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.
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
Indications
Prophylaxis of deep vein thrombosis LOVENOX® is indicated for
the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism:
- In patients undergoing abdominal surgery who are at risk for thromboembolic
complications [see Clinical Trials Experience 14.1].
- In patients undergoing hip-replacement surgery, during and following hospitalization
- In patients undergoing knee-replacement surgery
- In medical patients who are at risk for thromboembolic complications due to
severely restricted mobility during acute illness
Treatment of Acute Deep Vein Thrombosis
LOVENOX® is indicated for:
- The inpatient treatment of acute deep vein thrombosis with or without
pulmonary embolism, when administered in conjunction with warfarin sodium
- The outpatient treatment of acute deep vein thrombosis without pulmonary
embolism when administered in conjunction with warfarin sodium
Prophylaxis of Ischemic Complications of Unstable Angina and Non-Q-wave Myocardial
Infarction
LOVENOX® is indicated for the prophylaxis of ischemic complications of unstable
angina (UA) and non–Q-wave MI, when concurrently administered with aspirin.
Treatment of acute ST- segment Elevation Myocardial Infarction (STEMI)
Lovenox® has been shown to reduce the rate of the combined endpoint of recurrent
myocardial infarction or death in patients with acute STEMI receiving thrombolysis
and being managed medically or with Percutaneous Coronary Intervention (PCI).
LOVENOX®, when administered concurrently with aspirin, 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).
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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