**Criteria for Use: Fondaparinux (Arixtra®)^1^**

**VHA Pharmacy Benefits Management Services and the Medical Advisory
Panel**

*The following recommendations are based on current medical evidence.
The content of the document is dynamic and will be revised as new
clinical data become available. The purpose of this document is to
assist practitioners in clinical decision making, to standardize and
improve the quality of patient care, and to promote cost-effective drug
prescribing. The clinician, however, must make the ultimate judgment
regarding the propriety of any course of treatment in light on
individual patient situations*

Refer to the Fondaparinux drug monograph and addendum documents at
[www.pbm.va.gov](http://www.pbm.va.gov/) or
[http://vaww.pbm.va.gov](http://vaww.pbm.va.gov/)

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| **FDA APPROVED INDICATIONS FOR USE**                                  |
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| -   **Venous Thromboembolism (VTE) prophylaxis:** Fondaparinux has    |
|     demonstrated greater or equivalent efficacy to low-molecular      |
|     weight heparin (LMWH) in VTE prophylaxis for major orthopedic     |
|     procedures and abdominal surgery.                                 |
|                                                                       |
| -   **VTE Treatment (deep venous thrombosis \[DVT\] and pulmonary     |
|     embolism \[PE\]):** Fondaparinux has demonstrated similar         |
|     efficacy to LMWH and unfractionated heparin (UFH).                |
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| **EXCLUSION CRITERIA (If one is selected, patient is NOT eligible)**  |
+-----------------------------------------------------------------------+
| -   Creatinine clearance \<30 ml/min                                  |
|                                                                       |
| -   Weight \<50 kg for VTE prophylaxis in surgical patients           |
|                                                                       |
| -   Evidence of active bleeding                                       |
|                                                                       |
| -   Bacterial endocarditis                                            |
|                                                                       |
| -   Thrombocytopenia with a positive test for antiplatelet antibody   |
|     to fondaparinux                                                   |
|                                                                       |
| -   Hypersensitivity to fondaparinux                                  |
|                                                                       |
| -   Epidural/spinal anesthesia                                        |
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| **INCLUSION CRITERIA**                                                |
+-----------------------------------------------------------------------+
| *One of the following must be selected for patient to be eligible:*   |
|                                                                       |
| -   VTE prophylaxis when pharmacologic therapy is indicated           |
|     (acceptable patient populations include knee replacement, hip     |
|     replacement, hip fracture repair, abdominal surgery, acutely ill  |
|     medical patients^2^)                                              |
|                                                                       |
| -   VTE treatment in patient with acute DVT and/or PE in conjunction  |
|     with warfarin                                                     |
|                                                                       |
| -   Patient requiring anticoagulation with an allergy or history of   |
|     heparin induced thrombocytopenia (HIT)                            |
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| **DOSAGE AND ADMINISTRATION**                                         |
+-----------------------------------------------------------------------+
| -   **VTE prophylaxis:** 2.5 mg subcutaneous (SC) daily, initiated at |
|     least 6 hours post-operatively                                    |
|                                                                       |
| -   **VTE treatment:** 5 mg, 7.5 mg, or 10 mg SC daily for body       |
|     weights of \<50 kg, 50-100 kg, and \>100 kg, respectively         |
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| **MONITORING**                                                        |
+-----------------------------------------------------------------------+
| -   Patients should be monitored for signs and symptoms of bleeding.  |
|                                                                       |
| -   Platelet count should be checked at baseline and monitored        |
|     periodically thereafter.                                          |
|                                                                       |
| -   Renal function should be assessed at baseline and monitored       |
|     periodically thereafter.                                          |
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| **ISSUES FOR CONSIDERATION**                                          |
+-----------------------------------------------------------------------+
| -   Fondaparinux should be used with caution in the following         |
|     populations: patients \>75 years of age or those with low body    |
|     weight or impaired renal function, as increased risk of bleeding  |
|     has been demonstrated.                                            |
|                                                                       |
| -   Overdose with fondaparinux is not reversible with protamine       |
|     sulfate.                                                          |
|                                                                       |
| -   Given the relatively long half-life of fondaparinux (17 hrs) and  |
|     the inability for anticoagulation reversal, the drug should not   |
|     be used in patients where emergent anticoagulation reversal may   |
|     be necessary or where inability of anticoagulation reversal could |
|     have detrimental consequences (examples may include neurosurgery, |
|     acute trauma, or acute spinal cord injury patients).              |
|                                                                       |
| -   Duration of thromboprophylaxis was up to 11 days in clinical      |
|     trials. However, benefits of prolonged duration of VTE            |
|     prophylaxis have been documented.                                 |
|                                                                       |
| -   Recommended duration for thromboembolism treatment is at least 5  |
|     days [and]{.underline} until oral anticoagulation is within the   |
|     therapeutic range.                                                |
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^1^ These criteria are not intended to address the use of fondaparinux
in the management of acute coronary syndromes (ACS); fondaparinux is not
FDA approved for ACS and is currently under FDA review.

^2^ hospitalized patients with increased risk of VTE (including
admission for heart failure, acute respiratory illness, or patients
confined to bed with additional VTE risk factors such as active cancer,
inflammatory disorder, etc.)