Click here to download a PDF of this dosing guide. Medical Thromboprophylaxis FRAGMIN® is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness. * IU=international units. † SC=subcutaneously. Extended Treatment of Symptomatic VTE in Patients with Cancer FRAGMIN® is indicated for the extended treatment of symptomatic venous thromboembolism (VTE) (proximal DVT and/or PE), to reduce the recurrence of VTE in patients with cancer Multiple strengths of convenient prefilled syringes available for all weight ranges Convenient, once-daily dosing No drug waste with exact deliverable dose using prefilled syringes First 30 days: 200 IU/kg total body weight SC once daily Months 2 to 6: ≈150 IU/kg total body weight SC once daily The total daily dose should not exceed 18,000 IU. Safety and efficacy beyond 6 months have not been evaluated in patients with cancer and acute symptomatic VTE1 Dose reductions for thrombocytopenia in patients with cancer and acute symptomatic VTE1 In patients receiving FRAGMIN® who experience platelet counts of: — Between 50,000 and 100,000/mm3—reduce the daily dose of FRAGMIN® by 2500 IU until the platelet count recovers to ≥100,000/mm3 — <50,000/mm3—FRAGMIN® should be discontinued until the platelet count recovers above 50,000/mm3 Dose reductions for renal insufficiency in extended treatment of acute symptomatic VTE in patients with cancer1 In patients with severely impaired renal function (CrCl <30 mL/min): — Monitoring for anti-Xa levels is recommended to determine the appropriate FRAGMIN® dose — Target anti-Xa range is 0.5 to 1.5 IU/mL When monitoring anti-Xa in these patients: — Sampling should be performed 4 to 6 hours after FRAGMIN® dosing — Sample only after the patient has received 3 to 4 doses Hip-Replacement Surgery FRAGMIN® is indicated for the prophylaxis of DVT, which may lead to PE, in patients undergoing hip-replacement surgery. * Or later, if hemostasis has not been achieved. † Up to 14 days of treatment was well tolerated in controlled clinical trials, where the usual duration of treatment was 5 to 10 days postoperatively. ‡ Allow a minimum of 6 hours between this dose and the dose to be given on postoperative day 1. Adjust the timing of the dose on postoperative day 1 accordingly. § Allow approximately 24 hours between doses. Abdominal Surgery FRAGMIN® is indicated for the prophylaxis of DVT, which may lead to PE, in patients undergoing abdominal surgery who are at risk for thromboembolic complications. Dosage adjustment and routine monitoring of coagulation parameters are not required if the dosage and administration recommendations specified are followed. UA* and NQWMI FRAGMIN® is indicated for the prophylaxis of ischemic complications in unstable angina (UA) and non-Q-wave myocardial infarction (NQWMI), when concurrently administered with aspirin therapy. † Each multiple-dose vial contains either 10,000 or 25,000 anti-Factor Xa IU per 1 mL for a total of 95,000 anti-Factor Xa IU per vial. ‡ The 10,000 IU/1 mL graduated syringe is the same concentration of anti-Factor Xa as the 9.5 mL vial. In patients with UA or NQWMI, the recommended dose of FRAGMIN® is 120 IU/kg of body weight, but not more than 10,000 IU SC every 12 hours with concurrent oral aspirin (75 to 165 mg once daily) therapy. Treatment should be continued until the patient is clinically stabilized. The usual duration of administration is 5 to 8 days. Concurrent aspirin therapy is recommended except when contraindicated.      *With EKG changes.		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)
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