Fondaparinux: profile and news

Pivotal Study Published in British Medical Journal Reports ... Feb 13, 2006
13 /PRNewswire-FirstCall/ -- Results from the ARTEMIS study of ARIXTRA(R) (fondaparinux sodium) demonstrated that treatment with the antithrombotic reduced ... - PR Newswire (press release),

Arixtra Effective and Well Tolerated in Acutely Ill Medical ... Feb 14, 2006
LONDON, UK, and PHILADELPHIA, PA -- February 14, 2006 -- Results from the ARTEMIS study of Arixtra® (fondaparinux sodium) demonstrated that treatment with the ... - DG News

Arixtra Administered the Morning After Orthopedic Surgery ... Feb 3, 2006
PHILADELPHIA, PA -- February 3, 2006 -- Results from a new study of Arixtra(R) (fondaparinux sodium) called FLEXTRA (Flexibility in Administration of ... - DG News

ARIXTRA(R) Administered the Morning After Orthopedic Surgery ... Feb 3, 2006
3 /PRNewswire/ -- Results from a new study of ARIXTRA(R) (fondaparinux sodium) called FLEXTRA (Flexibility in Administration of Fondaparinux for Prevention of ... - International News Service,

Arixtra® Was Effective And Well Tolerated In Acutely Ill Medical ... Feb 14, 2006
Results from the ARTEMIS study of ARIXTRA® (fondaparinux sodium) demonstrated that treatment with the antithrombotic reduced patients' risk of overall VTE by ... - Medical News Today (press release),

GSK's Arixtra Shows Promise in Acutely Ill Patients Feb 14, 2006
Results from the study, named Artemis, demonstrated that treatment with Arixtra (fondaparinux sodium) reduced patients' risk of overall venous thromboembolism ... - International News Service,

Pivotal Study Published in British Medical Journal Reports ... Feb 13, 2006
LONDON and PHILADELPHIA, February 13, 2006 /PRNewswire-FirstCall/ -- Results from the ARTEMIS study of ARIXTRA(R) (fondaparinux sodium) demonstrated that ... - PharmaLive.com (press release),

Arixtra® administered the morning after orthopedic surgery ... Feb 3, 2006
Philadelphia, PA, February 3, 2006–Results from a new study of Arixtra® (fondaparinux sodium) called FLEXTRA (Flexibility in Administration of Fondaparinux ... - WebWire (press release),

ARIXTRA(R) Administered the Morning After Orthopedic Surgery ... Feb 3, 2006
3 /PRNewswire/ -- Results from a new study of ARIXTRA® (fondaparinux sodium) called FLEXTRA (Flexibility in Administration of Fondaparinux for Prevention of ... - Yahoo! News (press release)

New Oral Anticoagulants Show Promise Feb 14, 2006
One such factor Xa inhibitor, fondaparinux, is currently approved for use in the United States, but like low-molecular-weight heparin, it must be given by ... - Journal of American Medical Association (subscription),

ARIXTRA drug for venous thromboembolism Feb 4, 2006
ARIXTRA drug which is called as FLEXTRA (Flexibility in Administration of Fondaparinux for Prevention of Symptomatic Venous Thromboembolism in Orthopaedic ... - MedIndia,

Arixtra halves blood clot risk, study shows Feb 14, 2006
UK drugmaker GlaxoSmithKline's blood-thinner Arixtra (fondaparinux sodium) can cut patients' risk of forming venous blood clots by nearly half, according to a ... - Pharma Times (subscription),

New anti-thrombotic therapy effective, safer for patients Sep 10, 2005
Newswire) - The OASIS-5/MICHELANGELO study, presented today at the European Society of Cardiology meeting in Stockholm, Sweden, showed that fondaparinux, a new ... - I-Newswire.com (press release)

Safer, More Effective Anti-Thrombotics Sep 6, 2005
In the international OASIS-5/MICHELANGELO study, researchers compared the effectiveness and safety of fondaparinux, or Arixtra, to the commonly used enoxaparin ... - Ivanhoe

Glaxo drug safer than Sanofi's Lovenox -study Sep 5, 2005
Ironically, Glaxo acquired the medicine, whose generic name is fondaparinux, from Sanofi just last year, after the French company was forced to divest it on ... - Reuters

Health Highlights: Sept. 5, 2005 Sep 5, 2005
In research presented Monday at the European Society of Cardiology meeting in Stockholm, Canadian-led scientists said that fondaparinux, a synthetic drug that ... - Atlanta Journal Constitution (subscription),

European Society of Cardiology 2005: Round up Sep 7, 2005
The trials compared its new anti-thrombotic product, Arixtra (fondaparinux sodium) with the commonly used Lovenox/Clexane (enoxaparin). ... - Drug Researcher.com,

The robot resuscitator Sep 7, 2005
Such patients are prone to life-threatening bleeds but the drug, called fondaparinux, halves the number of bleeds and is safer than current therapy. ... - Daily Mail - UK,

ESC: Lovenox Reduces Bleeding in Elective Angioplasty Sep 7, 2005
7-Just 24 hours after the anti-coagulant Lovenox (enxaparin) came up short on safety compared with Arixtra (fondaparinux), investigators reported that the drug ... - MedPage Today,

ECS: Arixtra Halves Major Bleeding Events in Acute Coronary ... Sep 5, 2005
5-Arixtra (fondaparinux), the anti-coagulant approved to prevent deep vein thrombosis, halved the rate of major bleeding events, compared with Lovenox ... - MedPage Today,

FDA Safety Labeling Changes: Arixtra and Alora Aug 10, 2005
The US Food and Drug Administration (FDA) approved in May revisions to safety labeling to advise that prophylactic use of fondaparinux sodium injection is ... - Medscape (subscription)

Prevention of Venous Thromboembolic Disease After Total Hip and ... Sep 1, 2005
The results of randomized trials indicate that low-molecular-weight heparin, warfarin, and fondaparinux are the most effective prophylactic agents after total ... - Journal of Bone and Joint Surgery

Journal of the American Podiatric Medical Association Jul 21, 2005
Fondaparinux (Arixtra; Organon Sanofi-Synthelabo LLC, West Orange, New Jersey) is described as a selective inhibitor of activated factor X. 19 , 20 , 22 As ... - Journal of the American Podiatric Medical Association

International Approvals: Tarceva, Arixtra, 1D09C3 Jul 18, 2005
...non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen; The European Commission has approved fondaparinux sodium injection ... - Medscape (subscription)

EU Commission approves new use of Arixtra® for prevention of ... Jul 23, 2005
GlaxoSmithKline plc announced today that the European Commission (EC) has approved ARIXTRA® (fondaparinux sodium) for prevention of venous thromboembolic ... - I-Newswire.com (press release)

European Commission Approves New Use of Arixtra for Prevention of ... Jul 12, 2005
LONDON, July 12, 2005- GlaxoSmithKline plc announced today that the European Commission (EC) has approved ARIXTRA® (fondaparinux sodium) for prevention of ... - PharmaLive.com (press release)

FDA Approves New Indication for ARIXTRA(R) (fondaparinux sodium) ... May 27, 2005
...puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low-molecular-weight heparins, heparinoids or fondaparinux sodium are at ... - PR Newswire (press release)

FDA Approves New Indication for ARIXTRA(R) (Fondaparinux Sodium) ... May 27, 2005
PHILADELPHIA, May 27 /PRNewswire-FirstCall/ -- The anti-thrombotic drug ARIXTRA(R) is now indicated for use in patients undergoing abdominal surgery ... - RedNova.com,

FDA Approves Fondaparinux sodium for Prevention of Venous ... May 27, 2005
By GlaxoSmithKline, The anti-thrombotic drug ARIXTRA(R) is now indicated for use in patients undergoing abdominal surgery, GlaxoSmithKline (NYSE: GSK ... - RxPG NEWS,

Arixtra for prevention of venous thromboembolism in abdominal ... Jun 3, 2005
FDA ( Food and Drug Administration ) approved the supplemental New Drug Application (sNDA) for Arixtra ( Fondaparinux ) in the prevention of venous ... - Xagena.it,

FDA Approvals: Zemplar Capsules, Arixtra, Glumetza Jun 9, 2005
...for the prevention and treatment of secondary hyperparathyroidism in patients with stage III and IV chronic kidney disease; fondaparinux sodium injection for ... - Medscape (subscription)

GlaxoSmithKline's Arixtra gets nod from European Medicines Agency May 27, 2005
Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on extending the use of ARIXTRA (fondaparinux sodium) for ... - MarketWatch

Reviparin in Acute Myocardial Infarction—Reply May 31, 2005
...would be premature to use the results of the CREATE trial to recommend the use of other antithrombotic agents (eg, enoxaparin or fondaparinux, especially since ... - Journal of American Medical Association (subscription),

EU AUTHORITIES APPROVE GSK'S ACQUISITION OF TWO SANOFI THROMBOSIS ... May 26, 2005
The European Commission approved GlaxoSmithKline Plc’s acquisition of Sanofi-Synthelabo’s thrombosis drugs Arixtra (fondaparinux sodium) and Fraxiparine ... - PharmExec.com,

International Approvals: Pegasys, Arixtra, SOT-107 Mar 7, 2005
...use in the European Union peginterferon alfa-2a [40KD] injection for the treatment of chronic hepatitis B virus infection, and fondaparinux sodium injection ... - Medscape (subscription)

The Management of Patients With Heparin-Induced Thrombocytopenia ... Feb 21, 2005
Fondaparinux is a synthetic pentasaccharide that has been extensively studied for use in orthopedic and abdominal surgery prophylaxis, and the treatment of ... - RedNova.com,

Other information

Indication
For the treatment of prophylaxis of deep vein thrombosis.

Pharmacology
Fondaparinux is a synthetic and specific inhibitor of activated Factor X (Xa) indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism. Fondaparinux is also indicated for the treatment of acute deep vein thrombosis when administered in conjunction with warfarin, and the treatment of acute pulmonary embolism when administered in conjunction with warfarin. Fondaparinux does not inactivate thrombin (activated Factor II) and has no known effect on platelet function. At the recommended dose, Fondaparinux does not affect fibrinolytic activity or bleeding time.

Mechanism Of Action
The antithrombotic activity of Fondaparinux is the result of antithrombin III (ATIII)-mediated selective inhibition of Factor Xa. By selectively binding to ATIII, Fondaparinux potentiates (about 300 times) the innate neutralization of Factor Xa by ATIII. Neutralization of Factor Xa interrupts the blood coagulation cascade and thus inhibits thrombin formation and thrombus development.

Drug Category
Anticoagulants; Antithrombotics; ATC:B01AX05

Brand Names/Synonyms
Arixtra; Fondaparinux sodium

Dosage Forms
Solution

Absorption
100%

Interactions
Interactions for Fondaparinux: In clinical studies performed with Fondaparinux, the concomitant use of oral anticoagulants (warfarin), platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam), and digoxin did not significantly affect the pharmacokinetics/pharmacodynamics of fondaparinux sodium. In addition, Fondaparinux neither influenced the pharmacodynamics of warfarin, acetylsalicylic acid, piroxicam, and digoxin, nor the pharmacokinetics of digoxin at steady state. Agents that may enhance the risk of hemorrhage should be discontinued prior to initiation of Fondaparinux therapy. If co-administration is essential, close monitoring may be appropriate. In an in vitro study in human liver microsomes, inhibition of CYP2A6 hydroxylation of coumarin by fondaparinux (200 m m M i.e., 350 mg/L) was 17-28%. Inhibition of the other isozymes evaluated (CYPs 2A1, 2C9, 2C19, 2D6, 3A4, and 3E1) was 0-16%. Since fondaparinux does not markedly inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4) in vitro, fondaparinux sodium is not expected to significantly interact with other drugs in vivo by inhibition of metabolism mediated by these isozymes. Since fondaparinux sodium does not bind significantly to plasma proteins other than ATIII, no drug interactions by protein-binding displacement are expected.

Chemical IUPAC Name
decasodium 6-[6-[2-carboxylato-4-hydroxy-6-[4-hydroxy-6-methoxy-5-sulfonatoamino-2-(sulfonatooxymethyl)oxan-3-yl]oxy-5-sulfonatooxy-oxan-3-yl]oxy-5-sulfonatoamino-4-sulfonatooxy-2-(sulfonatooxymethyl)oxan-3-yl]oxy-3-[4,5-dihydroxy-3-sulfonatoamino-6-(sulfonatooxymethyl)oxan-2-yl]oxy-4,5-dihydroxy-oxane-2-carboxylate

Chemical Formula
C31H43N3Na10O49S8

Half Life
17-21 hours

Drug Type
Approved Drug

# Accession No
APRD00500

CAS Registry Number
114870-03-0