Privacy Policy

Genzyme Corporation (“Genzyme”), a subsidiary of Sanofi, respects individual privacy and is committed to protecting personally identifiable information in conformity with applicable legal and ethical standards.

This Privacy Policy and Notice of Information Practices sets forth Genzyme’s practices regarding the collection, use and disclosure of information that you may provide through this site. Please read this entire Privacy Policy before using this site or submitting information to Genzyme through this site.

By using this site and whenever you submit information through this site to Genzyme, you agree with the terms of Genzyme’s Privacy Policy and Notice of Information Practices written below.

Privacy Policy and Notice of Information Practices

Information Genzyme Collects

Personally Identifiable Information

Genzyme only collects personally identifiable information, such as your name, address, telephone number or email address, when you voluntarily submit it to Genzyme.

Cookies and Other Non-Personally Identifiable Information

We collect information about your usage of our site through cookies and similar technology. There are two types of cookies: session cookies (non persistent cookies) and persistent cookies. Session cookies temporarily store non-personally identifiable information about your visit to our website in your computer’s memory. The cookie is deleted as soon as you close your browser. Persistent or permanent cookies will uniquely identify your browser and will permanently save in your computer’s memory information requested by the website.

On some of our websites, we also use pixels, or transparent GIF files. These GIF files are provided by our ad management partner, DoubleClick. These files enable DoubleClick to recognize a unique cookie on your Web browser, which in turn enables us to learn which advertisements bring users to our website. The cookie was placed by us, or by another advertiser who works with DoubleClick.

With both cookies and transparent GIF files, the information that we collect and share is anonymous and not personally identifiable. It does not contain your name, address, telephone number, or email address.

We also track the total number of visitors to our website, the number of visitors to each page of the website, and the domain names of our visitors’ Internet service providers.  On certain Genzyme websites, we may also ask users that have opted to receive information to complete a survey.  No personally identifiable information is gathered in any of these processes.

How Genzyme Uses This Information

Personally Identifiable Information

This information may be used by Genzyme personnel or agents of Genzyme to obtain more information, to improve this site, or to provide you with information that you have requested or additional information which Genzyme believes may be of interest to you.

Genzyme does not sell any of your personally identifiable information for marketing or advertising purposes.

Cookies and Other Non-Personally Identifiable Information

Cookies allow us to bring you the content and features likely to be of greatest interest to you based on your previous activities on our site.  In Genzyme sites that require passwords, you are giving us explicit permission to use a “persistent cookie,” which is a small data file that is generated when you enter your assigned user id and password and access the site. This file is saved in your computer’s memory, and enables your browser to access each page that is in the password-protected area.

Pixels, or transparent GIF files, are used to help us manage our online advertising.  For example, third party vendors, including Google, show Genzyme ads on sites on the internet.  These vendors also use cookies to serve ads based on a user's prior visits to Genzyme’s website.

We use other non-personally identifiable information, including information obtained through surveys, to improve this site.

Storage and Transfer of Information

Genzyme, or in some cases its agents, may store the personally identifiable data collected via this site in an electronic database. Genzyme and its agents may also exchange such data with each other or with you over the internet or over intranet systems for the purposes of processing the data, mailing information to you in response to your request, or otherwise carrying out the services described above.  We may also release your personally identifiable data in response to a court order, subpoena, search warrant, or applicable law or regulation.

While Genzyme makes every reasonable effort to protect the personally identifiable data collected through its websites, please be aware that there is always some risk involved when submitting data over the Internet. We cannot guarantee that our website is 100% safe from illegal tampering or “hacking.” Any data transmitted over the Internet may be at risk; however, once it is received at Genzyme and entered into its database, it has the same protection that Genzyme extends to its own confidential information.

Your Information Choices

Personally Identifiable Information

If at any time you wish to stop receiving emails or other communications from us, or if you have submitted personally identifiable information through our website and would like to have that information deleted from our records, please notify us.  You may also request access to personal data about you that Genzyme holds and you may have the opportunity to request a correction or amendment to your personal data.

As a reminder to you when exchanging emails, any email that you send or receive on your employer’s email system may be the property of your employer. Consequently, your employer may have the ability to review your personal information sent via email.

Please note that although we attempt to adhere to requests to remove personal data from our records, it may not be possible to remove all copies depending on the manner in which the information was submitted to us.  In addition, we reserve the right not remove or amend information provided to us regarding an adverse drug effect and information is otherwise required to be retained by law.

Cookies and Other Non-Personally Identifiable Information

Your Web browser can be set to allow you to control whether you will accept cookies, reject cookies, or to notify you each time a cookie is sent to you. If your browser is set to reject cookies, sites like ours that are cookie-enabled will not recognize you when you return to the site and some site functionality may be lost.

Users may opt out of Google's use of cookies by visiting the Google advertising opt-out page.

For more information about how to opt out of Doubleclick, go to http://www.google.com/privacy_ads.html.  Users always have the option of declining to participate in any survey they receive from Genzyme.

Links to Third Party Sites

As a convenience to our visitors, our sites currently contain links to a number of other (non-Genzyme) sites that we believe may offer useful information. The privacy policy presented here does not apply to those sites. You should contact these sites directly for information on their privacy policies, confidentiality agreements, and data collection/distribution procedures.

Please note that linked non-Genzyme sites may also use cookies. Genzyme cannot control the use of cookies by these non-Genzyme sites. In addition, when you link from a Genzyme website to another website, that site may have the ability to recognize that you have come from a Genzyme site. If you do not want any other websites to know that you have been on this website, we recommend that you do not use the links provided in our site.

Children’s Policy

Our websites are not intended or designed to attract children under the age of 13. We do not collect personal information from any person we actually know is a child under the age of 13.

Privacy Policy Updates

Any changes to this Privacy Policy will be posted on this page.  If a change to this Privacy Policy results in a materially different use of your personally identifiable information provided prior to the date of the change, you may opt out of such use by providing notice to Genzyme.

This privacy policy only applies to websites linked to it.  A different privacy policy may apply to other Genzyme websites you visit. 

This privacy policy was last updated 9/21/2011.

 

Indication and Usage

Fabrazyme® (agalsidase beta) is used to treat patients with Fabry disease. Fabrazyme lowers the amount of a substance called globotriaosylceramide (GL-3), which builds up in cells lining the blood vessels of the kidney and certain other cells. The lowering of GL-3 suggests that Fabrazyme may improve how Fabry disease affects your body; however a relationship of lower GL-3 to specific signs and symptoms of Fabry disease has not been proven.

Important Safety Information

Life-threatening severe allergic (anaphylactic) reactions have been seen in patients during Fabrazyme infusions. Approximately 1% of patients who have received Fabrazyme either during a clinical study or after Fabrazyme was approved have experienced anaphylactic or severe allergic reactions during their infusion. These reactions have included: localized swelling of the face, mouth and throat, narrowing of breathing airways, low blood pressure, hives, difficulty swallowing, rash, trouble breathing, flushing, chest discomfort, itching and nasal congestion. People who have experienced these reactions have required treatment including heart/lung resuscitation, oxygen, fluids given through the vein, hospitalization, and have needed treatment with inhaled drugs called beta-adrenergic agonists to help open the breathing airways, antihistamines, epinephrine (also known as adrenalin), and a medication given through the vein called a corticosteroid (or steroid) which helps to decrease the body’s allergic reaction by decreasing inflammation. If you experience a severe allergic or anaphylactic reaction, your healthcare professional will immediately stop the infusion of Fabrazyme and provide you the necessary emergency medical treatment. Because of the possibility that severe allergic reactions may occur, appropriate medical support should be available during your Fabrazyme infusion.

  • For patients who have had reactions to their infusions, it is recommended that they be given anti-fever and antihistamine medications right before their next infusions.
  • Infusion reactions have happened in some patients even after taking these medications and steroids by mouth before their infusions.
  • If an infusion reaction occurs, slowing the infusion rate, stopping the infusion for a short time and/or giving more anti-fever and antihistamine medications and or steroids may improve the symptoms.
  • If severe infusion reactions happen, your healthcare professional should consider stopping the Fabrazyme infusion right away and should provide medical care for your condition.
  • Severe reactions are generally managed by giving antihistamine medications, corticosteroids, fluids through the vein, and/or oxygen when needed.
  • Because severe infusions reactions may happen, medical treatment should be readily available during your Fabrazyme infusion.

Providing Fabrazyme to patients who have experienced severe or serious allergic reactions to Fabrazyme should only be done after carefully considering the risks and benefits of continuing the treatment, and only under the direct supervision of a qualified healthcare professional and with appropriate medical support readily available.

The most common side effects reported with Fabrazyme are infusion reactions, some of which were severe. When Fabrazyme was tested in clinical studies, infusion reactions occurred in approximately 50-55% of patients. Serious and/or frequently occurring side effects (occurring in 5% or more of the patients) thought to be related to Fabrazyme have included one or more of the following: chills, fever, feeling hot or cold, trouble breathing, nausea, flushing of the skin, headache, vomiting, burning and/or tingling sensation, fatigue, itching, pain in the hands and feet, high blood pressure, chest pain, throat tightness, abdominal pain, dizziness, rapid heart rate, nasal congestion, diarrhea, swelling in the legs, muscle pain, back pain, paleness of the skin, slow heart rate, hives, low blood pressure, face swelling, rash and sleepiness.

People with advanced Fabry disease may have heart problems, which may put them at a higher risk for severe complications from infusion reactions, and these patients should be watched closely during their infusion if the decision is made to give them Fabrazyme.

Other serious side effects that were seen in the clinical studies included stroke, pain, lack of muscle coordination, slow or irregular heartbeat, stopping of the heartbeat, decreased blood pumped by the heart, dizziness, hearing loss, and kidney problems resulting in too much protein leaving the body in the urine (nephrotic syndrome). These side effects also occur as part of Fabry disease.

Severe and serious infusion reactions have been reported since Fabrazyme has been approved, some of which were life threatening including anaphylactic shock (a severe allergic reaction). In addition to the above side effects, the following have been reported since Fabrazyme has been approved: joint pain, lack of strength or energy, redness of the skin, increased sweating, reactions at the place where the catheter to give the infusion is placed, increased tearing from the eyes, allergic inflammation of blood vessels, enlarged lymph nodes, decreased sensitivity to touch or pressure, decreased sensitivity of the mouth, sensations of an abnormal heartbeat, runny nose, low oxygen (in general), and low oxygen levels reaching different parts of the body.

Since Fabrazyme has been approved, there have been side effects that resulted in death that may or may not be related to the use of Fabrazyme. These included: the heart and/or lungs stop working (known as cardiorespiratory arrest, respiratory failure, and/or cardiac failure), life-threatening infection in the blood stream (known as sepsis), stroke, heart attack, kidney failure, and pneumonia. Some of these side effects were reported in Fabry disease patients with significant underlying disease.

The safety and effectiveness of Fabrazyme in patients younger than 8 years of age have not been studied.

Most patients taking Fabrazyme who develop IgG antibodies, which are commonly produced by your immune system in response to things it does not recognize as naturally being part of your body, do so within the first three months of taking the medication. In children, the development of these IgG antibodies was associated with Fabrazyme staying in the body for a longer time (prolonged half-life), which was rarely seen in adult patients.

In the clinical studies, a few patients developed IgE antibodies or a reaction to an allergy skin test specific to Fabrazyme. IgE antibodies are usually produced by the body’s immune system during an allergic reaction. Your doctor should consider testing for IgE antibodies if you experience suspected allergic reactions and consider the risks and benefits of continued treatment with Fabrazyme if you have IgE antibodies against Fabrazyme.

Fabrazyme is available by prescription only. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch or call 1‑800‑FDA‑1088. You may also contact Sanofi Genzyme at 1-800-745-4447, option 2. To learn more, please see the full prescribing information (PDF) or contact Sanofi Genzyme at 1-800-745-4447.