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of methotrexate?

Otrexup (methotrexate) injection, for subcutaneous use.

OTREXUP is indicated in:

Severe Rheumatoid Arthritis. FIND OUT MORE>> Polyarticular Juvenile Idiopathic Arthritis. FIND OUT MORE>> Severe Recalcitrant Psoriasis. FIND OUT MORE>>
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Did you know:

Subcutaneously injected methotrexate may deliver better blood levels than oral methotrexate.1 An innovation in technology now makes it easier to get the benefits of subcutaneous methotrexate.2

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. For more information, go to www.otrexup.com or call 1-855-Otrexup (1-855-687-3987).

Indications and Important Safety Information Including Boxed Warning

INDICATIONS:

Otrexup is a single-dose auto-injector containing a prescription medicine, methotrexate. Methotrexate is used to:

  • Treat certain adults with severe, active rheumatoid arthritis, and children with active polyarticular juvenile idiopathic arthritis (pJIA), after treatment with other medicines including non-steroidal anti-inflammatory (NSAIDS) have been used and did not work well.
  • Control the symptoms of severe, resistant, disabling psoriasis in adults when other types of treatment have been used and did not work well.

Otrexup should not be used for the treatment of cancer.

Otrexup should not be used for the treatment of children with psoriasis.

This product includes the following Black Box Warning:

Otrexup can cause serious side effects that can lead to death, including:

  • Organ system toxicity. People who use methotrexate for the treatment of cancer, psoriasis, or rheumatoid arthritis, have an increased risk of death from organ toxicity. Types of organ toxicity can include: gastrointestinal, bone marrow, liver, immune system, nerve, lung, kidneys, and skin.

    Your doctor will do blood tests and other types of tests before you take and while you are taking Otrexup to check for signs and symptoms of organ toxicity. Call your doctor right away if you have any of the following symptoms of organ toxicity: vomiting, diarrhea, mouth sores, fever, confusion, weakness, temporary blindness, seizures, headache, back pain, neck stiffness, paralysis, irritability, sleepiness, problems with coordination, dry cough, trouble breathing, and severe skin rash.

  • Women who are pregnant are at increased risk for death of the baby and for birth defects in the baby. Women who are pregnant or who plan to become pregnant must not take Otrexup. A pregnancy test should be performed before starting Otrexup.

    Contraception should be used by both females and males while taking Otrexup. Pregnancy should be avoided if either partner is receiving Otrexup:

    • For a minimum of 3 months after treatment with Otrexup for males.
    • During and for at least 1 menstrual cycle after treatment with Otrexup for females.

What are the possible side effects of Otrexup?

Otrexup may cause serious side effects, including:

  • Fertility problems. Methotrexate, the active ingredient in Otrexup, may affect your ability to have a baby. Males may have a decreased sperm count, and females may have changes to their menstrual cycle. This can happen while taking Otrexup and for a short period of time after you stop.
  • Certain cancers. Some people who have taken methotrexate have had a certain type of cancer called Non-Hodgkin’s lymphoma and other tumors. Your doctor may tell you to stop taking Otrexup if this happens.
  • Tissue and bone problems. Taking Methotrexate while having radiation therapy may increase the risk of your tissue or bone not receiving enough blood. This may lead to death of the tissue or bone.

Common side effects of Otrexup include: nausea, stomach pain, indigestion (dyspepsia), mouth sores, and rash.

Who should not take Otrexup?

Do not take Otrexup if you:

  • Are pregnant or planning to become pregnant
  • Are breastfeeding; Otrexup can pass into your breast milk and may harm your baby
  • Have alcohol problems (alcoholism)
  • Have liver problems
  • Have problems fighting infection (immunodeficiency syndrome)
  • Have been told you have (or think you have) a blood disorder such as low levels of white blood cells, red blood cells (anemia), or platelets
  • Have had an allergy to methotrexate or any of the ingredients in Otrexup

What should I tell my doctor before taking Otrexup?
Before you take Otrexup, tell your doctor if you have any other medical conditions. Tell your doctor about all of the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

Otrexup may affect how other medicines work, and other medicines may affect how Otrexup works causing side effects. Ask your doctor or pharmacist for a list of medicines if you are not sure.

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Otrexup. For more information, ask your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For more information, go to www.otrexup.com or call 1-855-Otrexup (1-855-687-3987).

References

  1. Otrexup [package insert]. Ewing, NJ: Antares Pharma Inc.; 2013.
  2. Kivitz A, McLain D, Hill J, et al. “Nearly pain-free self-administration of methotrexate using an investigational auto-injector: Results of a phase-2 clinical trial in rheumatoid arthritis patients with mild-to-severe functional limitations.” Poster presented at: American College of Rheumatology Annual Meeting: October 26-30, 2013; San Diego, California. Poster 1337.

For more information, call 1-855-Otrexup (1-855-687-3987).    OTX-33-14-05A

Register now to receive updates about Otrexup.

Privacy Policy

Privacy Policy Statement

I. Information We Collect

We may have access to the following categories of information regarding you and your visit to our website. Only some of these 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. The next section of this Statement describes how Antares Pharma, Inc. (“Antares”) uses the information we collect.

Information That You Voluntarily Provide
Information That Is Routinely Collected By Our Site Technology:

II. How We Use Your Information

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. The personally identifying information and health-related information that you provide may be used to create customized offers, information, and services tailored to your interests and preferences.

Personally Identifying Information. You do not have to register to use certain information and services available for consumers on our website. If you choose to register, we may use the personally identifying information you give us to send you an e-mail confirming your registration with our site and to respond to questions from you. Upon your request, we may also, from time-to-time, send you e-mail with special promotions or newsletters with information that we think may be of interest to you.

Health-Related Information. If you choose to participate in our interactive services, we will collect the information you choose to disclose and analyze it 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.

We may offer interactive services such as health questionnaires and care management tools that ask you to furnish health-related information about you, your family members, or, if you are a health care provider, your patients. The information you disclose and provide in interactive services may be linked (pursuant to all applicable laws) with the personally identifying information you may choose to provide elsewhere on our site and together this may provide us with personally identifying information about your health and health care. We may combine your health-related information with that from other site users 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 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. 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 we determine that your patient is eligible for the trial, we will use the information you submit to contact you about your patient’s potential participation in the trial and to provide you with additional information.

Product Reports. If you contact Antares regarding your experience in using one of our products, we may use the information you provide in submitting reports to the U.S. Food and Drug Administration, and as otherwise required of us by law. We also may use the information to contact the prescribing physician to follow up regarding an unexpected event involving use of our product. IP Address. In addition to using the IP address of your computer to maintain communications with your computer as you move about our site, we also may use your IP address to personalize content provided on the website. We retain IP addresses, and we retain them together with personally identifying information.

Cookies. We use the data we obtain through the use of cookies to customize your site experience by anticipating the information and services that may be of interest to you. We also analyze the information collected with cookie technology to help us improve the functioning of our site by monitoring traffic in popular areas and to modify the services and information we provide to meet customer demand. We will link the clickstream data available to us through the use of cookies to the personally identifiable information and health-related information that you may choose to provide elsewhere on our site. We use the information we collect through the use of cookies for our business purposes, including operation of our site, as well as research and product analyses to help us better market our products.

Law Enforcement. In certain limited circumstances, Antares may be called upon to release your personal information in response to a court order, subpoena, search warrant, law, or regulation. We plan to cooperate in responding to such requests, taking appropriate measures to ensure that the requester understands the sensitive nature of the personally identifiable information or health-related personal information that the requester may receive. We also reserve the right to cooperate with law enforcement authorities in investigating and prosecuting users who violate our rules or engage in behavior that is illegal or harmful to other websites or their property.

III. Our Relationship To Third Parties

We may use third parties to provide services and information on our site and we may provide some co-branded services in partnership with others. We also may use third parties to analyze data collected on our site. We will not disclose your personally identifying information or health-related personal information to anyone other than Antares employees and those third parties with whom we have a business relationship. If we allow a third party contractor to have access to your personally identifying 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.

We pledge that we will not sell or disclose any personally identifying 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.

Other Important Information About Our Relationship With Third Parties

IV. Our Children’s Policy

Antares’s website content and services are intended for users over the age of 13. Our site is not designed to attract child users. If we learn that an under-13 user has volunteered personal or health-related 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 policy, which is described in the section below on Your Privacy Choices.

V. Your Privacy Choices

When you access any interactive tool or service on an Antares website, you will be asked to affirmatively choose (“opt-in”) to provide the requested information. You may always choose not to provide the requested information.

Receive E-mail. When you register with our site, you will be given the option of requesting to receive e-mail with information we think you might find useful, including promotions, announcements of new services and products, and newsletters on particular health topics.

Accept Cookies. Your browser software can be set to reject all cookies, but if you reject our cookies, certain aspects of the functions and conveniences of our site may not work properly. Cookies and similar technologies are how we ensure that we can promptly retrieve and deliver the information to you when you use our site.

Deletion Practices. The information that you provide Antares is stored in servers that are operated and maintained by Antares and third parties under contract with Antares. Website 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. 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. Nevertheless, we promise that upon receiving your request, Antares will delete all personal and/or health-related personal information stored in the databases Antares actively uses for research and daily business activities, or otherwise stored in readily searchable media. In addition, 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.

Please be aware that Antares may not comply with a consumer’s request to amend or remove information that was provided to Antares by a health care professional or a consumer regarding an adverse drug event.

Communicate With Antares By E-mail. At our website, consumers and providers may communicate with our staff to learn more about our products and services. We also offer interactive tools that enable consumers and health care professionals to submit customized e-mail requests for information about diseases and therapies. Please be aware of the limits on the confidentiality of these e-mail communications. We will not disclose personally identifiable information that we receive in e-mail, but all e-mail transmissions are vulnerable to unauthorized interception. In addition, we remind you that e-mail sent or received through an employer’s computer or computer system is not confidential and may be the legal property of the employer.

VI. Our Security Measures

We want your and your patient’s, if you are a health care professional, personal information to remain as secure as reasonably possible. Our success at improving our products and services depends upon your or your patients’ willingness to share information about patient health and health care with Antares.

Data Security. We use encryption practices to help insure the integrity and privacy of some of the personal and health-related personal information you provide to us. All personal and/or health-related personal information is kept physically behind firewalls that prevent intruders from gaining access. 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. Although we will make reasonable efforts to protect personal and/or health-related personal information from loss, misuse, or alteration by third parties, you should be aware that there is always some risk that an unauthorized third party could intercept an Internet transmission, or that someone will find a way to thwart our security systems.

VII. Changes In Our Privacy Statement

We will only use personal information in the manner described in the Privacy Statement in effect when the information was collected from you. However, we reserve the right to change the terms of this Privacy Statement at any time by posting revisions to our site. 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.

Terms of Use

PLEASE READ THESE TERMS OF USE CAREFULLY!

BY ACCESSING THIS SITE, YOU ACKNOWLEDGE THAT YOU HAVE READ THESE TERMS OF USE, AND UNDERSTAND AND AGREE TO ABIDE BY THEM.

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. If you do not agree to the terms and conditions of this Agreement, please do not use this website. Your use of certain pages or services within this website may be subject to additional terms and conditions. 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. If you agree to be bound, you will be given access to the page or service. If you do not agree to be bound, you will not be given access to the page or service.

Antares may at any time revise or modify this Agreement or impose new conditions for use of this website. 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. Any use of the website by you after such notice shall be deemed to constitute acceptance of such changes, revisions or modifications. Antares may modify its services at any time.

THIS WEBSITE DOES NOT PROVIDE MEDICAL OR PROFESSIONAL SERVICES ADVICE.

The content on this website is intended to be a general information resource in regard to the subject matter covered, and is provided solely on an “AS IS” and “AS AVAILABLE” basis. You are encouraged to confirm the information contained herein with other sources, and to review the information carefully with your professional health care provider. 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 desire or need such services or advice, you should consult a professional health care provider. You should not construe Antares’s 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.

Scope of Use

Antares invites you to view, use and download a single copy of this website for your informational, personal, non-commercial use. 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. You understand that Antares may discontinue, change, or restrict your use of this website for any reason without notice.

This website is for use by U.S. residents only. By using this website, you represent that you are at least eighteen (18) years old and a United States resident.

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The above exclusions may not apply in jurisdictions that do not allow the exclusion of certain implied warranties.

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You agree that by submitting content:

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The website may contain information, news and/or press releases about Antares. While this information was believed to be accurate as of the date it was prepared, Antares disclaims any duty or obligation to update this information, news or any press releases. 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.

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This Antares website may contain links to websites operated by other parties. 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. Such links do not imply Antares’s endorsement of material on any other site and Antares disclaims all liability with regard to your access to such linked websites. Antares provides links to other Internet sites as a convenience to users, and access to any other Internet sites linked to this website is at your own risk.

Unless otherwise set forth in a written agreement between you and Antares, you must adhere to Antares’s 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 Antares’s 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.

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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. 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.

Location, Governing Law and Arbitration

This website is operated by Antares. The law of the State of Delaware shall govern these terms and conditions, without reference to its choice of law rules. 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. 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.

Any controversy or claim arising under or related to this User Agreement or Antares’s products and/or services shall be settled by binding arbitration in accordance with the commercial rules of arbitration of the American Arbitration Association. 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. 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. 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.

Violations and Additional Policies

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.

Use of Information

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.

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This website may include statements concerning Antares’s operations, prospects, strategies, financial condition, future economic performance and demand for Antares’s products or services, as well as its intentions, plans and objectives, that are forward-looking statements. These statements are based upon a number of assumptions and estimates which are subject to significant uncertainties, many of which are beyond our control. When used on the website, words like “anticipates,” “expects,” “believes,” “estimates,” “seeks,” “plans,” “intends” and similar expressions are intended to identify forward-looking statements designed to fall within securities law safe harbors for forward looking statements. The website and the information contained herein does not constitute an offer or a solicitation of an offer for sale of any securities. None of the information contained herein is intended to be, and shall not be deemed to be, incorporated into any of Antares’s securities-related filings or documents.

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If you have any questions about these Terms of Use, please contact Antares at +1 (609) 359 3020. For all other inquiries, please contact us through the relevant product, support or Antares website.

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