LOVENOX®—use in special populations

Patient Characteristics 6

Pregnancy	-LOVENOX® is not predicted to increase the risk of developmental abnormalities -Pregnancy alone confers an increased risk for thromboembolism that is even higher for women with thromboembolic and certain high-risk pregnancy conditions (See Warnings and Precautions in full full prescribing information) -Pregnant women receive anticoagulants such as LOVENOX® are at risk for bleeding and should be carefully monitored for evidence of bleeding or excessive anticoagulation (see Boxed Warning in full prescribing information)

Nursing Mothers	-It is not known if this drug is excreted in human milk -Because many drugs are excreted in human milk, caution should be exercised when LOVENOX® is administered to nursing women
Pediatric Use	-Safety and effective of LOVENOX® in pediatric patients have not been established
Geriatric Use- DVT in Hip-or knee- Replacement or Abdominal surgery; Treatment of DVT; Prevention of ischemic Complications of UA and non-Q-wave-MI	The effectiveness of LOVENOX® in geriatric (>=65 years) was similar to that of younger patients (>65 years). The incidence of bleeding complications was similar between the geriatric and younger patients when 30 mg q12h or 40 mg once daily doses of LOVENOX® were employed. The incidence of bleeding complications was higher in geriatric patients as compared to younger patients when LOVENOX® was administered at doses of 1.5mg/kg q12h. The risk of LOVENOX® associated with bleeding increased with age. Serious adverse events increased with age in patients receiving LOVENOX®. Other clinical experience (including postmarketing surveillance and literature reports) has not revealed additional differences in the safety of LOVENOX® use in geriatric and younger patients . Careful attention to dosing intervals and concomitant medications (especially antiplatelet medications) is advised. LOVENOX® should be used with care in geriatric patients who may show delayed elimination of enoxaparin. Monitoring of geriatric patients with low body weight (<45 kg) and those predisposed to decreased renal function should be considered (See Warnings and Precautions in full full prescribing information).

Patient Characteristics⁶ Special Populations Patient Characteristics

Patient Characteristics 6

Geriatric use- Treatment of acute STEMI	-In the clinical study for treatment of acute STEMI, there was no evidence of difference in efficacy between patients >=75 years of age (n=1241) and patients <75 years of age (n=9015). Patients >=75 years of age did not receive a 30 mg IV bolus prior to the normal regimen and Had their SC dose adjusted to 0.75 mg/kg every 12 hours (see Dosing and Administration in full prescribing information) -The incidence of bleeding complications was higher in patients >=65 years of age as compared To younger patients (<65 years of age)
Patients with mechanical prosthetic heart valves	-Use of LOVENOX® in patients with mechanical prosthetic heart valves has not been adequately studied. Isolated cases of prosthetic heart valve thrombosis have been reported in patients with mechanical prosthetic heart valves who have received LOVENOX® for thromboprophylaxis. Some of these cases were pregnant women whom thrombosis led to maternal and fetal deaths. Insufficient data, the underlying disease and the possibility of inadequate anticoagulation Complicate the evaluation of these cases. -Pregnant women with mechanical prosthetic heart valves may be at higher risk for thromboembolism (See Warnings and Precautions in full full prescribing information).
Hepatic Impairment	-The impact of hepatic impairment on LOVENOX® exposure and antithrombotic effect has not been investigated. Caution should be exercised when administering LOVENOX® to patients with hepatic impairment.
Low-weight Patients	-An increase in exposure of LOVENOX® with prophylactic dosages (non-eight adjusted) has been observed in low-weight women (<45 kg) and low-weight men (<57 kg). All such should be observed carefully for signs and symptoms of bleeding (see Clinical Pharmacology in full prescribing information).

DVT=deep vein thrombosis; MI=myocardial infarction; STEMI=ST-segment elevation myocardial infarction; UA=unstable angina.

LOVENOX® may be largely neutralized (up to 60%) by the slow IV injection of protamine sulfate (1% solution).

Important Safety Information

WARNING: SPINAL/EPIDURAL HEMATOMAS

When neuraxial anesthesia (epidural/spinal anesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low-molecular-weight heparins or heparinoids for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis.

The risk of these events is increased by the use of indwelling epidural catheters for administration of analgesia or by the concomitant use of drugs affecting hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture.

Monitor patients for signs and symptoms of neurological impairment. If neurologic compromise is noted, urgent treatment is necessary.

Consider the potential benefit versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis (see Warnings and Precautions [5.1] and Drug Interactions [7]).

LOVENOX® (enoxaparin sodium injection) cannot be used interchangeably with other low-molecular-weight heparins or unfractionated heparin (UFH), as they differ in their manufacturing process, molecular weight distribution, anti-Xa and anti-IIa activities, units, and dosage.

As with other anticoagulants, use with extreme caution in patients with conditions that increase the risk of hemorrhage. Dosage adjustment is recommended in patients with severe renal impairment. Unless otherwise indicated, agents that may affect hemostasis should be discontinued prior to LOVENOX® therapy. 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. (See WARNINGS and PRECAUTIONS.)

In the ST-segment elevation myocardial infarction (STEMI) pivotal trial, 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 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 (MI), or ICH (a measure of net clinical benefit) was significantly lower in the LOVENOX® group (10.1%) as compared to the UFH group (12.2%).

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. (See WARNINGS and PRECAUTIONS.)

The use of LOVENOX® has not been adequately studied for thromboprophylaxis in pregnant women with mechanical prosthetic heart valves. (See WARNINGS and PRECAUTIONS.)

LOVENOX® is contraindicated in patients with hypersensitivity to enoxaparin sodium, heparin, or pork products, and in patients with active major bleeding.

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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