DVT risk reduction starts with DVT Patient Safety Path

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.

Continued below

Talk to your patients about deep vein thrombosis (DVT) risk:

—Prophylaxis is often underutilized,⁴³ potentially putting patients at risk
—Discharge begins at admission, so raise DVT awareness early and identify at-risk patients sooner
—Help ensure that appropriate prophylaxis is started at the right time

The DVT Patient Safety Path Program offers a variety of multimedia resources to help you meet enhanced requirements for DVT risk reduction and education. You can obtain them free of charge at www.DVTSafetyPath.com.

DVT Patient Safety Path Program's multi-media resources

Foster patient-hospital communication to meet National Patient Safety Goals (NPSGs) 13 and 13.01.01

Know More About Your Hospital Stay, the DVT Patient Safety Path program, informs patients about the risk of deep vein thrombosis/pulmonary embolism (DVT/PE) and how LOVENOX® may help reduce that risk
Educate patients in accordance with safety mandates by showing the customizable Improving Patient Safety video
For patients considering total hip- or knee-replacement surgery, the New Joints, New Beginnings video is an educational DVD that helps explain why they are at risk for DVT and why they need DVT prophylaxis

DVT Patient Safety Path Program's resources

Encourage appropriate prophylaxis and education to meet NPSG.03.05.01 and HCAHPS

Why You Need to Know About DVT Blood Clots Now patient education brochure
Using the Patient Risk Assessment Form, assess all patients for their risk of DVT/PE, whether they are of a younger age or have the appearance of good health
DVT Patient Safety Path implementation guide—for hospitals

Help increase postdischarge compliance

At Home with LOVENOX® patient discharge kit^a guides patients through the injection process at home and reminds them that DVT risk continues when they leave the hospital
LOVENOX® Prescription Reminder Service—enhance patient safety after discharge by enrolling patients to receive a phone call from a registered nurse within 24 hours of discharge
LOVENOX® patient hotline for self-administration

Here’s how this program will help:

Your hospital

—Helps ensure that appropriate prophylaxis is started at the right time
—Supports patient education efforts about DVT risk and appropriate prophylaxis
—Encourages patient/healthcare professional conversation in compliance with NPSG.13.01.01
—Helps reinforce patient education on medications given in the hospital and discharge
—Strengthens patient-hospital relationships leading to positive Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) evaluations

Your patients

—Educates patients and caregivers about a potential health risk
—Helps patients make informed decisions about their care
—Helps patients feel calmer about their hospital stay
—Increases patient compliance after discharge

Visit www.DVTSafetyPath.com to order now

^aThis kit does not contain drug.

Important Safety Information

WARNING: SPINAL/EPIDURAL HEMATOMA

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.

CONTRAINDICATIONS

LOVENOX® (enoxaparin sodium injection) is contraindicated in patients with active major bleeding; thrombocytopenia with a positive in vitro test for anti-platelet antibody in the presence of enoxaparin sodium; known hypersensitivity to enoxaparin sodium, heparin, pork products, or benzyl alcohol (multi-dose formulation only)

WARNINGS AND PRECAUTIONS

LOVENOX® should be used with extreme caution in conditions with increased risk of hemorrhage. Major hemorrhages including retroperitoneal and intracranial bleeding have been reported. Some of these cases have been fatal. Bleeding can occur at any site during LOVENOX® therapy. An unexplained fall in hematocrit (HCT) or blood pressure should lead to a search for a bleeding site
For percutaneous coronary revascularization procedures, obtain hemostasis at the puncture site before sheath removal and observe the site for signs of bleeding or hematoma formation
In the STEMI population, the rates of major hemorrhages (defined as requiring 5 or more units of blood for transfusion, or 15% drop in HCT or clinically overt bleeding, including intracranial hemorrhage [ICH]) at 30 days were 2.1% in the LOVENOX® group and 1.4% in the unfractionated heparin (UFH) group. The rates of ICH at 30 days were 0.8% in the LOVENOX® group and 0.7% in the UFH 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%) compared to the UFH group (12.2%)
LOVENOX® should be used with caution in patients with bleeding diathesis, uncontrolled arterial hypertension or a history of recent gastrointestinal ulceration, diabetic retinopathy, renal dysfunction, or hemorrhage
Thrombocytopenia can occur with LOVENOX®. In patients with a history of heparin-induced thrombocytopenia (HIT), 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 HIT have been observed in clinical practice
LOVENOX® cannot be used interchangeably with other branded LMWH or UFH, as they differ in their manufacturing process, molecular weight distribution, anti-Xa and anti-IIa activities, units, and dosages
Pregnant women with mechanical prosthetic heart valves and their fetuses may be at increased risk for thromboembolism. Frequent monitoring of anti-Factor Xa levels and adjusting of dosage may be needed
LOVENOX® multiple-dose vials contain benzyl alcohol and should be used with caution in pregnant women and only if clearly needed due to the risk of fatal "gasping syndrome" in premature neonates
Periodic complete blood counts, including platelet count, and stool occult blood tests are recommended during the course of treatment with LOVENOX®

ADVERSE REACTIONS

Most common adverse reactions (>1%) were bleeding, anemia, thrombocytopenia, elevation of serum aminotransferase, diarrhea, and nausea

For more information, contact your local sanofi-aventis U.S. Representative or call sanofi-aventis U.S. Medical Information Services at 1-800-633-1610.

Please see full Prescribing Information, including boxed WARNING.

Prescription LOVENOX® is available in pharmacies.

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