Lovenox^® (Enoxaparin Sodium) Injection

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

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

WARNINGS AND PRECAUTIONS

Increased Risk of Hemorrhage: Lovenox should be used with extreme caution in conditions with increased risk of hemorrhage. While the exact timing is not known the pharmacokinetic profile of Lovenox should be considered when determining the timing of placement/removal of an epidural catheter or lumbar puncture for each patient. Frequent monitoring must be exercised to detect any signs and symptoms of neurological impairment . If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression. 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.

Increased Risk of Bleeding following Percutaneous Coronary Revascularization Procedures: It is important to achieve hemostasis at the puncture site after PCI. 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.

Increased Risk of Bleeding in Patients with Concomitant Medical Conditions: 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.

Risk of Heparin-Induced Thrombocytopenia with or without Thrombosis: 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. Circulating antibodies may persist for several years. 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.

Thrombocytopenia: Thrombocytopenia can occur with Lovenox. Thrombocytopenia of any degree should be monitored closely. If the platelet counts fall below 100,000/mm³, Lovenox should be discontinued.

Interchangeability with other Heparins: Lovenox cannot be used interchangeably with other LMWH or UFH, as they differ in their manufacturing process, molecular weight distribution, anti-Xa and anti-IIa activities, units, and dosages.

Increased Risk of Thrombosis in Pregnant Women with Mechanical Prosthetic Heart Valves: Use of Lovenox for thromboprophylaxis in pregnant women with mechanical prosthetic heart valves may result in valve thrombosis. Women with mechanical prosthetic heart valves may be at higher risk for thromboembolism during pregnancy and, when pregnant, have a higher rate of fetal loss from stillbirth, spontaneous abortion, and premature delivery. Frequent monitoring of peak and trough anti-Factor Xa levels and adjusting of dosage may be needed.

Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative: 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.

ADVERSE REACTIONS

Most common adverse reactions (>1%) were bleeding, anemia, thrombocytopenia, elevation of serum aminotransferase, diarrhea, nausea, ecchymosis, fever, edema, peripheral edema, dyspnea, confusion, and injection site pain.