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

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) 4Patients 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 patients⁶

CrCl=creatinine clearance.

Treatment of acute STEMI patients⁶ Thrombolytic therapy (fibrin-specific or non-fibrin- specific)

Treatment of acute STEMI patients⁶

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 patients⁶ 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 bleeding⁶

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

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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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