Current and Emerging Trends in DVT Prophylaxis Highlights from a Clinical Roundtable

Important Safety Information for LOVENOX®

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.

LOVENOX® cannot be used interchangeably with other low-molecular weight heparins or unfractionated heparin, as they differ in their manufacturing process, molecular weight distribution, and anti-Xa and anti-IIa activities, units and dosages.

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.)

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 or heparin-induced thrombocytopenia, LOVENOX® should be used with extreme caution. Thromobocytopenia 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 see accompanying full Prescribing Information including boxed WARNING or visit www. Lovenox.com.

This presentation is sponsored by sanofi-aventis U.S. LLC in partnership with The Doctor's Channel.
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

US.ENO.10.03.003

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