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  1. Patient Information
  2. If Patients Must Self-administer Fondaparinux Sodium (e.g., If Fondaparinux Sodium Is Used At Home), They Should Be Advised Of The Following:

Patient Information 

SeeFDA-Approved Patient Labeling (17.2)

17.1 Patient Advice

If the patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDS, platelet inhibitors, or other anticoagulants, they should be informed to watch for signs and symptoms of spinal or epidural hematomas, such as back pain, tingling, numbness (especially in the lower limbs), muscular weakness, and stool or urine incontinence. If any of these symptoms occur, the patients should contact his or her physician immediately.

The use of aspirin and other NSAIDS may enhance the risk of hemorrhage. Their use should be discontinued prior to fondaparinux sodium therapy whenever possible; if co-administration is essential, the patient s clinical and laboratory status should be closely monitored. [SeeDrug Interactions(7).]

If Patients Must Self-administer Fondaparinux Sodium (e.g., If Fondaparinux Sodium Is Used At Home), They Should Be Advised Of The Following: 

  • Fondaparinux sodium should be given by subcutaneous injection. Patients must be instructed in the proper technique for administration
  • The most important risk with fondaparinux sodium administration is bleeding. Patients should be counseled on signs and symptoms of possible bleeding.
  • It may take them longer than usual to stop bleeding.
  • They may bruise and/or bleed more easily when they are treated with fondaparinux sodium. They should report any unusual bleeding, bruising, or signs of thrombocytopenia (such as a rash of dark red spots under the skin) to their physician [seeWarnings and Precautions(5.2,5.5)].
  • To tell their physicians and dentists they are taking fondaparinux sodium and/or any other product known to affect bleeding before any surgery is scheduled and before any new drug is taken [seeWarnings and Precautions(5.2)].
  • To tell their physicians and dentists of all medications they are taking, including those obtained without a prescription, such as aspirin or other NSAIDs. [SeeDrug Interactions(7)].

Keep out of the reach of children.

17.2 FDA-Approved Patient Labeling

Patient labeling is provided as a tear-off leaflet at the end of this full prescribing information.

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