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LOVENOX®—proven across the spectrum of ACS

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

LOVENOX® saved lives and reduced reinfarction vs UFH in acute STEMI patients ¹⁷

LOVENOX® has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction (MI) or death in patients with acute ST-segment elevation MI (STEMI) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (PCI).

ExTRACT–TIMI 25^a—landmark study in >20,000 acute STEMI patients ^17,18^,b

Cumulative incidence of the time to development of the primary efficacy endpoint (death or nonfatal MI) in the ITT population ^18,19

ITT=intent to treat.

Safety: the rates of major 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 ¹⁷

Benefit/risk profile
Based upon these calculations from trial results, LOVENOX® had an estimated 21 fewer deaths or MIs per 1000 STEMI patients vs UFH, with 7 additional major bleeds ¹⁰^,c

LOVENOX® provided a significant net clinical benefit vs UFH in STEMI patients ¹⁷

ExTRACT–TIMI 25 net clinical benefit at 30 days ¹⁸ ExTRACT-TIMI 25 net clinical benefit at 30 days

In UA/NSTEMI patients, LOVENOX® saved lives and reduced MIs and ischemia vs UFH

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

ESSENCE—LOVENOX® provided early and long-term superiority vs UFH in ischemic events ¹⁹

Proven efficacy in reducing death, MI, and recurrent angina ^19,20

ESSENCE (Efficacy and Safety of Subcutaneous Enoxaparin in Non–Q-wave Coronary Events) was a prospective, randomized, double blind, parallel-group, multicenter, multinational trial ¹⁹:

At 30 days, major bleeds were comparable (6.5% LOVENOX® vs 7.0% UFH; P=NS)—overall bleeding for LOVENOX® was higher vs UFH (18.4% vs 14.2%, respectively; P=0.001) ¹⁹
At 1-year follow-up, the need for diagnostic catheterization (55.8% vs 59.4%; P=0.036) and coronary revascularization (35.9% vs 41.2%; P=0.002) was lower for LOVENOX® vs UFH, respectively ²⁰

Benefit/risk profile
Based upon these calculations from trial results, LOVENOX® had an estimated 32 fewer deaths, MIs, or recurrent angina events per 1000 UA/non–ST-segment elevation MI (NSTEMI) patients vs UFH, with 5 fewer major bleeds ¹⁰^,c

^aExTRACT–TIMI 25=Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment–Thrombolysis in Myocardial Infarction 25.

^bA randomized, double-blind, double-dummy, parallel-group, multinational, active-controlled clinical trial comparing LOVENOX® with UFH in acute STEMI patients. ^17,18

^cThe NNT and the benefit/risk profile were not prespecified analyses in the trials and were calculated using the reported absolute risk reduction results. ¹⁰

View hypothetical patient profiles for acute coronary syndrome patients

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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Prespecified definitions	RR	LOVENOX® (N=10,256) %	UFH (N=10,223) %	RRR %
Death, nonfatal MI, or Nonfatal disabling stroke	95% Ct; P<0.001	10.1	12.3	18
Death, nonfatal MI, or Nonfatal major bleeding	95% Ct; P<0.001	11.0	12.8	<14/td>
Death, nonfatal MI, or Nonfatal ICH	95% Ct; P<0.001	10.1	12.2	17
.08	.09	1.0
LOVENOX® better	UFH better

LOVENOX®—proven across the spectrum of ACS

ExTRACT–TIMI 25a—landmark study in >20,000 acute STEMI patients 17,18,b

LOVENOX® provided a significant net clinical benefit vs UFH in STEMI patients 17

ESSENCE—LOVENOX® provided early and long-term superiority vs UFH in ischemic events 19

ExTRACT–TIMI 25^a—landmark study in >20,000 acute STEMI patients ^17,18^,b

LOVENOX® provided a significant net clinical benefit vs UFH in STEMI patients ¹⁷

ESSENCE—LOVENOX® provided early and long-term superiority vs UFH in ischemic events ¹⁹