Indicated for:

Prophylaxis of Deep Vein Thrombosis:

• The prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):

• 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:

• 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:

• The prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin.

Treatment of Acute ST-Segment Elevation Myocardial Infarction:

• Lovenox, when administered concurrently with aspirin, has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute ST-segment elevation myocardial infarction (STEMI) receiving thrombolysis and being managed medically or with percutaneous coronary intervention (PCI).

Do not administer Lovenox by intramuscular injection. Administer Lovenox by intravenous or subcutaneous injection only.

Lovenox cannot be used interchangeably (unit for unit) with heparin or other low molecular weight heparins as they differ in manufacturing process, molecular weight distribution, anti-Xa and anti-IIa activities, units, and dosage. Each of these medicines has its own instructions for use.

Evaluate all patients for a bleeding disorder before starting Lovenox treatment, unless treatment is urgently needed.

Lovenox should be used with extreme caution in conditions with increased risk of hemorrhage, such as bacterial endocarditis, congenital or acquired bleeding disorders, active ulcerative and angiodysplastic gastrointestinal disease, hemorrhagic stroke, or shortly after brain, spinal, or ophthalmological surgery, or in patients treated concomitantly with platelet inhibitors.

Major hemorrhages including retroperitoneal and intracranial bleeding have been reported. Some of these cases have been fatal.

Bleeding can occur at any site during therapy with Lovenox. An unexplained fall in hematocrit or blood pressure should lead to a search for a bleeding site.

Lovenox may cause Heparin-Induced Thrombocytopenia (HIT) or Heparin-Induced Thrombocytopenia with Thrombosis (HITTS). HITTS may lead to organ infarction, limb ischemia, or death. Monitor thrombocytopenia of any degree closely.

Only use Lovenox in patients with a history of HIT if more than 100 days have elapsed since the prior HIT episode and no circulating antibodies are present. Because HIT may still occur in these circumstances, the decision to use Lovenox in such a case must be made only after a careful benefit-risk assessment and after non-heparin alternative treatments are considered.

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.

Lovenox is contraindicated in patients with:

• Active major bleeding
• History of immune-mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies
• Known hypersensitivity to enoxaparin sodium (e.g., pruritus, urticaria,anaphylactic/anaphylactoid reactions)
• Known hypersensitivity to heparin or pork products
• Known hypersensitivity to benzyl alcohol (which is in only the multiple-dose formulation of Lovenox)

Obese patients are at higher risk for thromboembolism. The safety and efficacy of prophylactic doses of Lovenox in obese patients (BMI >30 kg/m²) has not been fully determined and there is no consensus for dose adjustment.

The use of Lovenox has not been adequately studied for thromboprophylaxis in patients with mechanical prosthetic heart valves and has not been adequately studied for long-term use in this patient population. Isolated cases of prosthetic heart valve thrombosis have been reported in patients with mechanical prosthetic heart valves who have received Lovenox for thromboprophylaxis.

Use of Lovenox for thromboprophylaxis in pregnant women with mechanical prosthetic heart valves may result in valve thrombosis.

Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low birth weight infants treated with benzyl alcohol-preserved drugs, including Lovenox multiple-dose vials.

Because benzyl alcohol may cross the placenta, if anticoagulation with Lovenox is needed during pregnancy, use the preservative-free formulations where possible.

It is unknown whether Lovenox is excreted in human milk. Animal studies: the passage of enoxaparin or its metabolites in the milk is very limited.

GoToSource

• Patients under the age of 18. GoToSource

• Use after left ventricular assist device implantation. GoToSource

• Disseminated lichen planus. GoToSource

• Use after mechanical heart valve replacement. GoToSource

• Use after intracranial hemorrhage from traumatic brain injury. GoToSource

• Recurrent aphthous stomatitis. GoToSource

• Prophylactic treatment for end-stage renal disease. GoToSource

• Preoperative administration in breast reconstruction patients. GoToSource

• Therapy for neuropsychiatric manifestations of antiphospholipid syndrome. GoToSource

• Postoperative inflammatory response in congenital cataract surgery. GoToSource

• Prevention of venous thromboembolic events after acute spinal cord injury. GoToSource

• Vulvodynia. GoToSource

• Ulcerative colitis. GoToSource

• Prevention of radiation-induced liver toxicity. GoToSource

• Exercise induced bronchoconstriction. GoToSource

 Rectus sheath hematoma (accumulation of blood in abdominal muscle). GoToSource

Drug reaction with eosinophilia systemic symptoms (severe drug reaction). GoToSource

Severe hematomas (collection of blood outside the blood vessels). GoToSource

Impaired bone metabolism. GoToSource

Tissue necrosis. GoToSource

Subcutaneous chest wall hemorrhage. GoToSource

Soft tissue bleeding. GoToSource

Alopecia (hair loss). GoToSource

Osteoporosis. GoToSource

Liver injury. GoToSource

Lawsuits filed for bleeding and paralysis caused by hematomas.