Product Details

Arixtra

Fondaparinux Sodium
7.5 mg/0.6 mL
Solution for Injection
0.6-mL Prefilled Syringe Pack (Preservative Free)

DIN/PIN/NPN

02258056

Manufacturer

Aspen Pharma Trading Limited

Formulary Listing Date

2014-07-30  

Unit Price

NA

Amount MOH Pays

NA

Coverage Status

Off-Formulary Interchangeable Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

B01AX05

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02406896 Fondaparinux Sodium Injection 18.1356 18.1356
02258056 Arixtra NA NA
 

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Anticoagulants

Fondaparinux

  • Brand(s): Arixtra and generic
  • Dosage Form/Strength: 2.5 mg

For the post-operative prophylaxis of venous thromboembolism following abdominal or pelvic surgery for cancer.

Standard Approval Duration: Maximum of 30 days


Fondaparinux

  • Brand(s): Arixtra (2.5mg) and Generic (2.5mg and 7.5mg). Check formulary or e-formulary for funded products
  • Dosage Form/Strength: 2.5 mg and 7.5 mg

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:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph