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The First And Only Weekly Auto-Injector Testosterone Therapy

XYOSTED AUTO-INJECTOR DISPOSAL PROGRAM

XY0-0131-03-21-02

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).

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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

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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.

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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.
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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.

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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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