Important Safety Information

  • WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

    See full prescribing information for complete boxed warning

    Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris and may become rapidly life-threatening or fatal if not recognized and treated early.

    • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
    • Immunize patients with a meningococcal vaccine at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risks of developing a meningococcal infection. (See Serious Meningococcal Infections for additional guidance on the management of the risk of meningococcal infection.)
    • Monitor patients for early signs of meningococcal infections, and evaluate immediately if infection is suspected.

    Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program.

Privacy Policy

At Alexion, we understand that various laws and regulations govern data protection and we respect the fact that protecting your privacy is important to you. We also recognize that health and medical information is particularly sensitive. For those reasons, we want to explain our Internet privacy policy to you in this Privacy Statement. Please review this Statement to learn about how Alexion collects, uses, shares and protects information. A separate statement regarding Safe Harbor compliance is provided at the end of this Privacy Statement.

First and foremost, the Alexion Sites only collect your personal information if you choose to give it to us. While we retain the right to share your personal information with our corporate affiliates and with outside companies or agents working on our behalf to help fulfill our business obligations, we do not share any of your personal information with third parties for their own use unless you explicitly give us permission to do so.

This Privacy Statement applies only to personal information collected online from Alexion Sites. Other Alexion privacy policies govern personal information that is not collected on Alexion Sites.

Information Collected — Information You Give Us

On the Alexion Sites, we collect only your personal information (such as your name, address, telephone number or e-mail address) when you choose to submit it to us, and we use it only for those purposes which you have approved. For example, you may choose to register to receive additional product information or information about a disease state that interests you, in which case your personal information will be used only for that purpose. In some cases, we remove personal identifiers from data and maintain it in aggregate form. We may combine this data with other information to produce anonymous, aggregated statistical information helpful to us in improving our products and services.

Automatically Collected Information

We automatically collect certain types of information whenever you interact with us on the Alexion Sites and in some e-mails we may send each other. Automatic technologies we use may include, for example, web server logs and IP addresses, cookies and web beacons.

Web Server Logs and IP Addresses: An IP address is a number assigned to your computer whenever you access the Internet that allows computers and servers to recognize and communicate with each other. Alexion collects IP addresses to conduct system administration and report aggregate information to affiliates, business partners, service providers and/or vendors to conduct website and Application analysis and performance reviews.

Cookies: A cookie is a piece of information that is placed on your computer when you access certain websites and Applications. The cookie uniquely identifies your browser to the server. Cookies allow us to store information on the server to help make your web experience better and to conduct website and Application analysis and performance reviews. Most web browsers are set up to accept cookies, although you can reset your browser to refuse all cookies or to indicate when a cookie is being sent. Note, however, that some portions of our Sites may not work properly if you refuse cookies. The Site hosting our proxy statement and annual report does not use cookies.

Web Beacons: On certain web pages or e-mails, Alexion may utilize a common Internet technology called a “web beacon” (also known as an “action tag” or “clear GIF technology”).

Web beacons help analyze the effectiveness of websites by measuring, for example, the number of visitors to a site or how many visitors clicked on key elements of a site.

Web beacons, cookies and other tracking technologies do not automatically obtain personal information about you. Only if you voluntarily submit personal information, such as by registering or sending e-mails, can these automatic tracking technologies be used to provide further information about your use of the websites to improve their usefulness to you.

Your Choices

You have certain options regarding your use of the Alexion Sites. Alexion may require you to provide certain personal information in order for you to receive additional product information or information about a disease state. You could decide not to submit any personal information at all by not entering it into any forms or data fields on our Sites and not using any available personalized services. Certain websites and Applications may ask for your permission for certain uses of your personal information and you can agree to or decline those uses. If you opt-in for particular services or communications, such as an e-newsletter, you will be able to unsubscribe at any time by following the instructions included in each communication. If you decide to unsubscribe from a service or communication, we will work to remove your information promptly, although we may require additional information before we can process your request.

As described above, if you wish to prevent cookies from tracking you anonymously as you navigate our Sites, you can reset your browser to refuse all cookies or to indicate when a cookie is being sent. Note, however, that some portions of our Sites may not work properly if you refuse cookies.

Use of Personal Information

Alexion and/or the service providers, vendors and other third parties we hire to perform services on our behalf may use any personal information you choose to give us to comply with your requests and as otherwise disclosed to you in this Privacy Statement or on the web page where you submit your information to us. We may refer to this information to better understand your needs and how we can improve our products and services. We also use depersonalized, aggregated information collected from our Sites to help us understand trends and customer needs. For example, we may analyze the gender or age of visitors to the Sites about a particular medication or disease state, and we may use that analysis of aggregate data internally or share it with others.

Data Sharing and Transfer

Alexion may share personal information about you with various outside companies or service providers or vendors working on our behalf to help further our business requirements, such as providing customer service, sending marketing communications about our products, services and offers, and doing technological maintenance. We may also share personal information with our company's affiliates.

We may also disclose personal information for these purposes:

  1. in connection with the sale, assignment or other transfer of the business of the site to which the data relates;

  2. to respond to requests of government or law enforcement agencies or where required or permitted by applicable laws, court orders, or government regulations; or

  3. when needed for corporate audits or to investigate or respond to a complaint or security threat.

No Third-Party Direct Marketing Use: Alexion will not sell or otherwise transfer the personal information you provide to us at our Sites to any third parties for their own direct marketing use unless we provide clear notice to you and obtain your explicit consent for your data to be shared in this manner.

E-mail a Friend or Colleague: On some Alexion Sites, you can choose to send a link or a message to a friend or colleague referring them to an Alexion Site. The e-mail addresses you may provide for a friend will be used to send your friend information on your behalf and will not be collected or used by Alexion or other third parties for additional purposes.

Note to Users of Business or Professional Websites: If you have a business or professional relationship with Alexion, we may use information you submit on our Sites, including sites intended specifically for business and professional users, to fulfill your requests and develop our business relationship with you and the entities you represent. We may also share such information with third parties acting on our behalf.

Links to Other Sites

Links to other websites not controlled by Alexion (non-Alexion) are provided for convenience only. By providing these links, we are not endorsing or agreeing with content contained at any of the linked sites. Furthermore, the content of the linked websites is not part of the Alexion Sites. We try to choose sites that are relevant. However, with the rapidly changing nature of some sites, we cannot express any opinion on their content and cannot guarantee their quality. We have no control over the non-Alexion linked sites and their policies. The privacy policy presented here DOES NOT APPLY to any non-Alexion websites. You should contact those sites directly for information on their privacy policies, confidentiality agreements, and data collection/distribution procedures.

Alexion will not be liable for any loss or damage resulting from the use or misuse of the information in this Site or any linked non-Alexion sites, and all users who access an Alexion Site or non-Alexion linked sites agree to do so at their own risk. Neither Alexion nor any other party involved in creating, producing, or delivering the Alexion Sites or any linked non-Alexion site from or to this site shall be liable in any manner whatsoever for any damages of any nature arising out of your access to this site or any linked non-Alexion site from this site, or any errors or omissions in their content. Please note that linked non-Alexion sites may use Cookies. Alexion cannot control the use of cookies by these linked non-Alexion sites. We also want you to know that when you link from an Alexion website to another website, that site may have the ability to recognize that you have come from an Alexion Site. If you do not want any other websites to know that you have been on this Site, we recommend that you do not use the links provided in our Site.

Privacy Statement for Children Under 18

Our Sites are not intended or designed for children under the age of 18. If you are under the age of 18 you must not provide your personal information. We do not collect personal information from any person we actually know is a child under the age of 18.

Additional Information on Websites

If an Alexion Site has particular provisions relating to privacy that differ from those stated here, those provisions will be disclosed to you on the page on which your personal information is collected.

Safe Harbor Privacy Statement

Alexion complies with the U.S.-EU Safe Harbor Framework and the U.S.-Swiss Safe Harbor Framework as set forth by the U.S. Department of Commerce regarding the collection, use, and retention of personal information from European Union member countries (EU) and Switzerland, respectively. Alexion has certified that it adheres to the Safe Harbor Privacy Principles of notice, choice, onward transfer, security, data integrity, access, and enforcement. To learn more about the Safe Harbor program, and to view Alexion’s certification, please visit http://www.export.gov/safeharbor/.

Limitation on Scope of Principles

Adherence by the Company to these privacy principles may be limited to the extent necessary to meet the Company’s regulatory, legal, governmental, or national security obligations.

Updates to Privacy Statement

ANY CHANGES TO THE ALEXION PRIVACY POLICY, INCLUDING THE SAFE HARBOR STATEMENT, WILL BE PROMPTLY POSTED ON THIS PAGE. THE DATE ON WHICH THE POLICY WAS LAST UPDATED IS INCLUDED AT THE END OF THIS LEGAL STATEMENT. WE MIGHT NOT NOTIFY YOU OF ANY CHANGES TO THIS PRIVACY POLICY, YOU SHOULD CHECK THIS PAGE PERIODICALLY FOR ANY CHANGES. BY ACCESSING AND UTILIZING THESE SITES, YOU AGREE THAT ALL DISPUTES AND OTHER MATTERS THAT MAY ARISE BETWEEN YOU OR YOUR REPRESENTATIVES AND ALEXION OR ITS EMPLOYEES, CONTRACTORS OR AGENTS IN CONNECTION WITH THESE SITES SHALL BE GOVERNED UNDER THE LAWS OF CONNECTICUT, UNITED STATES OF AMERICA, UNDER THE EXCLUSIVE JURISDICTION OF THE COURTS OF CONNECTICUT.

How to contact Alexion

If you have any questions about Alexion's Privacy Statement or the information practices of our Sites, you may contact us as follows:

Legal Department
Alexion Pharmaceuticals, Inc.
352 Knotter Drive
Cheshire, CT 06410
203-272-2596

© 2015 Alexion Pharmaceuticals, Inc.
Alexion®, Alexion logo®, Every Day Matters®, Soliris®, and OneSource™ are trademarks of Alexion Pharmaceuticals, Inc.

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Important Safety Information

CLOSE

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

See full prescribing information for complete boxed warning

Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris and may become rapidly life-threatening or fatal if not recognized and treated early.

  • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
  • Immunize patients with a meningococcal vaccine at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risks of developing a meningococcal infection. (See Serious Meningococcal Infections for additional guidance on the management of the risk of meningococcal infection.)
  • Monitor patients for early signs of meningococcal infections, and evaluate immediately if infection is suspected.

Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program.

Indications and Usage

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.

Atypical Hemolytic Uremic Syndrome (aHUS)

Soliris is indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Limitation of Use

Soliris is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

Contraindications

Soliris is contraindicated in:

  • Patients with unresolved serious Neisseria meningitidis infection

  • Patients who are not currently vaccinated against Neisseria meningitidis, unless the risks of delaying Soliris treatment outweigh the risks of developing a meningococcal infection

Warnings and precautions

Other Infections

Soliris blocks terminal complement activation; therefore patients may have increased susceptibility to infections, especially with encapsulated bacteria. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Children treated with Soliris may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenza type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenza type b (Hib) infections according to ACIP guidelines. Use caution when administering Soliris to patients with any systemic infection.

Monitoring Disease Manifestations After Soliris Discontinuation

Treatment Discontinuation for PNH

Monitor patients after discontinuing Soliris for at least 8 weeks to detect hemolysis.

Treatment Discontinuation for aHUS

After discontinuing Soliris, monitor patients with aHUS for signs and symptoms of thrombotic microangiopathy (TMA) complications for at least 12 weeks. In aHUS clinical trials, 18 patients (5 in the prospective studies) discontinued Soliris treatment. TMA complications occurred following a missed dose in 5 patients, and Soliris was reinitiated in 4 of these 5 patients.

Clinical signs and symptoms of TMA include changes in mental status, seizures, angina, dyspnea, or thrombosis. In addition, the following changes in laboratory parameters may identify a TMA complication: occurrence of two, or repeated measurement of any one of the following: a decrease in platelet count by 25% or more compared to baseline or the peak platelet count during Soliris treatment; an increase in serum creatinine by 25% or more compared to baseline or nadir during Soliris treatment; or, an increase in serum LDH by 25% or more over baseline or nadir during Soliris treatment.

If TMA complications occur after Soliris discontinuation, consider reinstitution of Soliris treatment, plasma therapy [plasmapheresis, plasma exchange, or fresh frozen plasma infusion (PE/PI)], or appropriate organ-specific supportive measures.

Thrombosis Prevention and Management

The effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established. Therefore, treatment with Soliris should not alter anticoagulant management.

Infusion Reactions

As with all protein products, administration of Soliris may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions. In clinical trials, no patients experienced an infusion reaction which required discontinuation of Soliris. Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.

Adverse Reactions

The most frequently reported adverse reactions in the PNH randomized trial (≥10% overall and greater than placebo) are: headache, nasopharyngitis, back pain, and nausea.

The most frequently reported adverse reactions in aHUS single arm prospective trials (≥20%) are: headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, pyrexia.

Please see full Prescribing Information for Soliris, including Boxed WARNING regarding serious meningococcal infection.