Product Details
Arixtra
Fondaparinux Sodium2.5 mg/0.5 mL
Solution for Injection
0.5-mL Prefilled Syringe Pack (Preservative Free)
DIN/PIN/NPN
02245531
Manufacturer
Aspen Pharma Trading Limited
Formulary Listing Date
2004-04-06
Unit Price
12.2124
Amount MOH Pays
11.1944
Coverage Status
Limited Use Product
ODB Formulary Therapeutic Classification
Therapeutic Note
NO
ATC Code
B01AX05
Interchangeable Products
| DIN/ PIN/ NPN | Brand name | Unit Price | Amount MOH pays |
|---|---|---|---|
| 02406853 | Fondaparinux Sodium Injection | 11.1944 | 11.1944 |
| 02245531 | Arixtra | 12.2124 | 11.1944 |
LU Clinical Criteria
| LU Code | Auth. Period | Clinical Criteria |
|---|---|---|
| 378 | 1 year | For the post-operative prophylaxis of venous thromboembolic events in patients undergoing orthopedic surgery of the lower limbs such as hip fracture, hip replacement or knee surgery. Note: Limited to 9 days of reimbursement. |
EAP Criteria
| Therapeutic Class | Reimbursement Criteria |
|---|---|
| Anticoagulants | Fondaparinux
For the post-operative prophylaxis of venous thromboembolism following abdominal or pelvic surgery for cancer. Standard Approval Duration: Maximum of 30 days Fondaparinux
For the treatment of venous thromboembolism (VTE) [deep vein thrombosis (DVT), pulmonary embolism (PE)] in the setting of acute heparin induced thrombocytopenia (HIT) Duration: 1 month if patient is able to transition to warfarin OR up to 1 year for patients who cannot be managed on warfarin* For the treatment of venous thromboembolism (VTE) [deep vein thrombosis (DVT), pulmonary embolism (PE)] in patients with previous HIT who cannot use rivaroxaban Duration: 1 month if patient is able to transition to warfarin OR up to 1 year for patients who cannot be managed on warfarin* *Patients may not be able to use warfarin as extended treatment or prophylaxis of VTE due to contraindication, previous clinical failure, inability to swallow/ take oral medications, immobility, inability to monitor INR, etc. The reasons why warfarin is not appropriate must be clearly described. Renewal of funding for the above indications may be considered on a case-by-case basis with documented clinical rationale that includes details pertaining to patient’s risks for recurrent VTE, risks of bleeding, update on whether warfarin therapy may now be considered, and response to therapy. For peri-operative bridging for patients with history of HIT who require long-term warfarin therapy and must temporarily discontinue it before and after surgery, and who are at moderate- to high-risk for an embolic event while off warfarin. Duration: As requested up to a maximum of 10 days before the date of surgery plus up to 7 days after surgery Renewal of funding will NOT be considered for this indication. EAP Drug Request Form: |