To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products. indication and in combination with other anabolic androgenic steroids (5.6). The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. Your healthcare provider will show you or your caregiver how to inject XYOSTED. TLANDO XR, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids. Increase in Blood Pressure: In Study 18-001, TLANDO increased systolic BP after 4 months of treatment by an average of 4.3 mmHg based on ambulatory blood pressure monitoring (ABPM) and 4.8 mmHg from baseline based on blood pressure cuff measurements. Testosterone can cause virilization of the female fetus when administered to a pregnant woman. Opens in a new tab or window, Visit us on Facebook. March 29, 2022. Frequent monitoring of INR and prothrombin time may be necessary in patients taking anticoagulants, especially at the initiation and termination of androgen therapy. Evaluate hematocrit approximately every 3 months during the first year of treatment, and then every 6 months thereafter while the patient is taking TLANDO. ANTARES SPECIFICALLY DISCLAIMS ANY LIABILITY, WHETHER BASED IN CONTRACT, TORT, STRICT LIABILITY OR OTHERWISE, FOR ANY DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES ARISING OUT OF OR IN ANY WAY CONNECTED WITH ACCESS TO OR USE OF THE WEBSITE, EVEN IF ANTARES HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INCLUDING BUT NOT LIMITED TO RELIANCE BY ANY PARTY ON ANY CONTENT OBTAINED THROUGH THE USE OF THE WEBSITE, OR THAT ARISES IN CONNECTION WITH MISTAKES OR OMISSIONS IN, OR DELAYS IN TRANSMISSION OF, INFORMATION TO OR FROM THE USER, INTERRUPTIONS IN TELECOMMUNICATIONS CONNECTIONS TO THE WEBSITE OR VIRUSES, WHETHER CAUSED IN WHOLE OR IN PART BY NEGLIGENCE, ACTS OF GOD, WAR, TERRORISM, TELECOMMUNICATIONS FAILURE, THEFT OR DESTRUCTION OF, OR UNAUTHORIZED ACCESS TO THE WEBSITE, OR RELATED INFORMATION OR PROGRAMS. News and updates from the National Adrenal Diseases Foundation, including COVID-19 recommendations, steroid dosing guidelines, and other news from NADF . Before you use XYOSTED, tell your healthcare provider about all of your medical conditions, including, if you any of the following:high blood pressure or heart problems, high red blood cell count, urinary problems due to an enlarged prostate, kidney or liver problems, a history of mental health illness including suicidal thoughts or actions, depression, anxiety or mood disorder, or problems breathing while you sleep (sleep apnea). 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. 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. Oral Anticoagulants: Changes in anticoagulant activity may be seen with androgens. Exposure of a female fetus to androgens may result in varying degrees of virilization. Reuters. If you do not have an account with us, we may ask for your email address, other forms of identification information. USE OF THE WEBSITE AND THE CONTENT AVAILABLE ON THE WEBSITE IS AT YOUR SOLE RISK. We also may use a third party verification provider to verify your identity. Study 18-001: 138 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately 4 months. Certain areas of this website enable you to submit e-mails, or otherwise provide feedback or information to Antares. The approval was based on a phase III trial in which about 80% of participants achieved 24-hour average serum testosterone concentrations within the normal range between 300 to 1,080 ng/dL with Tlando, meeting the primary efficacy endpoint. Lipid Changes: Changes in serum lipid profile may require dose adjustment of lipid lowering drugs or discontinuation of testosterone therapy. This privacy policy applies to this website and all websites owned and operated by Antares Pharma, Inc. (Antares). THIS WEBSITE DOES NOT PROVIDE MEDICAL OR PROFESSIONAL SERVICES ADVICE. By using this website, you represent that you are at least eighteen (18) years old and a United States resident. combination with other anabolic androgenic steroids. Interestingly, FDA advisory committees recommended against approval of both Tlando and Jatenzo back in 2018 largely due to cardiovascular concerns. You are encouraged to confirm the information contained herein with other sources, and to review the information carefully with your professional health care provider. By using the Site, you signify your acceptance of this Privacy Policy. If you do not have an account with us, we may ask for your email address, other forms of identification information. 1 0 obj Antares Pharma, Inc. 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. To submit a request to know, you may contact us at (877) 225-2908 or, The right to request that we delete any personal information we have collected about you. We will only use your Personal Information when the law allows us to. 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 targeted therapeutic areas. that, if you are a health care professional, you will not submit any information that would directly identify a patient or any information for which you do not have all necessary consents or authorizations to disclose; you will only submit content that complies with applicable law, and will not submit content that is abusive, defamatory, obscene, infringing, threatening, repetitive, or otherwise inappropriate, or that contains any viruses or other software that may adversely affect the operation of anothers computer; you understand and agree that such content that is submitted to a feedback page, will be deemed non-confidential; and. For example, do not take XYOSTED if you have low testosterone due to age. The above exclusions may not apply in jurisdictions that do not allow the exclusion of certain implied warranties. With a goal of improving dosing, reducing side effects, and improving patient compliance and outcomes, our pursuit of innovative therapies strives to . In addition, Lipocine has granted Antares Pharma an option . This website may require you to register or obtain a password prior to permitting access to the website or certain services available on this site. 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. 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. Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148, LPCN 1154, and LPCN 1107. Most commonly, we will use your Personal Information in the following circumstances: Health-related Personal Information. 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. 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. In addition to discontinuation of the drug, appropriate work up and management of edema may be required. TLANDO (testosterone undecanoate) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. To submit a request for deletion, you may you may contact us at (877) 225-2908 or. 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. 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. 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. It also recommends regular monitoring and treatment of any new-onset hypertension or exacerbations of pre-existing hypertension, paired with a re-evaluation of the benefits of the treatment. 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. XYOSTED is a prescription medicine that contains testosterone. To personalize content provided on the website. If serum prolactin remains elevated, discontinue TLANDO. Before being given access to these pages or services, you will be asked to indicate whether you agree to be bound by the additional terms and conditions. Halozyme will pay $5.60 per share for New Jersey-based Antares, a specialty firm that provides generic EpiPens and auto-injectors such as QuickShot and BigShot for drug delivery. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. As an added security precaution, we deploy various methods of protection such as host intrusion prevention and detection systems to maintain the integrity and confidentiality of data. The Personal Information and Health-related Personal Information that you provide may be used to create customized offers, information, and services tailored to your interests and preferences. Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO. This Privacy Policy does not address personal information that you provide to us in other contexts (e.g., through a business relationship not handled through the Site). 1:{HBRo!#V 3s,i$~sqr,cIp({C/ Before initiating TLANDO, consider the patients baseline cardiovascular risk and ensure blood pressure is adequately controlled. 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. Share on Facebook. The Company also markets NOCDURNA (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals. When you connect to a website that is linked to our Site, we encourage you to read the privacy statements of that website. 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. by Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. By submitting any such information, you represent and warrant that you have obtained your patients authorization to do so. 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. If you agree to be bound, you will be given access to the page or service. Medicine used to treat seizures, nerve pain, or bipolar disorder called carbamazepine. 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. XYOSTED is a prescription medicine that contains testosterone. To personalize content provided on the website. Under the agreement, Antares Pharma will undertake all commercialization, post-marketing obligations, and sourcing of TLANDO in the U.S. 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. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address . Reduced fertility is observed in some men taking testosterone replacement therapy. Antares Pharma, Inc.-----HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OTREXUP safely and . 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. 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. As previously announced, the U.S. Food and Drug Administration ("FDA") granted tentative approval to TLANDO. X8x_x9>z1-ti pE#!.F? Prior to treatment initiation, diagnosis of hypogonadism must be confirmed via morning measurements of serum testosterone concentrations on at least two separate days to see if levels are below the normal range. If you do not wish to receive emails or other communications from us, you may contact us atprivacy@antarespharma.comand request that your Personal Information be removed from our list. Antares Pharma's FDA-approved products include XYOSTED (testosterone enanthate) injection, OTREXUP (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. If you do not agree to the terms of this Privacy Policy, please do not use the Site. These are not all the possible side effects of XYOSTED. XYOSTED is used to treat adult men who have low or no testosterone due to certain medical conditions. This website is for use by U.S. residents only. Continue to Site 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. We are a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders. dy;rq% TLANDO contains testosterone undecanoate, a Schedule III controlled substance. 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%. Personal Information. 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. To send you an e-mail confirming your registration with our site and to respond to questions from you. Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH and hypertension. Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. 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. Re-evaluate serum prolactin levels 3 to 4 months after starting treatment. Antares may modify its services at any time. This Privacy Policy describes how we gather and use information about visitors to our Site (Visitors). 2 0 obj 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). 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. Find out how anabolic steroids affect the heart function and structure in this recent . It does not require dose titration. 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