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/mm
3,
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.
