Label Changes for:

Lovenox (enoxaparin sodium) injection

October 2013

Changes have been made to the BOXED WARNING, WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

October 2013

BOX WARNING

WARNING: SPINAL/EPIDURAL HEMATOMAS

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

WARNINGS AND PRECAUTIONS

Increased Risk of Hemorrhage
  • To reduce the potential risk of bleeding associated with the concurrent use of enoxaparin sodium and epidural or spinal anesthesia/analgesia or spinal puncture, consider the pharmacokinetic profile of enoxaparin [see Clinical Pharmacology (12.3)]. Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of enoxaparin is low; however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known.
  • Placement or removal of a catheter should be delayed for at least 12 hours after administration of lower doses (30 mg once or twice daily or 40 mg once daily) of Lovenox, and at least 24 hours after the administration of higher doses (0.75 mg/kg twice daily, 1 mg/kg twice daily, or 1.5 mg/kg once daily) of Lovenox. Anti-Xa levels are still detectable...

 

June 2013 

 

ADVERSE REACTIONS

Post-marketing Experience
  • ...systemic allergic Reactions (...including shock)
  • Cases of headache, hemorrhagic anemia, eosinophilia, alopecia, hepatocellular and cholestatic liver injury have been reported.
  • Osteoporosis has also been reported following long-term therapy.

 

July 2009 

 

WARNINGS AND PRECAUTIONS

  • Revised, no major change

ADVERSE REACTIONS

Clinical Trials Experience
  • The following serious adverse reactions are also discussed in other sections of the labeling
    • Spinal/epidural hematoma 
    •  Increased Risk of Hemorrhage 
    •  Thrombocytopenia
  • During clinical development for the approved indications, 15,918 patients were exposed to
    enoxaparin sodium. These included 1,228 for prophylaxis of deep vein thrombosis...

PATIENT COUNSELING INFORMATION

  • Section Revised

 

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