Overview
Fondaparinux (Arixtra) is a synthetic anticoagulant agent consisting of five monomeric sugar units and a O-methyl group at the reducing end of the molecule. It is structurally similar to polymeric glycosaminoglycan heparin and heparan sulfate (HS) when they are cleaved into monomeric units. The monomeric sequence in heparin and HS is thought to form the high affinity binding site for the natural anti-coagulant factor, antithrombin III (ATIII). Once bound to heparin or HS, the anticoagulant activity of ATIII is potentiated by 1000-fold. Fondaparinux potentiates the neutralizing action of ATIII on activated Factor X 300-fold. Fondaparinux may be used: to prevent venous thromboembolism in patients who have undergone orthopedic surgery of the lower limbs (e.g. hip fracture, hip replacement and knee surgery); to prevent VTE in patients undergoing abdominal surgery who are are at high risk of thromboembolic complications; in the treatment of deep vein thrombosis (DVT) and pumonary embolism (PE); in the management of unstable angina (UA) and non-ST segment elevation myocardial infarction (NSTEMI); and in the management of ST segment elevation myocardial infarction (STEMI).
Indication
Approved for: (1) prophylaxis of VTE for up to one month post surgery in patients undergoing orthopedic surgery of the lower limbs such as hip fracture, hip replacement and knee surgery; (2) prophylaxis of VTE patients undergoing abdominal surgery who are at high risk of thromboembolic complications (e.g. patients undergoing abdominal cancer surgery); (3) treatment of acute DVT and PE; (4) management of UA and NSTEMI for the prevention of death and subsequent myocardial infarction (MI); and (5) management of STEMI for the prevention of death and myocardial reinfarction in patients who are managed with thrombolytics or who are initially to receive no form of reperfusion therapy. Fondaparinux should not be used as the sole anticoagulant during percutaneous coronary intervention (PCI) due to an increased risk of guiding catheter thrombosis.
Associated Conditions
- Acute Pulmonary Embolism (PE)
- Deep Vein Thrombosis
- Non ST Segment Elevation Myocardial Infarction (NSTEMI)
- ST Segment Elevation Myocardial Infarction (STEMI)
- Unstable Angina Pectoris
- Acute, superficial, symptomatic Vein Thrombosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/11/29 | Phase 4 | Recruiting | |||
2024/04/17 | Phase 3 | Recruiting | |||
2021/08/12 | Phase 4 | Completed | |||
2020/06/25 | Phase 4 | Completed | National University of Malaysia | ||
2020/04/29 | Phase 2 | Completed | |||
2016/04/20 | Not Applicable | Completed | |||
2013/05/20 | Phase 3 | Completed | |||
2013/03/12 | Phase 4 | Completed | |||
2012/11/16 | Phase 4 | Terminated | G. d'Annunzio University | ||
2012/09/24 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Dr. Reddy's Laboratories Inc. | 43598-608 | SUBCUTANEOUS | 5 mg in 0.4 mL | 12/23/2022 | |
Mylan Institutional LLC | 67457-585 | SUBCUTANEOUS | 10 mg in 0.8 mL | 8/15/2020 | |
Mylan Institutional LLC | 67457-593 | SUBCUTANEOUS | 5 mg in 0.4 mL | 6/8/2020 | |
Mylan Institutional LLC | 67457-594 | SUBCUTANEOUS | 7.5 mg in 0.6 mL | 6/8/2020 | |
Eugia US LLC | 55150-231 | SUBCUTANEOUS | 5 mg in 0.4 mL | 10/18/2023 | |
Sandoz Inc. | 0781-3476 | SUBCUTANEOUS | 10 mg in 0.8 mL | 12/16/2021 | |
Mylan Institutional LLC | 67457-595 | SUBCUTANEOUS | 10 mg in 0.8 mL | 6/8/2020 | |
Mylan Institutional LLC | 67457-584 | SUBCUTANEOUS | 7.5 mg in 0.6 mL | 8/15/2020 | |
Sandoz Inc. | 0781-3465 | SUBCUTANEOUS | 7.5 mg in 0.6 mL | 12/16/2021 | |
Dr. Reddy's Laboratories Limited | 55111-679 | SUBCUTANEOUS | 5 mg in 0.4 mL | 8/18/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 3/20/2002 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
DIVITI SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 2.5MG/0.5ML | SIN16809P | INJECTION, SOLUTION | 2.5mg/0.5ml | 6/14/2023 | |
Arixtra Solution for Injection 5.0 mg/0.4 ml | SIN13587P | INJECTION, SOLUTION | 5.0 mg/0.4 ml | 12/19/2008 | |
ARIXTRA SOLUTION FOR INJECTION 2.5 mg/0.5 ml | SIN12059P | INJECTION | 2.5 mg/0.5 ml | 8/29/2002 | |
Arixtra Solution for Injection 7.5 mg/0.6 ml | SIN13586P | INJECTION, SOLUTION | 7.5 mg/0.6 ml | 12/19/2008 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Fondaparinux Sodium Injection | 国药准字H20203681 | 化学药品 | 注射剂 | 12/15/2020 | |
Fondaparinux Sodium Injection | 国药准字H20213107 | 化学药品 | 注射剂 | 2/2/2021 | |
Fondaparinux Sodium Injection | 国药准字H20193327 | 化学药品 | 注射剂 | 11/18/2019 | |
Fondaparinux Sodium Injection | 国药准字H20223783 | 化学药品 | 注射剂 | 11/1/2022 | |
Fondaparinux Sodium Injection | 国药准字H20213947 | 化学药品 | 注射剂 | 12/14/2021 | |
Fondaparinux Sodium Injection | 国药准字H20223701 | 化学药品 | 注射剂 | 9/30/2022 | |
Fondaparinux Sodium Injection | 国药准字H20233904 | 化学药品 | 注射剂 | 6/30/2023 | |
Fondaparinux Sodium Injection | 国药准字H20213568 | 化学药品 | 注射剂 | 6/30/2021 | |
Fondaparinux Sodium Injection | 国药准字H20183122 | 化学药品 | 注射剂 | 2/8/2023 | |
Fondaparinux Sodium Injection | 国药准字HJ20181230 | 化学药品 | 注射剂 | 6/16/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
ARIXTRA fondaparinux sodium 5.0mg/0.4mL solution for injection syringe | 97798 | Medicine | A | 11/29/2004 | |
ARIXTRA fondaparinux sodium 7.5mg/0.6mL solution for injection syringe | 97799 | Medicine | A | 11/29/2004 | |
ARIXTRA fondaparinux sodium 2.5mg/0.5mL solution for injection syringe | 80279 | Medicine | A | 3/25/2002 | |
ARIXTRA fondaparinux sodium 10mg/0.8mL solution for injection syringe | 97800 | Medicine | A | 11/29/2004 |
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