Privacy Policy
Welcome
This site is owned by Eisai Inc. This Privacy Policy is designed to tell you about our practices regarding collection, use, and disclosure of information that you may provide via this site. Please be sure to read this entire Privacy Policy before using or submitting information to this site. This site is intended for use by residents of the United States only.
About Children
This site is not intended for children under the age of 18. We will not knowingly collect personally identifiable information via this site from visitors in this age group. We encourage parents to talk to their children about their use of the Internet and the information they disclose to Web sites.
INFORMATION COLLECTION
Active Information Collection
Like many Web sites, this site actively collects information from its visitors both by asking you specific questions and by permitting you to communicate directly with us via e-mail, feedback forms, and/or chat rooms. Some of the information that you submit may be personally identifiable information (that is, information that can be uniquely identified with you, such as your full name, address, e-mail address, phone number, and so on).
Some areas of this site may ask you to submit personally identifiable information in order for you to benefit from the specified features (such as newsletter subscriptions, tips/pointers, order processing, or resume submission) or to participate in a particular activity (such as sweepstakes or other promotions). You will be informed what information is required and what information is optional.
Passive Information Collection
As you navigate through this site, certain anonymous information can be passively collected (that is, gathered without your actively providing the information) using various technologies, such as cookies, Internet tags or Web beacons, and navigational data collection (log files, server logs, clickstream). Your Internet browser automatically transmits to this site some of this anonymous information, such as the URL of the Web site you just came from and the Internet Protocol (IP) address and the browser version your computer is currently using. This site may also collect anonymous information from your computer through cookies and Internet tags or Web beacons. You may set your browser to notify you when a cookie is sent or to refuse cookies altogether, but certain features of this site might not work without cookies.
We may use and combine such passively collected anonymous information to provide better service to site visitors, customize the site based on your preferences, compile and analyze statistics and trends, and otherwise administer and improve the site for your use. Such information is not combined with personally identifiable information collected elsewhere on the site unless you have consented. More information about cookies and other passive tracking methods is discussed below.
A "cookie" is a bit of information that a Web site sends to your Web browser that helps the site remember information about you and your preferences.
"Session" cookies are temporary bits of information that are used to improve navigation, block visitors from providing information where inappropriate (the site "remembers" previous entries of age or country of origin that were outside the specified parameters and blocks subsequent changes), and collect aggregate statistical information on the site. They are erased once you exit your Web browser or otherwise turn off your computer.
"Persistent" cookies are more permanent bits of information that are placed on the hard drive of your computer and stay there unless you delete the cookie. Persistent cookies store information on your computer for a number of purposes, such as retrieving certain information you have previously provided (such as passwords), improving navigation, collecting aggregate statistical information, helping to determine what areas of the Web site visitors find most valuable, and customizing the Web site based on your preferences on an ongoing basis. Persistent cookies placed by this site on your computer may hold personally identifiable information, but only if you have registered or have otherwise consented to the retention of personally identifiable information you have provided at the site. Otherwise, our site's server only knows that an unidentified visitor with your cookie has returned to the site.
You can set your browser to accept all cookies, to reject all cookies, or to notify you whenever a cookie is offered so that you can decide each time whether to accept it. To learn more about cookies and how to specify your preferences, you can search for "cookie" in the "Help" portion of your browser.
A site may use Internet Protocol (IP) addresses. An IP address is a number assigned to your computer by your Internet service provider so you can access the Internet and is generally considered to be non-personally identifiable information, because in most cases an IP address is dynamic (changing each time you connect to the Internet), rather than static (unique to a particular user's computer). The IP address can be used to diagnose problems with a server, report aggregate information, determine the fastest route for your computer to use in connecting to a site, and administer and improve the site.
"Internet tags" (also known as single-pixel GIFs, clear GIFs, invisible GIFs, and 1-by-1 GIFs) are smaller than cookies and tell the Web site server information such as the IP address and browser type related to the visitor's computer. Tags may be placed both on online advertisements that bring people to the site and on different pages of the site. Such tags indicate how many times a page is opened and which information is consulted.
"Navigational data" (log files, server logs, and clickstream data) are used for system management, to improve the content of the site, market research purposes, and to communicate information to visitors.
Use and Disclosure of Information
Except as otherwise stated, we may use information collected via this site to improve the content of our site, to customize the site to your preferences, to communicate information to you (if you have requested it), for our marketing and research purposes, and for any other purpose specified. In addition, we may make full use of all information acquired through this site that is not in personally identifiable form.
If you provide personally identifiable information to this site, we may combine such information with other actively collected information unless we specify otherwise at the point of collection. We may disclose personally identifiable information you provide via this site to affiliates of Eisai Inc. or PriCara®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. worldwide that agree to treat it in accordance with this Privacy Policy and use it for the same purposes. We also may disclose personally identifiable information you provide via this site to third parties that are not affiliates of Eisai Inc. or PriCara®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., but only:
to contractors we use to support our business (such as fulfillment services, technical support, delivery services, and financial institutions), in which case we will require such third parties to agree to treat it in accordance with this Privacy Policy and use it for the same purposes; in connection with the sale, assignment, or other transfer of the business of this site to which the information relates, in which case we will require any such buyer to agree to treat it in accordance with this Privacy Policy and use it for the same purposes; or to respond to law enforcement requests or where required by applicable laws, court orders, or government regulations.
The collection, use, and disclosure of information contemplated in this Privacy Policy may involve a transfer of the information to jurisdictions located outside your country of residence that may not have equivalent laws and rules regarding personally identifiable information. In these cases, you will be asked to consent to such transfers and disclosures in accordance with this Privacy Policy.
Access, Correction, and Deletion
To keep personally identifiable information that you provide via this site accurate, current, and complete, please contact us as specified below and we will take appropriate steps to update or correct such information in our possession, or to delete your information from our contact list.
Security
We take reasonable steps to protect personally identifiable information as you transmit it to our site and to protect such information from loss, misuse, and unauthorized access, disclosure, alteration, or destruction. You should keep in mind that no Internet transmission is ever completely secure or error-free. In particular, e-mail sent to or from this site may not be secure.
Links to Other Web Sites
This site may contain links or references to other Web sites to which this Privacy Policy does not apply. We encourage you to read the Privacy Policy of every Web site you visit.
Other Terms
Your use of this site is subject to our Legal Notice.
How to Contact Us
If you have any questions, comments, requests, or concerns related to this Privacy Policy or the information practices of this site, please contact us as follows:
Eisai Inc.
Medical Services
100 Tice Boulevard
Woodcliff Lake, NJ 07677
1-888-422-4743
Changes to This Privacy Policy
If this Privacy Policy changes, the revised policy will be posted on this site. Please check back periodically, and especially before you provide any personally identifiable information. This Privacy Policy was last updated on March 25, 2008.
Indications
FRAGMIN® is a low molecular weight heparin (LMWH) indicated for:
- Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction
- Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness
- Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in patients with cancer. In these patients, the FRAGMIN® therapy begins with the initial VTE treatment and continues for six months.
Limitations of Use
- FRAGMIN® is not indicated for the acute treatment of VTE.
Important Safety Information
Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
- Use of indwelling epidural catheters
- Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
- A history of traumatic or repeated epidural or spinal punctures
- A history of spinal deformity or spinal surgery
Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.
Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions and Drug Interactions].
- FRAGMIN® is contraindicated in patients with active major bleeding, history of heparin induced thrombocytopenia, hypersensitivity to dalteparin sodium, heparin, or pork products.
- FRAGMIN® is contraindicated in patients undergoing epidural/neuraxial anesthesia as a treatment for unstable angina and non-Q-wave MI and for prolonged VTE prophylaxis due to an increased risk of bleeding associated with the dosage of FRAGMIN® recommended for these indications.
- FRAGMIN®, like other anticoagulants, should be used with extreme caution in patients who have an increased risk of hemorrhage; bleeding can occur at any site during therapy. An unexpected drop in hematocrit or blood pressure should lead to a search for a bleeding site.
- FRAGMIN® should be used with caution in patients with bleeding diathesis, thrombocytopenia or platelet defects, severe liver or kidney insufficiency, hypertensive or diabetic retinopathy, and recent gastrointestinal bleeding.
- FRAGMIN® should be used with extreme caution in patients
with history of heparin-induced thrombocytopenia.
- In FRAGMIN® clinical trials supporting non-cancer indications, platelet count of <50,000/mm3 occurred in <1% of patients.
- In FRAGMIN® clinical trials supporting the extended treatment of symptomatic VTE in patients with cancer, platelet counts of <100,000/mm3 occurred in 13.6% of patients, including 6.5% who also had platelet counts less than 50,000/mm3. In the same clinical trial, thrombocytopenia was reported as an adverse event in 10.9% of patients in the FRAGMIN® arm and 8.1% of patients in the oral anticoagulant arm. FRAGMIN® dose was decreased or interrupted in patients whose platelet counts fell below 100,000/mm3.
- Thrombocytopenia of any degree should be monitored closely. Heparin-induced thrombocytopenia can occur with administration of FRAGMIN®. The incidence of this complication is unknown at present. In clinical practice, rare cases of thrombocytopenia with thrombosis have also been observed.
- Each multiple-dose vial of FRAGMIN® contains benzyl alcohol as a preservative. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants. Because benzyl alcohol may cross the placenta, use caution when administering FRAGMIN® preserved with benzyl alcohol to pregnant women. If anticoagulation with FRAGMIN® is needed during pregnancy, use preservative-free formulations, where possible.
- Periodic routine complete blood counts, including platelet count, blood chemistry, and stool occult blood tests are recommended during the course of treatment with FRAGMIN®.
- The most commonly reported side effect is hematoma at the injection site.
- Allergic reactions (i.e., pruritus, rash, fever, injection site reaction, bulleous eruption) have occurred. A few cases of anaphylactoid reactions have been reported.
- Use FRAGMIN® with care in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents because of increased risk of bleeding.
- FRAGMIN® cannot be used interchangeably (unit for unit) with unfractionated heparin or other low molecular weight heparins.
- FRAGMIN® Injection is not intended for intramuscular administration.
For more information about FRAGMIN, please see Full Product Information.
