Patients should be lying down and LOVENOX® administered by deep subcutaneous (SC) injection.
To avoid the loss of drug when using the 30 mg and 40 mg prefilled syringes, do not
expel the air bubble from the syringe before the injection.
6
Administration should be alternated between the left and right anterolateral and
left and right posterolateral abdominal wall. The whole length of the needle should
be introduced into a skin fold held between the thumb and forefinger; the skin fold
should be held throughout the injection. To minimize bruising, do not rub the injection
site after completion of the injection.
6
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- Step 1. Wash and dry your hands thoroughly
- Step 2. Sit or lie in a comfortable position,
so that you can see your abdomen.
- Step 3. Choose an area on the right or left
side of your abdomen, at least 2 inches from your belly button. Think "love handles."
- Step 4. Clean the injection site with an
alcohol swab. Let dry.
- Step 5. Remove the needle cap by pulling
it straight off the syringe and discard it in a sharps collector. If you did not
receive a LOVENOX®Discharge Kit from the hospital, you can obtain a sharps collector
from your pharmacy.
- Step 6. Hold the syringe like a pencil in
your writing hand.
- Step 7. With your other hand, pinch an inch
of the cleansed area to make a fold in the skin. Insert the full length of the needle
straight down–at a 90° angle–into the fold of skin.
- Step 8. Press the plunger with your thumb
until the syringe is empty.
- Step 9. Pull the needle straight out at the
same angle that it was inserted, and release the skin fold.
- Step 10. Point the needle down and away from
yourself and others, and push down on the plunger to activate the safety shield.
- Step 11. Place the used syringe in the sharps
collector.
LOVENOX® syringes come prefilled and include details that help ensure proper
administration for patient safety and convenience.
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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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