 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. 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 . Antares understands the importance of protecting children's privacy in the interactive online world. 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. d):b9Z}~@B_@&NT[@zY`AsU"P Medicine used to treat seizures, nerve pain, or bipolar disorder called carbamazepine. Improper use of XYOSTED may effect bone growth in children. The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. Information about companies other than Antares contained in the news, press releases or otherwise, should not be relied upon as being provided or endorsed by Antares. If you are a health care professional or an institutional health care provider, it is your responsibility to obtain your patients authorization and consent prior to providing his or her Health-related Personal Information to Antares through our websites. Evaluate hematocrit approximately every 3 months during the first year of treatment, and then every 6 months thereafter while the patient is taking TLANDO. These statements are based upon a number of assumptions and estimates which are subject to significant uncertainties, many of which are beyond our control. We also may use a third party verification provider to verify your identity. Medpage Today is among the federally registered trademarks of MedPage Today, LLC and may not be used by third parties without explicit permission. 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. dy;rq% To create summary data that we will use for our business purposes, including research to improve our products and analyses that may help us better market our products. by However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Antares reserves the right to seek all remedies available at law and in equity for violations of these Terms of Use, including the right to block access from a particular Internet address to the website. For more information, go towww.XYOSTED.comor call 1-844-XYOSTED (1-844-996-7833). Antares Pharma. It is not our policy to intentionally collect or maintain information about anyone under the age of 13. Your exercise of these rights will have no adverse effect on the price and quality of our services. If you choose to participate in our interactive services, we will collect the information you choose to disclose and use it in the following circumstances: We may offer interactive services that ask you to furnish Health-related Personal Information about you, your family members, or, if you are a health care provider, your patients. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). BY ACCESSING THIS SITE, YOU ACKNOWLEDGE THAT YOU HAVE READ THESE TERMS OF USE, AND UNDERSTAND AND AGREE TO ABIDE BY THEM. 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. 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. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law. Use XYOSTED exactly as your healthcare provider tells you to take it. Medicine used to treat mood disorders, such as schizophrenia or bipolar disorder called chlorpromazine. The FDA has approved a new oral testosterone undecanoate capsule (Tlando) for hypogonadism, Antares Pharma announced. All personal and/or health-related personal information is kept physically behind firewalls that prevent intruders from gaining access. Opens in a new tab or window, Visit us on TikTok. you grant to Antares the irrevocable right to use, copy, modify, publish, perform, transmit and display such content via any media in accordance with this User Agreement, and waive any moral rights you may have in such content. Opens in a new tab or window. Hypercalcemia: Androgens, including TLANDO, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). The Personal Information and Health-related Personal Information that you provide may be used to create customized offers, information, and services tailored to your interests and preferences. 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). If you desire or need such services or advice, you should consult a professional health care provider. If you do not agree to the terms of this Privacy Policy, please do not use the Site. The right to know what personal information we have collected, used, disclosed and sold about you. 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. XYOSTED is the only FDA. ANTARES MAKES NO WARRANTY AS TO THE ACCURACY, COMPLETENESS, CURRENCY, OR RELIABILITY OF ANY CONTENT AVAILABLE THROUGH THIS WEBSITE. <> SAN DIEGO, May 24, 2022 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (" Halozyme ") today announced the successful completion of . YOU ARE RESPONSIBLE FOR TAKING ALL NECESSARY PRECAUTIONS TO ENSURE THAT ANY CONTENT YOU OBTAIN FROM THE WEBSITE IS FREE OF VIRUSES. This Terms of Use Agreement (this Agreement) 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 Antares co-branded websites. 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. 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 . 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. All rights reserved. If your blood pressure increases while you are on XYOSTED, blood pressure medicines may need to be started or new medicines may need to be added. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements. We also may use a third party verification provider to verify your identity. Any use of the website by you after such notice shall be deemed to constitute acceptance of such changes, revisions or modifications. With an expanded commercial footprint, we expect to continue to foster our strong physician relationships to support their patient-centric care and preference for different treatment options. 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. This Privacy Policy describes how we gather and use information about visitors to our Site (Visitors). Testosterone can cause virilization of the female fetus when administered to a pregnant woman. combination with other anabolic androgenic steroids. We believe TLANDOs oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. pF"_Ef=|DKW#ex/Jxj9 In addition to discontinuation of the drug, appropriate work up and management of edema may be required. 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. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. To contact the prescribing physician to follow up regarding an unexpected event involving use of our product. The website may contain information, news and/or press releases about Antares. TLANDO (testosterone undecanoate) capsules, for oral use, CIII. If a venous thromboembolic event is suspected, discontinue TLANDO and initiate appropriate workup and management. Drug dependence in individuals using approved doses for approved indications have not been documented. Before initiating TLANDO, consider the patients baseline cardiovascular risk and ensure blood pressure is adequately controlled. Study 18-001: 138 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately 4 months. Antares Pharma, Inc. (ATRS) ATRS : Summary for Antares Pharma, Inc. - Yahoo Finance Antares Pharma: Excellent Risk-Reward Profile Antares Pharma. 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. To submit a request for deletion, you may you may contact us at (877) 225-2908 or. For example, do not take XYOSTED if you have low testosterone due to age. Improper use of XYOSTED may effect bone growth in children. TLANDO is not a 17 alpha-alkyl androgen and is not known to produce hepatic adverse effects associated with 17-alpha-alkyl androgens. The Personal Information and Health-related Personal Information that you provide may be used to create customized offers, information, and services tailored to your interests and preferences. 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. Antares Pharma is a specialty pharmaceutical company that combines drug development expertise with proprietary delivery technology to deliver safe and effective medicines. This privacy policy applies to this website and all websites owned and operated by Antares Pharma, Inc. (Antares). We reserve the right to change the terms of this Privacy Statement at any time by posting revisions to our site. 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. If hematocrit becomes elevated, stop TLANDO until hematocrit decreases to an acceptable concentration. Are allergic XYOSTED or to any ingredients in XYOSTED including testosterone or sesame oil. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, has received tentative approval from the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. Have low testosterone without certain medical conditions. We improve compliance, absorption, and more with our proprietary drug delivery technology. By submitting any such information, you represent and warrant that you have obtained your patients authorization to do so. Antares will not sell your Personal Information or Health-related Personal Information. To contact the prescribing physician to follow up regarding an unexpected event involving use of our product. Evaluate serum prolactin levels prior to initiating treatment with TLANDO. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Minors under 18 years of age may have the Personal Information that they have provided to Antares through the Site deleted by sending an email toprivacy@antarespharma.comrequesting deletion. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Hypogonadism can be treated with testosterone replacement therapy. Sleep apnea may occur in those with risk factors (5.12). 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. Antares makes no representation that the information in the website is appropriate or available for use in other locations, and access to this website from territories where the content of this website may be illegal is prohibited. This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding the receipt of final FDA approval of TLANDO, the timing and amount of sales and development milestone payments and royalties under the License Agreement, the exercise of Antares' option with respect to TLANDO XR, the costs and timing of any post-marketing studies of TLANDO and clinical studies relating to TLANDO XR, our ability to compete in the TRT market, the degree to which TLANDO will gain market share in the TRT market, if at all, Antares Pharma's ability to successfully commercialize TLANDO, the benefits to Lipocine and Antares Pharma under the License Agreement, the potential benefits of TLANDO to patients, Lipocine's product candidates and related clinical trials, the potential uses and benefits of our product candidates, and our product development efforts. Especially, tell your healthcare provider if you take insulin, medicines that decrease blood clotting (blood thinners), corticosteroids or medicines for pain and cold. Please be aware that Antares may not comply with a consumers request to amend or remove information that was provided to Antares by a health care professional or a consumer regarding an adverse drug event. Patients treated with androgens may be at increased risk for prostate cancer. Interestingly, FDA advisory committees recommended against approval of both Tlando and Jatenzo back in 2018 largely due to cardiovascular concerns. 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. Your continued use of the Site following the posting of changes to these terms will mean that you accept those changes. 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 these Terms of Use, please contact Antares at +1 (609) 359 3020. 1A0Mc&]ufVn{$iIw^G>IFWNH-E A"N\e ,q4kb R&xbKR7 $0 q %j. 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. 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. 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. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products . 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. If you submit health-related personal information through our website to participate in a clinical trial, we may use that information to assess whether you qualify for enrollment in the trial, to contact you about potential participation in the trial, and to provide you with additional information about the trial. March 29, 2022 07:00 ET If you do not have an account with us, we may ask for your email address, other forms of identification information. Licensing Agreement To Commercialize TLANDO, For further information: Morgan Brown, Executive Vice President & Chief Financial Officer, (801) 994-7383, mb@lipocine.com; or Investors, Hans Vitzthum, (617) 535-7743, hans@lifesciadvisors.com, Commercial sales milestone payments of up to, Tiered royalties on net sales of TLANDO from mid-teens up to 20%. If you do not agree to the terms of this Privacy Policy, please do not use the Site. While this information was believed to be accurate as of the date it was prepared, Antares disclaims any duty or obligation to update this information, news or any press releases. Disclosure and Relationship To Third Parties. Monitor the lipid profile periodically after starting testosterone therapy. Testosterone, often in combination with other anabolic androgenic steroids, may be abused by athletes and bodybuilders. 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. About Antares. The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. ANTARES MAKES NO REPRESENTATIONS OR WARRANTIES THAT USE OF THE WEBSITE WILL BE UNINTERRUPTED OR ERROR-FREE. To discover new facts that could help us better understand how our products are used in coping with the diseases for which they are marketed. The Site may contain links to other websites. This site 2023 Antares Pharma. Consistent with our current core competency, this agreement allows us to focus diligently on progressing our innovative pipeline candidates with the goal of serving patients with serious unmet needs.". Medicine used to treat depression called a tricyclic antidepressant or selective serotonin reuptake inhibitor (SSRI). Opens in a new tab or window, Share on LinkedIn. Check BP approximately 3 weeks after initiating TLANDO and periodically thereafter. Check hematocrit prior to initiating TLANDO. 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. You are responsible for maintaining the confidentiality of your registration information and password, and for all uses of your password, whether or not authorized by you. It is not our policy to intentionally collect or maintain information about anyone under the age of 13. To perform the contract we are about to enter into or have entered into with you. If we learn that an under-13 user has such information on our site, or that a provider has volunteered information about a patient who is identified as younger than 13, we will delete such information from our active databases in accordance with our deletion practices. If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug. 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. Hepatic adverse effects associated with 17-alpha-alkyl androgens hematocrit becomes elevated, stop TLANDO until decreases., except as required by law if you agree to be bound you. 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