Nexus Nplate® (romiplostim)

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These Terms of Use describe the terms and conditions applicable to your use of any and all of Amgen Inc.'s and/or Amgen USA Inc.'s (collectively "Amgen") websites.

Amgen may at any time revise or modify these Terms of Use 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. Amgen may modify its services at any time.

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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 healthcare provider. Amgen 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 healthcare provider. You should not construe Amgen's publication of this content as an endorsement by Amgen 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
Amgen invites you to view, use and download a single copy of this website for your informational, 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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No Warranties
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you understand and agree that such content that is submitted to a feedback page, will be deemed non-confidential; and
you grant to Amgen the irrevocable right to use, copy, modify, publish, perform, transmit and display such content via any media in accordance with these Terms of Use, and waive any moral rights you may have in such content. Subject to all applicable federal laws, Amgen shall be free to use such content, including any ideas, concepts, know-how, or techniques contained in such content, for any reason whatsoever.

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Links
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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
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Any controversy or claim arising under or related to these Terms of Use 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.

Use of Information
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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.

Protecting Your Privacy
Amgen Inc. and Amgen USA Inc. (collectively "Amgen," "We" or "Our") are committed to respecting your privacy. Because facts about a person's demographic, health, health interests, and health care are private and sensitive, we know that you may have concerns about sharing information with us. This Privacy Policy is designed to answer your important questions about privacy, whether you are a consumer looking for health information , or a health care provider mining the experience of Amgen to refine your expertise in meeting the needs of your patients.

If you are a consumer, this website is intended only for use by healthcare providers and healthcare institutions. It is not intended for the direct use by patients. Patients, however, may wish to know how we use a patient’s personally identifiable information provided to us by a healthcare provider or healthcare institution in connection with such healthcare provider’s or institution’s use of this site, and how we protect this information from unauthorized use or disclosure.

If you are a health care professional or institutional provider,you'll want to know what steps we take to protect the sensitive data you may choose to share with us, and how we use information you provide about yourself, your patients and your professional services.

* We do collect personally identifying information and patient health-related personal information from users of this website. “Personally identifying information” is information that is provider and/or patient specific, such as name, address, telephone number, and e-mail address that could be used to contact such individual. When a patient’s personally identifying information is combined with any information on a patient’s health or medical status (pursuant to all applicable laws), we refer to the resulting information as "patient health-related personal information."

We urge all users of our site to read this Privacy Policy to learn more about the policies and practices that we have developed to safeguard personal and health information, and to better understand our relationships with the third parties who may have access to this information.

1. Information We Collect
We 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 (or your patient) directly, but each category offers some information about your interests and activities that could be used to make inferences about you (or your patient). The next section of this policy describes how Amgen uses the information we collect.

* Information That You Voluntarily Provide About Yourself or Your Patient(s)

Site Registration: We have constructed this website so that you may visit us and review information about the services we offer without revealing your identity or volunteering any personally identifying information. If you undertake the on-line enrollment in the Nplate^® NEXUS Program on this site, you are “registering” to use the website's features and services and we will collect "personally identifying information" from you.

Interactive Services: If you choose to participate in our interactive services you may disclose patient health-related information as well as personal facts that could be used to identify you or your patient.

Correspondence with Amgen. You may ask questions or report problems regarding our products to healthcare professionals hired by Amgen to address consumers' and health care professionals' questions regarding use of our products or the Nplate^® NEXUS Program by calling 1-877-Nplate1 (1-877-675-2831). If you communicate with or request information from Amgen or its Vendors, they will have any information you provide them, including whatever health-related and/or personal facts you chose to disclose. If you are reporting a product experience, we may ask you for specific facts, including the patient’s name or initials, age, and gender, and the name of the prescribing physician or institution, as applicable. Federal regulations require us to collect patient-identifiable information in order to file reports with the Federal Food and Drug Administration regarding the safety of our products.

* Information That Is Routinely Collected By Our Site Technology:

IP Address. We record the Internet Protocol (IP) address of your computer when you visit our site. Without more, the IP address does not identify you personally, but it is what allows us to maintain communications with you as you move about our site.

Cookies. We also collect information about your use of our site through cookies and similar technology. 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 personally identifying 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.

2. How We Use The Information You Provide Us
Whether a health care professional or an institution, we use the information about your use of the services and activities on our websites to monitor user traffic patterns and try to analyze what our users prefer so that we can design better services for you. The personally identifying information and health-related personal information that you provide may be used to create information, and services tailored to your interests, needs and preferences.

Personally Identifying Information. You have to register to use the information and services available on this website. If you choose to register, we will use the personally identifying information you give us to send you a fax confirming your registration with our site and may also communicate with you by fax to respond to questions from you.

Patient Health-Related Information. If you choose to participate in our interactive services, we will collect the information you may 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 offer interactive services such as health care management tools that ask you to furnish health-related information about the patient(s) you currently treat (or whom you intend to treat) with Nplate. We combine such health-related information with that from other site users to create de-identified summary data that we will use for our business purposes, including research to improve our products, information that we must provide to the FDA in connection with the Nplate^® NEXUS Program, and analyses that may help us better administer the Nplate^® NEXUS Program.

Product and Nplate^® NEXUS Program Reports. If you contact Amgen regarding your experience in using one of our products or the Nplate^® NEXUS Program, we may use the information you provide in submitting reports to the Federal Food and Drug Administration, and as otherwise required of us by law. And, when necessary, we also may use the information to contact the affected patient, prescribing physician or institutional provider, as applicable, to follow up regarding an unexpected event involving use of our product or issue concerning the Nplate^® NEXUS Program in accordance with Federal Food and Drug Administration requirements.

IP Address. In addition to using the Internet Protocol (IP) address of your computer to maintain communications with you 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 administer the Nplate^® NEXUS Program.

Law Enforcement. In certain limited circumstances, we may be called upon to release personal information and patient health-related 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 patient health-related personal information that they 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 website users.

3. Our Relationship to Third Parties
We use third parties to provide services and information on our site. We also use third parties to analyze data collected on our site. We will not disclose your or your patient’s personally identifying information or your patient’s health-related personal information to anyone other than Amgen 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, we will not authorize them to take it or use it for any purpose that is not consistent with this privacy policy.

We will not sell or disclose any personally identifying information or patient health-related personal information you provide on our site to an unrelated third party.

Other Important Information About Our Relationship with Third Parties:

* Advertisers. We do not permit advertisers to display their advertisements at our site, and we will not permit third party advertisers to use cookies to collect information from users at our site.

4. Privacy Choices
When you access any interactive tool or service on this website, you will be asked to affirmatively choose ("enroll") to provide the requested information. You may always choose not to provide the requested information. If you choose not to, you will not be eligible to enroll in the Nplate^® NEXUS Program through this website. Alternatively, you may be able to enroll through a paper-based enrollment method by calling 1-877-Nplate1 (1-877-675-2831).

Accept Cookies. Your browser software can be set to reject all cookies, but if you reject our cookies, certain 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.
Correct/Update Personal Information. You may correct or update the personal and/or health-related personal patient information you previously provided to the website at any time by logging on to www.Nplateportal.com and following the instructions provided there to update information.
Remove Personal Information. You may not be permitted to remove personal and/or patient health-related personal information you have provided previously to this website based on our obligation to retain information in connection with our administration of the Nplate^® NEXUS Program. Should you wish to request permanent removal of previously provided information from this website, please call calling 1-877-Nplate1 (1-877-675-2831).

Moreover, please be aware that Amgen may not comply with a patient’s request to amend or remove information that was provided to Amgen by a health care professional or institution regarding an adverse drug event or as provided to Amgen in connection with treatment of a patient through the Nplate^® NEXUS Program.

5. Our Security Measures
We want your, and your patients’, personal information and your patient’s health-related personal information to remain as secure as reasonably possible.

* 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. As an added security precaution, all personal and/or health-related personal information is kept physically behind firewalls that meet or exceed industry standards to prevent intruders from gaining access. Although we will make reasonable efforts to protect personal and/or patient 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 thieves will find a way to thwart our security systems.

6. Changes in Our Privacy Policy
We will only use personal information in the manner described in the Privacy Policy in effect when the information was collected from you. However, we reserve the right to change the terms of this Privacy Policy at any time by posting revisions to our site. If at any point, we decide to use personally identifiable information, including patient health-related personal information, in a manner different from that stated at the time it was collected, we will notify users by posting updates to this policy on this website, highlighting the changes that have been made.

Nplate^® is indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins
or splenectomy.

Nplate^® should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. Nplate^® should not be used in an attempt to normalize platelet counts.

IMPORTANT SAFETY INFORMATION

Serious adverse reactions associated with Nplate^® in clinical studies were bone marrow reticulin deposition
and worsening thrombocytopenia after Nplate^® discontinuation. Additional risks include Bone Marrow Fibrosis, Thrombotic/Thromboembolic Complications, Lack or Loss of Response to Nplate^®, and Hematological Malignancies and Progression of Malignancy in Patients with a Pre-existing Hematological Malignancy or Myelodysplastic Syndrome (MDS).

Nplate^® is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than chronic ITP.

Nplate^® is available only through a restricted distribution program called Nplate^® NEXUS (Network of Experts Understanding and Supporting Nplate^® and Patients) Program.

In the placebo-controlled studies, headache was the most commonly reported adverse drug reaction.