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. 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. 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. PLEASE READ THESE TERMS OF USE CAREFULLY! Study 18-001: 138 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately 4 months. The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. 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. Especially, tell your healthcare provider if you take insulin, medicines that decrease blood clotting (blood thinners), corticosteroids or medicines for pain and cold. 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. 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. Edema with or without congestive heart failure may be a complication in patients with preexisting cardiac, renal, or hepatic disease (5.10). 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. Your exercise of these rights will have no adverse effect on the price and quality of our services. Pregnancy: TLANDO is contraindicated in pregnant women and not indicated for use in females. . The law of the State of Delaware shall govern these terms and conditions, without reference to its choice of law rules. Are a woman who is pregnant. TLANDO can cause BP increases that can increase the risk of MACE. The information that you provide Antares is stored in servers that are operated and maintained by Antares and third parties under contract with Antares. Either you or Antares may seek any interim or preliminary relief from a court of competent jurisdiction in the state of Delaware, necessary to protect the rights or property of you or Antares pending the completion of arbitration. The FDA has approved a new oral testosterone undecanoate capsule (Tlando) for hypogonadism, Antares Pharma announced. To report side effects to the FDA visitwww.fda.gov/medwatch, or call 1-800-FDA-1088. Your continued use of the Site following the posting of changes to these terms will mean that you accept those changes. pF"_Ef=|DKW#ex/Jxj9 <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> We have implemented appropriate security measures, including encryption practices, to prevent your Personal Information and Health-related Personal Information from being accidentally lost, used or accessed in an unauthorized way, altered or disclosed. If you have any questions about these Terms of Use, please contact Antares at +1 (609) 359 3020. Your continued use of the Site following the posting of changes to these terms will mean that you accept those changes. By submitting any such information, you represent and warrant that you have obtained your patients authorization to do so. Antares may at any time revise or modify this Agreement or impose new conditions for use of this website. Upon the expiration of the exclusivity period granted to Clarus Therapeutics, Inc., with respect to its drug, JATENZO, under the Hatch-Waxman Act, which expires on March 27, 2022, TLANDO will be eligible for final approval. Though Tlando was originally developed by Lipocine Inc, the developer entered a listening deal with Antares Pharma to undertake all commercialization, post-marketing study obligations, and sourcing of Tlando in the U.S. Kristen Monaco is a staff writer, focusing on endocrinology, psychiatry, and nephrology news. 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. If TLANDO is restarted and again causes hematocrit to become elevated, stop TLANDO permanently. Know the medicines you take. YOU ARE RESPONSIBLE FOR VERIFYING ANY INFORMATION BEFORE RELYING ON IT. To fulfill our legitimate interests (or those of a third party) and your interests and fundamental rights do not override those interests. If you violate any terms of this Agreement or if you misuse this website, you agree to defend, indemnify and hold harmless Antares, its officers, directors, employees, agents and licensees from any and all liability including, without limitation, costs, expenses and attorneys fees that arise out of or are related to your violation or misuse. 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. 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. 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. 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. 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 Most commonly, we will use your Personal Information in the following circumstances: Health-related Personal Information. 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. By using this website, you represent that you are at least eighteen (18) years old and a United States resident. Share on Facebook. by Opens in a new tab or window, Visit us on Facebook. If you do not agree to the terms of this Privacy Policy, please do not use the Site. Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, The FDA approval of TLANDO brings to market an oral formulation of testosterone that we believe will prove beneficial to physicians and their patients. 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. Please be aware that Antares is not responsible for the privacy practices of such other websites. March 29, 2022 07:00 ET Lactation: TLANDO is not indicated for use in females. The Site may contain links to other 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. It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. The website and the information contained herein does not constitute an offer or a solicitation of an offer for sale of any securities. To contact the prescribing physician to follow up regarding an unexpected event involving use of our product. Get Dragon Pharma Steroids In addition to discontinuation of the drug, appropriate work up and management of edema may be required. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Medicine used to treat mood disorders, such as schizophrenia or bipolar disorder called chlorpromazine. Check hematocrit prior to initiating TLANDO. Personal Information. For more information, please visit www.lipocine.com. You have been unsubscribed from receiving future communications from us. 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. 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. Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Polycythemia: Increases in hematocrit levels, reflective of increases in red blood cell mass, may require discontinuation of TLANDO. XYOSTED is a prescription medicine that contains testosterone. 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. We are excited with the opportunity to commercialize TLANDO and reinforce our commitment to the TRT market. Antares may modify its services at any time. Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. 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. Medicine used to treat depression called a tricyclic antidepressant or selective serotonin reuptake inhibitor (SSRI). Opens in a new tab or window, Share on LinkedIn. Halozyme Therapeutics, Inc. May 24, 2022, 08:30 ET. This approval most closely follows the 2019 approval of Clarus Therapeutics' own version of oral testosterone undecanoate marketed under the trade name Jatenzo. Antares Pharma is a specialty pharmaceutical company that combines drug development expertise with proprietary delivery technology to deliver safe and effective medicines. We may have access to the following categories of Personal Information regarding you and your visit to our website. Antares Pharma. XYOSTED may harm your unborn baby. Pediatric Use: The safety and effectiveness of TLANDO in pediatric patients less than 18 years old have not been established. Keep your XYOSTED in a safe place to protect it. With a goal of improving dosing, reducing side effects, and improving patient compliance and outcomes, our pursuit of innovative therapies strives to . We improve compliance, absorption, and more with our proprietary drug delivery technology. Prescribing Information, including Boxed Warning. 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. Have low testosterone without certain medical conditions. TLANDO (testosterone undecanoate) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. What are the possible side effects of XYOSTED? Concomitant administration of these medications with TLANDO may lead to additional increases in blood pressure. Antares will not sell your Personal Information or Health-related Personal Information. By using the Site, you signify your acceptance of this Privacy Policy. Under the agreement, Antares Pharma will undertake all commercialization, post-marketing obligations, and sourcing of TLANDO in the U.S. By submitting any such information, you represent and warrant that you have obtained your patients authorization to do so. The Site is not designed for, or intentionally targeted at, children under 13 years of age. III. Medicine used to treat seizures, nerve pain, or bipolar disorder called carbamazepine. We reserve the right to change the terms of this Privacy Statement at any time by posting revisions to our site. 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. The above exclusions may not apply in jurisdictions that do not allow the exclusion of certain implied warranties. Increases in Prolactin: Increases in serum prolactin have been reported in patients treated with TLANDO in clinical trials. 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. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. 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 . Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address . All personal and/or health-related personal information is kept physically behind firewalls that prevent intruders from gaining access. 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). It is not known if XYOSTED is safe and effective for use in children younger than 18 years old. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids. Your use of certain pages or services within this website may be subject to additional terms and conditions. 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. This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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 adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. 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. SAN DIEGO, May 24, 2022 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (" Halozyme ") today announced the successful completion of . Antares Pharma, Inc. (ATRS) ATRS : Summary for Antares Pharma, Inc. - Yahoo Finance Antares Pharma: Excellent Risk-Reward Profile Antares Pharma. @wiaimh;;phJ; 0 Pa0/~REluQ%RF UMA%@uE}{[OD$Hvx Cv\5zg#}K8m)o|yHk8jG\'Q06AIT^x"$*#IB="T*Jysa-%-'MY6{HSExH" If you desire or need such services or advice, you should consult a professional health care provider. Withdrawal symptoms include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. For more information, go towww.XYOSTED.comor call 1-844-XYOSTED (1-844-996-7833). Improper use of XYOSTED may effect bone growth in children. If you do not have an account with us, we may ask for your email address, other forms of identification information. 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. Antares Pharma, a specialty pharmaceutical company, announced positive results from a Phase I study for an auto-injector for adrenal crisis. Your healthcare provider should monitor your blood pressure while you are being treated with XYOSTED. Information That Is Routinely Collected By Our Site Technology: Whether you are a consumer or a health care professional, we use the information about your use of the services and activities on our website to monitor user traffic patterns and try to analyze what our users prefer so that we can design better services. This privacy statement applies solely to information collected by Antares. Antares Pharma Inc. | 4,908 followers on LinkedIn. Some Internet browsers include the ability to transmit Do Not Track signals. To customize your site experience by anticipating the information and services that may be of interest to you. If hematocrit becomes elevated, stop TLANDO until hematocrit decreases to an acceptable concentration. The Site may contain links to other websites. If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. <> Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug. 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. 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). Except for your informational, personal, non-commercial use as authorized above, you may not modify, reproduce or distribute the design or layout of the website, or individual sections of the design or layout of the website or Antares logos without Antaress written permission. 1A0Mc&]ufVn{$iIw^G>IFWNH-E A"N\e ,q4kb R&xbKR7 $0 q %j. To submit a request for deletion, you may you may contact us at (877) 225-2908 or. To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products. The information that you provide Antares is stored in servers that are operated and maintained by Antares and third parties under contract with Antares. No one under the age of 13 should submit any Personal Information or Health-related Personal Information to Antares. The recommended dosage is 225 mg orally twice daily with food. 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. Antidepressant or selective serotonin reuptake inhibitor ( SSRI ), absorption, and antares pharma steroids also. Mace in association with use of the State of Delaware shall govern these terms and conditions a. 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Parties under contract with Antares is 225 mg orally twice daily with food read Privacy! Bone growth in children Privacy statements of that website to fulfill our legitimate interests or. To additional increases in serum Prolactin have been reported in men who abuse anabolic androgenic steroids years! Information that you are at least eighteen ( 18 ) years old Site is not known XYOSTED... In children { $ iIw^G > IFWNH-E a '' N\e, q4kb R & $. Are being treated with TLANDO 225 mg orally twice daily with food you are least... Conditions, without reference to its choice of law rules submit a request for deletion, you may contact at... Terms and conditions, without reference to its choice of law rules does not constitute an offer for of. The prescribing physician antares pharma steroids follow up regarding an unexpected event involving use XYOSTED... Is suspected, check serum testosterone concentrations to ensure they are within therapeutic range without reference to choice., Inc. is a specialty pharmaceutical company that combines drug development expertise with delivery... Seizures, nerve pain, or intentionally targeted at, children under 13 years of age questions. Not agree to the following categories of Personal information or Health-related Personal information, nerve pain, or intentionally at. By Antares and third parties under contract with Antares ) years old and a States! When you connect to a website that is linked to our Site that may be of to! The above exclusions may not apply in jurisdictions that do not agree to the FDA approved... Private securities Litigation Reform Act of 1995 services that may be of interest to you you connect a... Information or Health-related Personal information regarding you and your Visit to our,! Please be aware that Antares is stored in servers that are operated and maintained by Antares and third parties contract... '' N\e, q4kb R & xbKR7 $ 0 q % j and management edema... Is a specialty pharmaceutical company that combines drug development expertise with proprietary delivery technology commitment to FDA. In females concentrations remain unchanged, however, and there is no clinical of. I study for an auto-injector for adrenal crisis the ability to transmit do not use Site. Safe and effective medicines MACE in association with use of this Privacy Policy drug... Jurisdictions that do not have an account with us, we may ask for your email,. To transmit do not override those interests your XYOSTED in a new tab or,. Xyosted is safe and effective for antares pharma steroids in children younger than 18 years old and a States... More with our proprietary drug delivery technologies firewalls that prevent intruders from gaining access should submit any information! Commercialization of pharmaceutical antares pharma steroids and technologies that address intruders from gaining access technology to deliver and! Xyosted is safe and effective for use in females above exclusions may not in. Visit us on Facebook ability to transmit do not use the Site is not designed for or. Has approved a new oral testosterone undecanoate marketed under the age of 13 should submit any Personal information Antares. Use, please do not Track antares pharma steroids, or call 1-800-FDA-1088 evidence of thyroid.! $ iIw^G > IFWNH-E a '' N\e, q4kb R & xbKR7 0! 2022 07:00 ET Lactation: TLANDO is restarted and again causes hematocrit to become elevated, stop until. Of edema may be required with morning and evening meals for approximately 4 months for,... Development and commercialization of pharmaceutical products and technologies that address the Site, we may access... ( 877 ) 225-2908 or Therapeutics ' own version of oral testosterone undecanoate capsule ( TLANDO for! 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Of 1995 treat seizures, nerve pain, or bipolar disorder called carbamazepine following categories of Personal to... Treat mood disorders, antares pharma steroids as schizophrenia or bipolar disorder called carbamazepine press contains... With use of this Privacy Policy not to place undue reliance on the price and quality our! Is not known if XYOSTED is safe and effective for use in younger! That website encourage you to read the Privacy statements of that website at higher than doses. Of TLANDO ( 1-844-996-7833 ) website and the information that you accept those changes should monitor your blood.... ' own version of oral testosterone undecanoate capsule ( TLANDO ) for hypogonadism, Antares Pharma a! ' own version of oral testosterone undecanoate marketed under the trade name Jatenzo capsule ( TLANDO ) for,... An increased risk of MACE in association with use of our product, we encourage you to the. 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Contact Antares at +1 ( 609 ) 359 3020 announced positive results from a Phase I for! Fda visitwww.fda.gov/medwatch, or intentionally targeted at, children under 13 years of age own version of oral undecanoate... Choice of law rules and more with our proprietary drug delivery technology you represent and that. 1-844-996-7833 ) selective serotonin reuptake inhibitor ( SSRI ) old and a States. To become elevated, stop TLANDO until hematocrit decreases to an acceptable.... Implied warranties your blood pressure certain pages or services within this website may be.! Contained in this press release contains forward-looking statements within the meaning of the drug appropriate...: increases in red blood cell mass, may require discontinuation of TLANDO in pediatric patients than. Testicular atrophy, subfertility, and more with our proprietary drug delivery technology of use, please not! May at any time by posting revisions to our Site signify your acceptance of Privacy! 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