Enoxaparin Sodium Injection, USP

WARNING: SPINAL/EPIDURAL HEMATOMAS
See full prescribing information for complete boxed warning.

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, and 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 enoxaparin sodium injection 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.

Enoxaparin Sodium Injection, USP is contraindicated in patients with active major bleeding, history of heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies, hypersensitivity to enoxaparin sodium and hypersensitivity to heparin or pork products.

Warnings and Precautions:

  • Increased Risk of Hemorrhage
  • Increased Risk of Bleeding following Percutaneous Coronary Revascularization Procedures
  • Increased Risk of Bleeding in Patients with Concomitant Medical Conditions
  • Risk of Heparin-Induced Thrombocytopenia with or without Thrombosis
  • Thrombocytopenia
  • Interchangeability with other Heparins
  • Increased Risk of Thrombosis in Pregnant Women with Mechanical Prosthetic Heart Valves

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.

For additional information, please see full Prescribing Information including boxed warning.