Built on a foundation of innovation, ULTOMIRIS is the latest example of Alexion’s commitment to treating atypical Hemolytic Uremic Syndrome (atypical-HUS)

Privacy Policy

Privacy statement

Disclaimer

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.

ULTOMIRIS.com exists to provide patients and healthcare providers with key information about the ULTOMIRIS 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 OneSource Program. For more information on OneSource’s privacy practices, please refer to the OneSource Enrollment Form, available here.

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.

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 parties in connection with the sale, assignment or other transfer of an Alexion business;
  3. 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.
  4. 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: 18 December 2018

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.

 

INDICATION & IMPORTANT SAFETY INFORMATION for ULTOMIRIS® (ravulizumab-cwvz), INCLUDING BOXED WARNING

Show more

INDICATION

What is ULTOMIRIS?
ULTOMIRIS is a prescription medicine called a monoclonal antibody. ULTOMIRIS is used to treat:

  • adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). ULTOMIRIS is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

It is not known if ULTOMIRIS is safe and effective in children younger than 1 month of age.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ULTOMIRIS?
ULTOMIRIS is a medicine that affects your immune system. ULTOMIRIS can lower the ability of your immune system to fight infections.

  • ULTOMIRIS 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 ULTOMIRIS if you have not already had this vaccine.
  2. If your doctor decided that urgent treatment with ULTOMIRIS is needed, you should receive meningococcal vaccination as soon as possible.
  3. If you have not been vaccinated and ULTOMIRIS therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations.
  4. If you had a meningococcal vaccine in the past, you might need additional vaccination before starting ULTOMIRIS. 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 8 months after your last ULTOMIRIS dose. Your risk of meningococcal infection may continue for several months after your last dose of ULTOMIRIS. It is important to show this card to any doctor or nurse who treats you. This will help them diagnose and treat you quickly.

ULTOMIRIS is only available through a program called the ULTOMIRIS REMS. Before you can receive ULTOMIRIS, your doctor must:

  • enroll in the ULTOMIRIS 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 a meningococcal vaccine

ULTOMIRIS may also increase the risk of other types of serious infections.

  • People who take ULTOMIRIS may have an increased risk of getting infections caused by Streptococcus pneumoniae and Haemophilus influenzae.
  • Certain people may also have an increased risk of gonorrhea infection. Talk to your healthcare provider to find out if you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing.

Call your doctor right away if you have any new signs or symptoms of infection.

Who should not receive ULTOMIRIS?
Do not receive ULTOMIRIS if you:

  • have a meningococcal infection
  • Have not been vaccinated against meningococcal infection unless your doctor decides that urgent treatment with ULTOMIRIS is needed. See “What is the most important information I should know about ULTOMIRIS.”

Before you receive ULTOMIRIS, 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 ULTOMIRIS will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if ULTOMIRIS passes into your breast milk. You should not breast feed during treatment and for 8 months after your final dose of ULTOMIRIS.

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

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.

How should I receive ULTOMIRIS?

  • ULTOMIRIS is given through a vein by intravenous (I.V.) infusion usually over about 2 hours in adults and up to 4 hours in children.
  • If you are an adult with aHUS, you will usually receive:
    • a starting dose of ULTOMIRIS as an infusion by your doctor, and then
    • 2 weeks later, you will start to receive an infusion of ULTOMIRIS every 8 weeks.
  • Children 1 month of age and older with aHUS will usually receive:
    • a starting dose of ULTOMIRIS as an infusion by your doctor, and then
    • your doctor will decide how often your child will receive ULTOMIRIS, either every 4 weeks or every 8 weeks, depending on their weight, starting 2 weeks after the starting dose.
  • Your doctor will decide how long you need to take ULTOMIRIS for your aHUS.
  • If you are changing treatment from SOLIRIS to ULTOMIRIS, you should receive your starting dose of ULTOMIRIS 2 weeks after your last dose of SOLIRIS.
  • After each infusion, you should be monitored for at least 1 hour for infusion reactions. See “What are the possible side effects of ULTOMIRIS?”
  • If you have aHUS, your doctor will need to monitor you closely for at least 12 months after stopping treatment for signs of worsening aHUS symptoms or problems related to a type of abnormal clotting and breakdown of your red blood cells called thrombotic microangiopathy (TMA). Symptoms or problems that can happen with TMA may include:
    • confusion or loss of consciousness
    • seizures
    • chest pain (angina)
    • difficulty breathing
    • blood clots or stroke
  • If you miss an ULTOMIRIS infusion, call your doctor right away.

What are the possible side effects of ULTOMIRIS?
ULTOMIRIS can cause serious side effects including:

  • See “What is the most important information I should know about ULTOMIRIS?”
  • Infusion reactions. Infusion reactions may happen during your ULTOMIRIS infusion. Symptoms of an infusion reaction with ULTOMIRIS may include lower back pain, pain with the infusion, feeling faint or discomfort in your arms or legs. Tell your doctor or nurse right away if you develop these symptoms, or any other symptoms during your ULTOMIRIS infusion that may mean you are having a serious infusion reaction, including:
    • chest pain
    • trouble breathing or shortness of breath
    • swelling of your face, tongue, or throat
    • feel faint or pass out

Your doctor will treat your symptoms as needed.

The most common side effects of ULTOMIRIS in people with aHUS are:

  • upper respiratory infections
  • diarrhea
  • nausea
  • vomiting
  • headache
  • high blood pressure
  • fever

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 ULTOMIRIS. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

 

INDICATION & IMPORTANT SAFETY INFORMATION for ULTOMIRIS® (ravulizumab-cwvz), INCLUDING BOXED WARNING

Show more

INDICATION

What is ULTOMIRIS?
ULTOMIRIS is a prescription medicine called a monoclonal antibody. ULTOMIRIS is used to treat:

  • adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). ULTOMIRIS is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

It is not known if ULTOMIRIS is safe and effective in children younger than 1 month of age.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ULTOMIRIS?
ULTOMIRIS is a medicine that affects your immune system. ULTOMIRIS can lower the ability of your immune system to fight infections.

  • ULTOMIRIS 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 ULTOMIRIS if you have not already had this vaccine.
  2. If your doctor decided that urgent treatment with ULTOMIRIS is needed, you should receive meningococcal vaccination as soon as possible.
  3. If you have not been vaccinated and ULTOMIRIS therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations.
  4. If you had a meningococcal vaccine in the past, you might need additional vaccination before starting ULTOMIRIS. 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 8 months after your last ULTOMIRIS dose. Your risk of meningococcal infection may continue for several months after your last dose of ULTOMIRIS. It is important to show this card to any doctor or nurse who treats you. This will help them diagnose and treat you quickly.

ULTOMIRIS is only available through a program called the ULTOMIRIS REMS. Before you can receive ULTOMIRIS, your doctor must:

  • enroll in the ULTOMIRIS 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 a meningococcal vaccine

ULTOMIRIS may also increase the risk of other types of serious infections.

  • People who take ULTOMIRIS may have an increased risk of getting infections caused by Streptococcus pneumoniae and Haemophilus influenzae.
  • Certain people may also have an increased risk of gonorrhea infection. Talk to your healthcare provider to find out if you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing.

Call your doctor right away if you have any new signs or symptoms of infection.

Who should not receive ULTOMIRIS?
Do not receive ULTOMIRIS if you:

  • have a meningococcal infection
  • Have not been vaccinated against meningococcal infection unless your doctor decides that urgent treatment with ULTOMIRIS is needed. See “What is the most important information I should know about ULTOMIRIS.”

Before you receive ULTOMIRIS, 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 ULTOMIRIS will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if ULTOMIRIS passes into your breast milk. You should not breast feed during treatment and for 8 months after your final dose of ULTOMIRIS.

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

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.

How should I receive ULTOMIRIS?

  • ULTOMIRIS is given through a vein by intravenous (I.V.) infusion usually over about 2 hours in adults and up to 4 hours in children.
  • If you are an adult with aHUS, you will usually receive:
    • a starting dose of ULTOMIRIS as an infusion by your doctor, and then
    • 2 weeks later, you will start to receive an infusion of ULTOMIRIS every 8 weeks.
  • Children 1 month of age and older with aHUS will usually receive:
    • a starting dose of ULTOMIRIS as an infusion by your doctor, and then
    • your doctor will decide how often your child will receive ULTOMIRIS, either every 4 weeks or every 8 weeks, depending on their weight, starting 2 weeks after the starting dose.
  • Your doctor will decide how long you need to take ULTOMIRIS for your aHUS.
  • If you are changing treatment from SOLIRIS to ULTOMIRIS, you should receive your starting dose of ULTOMIRIS 2 weeks after your last dose of SOLIRIS.
  • After each infusion, you should be monitored for at least 1 hour for infusion reactions. See “What are the possible side effects of ULTOMIRIS?”
  • If you have aHUS, your doctor will need to monitor you closely for at least 12 months after stopping treatment for signs of worsening aHUS symptoms or problems related to a type of abnormal clotting and breakdown of your red blood cells called thrombotic microangiopathy (TMA). Symptoms or problems that can happen with TMA may include:
    • confusion or loss of consciousness
    • seizures
    • chest pain (angina)
    • difficulty breathing
    • blood clots or stroke
  • If you miss an ULTOMIRIS infusion, call your doctor right away.

What are the possible side effects of ULTOMIRIS?
ULTOMIRIS can cause serious side effects including:

  • See “What is the most important information I should know about ULTOMIRIS?”
  • Infusion reactions. Infusion reactions may happen during your ULTOMIRIS infusion. Symptoms of an infusion reaction with ULTOMIRIS may include lower back pain, pain with the infusion, feeling faint or discomfort in your arms or legs. Tell your doctor or nurse right away if you develop these symptoms, or any other symptoms during your ULTOMIRIS infusion that may mean you are having a serious infusion reaction, including:
    • chest pain
    • trouble breathing or shortness of breath
    • swelling of your face, tongue, or throat
    • feel faint or pass out

Your doctor will treat your symptoms as needed.

The most common side effects of ULTOMIRIS in people with aHUS are:

  • upper respiratory infections
  • diarrhea
  • nausea
  • vomiting
  • headache
  • high blood pressure
  • fever

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 ULTOMIRIS. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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