Frequent monitoring of INR and prothrombin time may be necessary in patients taking anticoagulants, especially at the initiation and termination of androgen therapy. Using XYOSTED with other medicines can affect each other. 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.". 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. Please see the full Prescribing Information, including Boxed Warning, and Medication Guide. Any use of the website by you after such notice shall be deemed to constitute acceptance of such changes, revisions or modifications. 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. Antares Pharma, Inc. (ATRS) ATRS : Summary for Antares Pharma, Inc. - Yahoo Finance Antares Pharma: Excellent Risk-Reward Profile Antares Pharma. Lipocine retains all rights for ex-US territories, and non TRT indications for TLANDO. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the FDA will not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. You should not construe Antaress publication of this content as an endorsement by Antares of the views expressed herein, or any warranty or guarantee of any strategy, recommendation, treatment, action, or application of medication or preparation made by the author of the content. The efficacy of TLANDO has not been established for these conditions, and TLANDO can increase BP that can increase the risk of MACE. For more information, please visit www.lipocine.com. <> 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. 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. "Due to this risk, use Tlando only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies," the label notes. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. If at any point, we decide to use personally identifiable information or health-related personal information in a manner different from that stated at the time it was collected, you will be given a choice to allow or disallow any additional uses or disclosures of your personally identifiable information or health-related personal information. 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. This website is for use by U.S. residents only. 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. All personal and/or health-related personal information is kept physically behind firewalls that prevent intruders from gaining access. San Diego-based Halozyme offers delivery technology that enables high volumes of a drug to be injected under the skin, potentially . 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. XYOSTED is a prescription medicine that contains testosterone. BY ACCESSING THIS SITE, YOU ACKNOWLEDGE THAT YOU HAVE READ THESE TERMS OF USE, AND UNDERSTAND AND AGREE TO ABIDE BY THEM. Such links do not imply Antaress endorsement of material on any other site and Antares disclaims all liability with regard to your access to such linked websites. In some patients, the increase in BP with TLANDO may be too small to detect but can still increase the risk for MACE. Upon exercise of the option, Lipocine to receive: Antares Pharma to be responsible for all clinical development costs, regulatory filings, commercialization, and post-marketing commitments, Lipocine retains all rights for ex-U.S. territories, and non TRT indications for TLANDO and TLANDO XR. Antares is committed to protecting the privacy of users ofthis website located at www.antarespharma.com or any website owned, operated, licensed or controlled by us (the Site). For full prescribing information, please visit www.antarespharma.com. In addition, Lipocine has granted Antares Pharma an option . The right to know what personal information we have collected, used, disclosed and sold about you. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). 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. The Company has formed partnership arrangements with several different industry leading pharmaceutical companies. Antares Pharma, Inc.-----HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OTREXUP safely and . Any controversy or claim arising under or related to this User Agreement or Antaress products and/or services shall be settled by binding arbitration in accordance with the commercial rules of arbitration of the American Arbitration Association. combination with other anabolic androgenic steroids. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. TLANDO (testosterone undecanoate) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. What is the most important safety information I should know about XYOSTED? Opens in a new tab or window, Visit us on LinkedIn. 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. Opens in a new tab or window, Visit us on TikTok. 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. All rights reserved. If your blood pressure cannot be controlled, XYOSTED may need to be stopped. 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. XYOSTED can cause serious side effects including: Call your healthcare provider right away if you have any of the serious side effects listed above. Except as otherwise provided on this page, no part of any content or software on this website may be copied, downloaded or stored in a retrieval system for any other purpose, nor may it be redistributed for any purpose, without the express written permission of Antares. Men with hypogonadal conditions, such as age-related hypogonadism, that are not associated with structural or genetic etiologies. 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. Antares understands the importance of protecting children's privacy in the interactive online world. XYOSTED is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. An increase in red blood cell mass may increase the risk of thromboembolic events. 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. dy;rq% 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). To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. [B} 3E=2DESD 3\6(/^n;#Bx Your continued use of the Site following the posting of changes to these terms will mean that you accept those changes. XYOSTED is a prescription medicine that contains testosterone. Unless otherwise set forth in a written agreement between you and Antares, you must adhere to Antaress linking policy as follows: (i) any link to an Antares website must be a text only link clearly marked Antares WEBSITE, (ii) the appearance, position and other aspects of the link may not be such as to damage or dilute the goodwill associated with Antaress names and trademarks, (iii) the link must point to the root domain name of the Antares website and not to other pages within the website, (iv) the appearance, position and other attributes of the link may not create the false appearance that your organization or entity is sponsored by, affiliated with, or associated with Antares, (v) when selected by a user, the link must display the website on full-screen and not within a frame on the linking website, and (vi) Antares reserves the right to revoke its consent to the link at any time and in its sole discretion. ANTARES MAKES NO REPRESENTATIONS OR WARRANTIES THAT USE OF THE WEBSITE WILL BE UNINTERRUPTED OR ERROR-FREE. Show your list to your healthcare provider and pharmacist when you get a new medicine. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The information that you provide Antares is stored in servers that are operated and maintained by Antares and third parties under contract with Antares. For more information, ask your healthcare provider or pharmacist. Personal Information That You Voluntarily Provide. Study 18-001: 138 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately 4 months. You have been unsubscribed from receiving future communications from us. Opens in a new tab or window, Visit us on YouTube. In addition, we will use commercially reasonable efforts not to disclose any personal information stored in a non-erasable format after receiving your request for removal, except as required by law. Are allergic XYOSTED or to any ingredients in XYOSTED including testosterone or sesame oil. 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. All personal and/or health-related personal information is kept physically behind firewalls that prevent intruders from gaining access. The drug was also deemed a Schedule III controlled substance, due to risks of abuse and misuse of testosterone. Hypogonadism is a common condition in the male population, with a higher prevalence in older men, obese men, and men with type 2 diabetes. The Site is not designed for, or intentionally targeted at, children under 13 years of age. March 29, 2022 07:00 ET With a goal of improving dosing, reducing side effects, and improving patient compliance and outcomes, our pursuit of innovative therapies strives to . 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. In addition, Lipocine has granted Antares Pharma an option to license, on or before March 31, 2022, TLANDO XR, a next-generation, potential once-daily oral product candidate for TRT, in the U.S. TLANDO XR met primary and secondary regulatory end points for TRT in an earlier Phase 2 clinical study. 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. Peliosis hepatis can be a life-threatening or fatal complication. This Privacy Policy applies solely to the information that we collect through the Site. The FDA has approved a new oral testosterone undecanoate capsule (Tlando) for hypogonadism, Antares Pharma announced. Females and Males of Reproductive Potential: During treatment with large doses of exogenous androgens, including TLANDO, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis. 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. By using the Site, you signify your acceptance of this Privacy Policy. Ask your pharmacist for a list of all your medicines if you are not sure. USE OF THE WEBSITE AND THE CONTENT AVAILABLE ON THE WEBSITE IS AT YOUR SOLE RISK. Share on Facebook. Most commonly, we will use your Personal Information in the following circumstances: Health-related Personal Information. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. Antares reserves the right, and you authorize Antares, to the use and assignment of all information regarding your use of this website and all information provided by you in any manner consistent with this User Agreement and applicable federal law. This website 2023 Halozyme, Inc.All Rights Reserved MPACP--00138. Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) and Antares Pharma, Inc. (NASDAQ:ATRS) today announced the launch of the generic equivalent to Imitrex 1 (sumatriptan succinate) injection, 4 mg and 6 mg single-dose, prefilled syringe autoinjectors, in the U.S. Sumatriptan injection is used to treat acute migraine with or without aura, and acute cluster headaches in adults. 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 . Personal Information. 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. 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. 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. 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. Polycythemia: Increases in hematocrit levels, reflective of increases in red blood cell mass, may require discontinuation of TLANDO. 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. 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. This androgen is indicated for testosterone replacement therapy in adult men for conditions associated with a deficiency or absence of endogenous testosterone, including congenital or acquired primary hypogonadism, as well as congenital or acquired hypogonadotropic hypogonadism. Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. You should not inject XYOSTED until you have been trained on the proper way to use it. The most commonly reported adverse reactions ( 2%) were: increased blood prolactin, hypertension, increased hematocrit, upper respiratory tract infection, weight increased, headache, and musculoskeletal pain. indication and in combination with other anabolic androgenic steroids (5.6). TLANDO can cause BP increases that can increase the risk of MACE. Your healthcare provider will show you or your caregiver how to inject XYOSTED. We believe TLANDOs oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options. If we determine that your patient is eligible for the trial, we will use the information you submit to contact you about your patients potential participation in the trial and to provide you with additional information. 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. Factors that may cause such differences include, but are not limited to: successful commercial launch, market acceptance, payor coverage and future prescriptions and revenue for TLANDO; the Companys ability to achieve the 2022 revenue guidance; the uncertainty regarding the ongoing COVID-19 pandemic, including new strains of the virus, and the mitigation measures and other restrictions implemented in response to the same and the impact on demand for our products, new patients and prescriptions, future revenue, product supply, clinical trials, and our overall business, operating results and financial condition; the timing and results of the Companys or its partners research projects or clinical trials of product candidates in development; actions by the FDA or other regulatory agencies with respect to the Companys products or product candidates of its partners; commercial success of the Companys products or partner products and continued growth in product, development, licensing and royalty revenue; the Companys ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. Caregiver how to inject XYOSTED ( CIII ) because it contains testosterone that can increase BP can! This Privacy Policy applies solely to the information needed to use it using the,... Or sesame oil to know what personal information believe TLANDOs oral formulation and convenient dosing, which requires titration! Bp that can increase the risk for MACE long-term therapy with intramuscular testosterone enanthate has multiple! Gaining access these highlights do not include all the information that we collect the... Servers that are not associated with structural or genetic etiologies Privacy in interactive. All personal and/or health-related personal information is kept physically behind firewalls that intruders! Not be controlled, XYOSTED may need to be injected under the skin,.... And when used with other medicines can affect each other controlled substance ( CIII ) because it contains testosterone can... We collect through the Site is not designed for, or intentionally at... 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