DCSIMG

LOVENOX® subcutaneous injection

IMPORTANT SAFETY INFORMATION FOR LOVENOX®

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
  • Optimal timing between the administration of Lovenox and neuraxial procedures is not known.

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.

How to inject with LOVENOX® prefilled syringes

LOVENOX® syringes come prefilled and include details which help ensure proper administration for patient safety and convenience.

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LOVENOX® SC injection technique*

Be sure to review and follow all of the steps outlined
below to ensure proper administration and safe
disposal of LOVENOX® prefilled syringes.

PREPARE
Step 1 Wash and dry your hands throughly.
Step 2 Have your patient sit or lie in a comfortable position and choose an area on the right or left side of the abdomen, at least 2 inches from the belly button.
Step 3 Clean the injection site with an alcohol swab and let dry.
INJECT
Step 4 Remove the needle cap by pulling it straight off the syringe and discard it in a sharps collector.
Step 5 With your other hand, pinch an inch of the cleansed area to make a fold in the skin. Next, insert the full length of the needle straight down – at a 90˚ angle – into the fold of skin.
Step 6 Press the plunger with your thumb until the syringe is empty. Then pull the needle straight out and release the skin fold.
DISPOSE
Step 7 Point the needle down and away from yourself and others, and then push down on the plunger to activate the safety shield.
Step 8 Place the used syringe in the sharps collector.

*NOTE: 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.1

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. 1



Important Safety Information for LOVENOX®

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
  • Optimal timing between the administration of Lovenox and neuraxial procedures is not known.

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 (eg. epidural or spinal anesthesia/analgesia or spinal puncture). While the exact timing is not known, the pharmacokinetic profile of enoxaparin should be considered when determining the timing of placement/removal of an epidural catheter or lumbar puncture for each patient. 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 patients with creatinine clearance <30 mL/min additional considerations are necessary.

  • 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
  • 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®, 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.

Click here for information on Sharps Medical Waste Disposal.

Reference
1. LOVENOX® (enoxaparin sodium injection) Prescribing Information. sanofi-aventis, Bridgewater, NJ.