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This Terms of Use Agreement (this “Agreement”) describes the terms and conditions applicable to your use of any and all of Amgen Inc.'s and/or Amgen USA Inc.'s (collectively "Amgen") or Amgen 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.

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Amgen 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 Amgen. You understand that Amgen may discontinue, change, or restrict your use of this website for any reason without notice.

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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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Indemnification

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User Submissions

Certain areas of this website enable you to submit e-mails, or otherwise provide feedback or information to Amgen.

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Links

This Amgen website may contain links to websites operated by other parties. The linked sites are not under the control of Amgen, and Amgen is not responsible for the content available on any other Internet sites linked to this website. Such links do not imply Amgen's endorsement of material on any other site and Amgen disclaims all liability with regard to your access to such linked websites. Amgen 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 Amgen, you must adhere to Amgen's linking policy as follows: (i) any link to an Amgen website must be a text only link clearly marked "Amgen WEBSITE," (ii) the appearance, position and other aspects of the link may not be such as to damage or dilute the goodwill associated with Amgen's names and trademarks, (iii) the link must "point" to the root domain name of the Amgen 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 Amgen, (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) Amgen reserves the right to revoke its consent to the link at any time and in its sole discretion.

Security

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Location, Governing Law and Arbitration

This website is operated by Amgen. The law of the State of California shall govern these terms and conditions, without reference to its choice of law rules. Amgen 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 Amgen'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 Los Angeles, California, and judgment on the arbitration award may be entered by any court of competent jurisdiction. Either you or Amgen may seek any interim or preliminary relief from a court of competent jurisdiction in Los Angeles County, California, necessary to protect the rights or property of you or Amgen pending the completion of arbitration.

Violations and Additional Policies

Amgen 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

Amgen reserves the right, and you authorize Amgen, 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.

Securities Laws

This website may include statements concerning Amgen's operations, prospects, strategies, financial condition, future economic performance and demand for Amgen'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 Amgen's securities-related filings or documents.

Questions

If you have any questions about these Terms of Use, please contact Amgen at +1 (805) 447-3505. For all other inquiries, please contact us through the relevant product, support or topical Amgen website.

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Indication

EPOGEN® (Epoetin alfa) is used to treat a lower than normal number of red blood cells (anemia) caused by chronic kidney failure in patients on dialysis. EPOGEN® stimulates the bone marrow to make more red blood cells and lessens the need for red blood cell transfusions. Having more red blood cells raises the hemoglobin level.

EPOGEN® should not be used for treatment of anemia in place of emergency treatment (red blood cell transfusions).

Important Safety Information

Using EPOGEN® can lead to death or other serious side effects.

All patients, including patients with cancer or chronic kidney failure:
You may get serious heart problems such as heart attack, stroke, heart failure, and may die sooner if you are treated with EPOGEN® to a hemoglobin level above 12 g/dL. Serious health problems may happen even if you take EPOGEN® and do not have an increase in your hemoglobin level. Your doctor should monitor your hemoglobin regularly.

You may get blood clots at any time while taking EPOGEN®. If you are going to have surgery, talk to your healthcare provider about whether you will need a blood thinner to lessen the chance of blood clots during or following surgery. Call your healthcare provider or get medical help right away if you have symptoms of blood clots such as chest pain; trouble breathing or shortness of breath; pain or swelling in your legs; arm or leg feels cool or appears pale; sudden confusion or trouble with speech; sudden numbness or weakness in your face, arm, or leg; sudden trouble seeing; sudden dizziness or trouble with walking or balance; loss of consciousness (fainting); your hemodialysis vascular access stops working.

Patients with cancer:
Your healthcare provider has received special training through the ESA APPRISE Oncology Program in order to prescribe EPOGEN®. Before you can begin to receive EPOGEN®, you must sign the ESA APPRISE Oncology Patient and Healthcare Professional (HCP) Acknowledgement Form to document that your healthcare provider discussed the risks of EPOGEN® with you. When you sign this form, you are stating that you are aware of the risks associated with use of EPOGEN®.

If you have breast, non-small cell lung, head and neck, lymphoid, or cervical cancer, your tumor may grow faster and you may die sooner when EPOGEN® is used experimentally to try to raise your hemoglobin beyond the amount needed to avoid red blood cell transfusion, or if you are taking EPOGEN® and not getting strong doses of chemotherapy. It is not known whether these risks exist when EPOGEN® is given according to the FDA-approved directions for use.

  • Your healthcare provider should prescribe the smallest dose of EPOGEN® to lower the chance of getting red blood cell transfusions
  • After you have finished your chemotherapy course, EPOGEN® treatment should be stopped
You should not take EPOGEN® if you:
  • Have cancer and have not been counseled by your healthcare provider regarding the risks of EPOGEN® and signed the ESA APPRISE Oncology Program Patient and Healthcare Professional (HCP) Acknowledgement Form before you begin to receive EPOGEN®.
  • Have high blood pressure that is not controlled (uncontrolled hypertension).
  • Have been told by your healthcare provider that you have or have ever had a type of anemia called Pure Red Cell Aplasia (PRCA) that starts after treatment with EPOGEN® or other erythropoietin medicines.
  • Have allergies to any of the ingredients in EPOGEN®.

Do not give EPOGEN® from multidose vials to premature babies.

Other side effects, which may also be serious, include:
  • High blood pressure in patients with chronic kidney failure. Your blood pressure may go up or be difficult to control with blood pressure medicine while taking EPOGEN®. This can happen even if you have never had high blood pressure before. Your healthcare provider should check your blood pressure often.
  • Seizures. Seizures have occurred in patients taking EPOGEN®. If you have a seizure, get medical help right away.
  • Antibodies to EPOGEN®. Your body may make antibodies to EPOGEN® that can block or lessen your body’s ability to make red blood cells and cause you to have severe anemia. Call your healthcare provider if you have signs of anemia such as unusual tiredness, lack of energy, dizziness, or fainting.
  • Serious allergic reactions. Serious allergic reactions can cause a rash over your whole body, shortness of breath, dizziness, and fainting because of a drop in blood pressure, swelling around your mouth or eyes, fast pulse, or sweating. If you have such a reaction, stop using EPOGEN® and get medical help right away.
  • Dangers of giving EPOGEN® to premature babies. EPOGEN® from multi-dose vials contains benzyl alcohol and should not be given to premature babies because it can cause death and brain damage.

While you are on EPOGEN®, tell your healthcare provider if you are, or are planning to, become pregnant or breast-feed.

Common side effectsof EPOGEN® in patients with chronic kidney failure include: high blood pressure, headache, joint pain, nausea, rash, swelling in legs and arms, and injection site reaction, including irritation and pain.

These are not all of the possible side effects of EPOGEN®. Tell your healthcare provider about any side effects that bother you or that do not go away.

You are encouraged to report negative side effects of prescription drugs to the U.S Food and Drug Administration (FDA). Visit www.fda.gov/medwatch or call 1-800-FDA-1088.