LOVENOX®—proven outcomes in abdominal surgery patients

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 patients undergoing abdominal surgery who are at risk for thromboembolic complications.

LOVENOX® has been proven to be a replacement for UFH

In patients with cancer, LOVENOX® 40 mg SC once daily was as effective as unfractionated heparin (UFH) 5000 IU SC 3 times daily ¹⁴

Incidence of DVT/PE in patients undergoing cancer surgery ^14,a Incidence in DVT/PE undergoing cancer surgery

Incidence of hemorrhage was comparable between the groups (P=NS) ¹⁴
No intracranial or intraocular hemorrhages ¹⁴
No cases of thrombocytopenia occurred in the LOVENOX® group ¹⁴

In patients with colorectal cancer, LOVENOX® 40 mg SC once daily was as effective as UFH 5000 IU SC 3 times daily ¹⁴

Incidence of DVT in patients undergoing colorectal cancer surgery ^14,^a Incidence in DVT in patients undergoing colorectal cancer surgery

The incidence of hemorrhage was comparable and not statistically significant between the groups ¹⁴

^aA prospective, double-blind, randomized, multicenter trial in 1115 patients undergoing planned elective curative surgery for abdominal or pelvic cancer. Patients received either LOVENOX® 40 mg SC once daily beginning 2 hours before operation and continuing for 10 ± 2 days or UFH 5000 IU SC beginning 2 hours before operation and then 3 times daily for 10 ± 2 days. ¹⁴

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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 abdominal surgery patients

LOVENOX® has been proven to be a replacement for UFH

In patients with cancer, LOVENOX® 40 mg SC once daily was as effective as unfractionated heparin (UFH) 5000 IU SC 3 times daily 14

In patients with colorectal cancer, LOVENOX® 40 mg SC once daily was as effective as UFH 5000 IU SC 3 times daily 14

In patients with cancer, LOVENOX® 40 mg SC once daily was as effective as unfractionated heparin (UFH) 5000 IU SC 3 times daily ¹⁴

In patients with colorectal cancer, LOVENOX® 40 mg SC once daily was as effective as UFH 5000 IU SC 3 times daily ¹⁴