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LOVENOX®—proven across multiple patient types ⁶

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

Hypothetical Patient Profiles

DVT Prophylaxis (Medical) DVT Prophylaxis (Surgical) DVT Treatment Acute Coronary Syndrome

LOVENOX^® 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.

Acutely ill medical patient—hypothetical patient profile

Ted

Male, 76 years old

Vitals:
Height: 6'0"
Weight: 205 lb
Heart rate: 105 bpm
BP: 170/90 mm Hg

Diagnostics: Ted was admitted to the hospital from the ED with NYHA Class III CHF.

DVT risk factors:

LVEF <20%
Age >40 years
Hospitalization for acute medical illness
Nursing home residence

DVT prophylaxis plan: Ted received LOVENOX® 40 mg SC once daily as prophylaxis for prevention of DVT/PE. He was stabilized and discharged back to the nursing home after 4 days. Ted’s physician was concerned about the ongoing risk of DVT/PE after hospital discharge. Approved duration of prophylaxis with LOVENOX® is 6–11 days, administered up to 14 days in the controlled clinical trial.

BP=blood pressure; CHF=congestive heart failure; DVT=deep vein thrombosis; DVT/PE=deep vein thrombosis/pulmonary embolism; ED=emergency department; LVEF=left ventricular ejection fraction;
NYHA=New York Heart Association; PE=pulmonary embolism.

LOVENOX^® is indicated for the prophylaxis of DVT, which may lead to PE, in patients undergoing hip-replacement surgery, during and following hospitalization.

Hip-replacement surgery—hypothetical patient profile

Sally

Female, 60 years old

Vitals:
Height: 5'4"
Weight: 115 lb
Heart rate: 71 bpm
BP: 135/85 mm Hg

Diagnosis: Following normal diagnostic results, Sally was scheduled for total hip arthroplasty of the left hip using standard surgical techniques.

DVT risk factors:

Major orthopedic surgery
Age >40 years
Immobility
Hormone-replacement therapy

DVT prophylaxis plan: Sally remained hospitalized for 4 days to recover from surgery and begin physical therapy. Sally continued recovery at home, scheduled outpatient physical therapy, and requested a comprehensive plan to minimize VTE risk. During and following hospitalization, she received LOVENOX® 30 mg SC every 12 hours for 7 to 10 days, followed by extended prophylaxis with LOVENOX® 40 mg SC once daily for 3 weeks.

LOVENOX^® is indicated for the prophylaxis of DVT, which may lead to PE, in patients undergoing knee-replacement surgery.

Knee-replacement surgery—hypothetical patient profile

Linda

Female, 55 years old

Vitals:
Height: 5'5"
Weight: 172 lb
Heart rate: 91 bpm
BP: 115/73 mm Hg

Diagnostics: Routine blood work, including a complete blood count, electrolytes, BUN, and serum creatinine were normal. ECG, chest X-ray, and coagulation panel were also normal.

DVT risk factors:

Immobility
Obesity
Major orthopedic surgery
Hormone-replacement therapy

DVT prophylaxis plan: Prior to surgery, Linda’s physician noted that hemostasis had been established. LOVENOX® 30 mg SC was initiated 12 hours postoperatively and every 12 hours for 4 days as Linda recovered. Her doctor was concerned about the risk of VTE following her surgery, and ordered continuation of DVT prophylaxis while convalescing.

LOVENOX^® is indicated for the prophylaxis of DVT, which may lead to PE, in patients undergoing abdominal surgery who are at risk for thromboembolic complications.

Abdominal surgery—hypothetical patient profile

Michael

Male, 68 years old

Vitals:
Height: 5'10"
Weight: 155 lb
Heart rate: 70 bpm
BP: 120/85 mm Hg

Diagnostics: Based on imaging, pathology, and results of surgical exploration, Michael was diagnosed with stage IIIA colon cancer. He was referred to a surgical oncologist and was scheduled for surgery.

DVT risk factors:

Malignancy
Surgery
Age >40 years

DVT prophylaxis plan: Michael received LOVENOX® 40 mg SC 2 hours prior to surgery. He underwent exploratory laparotomy with successful hemicolectomy. He received LOVENOX® 40 mg SC once daily for his 4-day hospital stay. On discharge, the surgeon prescribed LOVENOX® 40 mg SC once daily for 6 more days.

BP=blood pressure; BUN=blood urea nitrogen; DVT=deep vein thrombosis; ECG=electrocardiograph;
PE=pulmonary embolism; VTE=venous thromboembolism.

LOVENOX^® is indicated for:

—The inpatient treatment of acute DVT, with or without PE, when administered in conjunction with warfarin sodium
—The outpatient treatment of acute DVT, without PE, when administered in conjunction with warfarin sodium

DVT treatment—hypothetical patient profile

Paul

Male, 39 years old

Vitals:
Height: 5'10"
Weight: 165 lb
Heart rate: 65 bpm
BP: 120/80 mm Hg

Diagnosis: Former professional soccer player sustained a right lower extremity injury and was hospitalized. Clinically diagnosed with a DVT, which was confirmed by Doppler ultrasound.

DVT risk factors:

No overt risk factors in medical history

DVT treatment plan: Paul remained hospitalized for 4 days to recover from his injury. During and following hospitalization, he received LOVENOX® 1 mg/kg SC every 12 hours in conjunction with warfarin sodium therapy. Treatment continued for 7 days until INR=2.0–3.0.

BP=blood pressure; DVT=deep vein thrombosis; INR=international normalized ratio; PE=pulmonary embolism.

LOVENOX^® has been shown to reduce the rate of the combined endpoint of recurrent MI or death in patients with acute STEMI receiving thrombolysis and being managed medically or with PCI.

Acute STEMI—hypothetical patient profile

Diane

Female, 64 years old

Vitals:
Height: 5'4"
Weight: 189 lb
Heart rate: 102 bpm
BP: 140/85 mm Hg

Diagnosis: Three hours after onset of chest pain, Diane was admitted to the hospital from the ED after ECG showed evidence of an anterior wall acute STEMI. Immediate STEMI protocol was activated.

Additional risk factors:

Family history of coronary artery disease
Other risks include smoking, hypertension, and obesity

Treatment plan: Prep for immediate reperfusion therapy. Because door-to-balloon time was 3 hours, and no cardiac catheterization laboratory was available, she received fibrinolytic reperfusion therapy with a fibrin-specific agent, in combination with aspirin and LOVENOX® 30-mg IV bolus, plus 1 mg/kg SC injection followed by 1 mg/kg SC every 12 hours until hospital discharge, or 8 days (whichever came first).

LOVENOX^® is indicated for the prophylaxis of ischemic complications of UA and non–Q-wave MI when concurrently administered with aspirin.

UA/NSTEMI—hypothetical patient profile

Maria

Female, 68 years old

Vitals:
Height: 5'5"
Weight: 165 lb
Heart rate: 90 bpm
BP: 150/85 mm Hg

Diagnosis: Based on symptoms and ECG results, Maria was diagnosed with NSTEMI and admitted to the hospital for further evaluation and observation.

Additional risk factors:

Mother died of CHF
Hypertension (controlled), dyslipidemia, and overweight
Smoker

Prophylaxis plan: Maria receives acute anti-ischemic therapy (ie, nitroglycerin, ACE inhibitor, and current beta-blocker). She also receives 325 mg oral aspirin and LOVENOX® 1 mg/kg every 12 hours SC until stabilized (usually 2–8 days).

ACE=angiotensin-converting enzyme; BP=blood pressure; CHF=congestive heart failure; ECG=electrocardiograph; ED=emergency department; MI=myocardial infarction; PCI=percutaneous coronary intervention; STEMI=ST-segment elevation MI; UA/NSTEMI=unstable angina/non–ST-segment elevation MI.

Important Safety Information for LOVENOX^®

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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LOVENOX®—proven across multiple patient types 6

Hypothetical Patient Profiles

Acutely ill medical patient—hypothetical patient profile

Ted

Hip-replacement surgery—hypothetical patient profile

Sally

Knee-replacement surgery—hypothetical patient profile

Linda

Abdominal surgery—hypothetical patient profile

Michael

DVT treatment—hypothetical patient profile

Paul

Acute STEMI—hypothetical patient profile

Diane

UA/NSTEMI—hypothetical patient profile

Maria

LOVENOX®—proven across multiple patient types ⁶