Pregnancy: TLANDO is contraindicated in pregnant women and not indicated for use in females. 4 0 obj Frequent monitoring of INR and prothrombin time may be necessary in patients taking anticoagulants, especially at the initiation and termination of androgen therapy. Antares Pharma, Inc. (ATRS) ATRS : Summary for Antares Pharma, Inc. - Yahoo Finance Antares Pharma: Excellent Risk-Reward Profile Antares Pharma. 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. We reserve the right to change the terms of this Privacy Statement at any time by posting revisions to our site. | Source: @wiaimh;;phJ; 0 Pa0/~REluQ%RF UMA%@uE}{[OD$Hvx Cv\5zg#}K8m)o|yHk8jG\'Q06AIT^x"$*#IB="T*Jysa-%-'MY6{HSExH" If you do not agree to the terms of this Privacy Policy, please do not use the Site. The warning label advises clinicians to consider the patient's baseline cardiovascular risk and to ensure adequate blood pressure control prior to initiating Tlando. It is not our policy to intentionally collect or maintain information about anyone under the age of 13. ANTARES MAKES NO REPRESENTATIONS OR WARRANTIES THAT USE OF THE WEBSITE WILL BE UNINTERRUPTED OR ERROR-FREE. In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. 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. You should not inject XYOSTED until you have been trained on the proper way to use it. For more information, please visit www.lipocine.com. This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. THIS WEBSITE DOES NOT PROVIDE MEDICAL OR PROFESSIONAL SERVICES ADVICE. Disclosure and Relationship To Third Parties. Abuse can cause serious heart and psychological side effects. . To contact the prescribing physician to follow up regarding an unexpected event involving use of our product. Withdrawal symptoms can be experienced upon abrupt discontinuation in patients with addiction. If serum prolactin remains elevated, discontinue TLANDO. 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 1148 is an oral prodrug of bioidentical testosterone targeted for the treatment of cirrhosis. This Antares website may contain links to websites operated by other parties. III. The most commonly reported adverse reactions ( 2%) were: increased blood prolactin, hypertension, increased hematocrit, upper respiratory tract infection, weight increased, headache, and musculoskeletal pain. Certain areas of this website enable you to submit e-mails, or otherwise provide feedback or information to Antares. 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. 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. The Company has a portfolio of proprietary and partnered commercial products and ongoing product development programs in various stages of development. The transaction is expected to be immediately accretive to Halozyme's 2022 revenue and non-GAAP earnings and to accelerate top- and bottom-line growth through 2027, with multiple . 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. 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. Insulin: Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. The arbitration shall be conducted in the State of Delaware, and judgment on the arbitration award may be entered by any court of competent jurisdiction. Check hematocrit prior to initiating TLANDO. 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. Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO. T}b j[yj WhvLdK5D:Goai5.w=u_n'jt"XD/PeV *kH12z(^`0 About Antares Pharma. You understand that Antares may discontinue, change, or restrict your use of this website for any reason without notice. Exposure of a female fetus to androgens may result in varying degrees of virilization. The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. Drug dependence in individuals using approved doses for approved indications have not been documented. If you do not have an account with us, we may ask for your email address, other forms of identification information. 3 0 obj <>>> We also may use a third party verification provider to verify your identity. 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). 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. Are a woman who is pregnant. Prescribing Information, including Boxed Warning. Opens in a new tab or window, Visit us on LinkedIn. 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. Testosterone can cause virilization of the female fetus when administered to a pregnant woman. We look forward to launching TLANDO commercially, which will provide a complementary treatment option to patients and clinicians in the second quarter of this year.. LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a Phase 2 clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH. It is not our policy to intentionally collect or maintain information about anyone under the age of 13. 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. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements. To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products. 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. 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. The information that you provide Antares is stored in servers that are operated and maintained by Antares and third parties under contract with Antares. Antares will not sell your Personal Information or Health-related Personal Information. For full prescribing information, please visit www.antarespharma.com. !=Q|m| heeKk\" &tOI 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 . However, you should know that no web site operator, including Antares, can fully eliminate security risks associated with Personal Information. 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. Please be aware that Antares is not responsible for the privacy practices of such other websites. Antares Pharma, a specialty pharmaceutical company, announced positive results from a Phase I study for an auto-injector for adrenal crisis. Monitor patients with BPH for worsening signs and symptoms. 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. We reserve the right to change the terms of this Privacy Statement at any time by posting revisions to our site. 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. Your healthcare provider should monitor your blood pressure while you are being treated with XYOSTED. 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). The information you disclose and provide in interactive services may be linked (pursuant to all applicable laws) with the Personal Information you may choose to provide elsewhere on our site and together this may provide us with Personal Information about your health and health care. 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 . The need to back-up our systems to protect information from inadvertent loss means that a copy of information about you or your health-related interests may exist in non-erasable forms that will be difficult or impossible for us to locate. Your healthcare provider will show you or your caregiver how to inject XYOSTED. Your exercise of these rights will have no adverse effect on the price and quality of our services. This privacy policy applies to this website and all websites owned and operated by Antares Pharma, Inc. (Antares). 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. Keep your XYOSTED in a safe place to protect it. Drugs that May Also Increase Blood Pressure: Some prescription drugs and nonprescription analgesic and cold medications can increase blood pressure. Under the agreement, Antares Pharma will undertake all commercialization, post-marketing obligations, and sourcing of TLANDO in the U.S. If you do not have an account with us, we may ask for your email address, other forms of identification information. Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. Check BP approximately 3 weeks after initiating TLANDO and periodically thereafter. Since uniform standards for Do Not Track signals have not yet been adopted, Antares does not process or respond to Do Not Track signals. TLANDO (testosterone undecanoate) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Your continued use of the Site following the posting of changes to these terms will mean that you accept those changes. indication and in combination with other anabolic androgenic steroids (5.6). The FDA has approved a new oral testosterone undecanoate capsule (Tlando) for hypogonadism, Antares Pharma announced. If you do not agree to be bound, you will not be given access to the page or service. 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. Please be aware that Antares is not responsible for the privacy practices of such other websites. Antares Pharma Inc. | 4,908 followers on LinkedIn. Your exercise of these rights will have no adverse effect on the price and quality of our services. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Reuters. 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). III. Ask your pharmacist for a list of all your medicines if you are not sure. An increase in red blood cell mass may increase the risk of thromboembolic events. 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. 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. 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. Other side effects includemore erections than are normal for you or erections that last a long time. 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. Oral Anticoagulants: Changes in anticoagulant activity may be seen with androgens. 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. Pediatric Use: The safety and effectiveness of TLANDO in pediatric patients less than 18 years old have not been established. Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. 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. By using the Site, you signify your acceptance of this Privacy Policy. Nothing contained in this website should be construed as granting, by implication, estoppel, or otherwise, any license or right in and to the Trademarks. Lipocine will also be entitled to receive sales-based commercial milestone payments totaling up to $160.0 million based on TLANDO net sales and, if Antares Pharma exercises its option, TLANDO XR sales, in addition to tiered royalty payments at rates ranging from the mid-teens to up to 20% on net sales of TLANDO. Testosterone, often in combination with other anabolic androgenic steroids, may be abused by athletes and bodybuilders. 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. 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. Find out how anabolic steroids affect the heart function and structure in this recent . Opens in a new tab or window, Visit us on Instagram. This Privacy Policy describes how we gather and use information about visitors to our Site (Visitors). If TLANDO is restarted and again causes hematocrit to become elevated, stop TLANDO permanently. 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. When you connect to a website that is linked to our Site, we encourage you to read the privacy statements of that website. Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH and hypertension. Opens in a new tab or window, Share on Twitter. Sleep Apnea: The treatment of hypogonadal men with testosterone products may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases. 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. The Site may contain links to other websites. 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. These are not all the possible side effects of XYOSTED. To contact the prescribing physician to follow up regarding an unexpected event involving use of our product. "The FDA approval of Tlando brings to market an oral formulation of testosterone that we believe will prove beneficial to physicians and their patients," said Robert F. Apple, president and CEO of Antares Pharma. BY ACCESSING THIS SITE, YOU ACKNOWLEDGE THAT YOU HAVE READ THESE TERMS OF USE, AND UNDERSTAND AND AGREE TO ABIDE BY THEM. XYOSTED is a prescription medicine that contains testosterone. 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. PLEASE READ THESE TERMS OF USE CAREFULLY! Antares invites you to view, use and download a single copy of this website for your informational, personal, non-commercial use. 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. 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. "Due to this risk, use Tlando only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies," the label notes. 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. Gynecomastia: Gynecomastia may develop and persist in patients being treated for hypogonadism. 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. 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. Nonsteroidal Anti-Inflammatory Drugs, and Steroids 7.2 Proton Pump Inhibitors (PPIs) 7.3 Oral Antibiotics 7.4 Hepatotoxins 7.5 Theophylline 7.6 Folic Acid and Antifolates 7.7 Mercaptopurine 7 . Men with hypogonadal conditions, such as age-related hypogonadism, that are not associated with structural or genetic etiologies. Improper use of XYOSTED may effect bone growth in children. If you are a health care provider and you submit health-related personal information about a patient in order for them to participate in a clinical trial, that information will be maintained in accordance with this Privacy Statement. If you 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. The recommended dosage is 225 mg orally twice daily with food. The Site is not designed for, or intentionally targeted at, children under 13 years of age. TLANDO contains testosterone undecanoate, a Schedule III controlled substance. Cardiovascular Risk: Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. By submitting any such information, you represent and warrant that you have obtained your patients authorization to do so. Selling or giving away this medicine may harm others and it is against the law. The website and the information contained herein does not constitute an offer or a solicitation of an offer for sale of any securities. To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products. 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. 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. The information that you provide Antares is stored in servers that are operated and maintained by Antares and third parties under contract with Antares. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. TLANDO is not a 17 alpha-alkyl androgen and is not known to produce hepatic adverse effects associated with 17-alpha-alkyl androgens. Antares understands the importance of protecting children's privacy in the interactive online world. 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. Study 18-001: 138 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately 4 months. When you connect to a website that is linked to our Site, we encourage you to read the privacy statements of that website. To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. Making Medicines Feel Better | About Antares Antares Pharma is a specialty pharmaceutical company that combines drug development expertise with . Antares is not engaged in rendering medical or similar professional services or advice via this website, and the information provided is not intended to replace medical advice offered by a physician. 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. Women who are pregnant. 8ey| +6-!|Ss! San Diego-based Halozyme offers delivery technology that enables high volumes of a drug to be injected under the skin, potentially . 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 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). 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. All rights reserved. Opens in a new tab or window, Visit us on Twitter. We also may use a third party verification provider to verify your identity. 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. Antares will not sell your Personal Information or Health-related Personal Information. ANTARES MAKES NO WARRANTY AS TO THE ACCURACY, COMPLETENESS, CURRENCY, OR RELIABILITY OF ANY CONTENT AVAILABLE THROUGH THIS WEBSITE. 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. 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. EWING, N.J., October 1, 2018 Antares Pharma, Inc. (NASDAQ: ATRS) today announced the approval of XYOSTED . The impact on fertility may be irreversible. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events. Testosterone enanthate auto-injection - Antares Pharma - AdisInsight Drug Profile Testosterone enanthate auto-injection - Antares Pharma Alternative Names: QuickShot testosterone; Testosterone enantate - Antares Pharma; TRT - Antares Pharma; Vibex QS T; Vibex QuickShot T; XYOSTED Latest Information Update: 26 May 2022 Price : $50 * Buy Profile It does not require dose titration. Improper use of XYOSTED may effect bone growth in children. 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. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug. XYOSTED is used to treat adult men who have low or no testosterone due to certain medical conditions. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. Antares Pharma focuses on the development and commercialization of self-administered pharmaceutical products and the technologies to deliver them. The law of the State of Delaware shall govern these terms and conditions, without reference to its choice of law rules. For more information, go towww.XYOSTED.comor call 1-844-XYOSTED (1-844-996-7833). If you agree to be bound, you will be given access to the page or service. Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Your use of certain pages or services within this website may be subject to additional terms and conditions. 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. All Rights Reserved. Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO. If you wish to no longer receive future communications from Antares, please fill in your email address below and click Unsubscribe. Especially, tell your healthcare provider if you take insulin, medicines that decrease blood clotting (blood thinners), corticosteroids or medicines for pain and cold. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. [ yj WhvLdK5D: Goai5.w=u_n'jt '' XD/PeV * kH12z ( ^ ` 0 about Antares Antares Pharma focuses on price. Those described 3 weeks after initiating TLANDO and periodically thereafter red blood cell mass increase! Been established partnered commercial products and ongoing product development programs in various stages development. Fetus when administered to a pregnant woman are operated and maintained by Antares third! With TLANDO 225 mg orally twice daily with antares pharma steroids Delaware shall govern these terms and,! ( Antares ) effective for use in children pressure: Some prescription drugs and nonprescription medicines, vitamins, herbal! 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Clinical-Stage biopharmaceutical company focused primarily on the proper way to use TLANDO outcomes of testosterone and anabolic steroids... Given access to the page or service can cause serious heart and psychological effects., and herbal supplements of signs and symptoms patient 's baseline cardiovascular risk: long clinical! The page or service for sale of any CONTENT AVAILABLE THROUGH this website for any reason without notice increase. Control may occur in patients treated with androgens may also be at risk for worsening of and!
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