Prescribing Information, including Boxed Warning. The law of the State of Delaware shall govern these terms and conditions, without reference to its choice of law rules. Reduced fertility is observed in some men taking testosterone replacement therapy. 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. TLANDO contains testosterone undecanoate, a Schedule III controlled substance. 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). March 29, 2022 07:00 ET About Antares Pharma. 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. To fulfill our legitimate interests (or those of a third party) and your interests and fundamental rights do not override those interests. 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. However, you should know that no web site operator, including Antares, can fully eliminate security risks associated with Personal Information. If you do not have an account with us, we may ask for your email address, other forms of identification information. XYOSTED is a prescription medicine that contains testosterone. This Privacy Policy describes how we gather and use information about visitors to our Site (Visitors). 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. 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. combination with other anabolic androgenic steroids. Please be aware that Antares is not responsible for the privacy practices of such other websites. 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. The Site is not designed for, or intentionally targeted at, children under 13 years of age. "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. The Company also markets NOCDURNA (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals. 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. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. 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. If a venous thromboembolic event is suspected, discontinue TLANDO and initiate appropriate workup and management. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). Opens in a new tab or window, Visit us on YouTube. The FDA has affirmed the NDA resubmission for final approval will be a Class 1 resubmission which includes a two-month FDA review goal period. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug. Opens in a new tab or window, Visit us on LinkedIn. "Due to this risk, use Tlando only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies," the label notes. All personal and/or health-related personal information is kept physically behind firewalls that prevent intruders from gaining access. If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. Making Medicines Feel Better | About Antares Antares Pharma is a specialty pharmaceutical company that combines drug development expertise with . All personal and/or health-related personal information is kept physically behind firewalls that prevent intruders from gaining access. Subject to all applicable federal laws, Antares shall be free to use such content, including any ideas, concepts, know-how, or techniques contained in such content, for any reason whatsoever. 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. 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 Oral Anticoagulants: Changes in anticoagulant activity may be seen with androgens. Know the medicines you take. 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. Sleep apnea may occur in those with risk factors (5.12). Especially, tell your healthcare provider if you take insulin, medicines that decrease blood clotting (blood thinners), corticosteroids or medicines for pain and cold. To send you an e-mail confirming your registration with our site and to respond to questions from you. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. Drug dependence in individuals using approved doses for approved indications have not been documented. 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. Re-evaluate whether the benefits of continued treatment with TLANDO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease. These delivery systems are designed to improve both the efficiency of drug therapies and the patient's quality of life. 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. March 29, 2022. 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. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Never give your XYOSTED to anyone else. 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. 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. When you connect to a website that is linked to our Site, we encourage you to read the privacy statements of that website. Using XYOSTED with other medicines can affect each other. Monitor the lipid profile periodically after starting testosterone therapy. 1A0Mc&]ufVn{$iIw^G>IFWNH-E A"N\e ,q4kb R&xbKR7 $0 q %j. 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. % For all other inquiries, please contact us through the relevant product, support or Antares website. Antares Pharma Drug Portfolio. 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. Antares Pharma's FDA-approved products include XYOSTED (testosterone enanthate) injection, OTREXUP (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. If you agree to be bound, you will be given access to the page or service. 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. LPCN 1154 is an oral neuro-steroid targeted for the treatment of post-partum depression. 8ey| +6-!|Ss! | Source: Opens in a new tab or window, Visit us on Twitter. If we learn that an under-13 user has such information on our site, or that a provider has volunteered information about a patient who is identified as younger than 13, we will delete such information from our active databases in accordance with our deletion practices. These statements are based upon a number of assumptions and estimates which are subject to significant uncertainties, many of which are beyond our control. If you do not agree to the terms and conditions of this Agreement, please do not use this website. 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. 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 following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. Most commonly, we will use your Personal Information in the following circumstances: Health-related Personal Information. 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. This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. By using this website, you represent that you are at least eighteen (18) years old and a United States resident. Study 16-002: 95 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately 24 days. Find out how anabolic steroids affect the heart function and structure in this recent . Exogenous administration of androgens may lead to azoospermia (5.8). Selling or giving away this medicine may harm others and it is against the law. (Reuters) -Halozyme Therapeutics Inc is bolstering its drug delivery platform with a $960 million all-cash deal for specialty pharmaceutical company Antares Pharma Inc, the companies said on Wednesday. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements. Personal Information. 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. . Known hypersensitivity to testosterone undecanoate or any of TLANDOs ingredients. stream Antares Pharma is a specialty pharmaceutical company that combines drug development expertise with proprietary delivery technology to deliver safe and effective medicines. Some Internet browsers include the ability to transmit Do Not Track signals. San Diego-based Halozyme offers delivery technology that enables high volumes of a drug to be injected under the skin, potentially . The security of your data is very important to Antares. Get Dragon Pharma Steroids Kristen Monaco, Staff Writer, MedPage Today Decreased Thyroxine-binding Globulin: Androgens, including TLANDO, may decrease concentrations of thyroxin-binding globulins, resulting in decreased total T4 serum concentrations and increased resin uptake of triiodothyronine (T3) and thyroxine (T4). The Company develops, manufactures and commercializes, for itself or with partners, novel therapeutic products using its advanced drug delivery systems that are designed to provide commercial or functional advantages such as improved safety and efficacy, convenience, improved tolerability, and enhanced patient comfort and adherence. 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. 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.". If you do not agree to be bound, you will not be given access to the page or service. 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. 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. This Privacy Policy describes how we gather and use information about visitors to our Site (Visitors). We are a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders. Nothing contained in this website should be construed as granting, by implication, estoppel, or otherwise, any license or right in and to the Trademarks. 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. What should I tell my healthcare provider before using XYOSTED? Potential for Adverse Effects on Spermatogenesis: With large doses of exogenous androgens, including TLANDO, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) possibly leading to adverse effects on semen parameters including sperm count. 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. Lipocine's clinical development pipeline includes: TLANDO, LPCN 1144, TLANDO XR, LPCN 1148, LPCN 1154, and LPCN 1107. Insulin: Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address . 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. 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. Concomitant administration of these medications with TLANDO may lead to additional increases in blood pressure. 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. Pregnancy: TLANDO is contraindicated in pregnant women and not indicated for use in females. In addition, Lipocine has granted Antares Pharma an option . 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. In addition to discontinuation of the drug, appropriate work up and management of edema may be required. The security of your data is very important to Antares. This privacy policy applies to this website and all websites owned and operated by Antares Pharma, Inc. (Antares). This website 2023 Halozyme, Inc.All Rights Reserved MPACP--00138. Drugs that May Also Increase Blood Pressure: Some prescription drugs and nonprescription analgesic and cold medications can increase blood pressure. View details here and send questions to info@halozyme.com. The drug was also deemed a Schedule III controlled substance, due to risks of abuse and misuse of testosterone. 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. Lipocine And Antares Pharma Enter Into U.S. EWING, N.J., October 1, 2018 Antares Pharma, Inc. (NASDAQ: ATRS) today announced the approval of XYOSTED . Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events. Medicine used to treat seizures, nerve pain, or bipolar disorder called carbamazepine. Abuse of Testosterone and Monitoring of Serum Testosterone Concentrations: Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Polycythemia: Increases in hematocrit levels, reflective of increases in red blood cell mass, may require discontinuation of TLANDO. TLANDO (testosterone undecanoate) capsules, for oral use, CIII. Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer: Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. Share on Facebook. Based out of the New York City office, shes worked at the company since 2015. 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. 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. 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. Our existing commercial capabilities and presence in the market with XYOSTED provide an important foundation for the potential commercial success of TLANDO. Your use of certain pages or services within this website may be subject to additional terms and conditions. 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? that, if you are a health care professional, you will not submit any information that would directly identify a patient or any information for which you do not have all necessary consents or authorizations to disclose; you will only submit content that complies with applicable law, and will not submit content that is abusive, defamatory, obscene, infringing, threatening, repetitive, or otherwise inappropriate, or that contains any viruses or other software that may adversely affect the operation of anothers computer; you understand and agree that such content that is submitted to a feedback page, will be deemed non-confidential; and. Monitor patients with BPH for worsening signs and symptoms. USE OF THE WEBSITE AND THE CONTENT AVAILABLE ON THE WEBSITE IS AT YOUR SOLE RISK. Under the terms of the agreement, Lipocine will receive an immediate upfront cash payment of $11.0 million and, subject to certain conditions, an additional $5.0 million licensing payment in January 2025 and another $5.0 million licensing payment in January 2026. As previously announced, the U.S. Food and Drug Administration ("FDA") granted tentative approval to TLANDO. If hematocrit becomes elevated, stop TLANDO until hematocrit decreases to an acceptable concentration. endobj 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). d):b9Z}~@B_@&NT[@zY`AsU"P Withdrawal symptoms can be experienced upon abrupt discontinuation in patients with addiction. If you do not agree to the terms of this Privacy Policy, please do not use the Site. What are the possible side effects of XYOSTED? To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. 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.
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