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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.
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:
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.
Prophylaxis of DVT
Treatment of symptomatic VTE
Prophylaxis of ischemic complications
Reference: 1. FRAGMIN prescribing information. Eisai Inc.; 2010.