LOVENOX® dosing—proven outcomes in STEMI and UA/NSTEMI

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® 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).

STEMI dosing

Thrombolytic therapy (fibrin-specific or non-fibrin-specific) 4 Patients transitioned to PCI 4

Patient Type	Dosing	Duration of Therapy
<75 years of age	30 mg single IV bolus plus 1mg /kg SC followed by 1 mg/kg SC every 12 hours (maximum 100 mg for each of the first 2 SC doses only, followed by 1 mg/kg dosing for the remaining doses). In pivotal trial, first SC doses given within 15 minutes of IV bolus.	- LOVENOX® treatment duration in the pivotal clinical trial was 8 days or until hospital discharge, whichever came first. An optimal duration of treatment is unknown, but it is likely to be longer than 8 days.
<75 years of age with severe renal impairment (CrCl <30 mg/min); does not apply to hemodialysis patients	30 mg single IV bolus plus 1 /kg SC followed by 1 mg/kg SC once daily	- LOVENOX® treatment duration in the pivotal clinical trial was 8 days or until hospital discharge, whichever came first.
>= 75 years of age	No initial IV bolus; .75 mg/kg SC every 12 hours (maximum of 75 mg for each of the first 2 SC doses only, followed by .75 mg/kg dosing for the remaining doses)	LOVENOX® treatment duration in the pivotal clinical trial was 8 days or until hospital discharge, whichever came first. An optimal duration of treatment is unknown, but it is likely to be longer than 8 days.
<= 75 years of age with severe renal impairment (CrCl <30mg/min); does not apply to hemodialysis patients	No initial IV bolus; 1 mg/kg SC once daily	- LOVENOX® treatment duration in the pivotal clinical trial was 8 days or until hospital discharge, whichever came first. An optimal duration of treatment is unknown, but it is likely to be longer than 8 days.
When LOVENOX® is administered in conjunction with a thrombolytic	LOVENOX® should be given between 15 minutes before and 30 minutes after the start on fibrinolytic therapy
If the last LOVENOX® SC administration was given: < 8 hours before balloon inflation >8 hours before balloon inflation	No additional dosing needed Administer LOVENOX® 0.3 mg/kg IV bolus

Treatment of acute STEMI patients ⁶

CrCl=creatinine clearance.

Treatment of acute STEMI patients ⁶ Thrombolytic therapy (fibrin-specific or non-fibrin- specific)

Treatment of acute STEMI patients ⁶

All patients should receive acetylsalicylic acid (ASA) as soon as they are identified as having STEMI, and maintained with 75 mg to 325 mg once daily, unless contraindicated.

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

UA/NSTEMI dosing

Prophylaxis of ischemic complications in UA/NSTEMI patients ⁶ Patients transitioned to PCI

UA/NSTEMI=unstable angina/non–ST-segment elevation MI.

LOVENOX® requires no dose adjustments with moderate (CrCl=30 to 50 mL/min) and mild (CrCl=50 to 80 mL/min) renal impairment; all such patients should be observed carefully for signs and symptoms of bleeding ⁶

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

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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Patient Type	Dosing	Duaration of Therapy
UA/STEMI (non-Q-wave-MI)	1 mg/kg SC every 12 hours (in conjunction with oral aspirin therapy 100 mg to 325 mg once daily)	-Minimum: 2 days and continued until clinical stabilization -Usual: 2 to 8 days -Administered up to 12.5 days in clinical trials
Severe renal impairment (CrCl <30 mL/min); does not apply to hemodialysis patients	1 mg/kg SC once daily (in conjunction with oral aspirin therapy 100 mg to 325 mg once daily)	-Minimum: 2 days and continued until clinical stabilization -Usual: 2 to 8 days