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XYOSTED AUTO-INJECTOR DISPOSAL PROGRAM

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Important Safety Information

IMPORTANT SAFETY INFORMATION

What is the most important safety information I should know about XYOSTED?

Blood Pressure Increases – XYOSTED can increase your blood pressure, which can increase your risk of having a heart attack or stroke and can increase your risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke. If your blood pressure increases while you are on XYOSTED, blood pressure medicines may need to be started or new medicines may need to be added. If your blood pressure cannot be controlled, XYOSTED may need to be stopped. Your healthcare provider should monitor your blood pressure while you are being treated with XYOSTED.

What is XYOSTED?

XYOSTED is a prescription medicine that contains testosterone. 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. Improper use of XYOSTED may effect bone growth in children.

XYOSTED is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your XYOSTED in a safe place to protect it. Never give your XYOSTED to anyone else. Selling or giving away this medicine may harm others and it is against the law.

XYOSTED is not meant for use by women.

Do not use XYOSTED if you:

Are a man who has breast cancer.
Have or might have prostate cancer.
Are a woman who is pregnant. XYOSTED may harm your unborn baby.
Are allergic XYOSTED or to any ingredients in XYOSTED including testosterone or sesame oil.
Have low testosterone without certain medical conditions. For example, do not take XYOSTED if you have low testosterone due to age.

What should I tell my healthcare provider before using XYOSTED?

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).

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Using XYOSTED with other medicines can affect each other. Especially, tell your healthcare provider if you take insulin, medicines that decrease blood clotting (blood thinners), corticosteroids or medicines for pain and cold. Know the medicines you take. Ask your pharmacist for a list of all your medicines if you are not sure. Show your list to your healthcare provider and pharmacist when you get a new medicine.

How should I use XYOSTED?

See the detailed Instructions for Use for Information about how to use XYOSTED.
Use XYOSTED exactly as your healthcare provider tells you to take it.
Your healthcare provider will show you or your caregiver how to inject XYOSTED. You should not inject XYOSTED until you have been trained on the proper way to use it.

What are the possible side effects of XYOSTED?

XYOSTED can cause serious side effects including:

See “What is the most important information I should know about XYOSTED?” above.
Increase in blood pressure. XYOSTED can increase your blood pressure, which can increase your risk of having a heart attack or stroke and can increase your risk of death due to heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.
Increase in red blood cell count, hematocrit or hemoglobin. High red blood cell counts increase the risk of clots, strokes, and heart attacks. You may need to stop XYOSTED if your red blood cell count increases. Your healthcare provider should check your red blood cell count, hematocrit and hemoglobin while you use XYOSTED.
Cardiovascular Risk. Possible Increase risk of heart attack, death, or stroke.
If you already have an enlarged prostate, your signs and symptoms may get worse while using XYOSTED. This can include: increased nighttime urination, trouble starting urination, more frequent urination, feeling an urge to urinate, having a urine accident, and being unable to pass urine or weak urine flow
Increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use XYOSTED.
Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
Abuse. Testosterone can be abused, when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.
In large doses XYOSTED may lower your sperm count.
Liver problems. Symptoms of liver problems may include nausea or vomiting, yellowing of your skin or whites of your eyes, dark urine or pain on the right side of your stomach area (abdominal pain).
Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney or liver disease.
Enlarged or painful breasts.
Problems breathing while you sleep (sleep apnea).
Change in mood. Talk to your healthcare provide if you have changes in mood or behavior including, new or worsening depression, or suicidal thoughts.

Call your healthcare provider right away if you have any of the serious side effects listed above.

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.

Other side effects include more erections than are normal for you or erections that last a long time. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of XYOSTED. For more information, ask your healthcare provider or pharmacist.

For more information, go to www.XYOSTED.com or call 1-844-XYOSTED (1-844-996-7833).

To report side effects to the FDA visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the full Prescribing Information, including Boxed Warning, and Medication Guide.

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Last Updated: December 1, 2020

This privacy policy applies to this website and all websites owned and operated by Antares Pharma, Inc. (“Antares”). Antares is committed to protecting the privacy of users of this website located at www.antarespharma.com or any website owned, operated, licensed or controlled by us (the “Site”). This Privacy Policy describes how we gather and use information about visitors to our Site (“Visitors”). This Privacy Policy applies solely to the information that we collect through the Site. 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).

Acceptance of Privacy Policy

By using the Site, you signify your acceptance of this Privacy Policy. If you do not agree to the terms of this Privacy Policy, please do not use the Site. Your continued use of the Site following the posting of changes to these terms will mean that you accept those changes.

I. Information We Collect

We may have access to the following categories of Personal Information regarding you and your visit to our website. 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.

Personal Information That You Voluntarily Provide

Site Registration. We have constructed this Site so that you may visit and review information about the services/products we offer without revealing your identity or volunteering any Personal Information. If you register to use the website’s features and services, either as a consumer or a health care professional, we will collect “Personal Information” from you. “Personal Information” means information that identifies you or could reasonably be used to identify you. Examples of Personal Information include your name, company name, mailing address, phone number, and/or email address. When this information is combined with any information on health or medical status (pursuant to all applicable laws), we refer to the resulting information as “Health-related Personal Information.”
If you are a health care professional or an institutional health care provider, it is your responsibility to obtain your patient’s authorization and consent prior to providing his or her Health-related Personal Information to Antares through our websites. By submitting any such information, you represent and warrant that you have obtained your patient’s authorization to do so.
Interactive Services. Antares collects information through various points of contact, including questionnaires, surveys, HR link, Contact Us link, business development inquiries and Antares’ Co-pay Support Programs where visitors may provide certain Personal Information in order to obtain co-pay assistance cards. If you choose to participate in our interactive services, you may disclose Personal Information as well as Health-related Personal Information that could be used to identify you or your family members. Providers who use our benchmarking services and quality of care assessments may choose to disclose facts about their practice and patients that include extremely sensitive, personal data.
Correspondence with Antares. You may use our site to ask questions or report problems regarding our products and/or services to health care professionals hired by Antares to address consumers’ and health care professionals’ questions regarding use of our products and/or services. If you communicate with or request information from Antares personnel, they will have your Personal Information such as your e-mail address, as well as whatever health-related and/or personal facts you choose to include in your e-mail. If you are reporting a product experience, we may ask you for specific facts, including patient initials, age gender, and prescribing physician. U.S. regulations require us to collect patient-identifiable information in order to file reports with the U.S. Food and Drug Administration regarding the safety of our products.

Information That Is Routinely Collected By Our Site Technology:

IP Address. Each time you comes to the Site, Antares collects some information to improve the overall quality of your online experience. We record the Internet Protocol (“IP”) address of your computer when you visit our site. An IP address is a number that automatically identifies the computer or device you have used to access the Internet. Without more, the IP address does not identify you personally, but it is what allows us to maintain communications with your computer as you move about our site.
Cookies and Other Technologies. We also collect information about your use of our site through technology such as cookies and web beacons. A “web beacon” is a piece of code on our site that enables us to monitor things like user activity and site traffic. Some web beacons may be unusable if you elect to reject their associated cookies. A “cookie” is a unique numeric code that we transfer to your computer so that we can keep track of your interests and preferences and recognize you as a return visitor to our site. Cookie technology allows us to collect “clickstream” data, which is not Personal Information, but which reflects your activities on the site, including your interest in certain health care conditions. A cookie does not collect or keep your name or other personal identifying information, but when you revisit our site the cookie allows us to bring you the content and features likely to be of greatest interest to you based on your previous activities on our site. You can set your browser to refuse all or some browser cookies, or to alert you when websites set or access cookies. If you disable or refuse cookies, please note that some parts of this website may become inaccessible or not function properly.
Third-Party Advertising. We use third-party advertising companies to serve ads on other websites. These companies may use information (not including your name, e-mail, address, or telephone number) obtained from cookies and web beacons about your visits to this site and other websites in order to measure advertising effectiveness and to provide advertisements about goods and services of interest to you.

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 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. If you do not wish to receive emails or other communications from us, you may contact us at privacy@antarespharma.com and request that your Personal Information be removed from our list.

Personal Information. We will only use your Personal Information when the law allows us to. Most commonly, we will use your Personal Information in the following circumstances:

To perform the contract we are about to enter into or have entered into with you.
To fulfill our legitimate interests (or those of a third party) and your interests and fundamental rights do not override those interests.
To comply with a legal obligation.
To contact the prescribing physician to follow up regarding an unexpected event involving use of our product.
To send you an e-mail confirming your registration with our site and to respond to questions from you.
To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you.
To personalize content provided on the website.
To customize your site experience by anticipating the information and services that may be of interest to you.
To improve the functioning of our site.
To fulfill business purposes, including operation of our site, as well as research and product analyses to help us better market our products.

Health-related Personal Information. 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:

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.
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.

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. 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.

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.

III. Disclosure and Relationship To Third Parties

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. 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.

Third Parties Assisting In Our Operations. Antares may share your Personal Information under confidentiality agreements with other companies that work with, or on behalf of, Antares to provide products and services. These companies may use your Personal Information to assist Antares in its operations. We will not authorize our vendors and suppliers to use your personally identifiable information for any purpose not related to Antares’s business operation.
Co-branded Sites. We will partner with other companies to provide you with content or services on a joint or “co-branded” basis. At a co-branded site you will see both the Antares logo and the logo of the co-branded partner displayed on your screen. To access the services available on a co-branded site you may have to complete a new on-line registration form, and this registration information may be shared with Antares’s co-branded partners. You should read the individual privacy policies of our co-branded partners, as these may differ in some respects from ours. Reading these policies will help you to make an informed decision about whether to provide your information to a given site. Remember, you may always opt-out of sharing your information with a partner site by choosing not to use the service or content provided by the co-branded site.
Advertisers. We do not permit advertisers to display their advertisements at our site.
Disclosure to Subsequent Owner or Operator. We may share your Personal Information with other business entities in connection with the sale, assignment, merger or other transfer of all or a portion of Antares’ business to such business entity. We will try to assure that no personally identifiable information that is transferred will be used or shared in a manner inconsistent with this Statement without your consent. However, in the event of a sale or merger, your continued use of this site signifies your agreement to be bound by the privacy statement and other applicable terms of the subsequent owner or operator.

IV. Our Security Measures

The security of your data is very important to Antares. 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. 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.

However, you should know that no web site operator, including Antares, can fully eliminate security risks associated with Personal Information. 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.

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.

V. Links to Other Sites

The Site may contain links to other websites. Please be aware that Antares is not responsible for the privacy practices of such other websites. When you connect to a website that is linked to our Site, we encourage you to read the privacy statements of that website. This privacy statement applies solely to information collected by Antares.

VI. Response to “Do Not Track” Signals

Some Internet browsers include the ability to transmit “Do Not Track” signals. Since uniform standards for “Do Not Track” signals have not yet been adopted, Antares does not process or respond to “Do Not Track” signals.

VII. Our Children’s Policy

Under Age 13

Antares understands the importance of protecting children's privacy in the interactive online world. The Site is not designed for, or intentionally targeted at, children under 13 years of age. It is not our policy to intentionally collect or maintain information about anyone under the age of 13. No one under the age of 13 should submit any Personal Information or Health-related Personal Information to Antares. 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.

Under Age 18

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 to privacy@antarespharma.com requesting deletion. 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.

VIII. Deletion Practices

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. 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. 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. The information that you provide Antares is stored in servers that are operated and maintained by Antares and third parties under contract with 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.

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.

IX. California Consumer Privacy Act

If you are a California resident, California law provides you with the following rights with respect to your Personal Information:

The right to know what personal information we have collected, used, disclosed and sold about you. To submit a request to know, you may contact us at (877) 225-2908 or privacy@antarespharma.com. You also may designate an authorized agent to make a request for access on your behalf.
The right to request that we delete any personal information we have collected about you. To submit a request for deletion, you may you may contact us at (877) 225-2908 or privacy@antarespharma.com. You also may designate an authorized agent to make a request for deletion on your behalf.

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. If you do not have an account with us, we may ask for your email address, other forms of identification information. We also may use a third party verification provider to verify your identity.

Your exercise of these rights will have no adverse effect on the price and quality of our services.

Antares will not sell your Personal Information or Health-related Personal Information.

X. Changes In Our Privacy Statement

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. 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 at privacy@antarespharma.com.

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