LEGAL STATEMENT

Alexion Pharmaceuticals, Inc. and its affiliated companies (together, “Alexion”, “we”, or “the Company”) provide this website as a source of general information about the Company. This website is linked to other websites and applications for mobile devices (“Applications”) provided by Alexion, which together with this website shall be referred to in this statement as the “Alexion Sites” or “Sites.”

PLEASE READ THIS LEGAL STATEMENT CAREFULLY BEFORE USING THE SITES. THIS STATEMENT INCLUDES:

BY USING THE SITES, YOU SIGNIFY YOUR ASSENT TO THESE TERMS. IF YOU DO NOT AGREE TO THESE TERMS, PLEASE DO NOT USE THE SITES.

Alexion has made reasonable efforts to ensure that information is complete and accurate when posted. However, Alexion makes no warranties or representations as to the completeness or accuracy of the information presented. Further, Alexion does not undertake any obligation to update any information that may change after posting. The medical information contained on the Sites is intended for informational purposes only. It is not a substitute for actual medical care. Persons requiring diagnosis or treatment or with questions specific to a single individual are urged to contact their local healthcare provider.

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TERMS OF USE

Scope of the Site

The Site is intended to provide information on Alexion’s pharmaceutical products and/or information relating to treatments, disease awareness, and/or diagnostics.

The information contained on the Site is intended for informational purposes only. It is not a substitute for actual medical care, advice and is in no way intended to replace professional medical care or attention by a healthcare professional. Persons requiring diagnosis or treatment or with questions specific to a single individual are urged to contact their local healthcare provider. You should not use the information contained herein for diagnosing a health and/or fitness problem and/or disease. The information provided on the Site is not intended for minors.

Alexion has made reasonable efforts to ensure that information is complete and accurate when posted. However, Alexion makes no warranties or representations as to the completeness or accuracy of the information presented.

The Site may offer opinions by experts consulted in a particular field in relation to the content of the Site or excerpts from press articles. Experts’ opinions reflect their own personal views and should never be interpreted as being the opinion or responsibility of Alexion and its affiliates.

Information, especially financial (if any), published on the Site shall not be considered as an encouragement to invest. The Site may contain forward-looking statements regarding Alexion’s operations, financial condition, prospects, products, services, and strategies. Such forward-looking statements are based on estimates and projections about our industry, management’s beliefs, and certain assumptions made by our management. Such statements are subject to certain factors which may cause Alexion’s plans or results to differ from those expected, including, without limitation, decisions of regulatory authorities regarding marketing approval or material limitations on marketing of Alexion’s products; delays in arranging satisfactory manufacturing capability and establishing commercial infrastructure; the possibility that results of clinical trials are not predictive of safety and efficacy results of Alexion’s products in broader patient populations in the disease studied or other diseases; the risk that acquisitions will not result in short-term or long-term benefits; the possibility that current results of commercialization are not predictive of future rates of commercialization; the risk that third parties will not agree to license any necessary intellectual property to Alexion on reasonable terms or at all; the risk that third party payers (including governmental agencies) will not reimburse for the use of Alexion’s products at acceptable rates or at all; the risk that estimates regarding the number of patients is inaccurate; our ability to successfully complete preclinical or clinical development of our products; our ability to expand the use of our product in other indications; and other risks set forth from time to time in Alexion’s filings with the US Securities and Exchange Commission. Alexion undertakes no obligation to update any of these forward-looking statements.

You may use the Site for lawful purposes only. Alexion specifically prohibits the use of the Site for, and you agree not to: (i) use any device, software or routine to interfere or attempt to interfere with the proper working of the Site; (ii) take any action that imposes an unreasonably large load on the Site’s infrastructure; and (iii) decipher, decompile, disassemble, or reverse engineer any of the software comprising or in any way making up any part of the Site, or attempt to do the same.

Information included and published on the Site may include direct or indirect references to products, programs and services of Alexion that are not announced or available in some countries or some regions or that may be supplied under a different name and may be subject to regulations and terms of use that differ depending on the country. Such references do not mean that Alexion intends to sell those products, programs or services in your country. Please contact Alexion for any information about the products, programs and services available to you.

Restrictions on Use of Materials and Intellectual Property

The Site is owned and operated by Alexion. The contents of the Site, such as text, graphics, images, logos, button icons, software and other material (the “Material”) are protected under copyright, trademark, and other laws. You may not copy, reproduce, republish, modify, upload, post, transmit, or distribute Material in any way. For purposes of these Terms, the use of the Material or a modification of the Material on any other Site or networked computer environment is prohibited unless permission is obtained in writing from Alexion. You may not copy or adapt any Material we use to generate the web pages. This is also protected by copyright and other laws.

Links to Third-Party Websites and Social Plugins

Links to other websites not controlled by Alexion (non-Alexion) are provided for convenience only. The Site also may use social plugins from social networking, including but not limited to Facebook, Twitter, LinkedIn, Google+, etc. operated by third-parties.

In case you use such a plugin, your browser will contact the third-party server and load the visual presentation of the plugin as well as present it to you. During this exercise, the third-party server receives information concerning your visit of the Site of our internet presence as well as further data like your IP address.

By providing these links and social plugins, 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 Site. The use of third-party sites and social plugins is at your own risk and subject to the terms and conditions of the third-party site.

Neither Alexion nor any other party involved in creating, producing, or delivering the Site 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 and/or social plugin from this Site, or any errors or omissions in their content. In addition, you are responsible for taking the precautions necessary to prevent any infection, in particular by one or more computer viruses, Trojan horses or any other “virus.”

We also want you to know that when you link from an Alexion website to another website and/or use the social plugin function, the website and/or the social plugin provider may have the ability to recognize that you have come from the Site. If you do not want any other websites and/or provider to know that you have been on this Site, we recommend that you do not use the links and social plugins provided in our Site.

Submissions

Alexion appreciates hearing from interested parties and welcomes your comments regarding Alexion’s products or technologies, including Alexion’s on-line services. However, Alexion’s company policy does not allow it to accept or consider confidential creative ideas, suggestions, inventions, note drawings, concepts, materials or other information (collectively “Information) other than those it has specifically requested in writing. If you nonetheless send us any Information, it shall be deemed, and shall remain, the property of Alexion. None of the Information shall be subject to any obligation of confidence on the part of Alexion and Alexion shall not be liable for any use or disclosure of any Information. Without limitation of the foregoing, Alexion shall exclusively own all now known or hereafter existing rights to the Information and shall be entitled to unrestricted use of the Information for any purpose whatsoever, commercial or otherwise, without compensation to the provider of the Information.

Limitation on Liability

The Site is for informational purposes only. You should not use the information contained herein for diagnosing a health or fitness problem or disease. Alexion makes no warranties or representations as to its accuracy. The materials in this Site are provided “as is” and without warranties of any kind either expressed or implied. To the fullest extent permissible pursuant to applicable law, Alexion disclaims all explicit or implicit warranties, including but not limited to implied warranties of merchantability and suitability for a particular purpose of the Site.

Consequently, except for direct damages resulting from gross negligence or willful misconduct, Alexion assumes no liability or responsibility for any direct, indirect, special, incidental or consequential damages under any legal theory arising out of or in connection with this Site; for any inaccuracy, errors or omissions in the content of Site; for any damage resulting from fraudulent intrusion by a third party resulting in an alteration of information or items made available on the Site or for the ability or inability to use the Site or the information contained herein. Furthermore, Alexion does not warrant that the functions contained in the materials will be uninterrupted or error free; that defects will be corrected or that this Site or the server that makes it available are free of viruses or other harmful components.

Availability of the Site

You acknowledge that (i) it is technically impossible to provide the Site free from any defect and that Alexion cannot undertake to do so; (ii) defects may lead to the Site being temporarily unavailable; and (iii) operation of the Site can be affected by events and/or matters that Alexion does not control. Alexion may, at any time, alter or interrupt, temporarily or permanently, all or part of the Site to undertake maintenance and/or make improvements and/or changes to the Site. Alexion is not responsible for any alteration, suspension or interruption of the Site.

TRADEMARK AND COPYRIGHT INFORMATION

©Copyright 1998-2019 Alexion Pharmaceuticals, Inc. This Alexion website is protected by copyright, including images, layout, and text. All rights reserved.

ALEXION, the ALEXION logo, DEDICATED TO RARE DISEASES, EVERY DAY WITH HPP, KANUMA, the KANUMA logo, PNHSOURCE, PNH REGISTRY, RXPEDITE, SOLIRIS, STRENSIQ, and ULTOMIRIS, whether or not appearing in bold typeface or with the trademark symbol ®, are trademarks of Alexion Pharmaceuticals, Inc. Alexion’s trademarks are registered in the United States, European Union, and in other countries worldwide and may not be used without permission. Use, reproduction, copying, or redistribution of these trademarks is prohibited.

The use or misuse of these trademarks, copyrights, or other materials is expressly prohibited and may be in violation of copyright law, trademark law, communications regulations and statutes, and other laws, statutes, and/or regulations.

Photo/Video Credits:

All photos and videos are used with permission.

Legal Provisions

The Site and its content are governed by and interpreted in accordance with the laws of the United States of America, any dispute relating thereto are subject to the jurisdiction of the courts of Connecticut. Alexion reserves the right to limit provision of any product or service to any person, geographic region or jurisdiction and to limit the products or services that we provide.

Severability

If any of these Terms are held invalid or unenforceable by any court of competent jurisdiction, the other provisions of these Terms shall remain in full force and effect. If any provision of these Terms are held invalid or unenforceable only in part or degree, the remainder will continue in full force and effect to the extent not held invalid or unenforceable.

How to contact Alexion

If you have any questions about the Terms of the Site, you may contact us as follows:

Alexion Pharmaceuticals, Inc.
Legal Department
121 Seaport Blvd | Boston, MA | 02210
United States of America

Tel.: 475-230-2596
Last updated on: 6/28/2019

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PRIVACY NOTICE

At Alexion, our mission is to provide hope to patients and families affected by rare diseases. As stewards of data about these patients and the health care professionals who treat them, we believe that respecting and protecting that data is a key part of delivering lifesaving medications. We are committed to handling personal data fairly and transparently in support of our mission and in accordance with the laws and regulations that govern data protection and privacy.

Solirisinfusionfinder.com exists to provide patients and healthcare providers with key information about the Soliris therapy and the OneSource patient support program.

Alexion Pharmaceuticals, Inc., 121 Seaport Boulevard, Boston, Massachusetts 02210, USA, and the Alexion affiliate in the country in which you are located, and our affiliates (“Alexion”, “we”, “us”) as data controllers are providing this statement of our privacy and data protection practices to inform you of the reasons that we collect data about you and how we will respect your rights. This is a statement of our privacy practices relating to how Alexion may collect, store, process and use certain information about you; this is not a contract.

How We Collect Personal Data and Why We Use It

We collect personal data (“Personal Data”) about you both through interactions we have with you as well as from third party professional sources. We use that Personal Data in the following ways:

Respond to You: We collect your data, such as name, address, email, zip code, phone number and any other Personal Data that you share when you voluntarily provide it to us via email or via the forms available on this Site.

By providing Personal Data to us, you give your explicit consent to these being processed by Alexion for the purpose of answering your question, granting you access to the Site or some other aspects defined on the Site or requested by you. If you submit Personal Data, we may use that information to contact you by email, phone or mail depending on the contact mechanism you have indicated. This contact will be used to provide you with information you have requested or to clarify your request in order to be able to meet your request. Where you provide us with additional information that does not identify you as an individual in whatever form: documents, data, graphics, questions, suggestions, concepts, remarks or other - this will in no way be considered as confidential. The simple fact of you transmitting this non-personal data to us grants us the right to use, reproduce, diffuse or modify this data, or to transmit it in the aim of processing your request provided we do so in a manner that has removed any personal information from it.

Our Site is not intended to collect your Sensitive Personal Data. If you provide us with any Sensitive Personal Data by emailing Alexion, you will be directed to our One Source Program. For more information on One Source’s privacy practices, please refer to the One Source Enrollment Form, available here.

To Provide You Infusion Sites in Your Search Area: The Site provides access to a locator tool, which shows sites providing infusion services. The Site will proximate infusion services location based upon the zip code entered by you on the finder. Alexion will not collect data on your search or search results in our systems. The enabling program we utilize, provided by Google Maps, does leverage analytic tools, which include features that store and track features consistent with their privacy policy, which can be found here: https://policies.google.com/privacy. By using this function, you will be leveraging a different site, in which this Privacy Notice does not apply. Alexion assumes no responsibility or oversight for Google Maps or its functionality.

Data automatically collected via our Site: We may automatically collect certain types of Personal Data whenever you interact with us on the Site. Examples of such Personal Data include your IP address, geographical location, browser type, device type, operating system, etc. We may use this Personal Data to improve the quality of the Site and it is only used in an aggregated form. This depersonalized, aggregated information collected from our Site help us to understand trends and your needs. For example, we may analyze location of visitors and the pages visited on the Site and time spent related to a particular medication or disease state, and we may use that analysis of aggregate data internally or share it with others for the purposes set forth in this Privacy Notice. Alexion gathers this usage data and site information in order to maintain our Site and provide you services, which we do so under Alexion’s legitimate interests in order to support, maintain and improve upon our Site. Additionally by continuing to use our website, you consent to the processing of this Personal Data. For further information please see our Cookie and Site Usage Tracking Notice. [“Cookie” section of Alexion Cookie and Site Usage Notice section below]

If you have any questions regarding the legal basis for our usage or collection of your Personal Data, please feel free to contact Alexion as provided below.

Other Processing

Due to the nature of its business, Alexion is subject to a range of regulation and legislation, mainly related to patient safety. As a result Alexion may be required to process Personal Data in order to meet its legal obligations. Where this is necessary, we will do so in a way which protects your privacy to the extent possible while still complying with obligations.

Personal Data Sharing and Recipients

Alexion will not disclose to third parties your Personal Data without adequate organizational and technical measures in place in order to protect your Personal Data. Third parties Alexion might work with are:

  1. Vendors and service providers who assist Alexion with website development, deployment and content management.
  2. Third party partners who assist Alexion with identifying infusion sites within the US, web-based map functionality which enables assigning proximity of a searched zip code to surrounding infusion sites.
  3. Third parties in connection with the sale, assignment or other transfer of an Alexion business;
  4. Third parties to respond to requests of government or law enforcement agencies or where required or permitted by applicable laws, court orders, or government regulations; or When needed for corporate audits or to investigate or respond to a complaint or security threat.
  5. Any affiliated entity, vendor or service provider, or other third party who has permitted access to or to whom we transfer Personal Data is required to keep it confidential and secure, as well as to process it only for the purposes we have informed you of in this privacy statement or for which you have consented.

Protecting Your Personal Data

Alexion takes seriously our responsibility to protect the Personal Data entrusted to us. As such, we use appropriate privacy and security controls and processes that are designed to help protect and safeguard your Data.

International Personal Data Transfer

Alexion is an international organization with affiliates and subsidiaries worldwide. Some of these have their registered offices or are located in countries not providing for the same level of data protection as the country where you reside (including in other countries that do not provide for the same level of regulatory data protection). In order to protect your privacy, where data are transferred by or on behalf of Alexion to other countries or organizations that have not been recognized as providing regulatory protection similar to your country, Alexion contractually obliges its international entities, affiliates and service providers to comply with the applicable data protection laws and principles through standard clauses that have been approved or recognized by the relevant regulators.

Website Hosting

The Site will be hosted by third party in the United States.

Your Rights

You may contact us to request access to your Personal Data or to receive your data in a portable form (to the extent the right to data portability is provided under your applicable law) by contacting us as provided below. To the extent provided for under applicable law, you may also inquire about correcting inaccurate information, accessing a list of providers and their data processing locations currently used by Alexion, or to raise other concerns about how we are handling Personal Data, to opt out of or suppress certain data processing or to request deletion, restrictions or withdrawal of your explicit consent. We will honor your request in accordance with the applicable laws and regulations and in a manner consistent with Alexion’s privacy commitment. In accordance with applicable law, as a result of withdrawal of your consent, your Personal Data will be deleted from Alexion records, and Alexion will ensure that this Personal Data is deleted from its associated service providers, unless the Personal Data cannot be deleted where we are required to retain it by applicable laws and regulations.

You may contact us through the following ways:

By mail:
Privacy Officer
c/o Alexion Pharmaceuticals
121 Seaport Boulevard
Boston, MA 02210

By email: privacy@alexion.com

Alexion Data Protection Officer
c/o Veneto Privacy Services Ltd.
20-21 Saint Patricks Road
Dalkey
Co. Dublin
A96 DV76, IRELAND

By email: info@venetoprivacy.ie

You also have the right to lodge a complaint with the privacy or data protection regulator in your country of residence.

Privacy Statement for Minors

Our Site is not intended or designed for persons under the age of 18 (hereinafter “minor”). If you are under the age of 18, you must not provide your Personal Data. We will not knowingly collect, use or disclose Personal Data from minors without the prior written consent from his/her parents and/or legal guardian.

Additional Information on Websites

If parts of the Site have 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 Data is collected.

Retention of your Personal Data

Alexion retains your Personal Data no longer than necessary for the purpose for which it was processed for the duration of our relationship with you, unless a longer period is required to comply with applicable laws. Retention periods may vary depending on purpose for which the Personal Data was collected and used. Some of the criteria we use to assess appropriate retention periods includes: i) the nature of your data and the activities involved, ii) the length of your interaction with Alexion, or iii) whether there are legal obligations to which we are subject.

ANY CHANGES TO THE ALEXION PRIVACY NOTICE WILL BE PROMPTLY POSTED ON THIS PAGE. THE DATE ON WHICH THE NOTICE WAS LAST UPDATED IS INCLUDED AT THE END OF THIS LEGAL STATEMENT. WE MIGHT NOT NOTIFY YOU OF ANY CHANGES TO THIS PRIVACY NOTICE, 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 COMMONWEALTH OF MASSACHUSETTS, UNITED STATES OF AMERICA, UNDER THE EXCLUSIVE JURISDICTION OF THE COURTS OF COMMONWEALTH OF MASSACHUSETTS.

Last updated on: 28 June 2019

Alexion Cookie and Site Usage Notice

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.

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.

Last updated on: 12/2018
@ 2018 Alexion Pharmaceuticals, Inc.

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IMPORTANT SAFETY INFORMATION & INDICATION FOR SOLIRIS® (eculizumab), INCLUDING BOXED WARNING
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IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SOLIRIS?
SOLIRIS is a medicine that affects your immune system. SOLIRIS can lower the ability of your immune system to fight infections.
  • SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early.
  1. You must receive meningococcal vaccines at least 2 weeks before your first dose of SOLIRIS if you have not already had this vaccine.
  2. If your doctor decided that urgent treatment with SOLIRIS is needed, you should receive meningococcal vaccination as soon as possible.
  3. If you have not been vaccinated and SOLIRIS therapy must be initiated immediately, you should also receive two weeks of antibiotics with your vaccinations.
  4. If you had a meningococcal vaccine in the past, you might need additional vaccination before starting SOLIRIS. Your doctor will decide if you need additional meningococcal vaccination.
  5. Meningococcal vaccines reduce the risk of meningococcal infection but do not prevent all meningococcal infections. Call your doctor or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection:
    • headache with nausea or vomiting
    • headache and fever
    • headache with a stiff neck or stiff back
    • fever
    • fever and a rash
    • confusion
    • muscle aches with flu-like symptoms
    • eyes sensitive to light

Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. Carry it with you at all times during treatment and for 3 months after your last SOLIRIS dose. Your risk of meningococcal infection may continue for several weeks after your last dose of SOLIRIS. It is important to show this card to any doctor or nurse who treats you. This will help them diagnose and treat you quickly.

SOLIRIS is only available through a program called the SOLIRIS REMS. Before you can receive SOLIRIS, your doctor must:
  • enroll in the SOLIRIS REMS program
  • counsel you about the risk of meningococcal infection
  • give you information about the symptoms of meningococcal infection
  • give you a Patient Safety Card about your risk of meningococcal infection, as discussed above
  • make sure that you are vaccinated with the meningococcal vaccine and, if needed, get revaccinated with the meningococcal vaccine. Ask your doctor if you are not sure if you need to be revaccinated.

SOLIRIS may also increase the risk of other types of serious infections. Certain people may be at risk of serious infections with gonorrhea. Talk to your doctor about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing. Certain fungal infections (Aspergillus) may also happen if you take SOLIRIS and have a weak immune system or a low white blood cell count.

Who should not receive SOLIRIS?
Do not receive SOLIRIS if you:
  • have a meningococcal infection.
  • have not been vaccinated against meningitis infection unless your doctor decides that urgent treatment with SOLIRIS is needed. See “What is the most important information I should know about SOLIRIS?”
Before you receive SOLIRIS, tell your doctor about all of your medical conditions, including if you:
  • have an infection or fever.
  • are pregnant or plan to become pregnant. It is not known if SOLIRIS will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if SOLIRIS passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SOLIRIS and other medicines can affect each other causing side effects.

It is important that you:
  • have all recommended vaccinations before you start SOLIRIS
  • receive 2 weeks of antibiotics if you immediately start SOLIRIS
  • stay up-to-date with all recommended vaccinations during treatment with SOLIRIS

Know the medications you take and the vaccines you receive. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of SOLIRIS?
SOLIRIS can cause serious side effects including:
  • See “What is the most important information I should know about SOLIRIS?”
  • Serious allergic reactions. Serious allergic reactions can happen during your SOLIRIS infusion. Tell your doctor or nurse right away if you get any of these symptoms during your SOLIRIS infusion:
    • chest pain
    • trouble breathing or shortness of breath
    • swelling of your face, tongue, or throat
    • feel faint or pass out

If you have an allergic reaction to SOLIRIS, your doctor may need to infuse SOLIRIS more slowly, or stop SOLIRIS. See “How will I receive SOLIRIS?” in the Medication Guide.

The most common side effects in people with NMOSD treated with SOLIRIS include:
  • common cold (upper respiratory infection)
  • pain or swelling of your nose or throat (nasopharyngitis)
  • diarrhea
  • back pain
  • dizziness
  • flu like symptoms (influenza) including fever, headache, tiredness, cough, sore throat, and body aches
  • joint pain (arthralgia)
  • throat irritation (pharyngitis)
  • bruising (contusion)

Tell your doctor about any side effect that bothers you or that does not go away. These are not all the possible side effects of SOLIRIS. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch, or call 1-800-FDA-1088.

INDICATION
What is SOLIRIS?
Soliris is a prescription medicine called a monoclonal antibody. SOLIRIS is used to treat:
  • adults with a disease called neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive

It is not known if SOLIRIS is safe and effective in children with NMOSD.

Please see the full Prescribing Information and Medication Guide for SOLIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections.

IMPORTANT SAFETY INFORMATION & INDICATION FOR SOLIRIS® (eculizumab), INCLUDING BOXED WARNING
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about SOLIRIS?
SOLIRIS is a medicine that affects your immune system. SOLIRIS can lower the ability of your immune system to fight infections.
  • SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early.
  1. You must receive meningococcal vaccines at least 2 weeks before your first dose of SOLIRIS if you have not already had this vaccine.
  2. If your doctor decided that urgent treatment with SOLIRIS is needed, you should receive meningococcal vaccination as soon as possible.
  3. If you have not been vaccinated and SOLIRIS therapy must be initiated immediately, you should also receive two weeks of antibiotics with your vaccinations.
  4. If you had a meningococcal vaccine in the past, you might need additional vaccination before starting SOLIRIS. Your doctor will decide if you need additional meningococcal vaccination.
  5. Meningococcal vaccines reduce the risk of meningococcal infection but do not prevent all meningococcal infections. Call your doctor or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection:
    • headache with nausea or vomiting
    • headache and fever
    • headache with a stiff neck or stiff back
    • fever
    • fever and a rash
    • confusion
    • muscle aches with flu-like symptoms
    • eyes sensitive to light

Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. Carry it with you at all times during treatment and for 3 months after your last SOLIRIS dose. Your risk of meningococcal infection may continue for several weeks after your last dose of SOLIRIS. It is important to show this card to any doctor or nurse who treats you. This will help them diagnose and treat you quickly.

SOLIRIS is only available through a program called the SOLIRIS REMS. Before you can receive SOLIRIS, your doctor must:
  • enroll in the SOLIRIS REMS program
  • counsel you about the risk of meningococcal infection
  • give you information about the symptoms of meningococcal infection
  • give you a Patient Safety Card about your risk of meningococcal infection, as discussed above
  • make sure that you are vaccinated with the meningococcal vaccine and, if needed, get revaccinated with the meningococcal vaccine. Ask your doctor if you are not sure if you need to be revaccinated.

SOLIRIS may also increase the risk of other types of serious infections. Certain people may be at risk of serious infections with gonorrhea. Talk to your doctor about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing. Certain fungal infections (Aspergillus) may also happen if you take SOLIRIS and have a weak immune system or a low white blood cell count.

Who should not receive SOLIRIS?
Do not receive SOLIRIS if you:
  • have a meningococcal infection.
  • have not been vaccinated against meningitis infection unless your doctor decides that urgent treatment with SOLIRIS is needed. See “What is the most important information I should know about SOLIRIS?”
Before you receive SOLIRIS, tell your doctor about all of your medical conditions, including if you:
  • have an infection or fever.
  • are pregnant or plan to become pregnant. It is not known if SOLIRIS will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if SOLIRIS passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SOLIRIS and other medicines can affect each other causing side effects.

It is important that you:
  • have all recommended vaccinations before you start SOLIRIS
  • receive 2 weeks of antibiotics if you immediately start SOLIRIS
  • stay up-to-date with all recommended vaccinations during treatment with SOLIRIS

Know the medications you take and the vaccines you receive. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

What are the possible side effects of SOLIRIS?
SOLIRIS can cause serious side effects including:
  • See “What is the most important information I should know about SOLIRIS?”
  • Serious allergic reactions. Serious allergic reactions can happen during your SOLIRIS infusion. Tell your doctor or nurse right away if you get any of these symptoms during your SOLIRIS infusion:
    • chest pain
    • trouble breathing or shortness of breath
    • swelling of your face, tongue, or throat
    • feel faint or pass out

If you have an allergic reaction to SOLIRIS, your doctor may need to infuse SOLIRIS more slowly, or stop SOLIRIS. See “How will I receive SOLIRIS?” in the Medication Guide.

The most common side effects in people with NMOSD treated with SOLIRIS include:
  • common cold (upper respiratory infection)
  • pain or swelling of your nose or throat (nasopharyngitis)
  • diarrhea
  • back pain
  • dizziness
  • flu like symptoms (influenza) including fever, headache, tiredness, cough, sore throat, and body aches
  • joint pain (arthralgia)
  • throat irritation (pharyngitis)
  • bruising (contusion)

Tell your doctor about any side effect that bothers you or that does not go away. These are not all the possible side effects of SOLIRIS. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch, or call 1-800-FDA-1088.

INDICATION
What is SOLIRIS?
Soliris is a prescription medicine called a monoclonal antibody. SOLIRIS is used to treat:
  • adults with a disease called neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive

It is not known if SOLIRIS is safe and effective in children with NMOSD.

Please see the full Prescribing Information and Medication Guide for SOLIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections.