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LOVENOX®—proven outcomes in acutely ill medical patients from landmark MEDENOX trial

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® is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness.

Significantly fewer DVT/PE events with LOVENOX® vs placebo ⁹

Results from the landmark MEDENOX trial...

In MEDENOX (Prophylaxis in Medical Patients With Enoxaparin), a multicenter, multinational, double-blind study, 1102 acutely ill medical patients were randomized to either LOVENOX® (20 mg or 40 mg) SC once daily or placebo for a planned 6 to 14 days. ⁹

DVT/PE events in MEDENOX—results from total population ¹¹ DVT/PE events in MEDENOX- results from total population

LOVENOX® demonstrated consistent safety outcomes in a wide range of patients ^6,9

No statistically significant difference in major bleeding events comparing LOVENOX® 40 mg SC once daily with placebo (1.7% vs 1.1%, respectively) ^6,9^,b,c
No statistically significant difference in thrombocytopenia comparing LOVENOX® 40 mg SC once daily with placebo (2.2% vs 3.6%, respectively) ⁹

Benefit/risk profile
Based upon these calculations from trial results, LOVENOX® had an estimated 94 fewer DVT/PE events per 1000 acutely ill medical patients vs placebo, with 6 additional major bleeds ^10,^a

Results from subgroup analyses of the MEDENOX trial…

LOVENOX® was associated with a reduction in DVT/PE in high-risk patients across characteristics ^7,9^,d

In MEDENOX subgroup analyses, LOVENOX® showed trending toward reductions in DVT/PE events across all patient characteristics ⁷

Incidence of DVT/PE (days 1-14) by patient characteristics ^11,12 DVT/PE events in MEDENOX- results from total population

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

^bBased on the rate of major bleeding on LOVENOX® up to 24 hours after the last dose. ⁶

^cHemorrhage was classified as major if bleeding was overt and was associated with the need for transfusion of 2 or more units of packed red blood cells or whole blood, or with a decrease in the Hgb concentration of 2.0 g/dL or more from baseline, or if bleeding was retroperitoneal, intracranial, or fatal. ⁹

^dResults from a post hoc analysis in predefined subgroups of the MEDENOX study. Patients included were hospitalized for acute heart failure (New York Heart Association class III [moderate] or class IV [severe] congestive heart failure) or acute respiratory failure that did not require immediate ventilatory support. Other patients had 1 of 3 medical conditions (acute infectious disease without septic shock, an acute rheumatic disorder, or an active episode of inflammatory bowel disease) and at least 1 more predefined DVT/PE risk factor. Overall, there was a 63% RRR in DVT/PE. ⁷

View a hypothetical patient profile for an acutely ill medical patient

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 outcomes in acutely ill medical patients from landmark MEDENOX trial

Significantly fewer DVT/PE events with LOVENOX® vs placebo 9

LOVENOX® demonstrated consistent safety outcomes in a wide range of patients 6,9

Results from subgroup analyses of the MEDENOX trial…

LOVENOX® was associated with a reduction in DVT/PE in high-risk patients across characteristics 7,9,d

Significantly fewer DVT/PE events with LOVENOX® vs placebo ⁹

LOVENOX® demonstrated consistent safety outcomes in a wide range of patients ^6,9

LOVENOX® was associated with a reduction in DVT/PE in high-risk patients across characteristics ^7,9^,d