1. FRAGMIN® Prescribing Information. 2. Staton CA, Lewis CE. Angiogenesis inhibitors found within the haemostasis pathway. J Cell Mol Med. 2005;9:286-302. 3. Handin RI. Bleeding and thrombosis. In: Braunwald E et al, eds. Harrison's Principles of Internal Medicine, 15th ed. New York, NY: McGraw-Hill Companies; 2001:354-360. 4. Bakken AM and Davies MG. Combined Mechanical and Pharmacological Thrombolysis for Iliofemoral DVT presenting as Phlegmasia Cerulea Dolens. Available at: http://www.vascularweb.org/_CONTRIBUTION_PAGES/Clinical_Information/ Images_Cases/Combined_Mechanical_and_Pharmac-9_27_2005.html. Accessed on 5/22/2007. 5. Venous Thrombosis. Available at: http://www.clinicalresearch.nl/epidemiology/wright/venous%20thrombosis.htm. Accessed on 5/22/2007. 6. Hirsh J, Hoak J. Management of deep vein thrombosis and pulmonary embolism: a statement for healthcare professionals from the Council on Thrombosis (in consultation with the Council on Cardiovascular Radiology), American Heart Association. Circulation. 1996;93:2212-2245. 7. Bosker G, Poponick J, Emerman C, Kleinschmidt K. The current challenges of venous thromboembolism (VTE) in the hospitalized patient. Part II. Treatment and prevention of DVT and PE-evolving risk-stratification and prophylaxis strategies for hospital-based medicine. American Health Consultants [serial online]. July 2002:2-16. 8. Geerts WH, Pineo GF, Heit JA, et al. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126(suppl):338S-400S. 9. Heit JA. Cancer and venous thromboembolism: scope of the problem. Cancer Control. 2005;12:5-10. 10. Hillen HFP. Thrombosis in cancer patients. Ann Oncol. 2000;11(suppl 3):273-276. 11. Anderson FA Jr., Spencer FA. Risk factors for venous thromboembolism. Circulation. 2003;107:1-9-1-16. 12. Bates SM, Ginsberg JS. Treatment of deep-vein thrombosis. N Engl J Med. 2004;351:268-277. 13. Tanios MA, Simon AR, Hassoun PM. Management of venous thromboembolic disease in the chronically critically ill patient. Clin Chest Med. 2001;22:105-122. 14. Tapson VF. Prophylaxis strategies for patients with acute venous thromboembolism. Am J Manag Care. 2001;7:S524-S534. 15. Cohen AT. Discoveries in thrombosis care for medical patients. Semin Thromb Hemost. 2002;28:13-17. 16. Bick RL, Haas S. Thromboprophylaxis and thrombosis in medical, surgical, trauma and obstetric/gynecologic patients. Hematol Oncol Clin N Am. 2003;17:217-258. 17. Douketis JD, Moinuddin I. Prophylaxis against venous thromboembolism in hospitalized medical patients: an evidence-based and practical approach. Pol Arch Med Wewn. 2008; 118 (4): 209-215 18. The Joint Commission. 2008 National Patient Safety Goals: Hospital Program. © 2008 19. Goldhaber SZ, Tapson VF, for the DVT FREE Steering Committee. A prospective registry of 5,451 patients with ultrasound-confirmed deep vein thrombosis. Am J Cardiol. 2004;93:259-262. 20. Leizorovicz A, Cohen AT, Turpie AGG, Olsson C-G, Vaitkus PT, Goldhaber SZ, for the PREVENT Medical Thromboprophylaxis Study Group. Randomized, placebocontrolled trial of dalteparin for the prevention of venous thromboembolism in acutely ill medical patients. Circulation. 2004;110:874-879. 21. Geerts W, Bergqvist D, Pineo G, et al. Prevention of Venous Thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008;133;381-453 22. Gallus AS. Prevention of post-operative deep leg vein thrombosis in patients with cancer. Thromb Haemost. 1997;78:126-13232. 23. Kakkar AK, Williamson RCN. Prevention of venous thromboembolism in cancer patients. Semin Thromb Haemost. 1999;25:23239-243. 24. Bona R. Thrombotic complications of central venous catheters in cancer patients. Semin Thromb Haemost. 1999;25:147-155. 25. Prandoni P. Antithrombotic strategies in patients with cancer. Thromb Haemost. 1997;78:141-144. 26. Levine MN. Prevention of thrombotic disorders in cancer patients undergoing chemotherapy. Thromb Haemost. 1997;13333-136. 27. Levitan N, Dowlati A, Remick SC, et al. Rates of initial and recurrent thromboembolic disease among patients with malignancy versus those without malignancy: risk analysis using Medicare claims data. Medicine. 1999;78:285-291. 28. Hutten BA, Prins MH, Gent M, et al. Incidence of recurrent thromboembolic and bleeding complications among patients with venous thromboembolism in relation to both malignancy and achieved international normalized ratio: a retrospective analysis. J Clin Oncol. 2000;18:3078-3083. 29. Prandoni P, Lensing AWA, Piccioli A, et al. Recurrent venous thromboembolism and bleeding complications during anticoagulant treatment in patients with cancer and venous thrombosis. Blood. 2002;100:3484-3488. 30. Lee AYY, Levine MN, Baker RI, et al. Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. N Engl J Med. 2003;349:146-153. 31. Bergqvist D, Benoni G, Björgell O, et al. Low-molecular-weight heparin (enoxaparin) as prophylaxis against venous thromboembolism after total hip replacement. N Engl J Med. 1997;335:696-700. 32. Data on file, Eisai Inc. 33. Kearon C. Duration of Venous Thromboembolism Prophylaxis After Surgery. Chest 2003;124;386-392 34. Agnelli G. Venous thromboembolism and cancer: a two-way clinical association. Thromb Haemost. 1997:78:117-120. 35. Donati MB. Cancer and thrombosis. Haemostasis. 1994;24:128-131. 36. Wallentin L, Ohlsson J, Swahn E, for the FRAGMIN® during Instability in Coronary Artery Disease (FRISC) study group. Low-molecular-weight heparin during instability in coronary artery disease. Lancet. 1996;347:561-568.		The content on this Web site is dynamic and will be updated on a regular basis. You will find a robust collection of information, such as: Review of FRAGMIN® across its indications Dosing Information Details about the use of FRAGMIN® For information on: Patient Kits Benefits Verification Patient Assistance Program Contacting a Sales Rep Call the FRAGMIN® HOTLINE 1-866-272-8804 Mon thru Fri 9am to 6pm (EST)
Indications FRAGMIN® injection 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, in patients undergoing hip-replacement surgery, and in patients undergoing abdominal surgery who are at risk for thromboembolic complications. 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. FRAGMIN® is also indicated for the prophylaxis of ischemic complications in UA‡ and NQWMI, when concurrently administered with aspirin therapy. ‡ With EKG changes.
Important Safety Information SPINAL/EPIDURAL HEMATOMAS When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low molecular weight heparins or heparinoids for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis. The risk of these events is increased by the use of indwelling epidural catheters for administration of analgesia or by the concomitant use of drugs affecting hemostasis such as non steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture. Patients should be frequently monitored for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. The physician should consider the potential benefit versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis (also see WARNINGS, Hemorrhage and PRECAUTIONS, Drug Interactions). FRAGMIN® is contraindicated in patients with active major bleeding or with known hypersensitivity to the drug, heparin, or pork products, or with thrombocytopenia associated with a positive antiplatelet antibody test Patients undergoing regional anesthesia should not receive FRAGMIN® for unstable angina or non–Q-wave myocardial infarction, and patients with cancer undergoing regional anesthesia should not receive FRAGMIN® for extended treatment of symptomatic VTE, due to an increased risk of bleeding associated with the dosage of FRAGMIN® recommended for these indications FRAGMIN® Injection is not intended for intramuscular administration FRAGMIN® cannot be used interchangeably (unit for unit) with unfractionated heparin or other low–molecular-weight heparins 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 extreme caution in patients with history of heparin-induced thrombocytopenia In FRAGMIN® clinical trials supporting non-cancer indications, platelet counts of <100,000/mm3 and <50,000/mm3 occurred in <1% and <1%, respectively In a clinical trial of patients with cancer and acute symptomatic VTE treated for up to 6 months in the FRAGMIN® treatment arm, 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 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 Each multiple-dose vial of FRAGMIN® contains benzyl alcohol as a preservative [which] has been reported to be associated with a fatal “Gasping Syndrome” in premature infants. Because benzyl alcohol may cross the placenta, FRAGMIN® preserved with benzyl alcohol should be used with caution in pregnant women and only if clearly needed. If anticoagulation with FRAGMIN® is needed during pregnancy, preservative-free formulations should be used, where possible FRAGMIN® should be used with care in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents because of increased risk of bleeding (see PRECAUTIONS, Laboratory Tests). Aspirin, unless contraindicated, is recommended in patients treated for unstable angina or non–Q-wave myocardial infarction (see DOSAGE AND ADMINISTRATION) Allergic reactions (i.e., pruritus, rash, fever, injection site reaction, bulleous eruption) have occurred rarely. A few cases of anaphylactoid reactions have been reported The most commonly reported side effect is hematoma at the injection site Legal Notices | Privacy Policy | Prescribing Information This Web site contains information relating to various medical conditions and their treatment. Such information is provided for educational purposes only and is not meant to substitute the advice of a physician or other health care professional. The laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The information provided in this Web site is intended for residents/physicians of the United States only. The products discussed herein may have different product labeling in different countries. FRAGMIN® is a registered trademark of Pfizer Health AB and is licensed to Eisai Inc. Brought to you by Eisai. © 2008 Eisai Inc. All rights reserved. Frweb001a