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Fondaparinux

Generic Name
Fondaparinux
Brand Names
Arixtra
Drug Type
Small Molecule
Chemical Formula
C31H53N3O49S8
CAS Number
104993-28-4
Unique Ingredient Identifier
J177FOW5JL

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.

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