Important Safety Information
Spinal/Epidural Hematomas
When epidural/spinal anesthesia or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low—molecular-weight heparins, heparinoids or fondaparinux sodium are at risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis. The risk of these events may be higher with postoperative use of indwelling epidural catheters or concomitant use of drugs affecting hemostasis. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture. Patients should be frequently monitored for signs and symptoms of neurological impairment (see BOXED WARNING).
Indications
ARIXTRA is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing hip fracture (including extended prophylaxis), knee replacement, hip replacement, or abdominal (who are at risk for thromboembolic complications) surgeries.
ARIXTRA Injection is indicated for the treatment of acute deep vein thrombosis (DVT) when administered in conjunction with warfarin sodium, and the treatment of acute pulmonary embolism (PE) when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital.
Contraindications
ARIXTRA is contraindicated in patients with severe renal impairment (creatinine clearance <30 mL/min); patients with body weight <50 kg undergoing hip fracture, hip replacement or knee replacement surgery, and abdominal surgery (prophylaxis only); patients with active major bleeding; bacterial endocarditis; patients with thrombocytopenia associated with a positive in vitro test for antiplatelet antibody in the presence of fondaparinux sodium; or patients with hypersensitivity to fondaparinux sodium.
Warnings and Precautions
ARIXTRA is not intended for intramuscular administration.
ARIXTRA cannot be used interchangeably with heparin, low-molecular-weight heparins or heparinoids, as they differ in manufacturing process, anti-Xa and anti-IIa activity, units, and dosage.
The risk of hemorrhage with ARIXTRA increases with decreasing renal function. ARIXTRA should be used with caution in patients with moderate renal impairment. Renal function should be assessed periodically in patients receiving ARIXTRA and should be discontinued immediately in patients who develop severe renal impairment.
ARIXTRA, like other anticoagulants, should be used with extreme caution in conditions with increased risk of hemorrhage.
Thrombocytopenia can occur with ARIXTRA. If the platelet count falls below 100,000/mm3, ARIXTRA should be discontinued.
Because routine coagulation tests such as prothrombin time (PT) and activated partial thromboplastin time (aPTT) are relatively insensitive measures of ARIXTRA activity and international standards of heparin or LMWH are not calibrators to measure anti-Factor Xa activity of ARIXTRA, if during ARIXTRA therapy unexpected changes in coagulation parameters or major bleeding occurs, ARIXTRA should be discontinued.
Administration of ARIXTRA before 6 hours after surgery has been associated with an increased risk of major bleeding.
ARIXTRA should be used with caution in elderly patients.
