LOVENOX®—use in special populations

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

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 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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