Fondaparinux precautions

Precautions

General

Arixtra Injection should be administered according to the recommended regimen, especially with respect to the timing of the first dose after surgery. In the hip fracture, hip replacement, knee replacement, or abdominal surgery clinical studies, the administration of Arixtra before 6 hours after surgery has been associated with an increased risk of major bleeding.

Arixtra Injection should be used with care in patients with a bleeding diathesis, uncontrolled arterial hypertension, or a history of recent gastrointestinal ulceration, diabetic retinopathy, and hemorrhage.

Arixtra Injection should be used with caution in elderly patients.

Arixtra should be used with caution in patients with a low body weight (<50 kg) for the treatment of PE and DVT.

The needle guard of the prefilled syringe of Arixtra contains dry natural latex rubber that may cause allergic reactions in latex sensitive individuals.

Arixtra Injection should not be mixed with other injections or infusions.

If thrombotic events occur despite prophylaxis with Arixtra, appropriate therapy should be initiated.

Laboratory Tests

Periodic routine complete blood counts (including platelet count), serum creatinine level, and stool occult blood tests are recommended during the course of treatment with Arixtra Injection.

When administered at the recommended doses, routine coagulation tests such as Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) are relatively insensitive measures of Arixtra activity, and are therefore, unsuitable for monitoring.

The anti-Factor Xa activity of fondaparinux sodium can be measured by anti-Xa assay using the appropriate calibrator (fondaparinux). Since the international standards of heparin or LMWH are not appropriate calibrators, the activity of fondaparinux sodium is expressed in milligrams (mg) of the fondaparinux and cannot be compared with activities of heparin or low molecular weight heparins.