National Patient Safety Goals (NPSGs) could impact your practice
For the latest updates on all the quality measures and guidelines that affect thrombosis
management, visit these Web sites.
NPSG 3—improve the safety of using medications
NPSG.03.05.01
Reduce the likelihood of patient harm associated with the use of anticoagulant therapy.
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Continuing Steps features a wide range of proven, practical, and diverse
resources your hospital can use to support and enhance its own deep vein thrombosis/pulmonary
embolism (DVT/PE) management programs and strategies. Continuing Steps focuses on appropriate prophylaxis
and treatment of DVT/PE, as well as management of acute coronary syndrome (ACS).
Visit www.ContinuingSteps.com
for example-based tools and resources that help healthcare professionals take action
against DVT/PE and ACS in at-risk patients.
Designed to educate healthcare professionals about optimizing patient outcomes,
incorporating quality measures and guidelines, and reducing overall costs of care,
DVT Aware Care
is a customizable program for healthcare institutions of all sizes. Visit www.DVTAwareCare.com.
Our Helpful Web
sites page offers access to a wide variety of Web sites with additional information
on DVT, PE, ACS, and related topics.
For more specific information on LOVENOX® by indication, visit Indications.
Important Safety Information
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
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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