In patients with unstable angina (UA) or non-Q-wave myocardial infarction (NQWMI), FRAGMIN significantly reduced the incidence of death and/or MI to 1.8% compared to 4.8% in placebo by day 6 (P=0.001).1

FRAGMIN is indicated for the prophylaxis of ischemic complications in unstable angina and non–Q-wave myocardial infarction, when concurrently administered with aspirin therapy.

FRAGMIN reduced the incidence of deep vein thrombosis (DVT)/pulmonary embolism (PE) or sudden death in medically ill patients by 44% as compared to placebo (2.8% vs. 5.0%, respectively; (P=0.0015) by day 21.1,2

FRAGMIN is indicated for the prophylaxis of DVT, which may lead to PE, in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness.

The probability of recurrent VTE with FRAGMIN in patients with cancer was 9% over a 6-month treatment period compared to 17% with warfarin (P=0.002).1,2

FRAGMIN is indicated for the extended treatment of symptomatic VTE (proximal DVT and/or PE), to reduce the recurrence of VTE in patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for 6 months. FRAGMIN is not indicated for the acute treatment of VTE.

In hip replacement surgery patients, the incidence of total DVT in FRAGMIN patients was 13.1% as compared to 24.0% in warfarin patients(P<0.001)

FRAGMIN is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients undergoing hip replacement surgery.

In a clinical trial involving major abdominal surgery, FRAGMIN significantly reduced the incidence of total DVT by 75% as compared to placebo (4.44% vs 17.6% respectively; P=0.008).1

FRAGMIN is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients undergoing abdominal surgery who are at risk for thromboembolic complications.

Privacy Policy

Eisai is committed to your privacy and to keeping your personal information private. That is why we want you to know about our policies and practices regarding information we obtain from you on this website. By accessing our website, you accept, without limitation or qualification, all the terms of this Privacy Policy. 

1. Your Information
Eisai.com collects and maintains certain personal information about you and non-personal information about your visit when you access our site. The personal information we collect includes resumes and any other supporting documentation and information you voluntarily submit through our online recruiting system. Your submissions may contain personal information that can identify you and your business individually, including, but not limited to, your name, address, phone number, e-mail address, and any other information which, when used by itself or in combination with other data, might identify you or another individual. 

Eisai.com also collects, or logs, certain other information that cannot identify you personally when you visit our website. This information includes your Internet Protocol (“IP”) address and the domain name of your Internet Service Provider (“ISP”). An IP address is a number that is automatically assigned to your computer by the ISP computer through which you access the web and a domain name is the name of the ISP computer itself through which you access the web.

In addition, Eisai.com may use “cookies” to collect information about online visitors. A cookie is a piece of information that is sent to your browser from a web server and stored on your computer's hard drive. A cookie allows Eisai to determine that a visit has occurred within our site, as well as which pages were viewed. Cookies are not used to identify you and will not collect personal information. You can decide if and how your computer will accept cookies by configuring your preferences option within your web browser. If you choose to decline cookies, however, you may be prevented from taking advantage of some of the interactivity our website offers. 

2. Use of Your Information
Eisai will not rent, sell, or share your personal information with third parties without your consent except in accordance with this policy. We use the personal information you provide us to respond to your requests, complaints, or comments, and to provide valuable services to you. For example, if you provide a resume and any other supporting documentation or information to Eisai, we use this information for internal business purposes to make employment determinations, to process and manage data, to run background checks, to provide backup and/or other technology services, and to contact you, as appropriate. We may also use the information for billing and collection purposes. To do all of these things, we may share your personal information with our worldwide affiliates, business partners or others who work for us such as service providers, vendors, contractors and agents for the purpose of enabling them to perform certain business services for us. Before you submit any personal information to us you will be required to affirm that you have reviewed this policy and our Personal Data Statement. By doing so, you consent to our use of your information in accordance with these agreements.

If you send us e-mail or contact us with a request, complaint, or comment relating to any web site that displays the Eisai logo, we may forward your request, complaint, or comment to the appropriate website. That website may respond to the request, complaint or comment that you have sent us.

Eisai may sell or share non-personal information with third parties. The non-personal information we collect in the aggregate about visits to our website is used to better understand our audience and improve this website. By logging our visitors' IP addresses and domain names, we can monitor the use of our site including the number of visits, the average time spent on our site, the number of pages viewed, and various other site use statistics. This monitoring helps us evaluate how our website is used and enables us to continuously improve the content and user-friendliness of our site. Eisai does not link IP addresses or domain names with any personally identifiable information, which means that a visitor's session will be logged on our servers but the visitor will always remain anonymous.

We will disclose information concerning the use of our website (personal and non-personal) pursuant to a valid legal request such as a search warrant, subpoena, or court order or requests from regulatory authorities. We may also use or disclose your information to prevent fraudulent transactions, to protect the rights or property of Eisai, our customers, our website, or its users, or when we otherwise believe in good faith that the law requires it. Absent a legal or internal Eisai corporate need, your information may be shared with consumer reporting agencies or with a successor in interest in connection with a proposed or actual sale, merger, or transfer of all or a portion of a business or an operating unit.

3. Accessing or Changing Your Information
You can access, edit or delete any of the personally identifiable information you have provided to us by logging in to our online recruiting system with your unique username and password and clicking on the “Edit My Profile” link.

4. Security
We take reasonable precautions to protect your personally identifiable information in our possession from loss, misuse, and unauthorized access, disclosure, alteration and destruction. You should keep in mind that no Internet transmission is ever 100% secure or error-free. In addition to the steps Eisai is taking to protect your privacy, you should also take measures to safeguard your personal information, including selecting a password for access to your online recruiting system profile that cannot be easily guessed. 

5. Links to Other Web Sites
As a convenience to our visitors, this website may contain links or references to other websites. This policy applies only to websites and services that are owned or operated by Eisai. We are not responsible for the privacy practices or the content of any other websites. We encourage you to read the privacy policy of every website you visit.

6. Protection of Children's Online Privacy
Eisai.com is a general audience site and does not knowingly collect or use any personally identifiable information from children under the age of 13 without verifiable parental consent. Nor does Eisai market online products and services to children. If you are under the age of 13, please do not provide personally identifiable information of any kind whatsoever. 

7. Additional Privacy Rights and Resources
You may have other privacy protections under state laws and Eisai will comply with applicable state laws with regard to our information practices. 

8. Other Terms
Your use of this site is subject to our Legal Notices.

9. Changes to Eisai's Privacy Policy
Eisai reserves the right to modify or amend this Privacy Policy at any time and for any reason. When we modify or amend this policy we will post the revised Privacy Policy on this page. Your decision to continue receiving the Service after we make any changes to this Policy shall be deemed to be your express consent to the changes in the revised Policy pertaining to personal information we collect. 

Effective Date: September 2, 2004
Last Updated: January 25, 2008

IMPORTANT SAFETY INFORMATION

WARNING: SPINAL/EPIDURAL HEMATOMA

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.

  • 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 Prescribing Information

INDICATIONS

When patients are at risk for thrombotic complications1

Prophylaxis of DVT

  • Medical
    • For patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness
  • Orthopedics
    • In patients undergoing hip replacement surgery
  • Surgery
    • In patients undergoing abdominal surgery who are at risk for thromboembolic complications

Treatment of symptomatic VTE

  • Oncology
    • Extended treatment of symptomatic VTE to reduce the recurrence of VTE in patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for 6 months
    • FRAGMIN is not indicated for the acute treatment of VTE

Prophylaxis of ischemic complications

  • Cardiology
    • Prophylaxis of ischemic complications in unstable angina (UA) and non–Q-wave myocardial infarction (NQWMI) when concurrently administered with aspirin therapy

Reference: 1. FRAGMIN prescribing information. Eisai Inc.; 2010.