|
Listen to a panel of three physicians who provide various perspectives on deep-vein thrombosis (DVT) prophylaxis from a clinical roundtable held on July 13, 2009 during the XXII Congress of the International Society of Thrombosis and Haemostasis (ISTH).
Moderator
David Best, MD, MBA
The Doctor's Channel
Panel
Steven Deitelzweig, MD, MMM, FACP, FSVMB, RVT
Department Chairman of Hospital of Medicine and Vice President of Medical Affairs at Ochsner Medical Center
Fred Cushner, MD
Director of the Insall Scott Kelly Institute
Associate Clinical Professor, Albert Einstein College of Medicine
Alpesh Amin, MD, MBA, FACP, FHM
Executive Director, Hospitalist Program
Medical Director, Anticoagulation Clinic
Vice Chair for Clinical Affairs & Quality Department of Medicine
University of California, Irvine
Lovenox® Indications and Usage
Prophylaxis of Deep Vein Thrombosis
Lovenox is indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism: - in patients undergoing abdominal surgery who are at risk for thromboembolic complications.
- in patients undergoing hip replacement surgery, during and following hospitalization.
- in patients undergoing knee replacement surgery.
- in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness.
Treatment of Acute Deep Vein Thrombosis
Lovenox is indicated for: - the inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium;
- the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium.
Prophylaxis of Ischemic Complications of Unstable Angina and Non-Q-Wave Myocardial Infarction
Lovenox is indicated for the prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin.
Treatment of acute ST- segment Elevation Myocardial Infarction (STEMI)
Lovenox has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute STEMI receiving thrombolysis and being managed medically or with Percutaneous Coronary Intervention (PCI).
Important Safety Information
WARNING: 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.
Monitor patients for signs and symptoms of neurological impairment. If neurologic compromise is noted, urgent treatment is necessary.
Consider the potential benefit versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis. (See WARNINGS and PRECAUTIONS[5.1] and Drug Interactions[7]).
LOVENOX® (enoxaparin sodium injection) cannot be used interchangeably with other low-molecular-weight heparins or unfractionated heparin, as they differ in their manufacturing process, molecular weight distribution, anti-Xa and anti-IIa activities, units, and dosage.
As with other anticoagulants, use with extreme caution in patients with conditions that increase the risk of hemorrhage. Dosage adjustment is recommended in patients with severe renal impairment. Unless otherwise indicated, agents that may affect hemostasis should be discontinued prior to LOVENOX® therapy. Bleeding can occur at any site during LOVENOX® therapy. An unexplained fall in hematocrit or blood pressure should lead to a search for a bleeding site. (See WARNINGS and PRECAUTIONS.)
In the STEMI pivotal trial, the rates of major hemorrhages (defined as requiring 5 or more units of blood for transfusion, or 15% drop in hematocrit or clinically overt bleeding, including intracranial hemorrhage) at 30 days were 2.1% in the LOVENOX® group and 1.4% in the unfractionated heparin group. The rates of intracranial hemorrhage at 30 days were 0.8% in the LOVENOX® group and 0.7% in the unfractionated heparin group. The 30-day rate of the composite endpoint of death, myocardial infarction or ICH (a measure of net clinical benefit) was significantly lower in the LOVENOX® group (10.1%) as compared to the unfractionated heparin group (12.2%).
Thrombocytopenia can occur with LOVENOX®. In patients with a history of heparin-induced thrombocytopenia, LOVENOX® should be used with extreme caution. Thrombocytopenia of any degree should be monitored closely. If the platelet count falls below 100,000/mm³, LOVENOX® should be discontinued. Cases of heparin-induced thrombocytopenia have been observed in clinical practice. (See WARNINGS.)
The use of LOVENOX® has not been adequately studied for thromboprophylaxis in pregnant women with mechanical prosthetic heart valves. (See WARNINGS.)
LOVENOX® is contraindicated in patients with hypersensitivity to enoxaparin sodium, heparin, or pork products, and in patients with active major bleeding.
Please click on link for full Prescribing Information including boxed WARNING: http://products.sanofi-aventis.us/lovenox/lovenox.html#Boxed%20Warning
US.ENO.09.08.075
|
668 Views
