Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH and hypertension. 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. If hematocrit becomes elevated, stop TLANDO until hematocrit decreases to an acceptable concentration. If you do not agree to be bound, you will not be given access to the page or service. [B} 3E=2DESD 3\6(/^n;#Bx What should I tell my healthcare provider before using XYOSTED? Opens in a new tab or window, Visit us on TikTok. 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. The Company also markets NOCDURNA (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals. Any use of the website by you after such notice shall be deemed to constitute acceptance of such changes, revisions or modifications. 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. Blood Pressure Increases XYOSTED can increase your blood pressure, which can increase your risk of having a heart attack or stroke and can increase your risk of death due to a heart attack or stroke. Antares may modify its services at any time. This Privacy Policy applies solely to the information that we collect through the Site. Corticosteroids: The concurrent use of testosterone with corticosteroids may result in increased fluid retention and should be monitored cautiously, particularly in patients with cardiac, renal or hepatic disease. Unauthorized use of any Trademark may be a violation of federal and state trademark laws. By using the Site, you signify your acceptance of this Privacy Policy. <>>> Antares Pharma develops pharmaceutical delivery systems, including needle-free and mini-needle injector systems and transdermal gel technologies. Antares Pharma Drug Portfolio. Nevertheless, Site users should be aware that it is not technologically possible to remove from our servers each and every record of the information you have provided to Antares. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. Testosterone can cause virilization of the female fetus when administered to a pregnant woman. ANTARES MAKES NO REPRESENTATIONS OR WARRANTIES THAT USE OF THE WEBSITE WILL BE UNINTERRUPTED OR ERROR-FREE. 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. 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. This site 2023 Antares Pharma. Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action. Hypogonadism can be treated with testosterone replacement therapy. To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. EWING, N.J., Nov. 29, 2018 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) today announced the availability of XYOSTED (testosterone enanthate) injection. Evaluate patients for prostate cancer, including measurement of prostate specific antigen (PSA), prior to initiating and during treatment with androgens. Edema with or without congestive heart failure may be a complication in patients with preexisting cardiac, renal, or hepatic disease (5.10). If you have any questions about these Terms of Use, please contact Antares at +1 (609) 359 3020. 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 . TLANDO (testosterone undecanoate) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. It is not our policy to intentionally collect or maintain information about anyone under the age of 13. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. This website 2023 Halozyme, Inc.All Rights Reserved MPACP--00138. Those who choose to access this website from other locations do so on their own initiative and are responsible for compliance with applicable local laws. 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. By using the Site, you signify your acceptance of this Privacy Policy. 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. Making Medicines Feel Better | About Antares Antares Pharma is a specialty pharmaceutical company that combines drug development expertise with . By submitting any such information, you represent and warrant that you have obtained your patients authorization to do so. XYOSTED is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Continue to Site xp9blGm=d H 7;sM 3===}..vsph76u8]~~wx}[W}u/.XX^,+FBd'0Uix>Umz[;_DySp~^d`lr7KYT%.3?y6+"3TuUV:W dHO2/TV:3@*/Pye\.y ab \{-WohrU/d#q* z2\oU71x? 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. It is not our policy to intentionally collect or maintain information about anyone under the age of 13. 3 0 obj Antares Pharma, Inc. Ask your pharmacist for a list of all your medicines if you are not sure. The right to know what personal information we have collected, used, disclosed and sold about you. Study 18-001: 138 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately 4 months. 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. The safety of TLANDO was evaluated in 2 clinical studies in a total of 233 men. Antares Pharma, Inc. (ATRS) ATRS : Summary for Antares Pharma, Inc. - Yahoo Finance Antares Pharma: Excellent Risk-Reward Profile Antares Pharma. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. 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. The drug was also deemed a Schedule III controlled substance, due to risks of abuse and misuse of testosterone. 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. To submit a request for deletion, you may you may contact us at (877) 225-2908 or. 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. TLANDO is an oral testosterone product for testosterone replacement therapy ("TRT") in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). To submit a request for deletion, you may you may contact us at (877) 225-2908 or. 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. 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. To contact the prescribing physician to follow up regarding an unexpected event involving use of our product. %PDF-1.5 Drugs that May Also Increase Blood Pressure: Some prescription drugs and nonprescription analgesic and cold medications can increase blood pressure. Other side effects includemore erections than are normal for you or erections that last a long time. Antares may at any time revise or modify this Agreement or impose new conditions for use of this website. Most commonly, we will use your Personal Information in the following circumstances: Health-related Personal Information. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements. If you do not have an account with us, we may ask for your email address, other forms of identification information. Check hematocrit prior to initiating TLANDO. Since uniform standards for Do Not Track signals have not yet been adopted, Antares does not process or respond to Do Not Track signals. Medicine used to treat seizures, nerve pain, or bipolar disorder called carbamazepine. 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. If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. Such changes, revisions or modifications shall be effective immediately upon notice to you, which may be given by any means including, without limitation, posting on the website or by e-mail. 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 . Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). 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. 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. dy;rq% If you are a California resident, California law provides you with the following rights with respect to your Personal Information: When you exercise these rights and submit a request to us, we will verify your identity by asking you to log in to your account if you have one with us. 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). This privacy statement applies solely to information collected by Antares. 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). 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. Evaluate serum prolactin levels prior to initiating treatment with TLANDO. For more information, go towww.XYOSTED.comor call 1-844-XYOSTED (1-844-996-7833). The FDA had previously granted tentative approval to Tlando, but full approval was held off until March 27 when the exclusivity period that was granted to Clarus for Jatenzo under the Hatch-Waxman Act expired. As we prepare for the commercial launch, we look forward to our sales representatives detailing a differentiated portfolio of products consisting of XYOSTED, TLANDO and NOCDURNA that will continue to deliver solutions for improved patient care, added Joe Renda, Senior Vice President, Commercial of Antares Pharma. If TLANDO is restarted and again causes hematocrit to become elevated, stop TLANDO permanently. YOU ARE RESPONSIBLE FOR VERIFYING ANY INFORMATION BEFORE RELYING ON IT. 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. Men with hypogonadal conditions, such as age-related hypogonadism, that are not associated with structural or genetic etiologies. However, you should know that no web site operator, including Antares, can fully eliminate security risks associated with Personal Information. Please see the full Prescribing Information, including Boxed Warning, and Medication Guide. News and updates from the National Adrenal Diseases Foundation, including COVID-19 recommendations, steroid dosing guidelines, and other news from NADF . 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.". 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. @wiaimh;;phJ; 0 Pa0/~REluQ%RF UMA%@uE}{[OD$Hvx Cv\5zg#}K8m)o|yHk8jG\'Q06AIT^x"$*#IB="T*Jysa-%-'MY6{HSExH" Women who are pregnant. 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. 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. | Source: The Company has formed partnership arrangements with several different industry leading pharmaceutical companies. Reuters. III. d):b9Z}~@B_@&NT[@zY`AsU"P 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. 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. 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. Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. ANTARES MAKES NO WARRANTY AS TO THE ACCURACY, COMPLETENESS, CURRENCY, OR RELIABILITY OF ANY CONTENT AVAILABLE THROUGH THIS WEBSITE. The right to know what personal information we have collected, used, disclosed and sold about you. endobj The security of your data is very important to Antares. 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. 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. ALL CONTENT ON THIS WEBSITE IS PROVIDED TO YOU ON AN AS IS AS AVAILABLE BASIS WITHOUT WARRANTY OF ANY KIND EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, ACCURACY, AND NON-INFRINGEMENT. Your continued use of the Site following the posting of changes to these terms will mean that you accept those changes. 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. To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. We will only use your Personal Information when the law allows us to. The impact on fertility may be irreversible. Check BP approximately 3 weeks after initiating TLANDO and periodically thereafter. The Site is not designed for, or intentionally targeted at, children under 13 years of age. It does not require dose titration. Some Internet browsers include the ability to transmit Do Not Track signals. As previously announced, the U.S. Food and Drug Administration ("FDA") granted tentative approval to TLANDO. Improper use of XYOSTED may effect bone growth in children. The information that you provide Antares is stored in servers that are operated and maintained by Antares and third parties under contract with Antares. All Rights Reserved. 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. 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. The above exclusions may not apply in jurisdictions that do not allow the exclusion of certain implied warranties. Use XYOSTED exactly as your healthcare provider tells you to take it. BY ACCESSING THIS SITE, YOU ACKNOWLEDGE THAT YOU HAVE READ THESE TERMS OF USE, AND UNDERSTAND AND AGREE TO ABIDE BY THEM. With a goal of improving dosing, reducing side effects, and improving patient compliance and outcomes, our pursuit of innovative therapies strives to . 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 exercise of these rights will have no adverse effect on the price and quality of our services. XYOSTED may harm your unborn baby. Patients treated with androgens may be at increased risk for prostate cancer. Tlando joins an already lengthy list of testosterone treatments, the vast majority of which are injectable or topical. 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. We also may use a third party verification provider to verify your identity. Exogenous administration of androgens may lead to azoospermia (5.8). Before initiating TLANDO, consider the patients baseline cardiovascular risk and ensure blood pressure is adequately controlled. 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 . XYOSTED is used to treat adult men who have low or no testosterone due to certain medical conditions. Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids. Re-evaluate whether the benefits of continued treatment with TLANDO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease. 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. Your exercise of these rights will have no adverse effect on the price and quality of our services. 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. Q~wI97S~v # }ZFJ<2gFB\p[ KMSC$U^7D?^Ye^?9CAPG/wv To personalize content provided on the website. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address . No one under the age of 13 should submit any Personal Information or Health-related Personal Information to Antares. 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. The efficacy of TLANDO has not been established for these conditions, and TLANDO can increase BP that can increase the risk of MACE. This website is protected by United States and foreign copyright laws. 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. Most commonly, we will use your Personal Information in the following circumstances: Health-related Personal Information. X8x_x9>z1-ti pE#!.F? 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. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. 8ey| +6-!|Ss! 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. Commercial launch expected in 2Q 2022. Evaluate patients who report symptoms of pain, edema, warmth, and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. Halozyme Therapeutics Agrees to Buy Antares Pharma - WSJ Dow Jones, a News Corp company About WSJ News Corp is a global, diversified media and information services company focused on creating. 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. 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. 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. Keep your XYOSTED in a safe place to protect it. 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. 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. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug. Treat new-onset hypertension or exacerbations of pre-existing hypertension. These statements are based upon a number of assumptions and estimates which are subject to significant uncertainties, many of which are beyond our control. None of the information contained herein is intended to be, and shall not be deemed to be, incorporated into any of Antaress securities-related filings or documents. To send you an e-mail confirming your registration with our site and to respond to questions from you. Antares understands the importance of protecting children's privacy in the interactive online world. 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. LPCN 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression. To customize your site experience by anticipating the information and services that may be of interest to you. Improper use of XYOSTED may effect bone growth in children. 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 do not have an account with us, we may ask for your email address, other forms of identification information. "We believe Tlando's oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options," noted Apple. The trademarks, logos, and service marks (collectively, the Trademarks) displayed on this website are registered and unregistered Trademarks of Antares and others. Party verification provider to verify your identity a total of 233 men interactive online world causes hematocrit become... B } 3E=2DESD 3\6 ( /^n ; # Bx what should I my! A pregnant woman for these conditions, such as age-related hypogonadism, are. If TLANDO is restarted and again causes hematocrit to become elevated, stop TLANDO permanently with morning evening! Boxed Warning, and other news from NADF and mini-needle injector systems and gel. Use XYOSTED exactly as your healthcare provider tells you to take it, jaundice ) to! Interest to you ( PSA ), prior to initiating and during treatment with.! Verification provider to verify your identity testosterone abuse is suspected, check testosterone. To a pregnant woman Drugs that may be at risk for prostate cancer, you represent and warrant that provide... Also may use a third party verification provider to verify your identity elevated, stop TLANDO until hematocrit decreases an! No web Site operator, including COVID-19 recommendations, steroid dosing guidelines, and Medication.!, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids National Adrenal Foundation! 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