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.

 

INDICATIONS

KYNAMRO (mipomersen sodium) injection is an oligonucleotide inhibitor of apolipoprotein B-100 synthesis indicated as an adjunct to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (apo B), total cholesterol (TC), and non-high density lipoprotein-cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).

Limitations of use

  • The safety and effectiveness of KYNAMRO have not been established in patients with hypercholesterolemia who do not have HoFH.
  • The effect of KYNAMRO on cardiovascular morbidity and mortality has not been determined.
IMPORTANT SAFETY INFORMATION


WARNING: RISK OF HEPATOTOXICITY

KYNAMRO can cause elevations in transaminases. In the KYNAMRO clinical trial in patients with HoFH, 4 (12%) of the 34 patients treated with KYNAMRO compared with 0% of the 17 patients treated with placebo had at least one elevation in alanine aminotransferase (ALT) ≥3x upper limit of normal (ULN). There were no concomitant clinically meaningful elevations of total bilirubin, international normalized ratio (INR) or partial thromboplastin time (PTT).

KYNAMRO also increases hepatic fat, with or without concomitant increases in transaminases. In the trials in patients with heterozygous familial hypercholesterolemia (HeFH) and hyperlipidemia, the median absolute increase in hepatic fat was 10% after 26 weeks of treatment, from 0% at baseline, measured by magnetic resonance imaging (MRI). Hepatic steatosis is a risk factor for advanced liver disease; including steatohepatitis and cirrhosis.

Measure ALT, AST, alkaline phosphatase, and total bilirubin before initiating treatment and then ALT, AST regularly as recommended. During treatment, withhold the dose of KYNAMRO if the ALT or AST are ≥3 x ULN. Discontinue KYNAMRO for clinically significant liver toxicity.

Because of the risk of hepatotoxicity, KYNAMRO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYNAMRO REMS.

OTHER WARNINGS AND PRECAUTIONS

Patients are advised to read the KYNAMRO medication guide before starting treatment with KYNAMRO, and each time they receive a refill. There may be new information. This information does not take the place of talking to a doctor about a medical condition or treatment.

KYNAMRO may cause serious side effects, including liver problems. A doctor should be informed of any liver problems, including liver problems while taking other medicines, or if a patient has any of these symptoms of liver problems while taking KYNAMRO: nausea, vomiting, fever, loss of appetite, being (or feeling) more tired than usual, yellowing of eyes or skin, dark urine, itching, or stomach pain.

Alcohol may increase levels of hepatic fat and induce or exacerbate liver injury. It is recommended that patients taking KYNAMRO should consume no more than one alcoholic drink per day.

Caution should be exercised when KYNAMRO is used with other medications known to have potential for hepatotoxicity.

KYNAMRO should be used during pregnancy only if clearly needed. Females who become pregnant during KYNAMRO therapy should notify their healthcare provider.

Safety and effectiveness have not been established in pediatric patients.

KYNAMRO is not recommended in patients with severe renal impairment, clinically significant proteinuria, or on renal dialysis.

The safety and effectiveness of KYNAMRO as an adjunct to LDL apheresis have not been established; therefore, the use of KYNAMRO as an adjunct to LDL apheresis is not recommended.

CONTRAINDICATIONS

KYNAMRO is contraindicated in the following conditions:

  • Moderate or severe hepatic impairment (Child-Pugh B or C) or active liver disease, including unexplained persistent elevations of serum transaminases.
  • Patients with a known hypersensitivity to any component of this product.

COMMON SIDE EFFECTS

In clinical trials the most commonly-reported adverse reactions were injection site reactions occurring in 84% of patients receiving KYNAMRO versus 33% of placebo treated patients. The most common injection site reactions were erythema (59%), pain (56%), hematoma (32%), pruritus (29%), swelling (18%) and discoloration (17%). Injection site reactions did not occur with every injection but resulted in discontinuation of therapy in 5% of patients in pooled phase 3 trials.

Flu-like symptoms, defined as any one of the following: influenza-like illness, pyrexia, chills, myalgia, arthralgia, malaise or fatigue and occurring within 2 days of injection, have been reported more frequently in patients receiving KYNAMRO (30%) versus placebo (16%) in the pooled Phase 3 trials. Flu-like symptoms did not occur with all injections but resulted in discontinuation of therapy in 3% of patients in pooled phase 3 trials.

See full Prescribing Information for more details about Warnings & Precautions, complete list of Adverse Reactions and Boxed Warning.