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U.S. Department of Health and Human Services

Safety

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Arixtra (fondaparinux sodium) injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2009

 

Summary View

 

WARNINGS AND PRECAUTIONS

Hemorrhage (sections rewritten)
  • uncontrolled arterial hypertension, diabetic retinopathy...
  • Isolated cases of elevated aPTT temporally associated with bleeding events have been reported following administration of Arixtra (with or without concomitant administration of other anticoagulants)
  • Do not administer agents that enhance the risk of hemorrhage with Arixtra unless essential for the management of the underlying condition, such as vitamin K antagonists for the treatment of VTE. If co-administration is essential, closely monitor patients for signs and symptoms of bleeding.
  • Do not administer the initial dose of  Arixtra before earlier than 6-8 hours after surgery.
Renal Impairment and Bleeding Risks (section rewritten)
  • Arixtra increases the risk of bleeding in patients with impaired renal function due to reduced clearance.
Body Weight <50 Kg and Bleeding Risk
  • Arixtra increases the risk for bleeding in patients who weigh less than 50 kg, compared to patients with higher weights. In patients who weigh less than 50 kg:
    • Do not administer Arixtra as prophylactic therapy for patients undergoing hip fracture, hip replacement, or knee replacement surgery, and abdominal surgery....
Thrombocytopenia
  • Isolated occurrences of thrombocytopenia with thrombosis that manifested similar to heparin-induced thrombocytopenia have been reported with the use of Arixtra in postmarketing experience. Monitor patients closely if thrombocytopenia of any degree occurs and discontinue Arixtra if the platelet count falls below 100,000/mm3.
Neuraxial Anesthesia and Post-operative Indwelling Epidural Catheter Use (section modified)

ADVERSE REACTIONS

  • Anemia, insomnia, increased wound drainage, hypokalemia, urinary tract infection, dizziness, hypotension, confusion, bullous eruption, hematoma and post-operative hemorrhage may occur.