LTHT Drug and Therapeutics Group Summary Fondaparinux for VTE prophylaxis and treatment for patients who previously have had Heparin Induced Thrombocytopenia, or who wish to avoid porcine derived products
Supported for use
Application summary - 24/04/1 3
Fondaparinux is a synthetic and selective inhibitor of activated Factor X (Xa). • The antithrombotic activity of fondaparinux is the result of antithrombin III mediated selective inhibition of Factor Xa. This interrupts the blood coagulation cascade and inhibits thrombin formation and thrombus development. Fondaparinux does not inactivate thrombin (activated Factor II) and has no effects on platelets (unlike low molecular weight heparins) • The proposed use of fondaparinux in this application is for VTE prophylaxis and treatment for patients who require anti-coagulation with a history of heparin-induced thrombocytopenia (HIT) or those that refuse porcine products. • Fondaparinux is unlicensed for patients with a past history of HIT requiring VTE prophylaxis but there is a licensed dose for VTE prophylaxis in surgical patients and this dose can be used for any adult patients with HIT requiring prophylaxis. • Due to the risk of cross-sensitivity, patients who have had a history of HIT within the past 3 months prior to current surgery should be prescribed danaparoid. • Advantages of fondaparinux: synthetic product with a once daily subcutaneous injection allowing patients to be treated on an outpatient basis. • Disadvantages of fondaparinux: long half-life (particularlyof concern if patients require emergency surgery or invasive procedures), there is no specific antidote (recombinant factor VIIa may be effective) and there have been isolated reports of HIT associated with the use of fondaparinux.
Place in therapy
For the following groups of patients with either previous HIT or where porcine derived products are not acceptable: • Prevention of VTE for adults undergoing major orthopaedic surgery of the lower libs such as hip fracture, major knee surgery or hip replacement surgery • Prevention of VTE for adults undergoing abdominal surgery who are at high risk of thromboembolic complications such as patients undergoing abdominal cancer surgery • Prevention of VTE for adult medical patients who are at high risk for VTE and immobilised due to acute illness such as cardiac insufficiency and/or acute respiratory disorders, and/or acute infectious or inflammatory disease.
• Treatment of unstable angina or non-ST segment elevation myocardial infarction in adults for whom urgent (< 120 mins) invasive management PCI is not indicated. • Treatment of ST segment elevation myocardial infarction (STEMI) in adults who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy. The first dose of fondaparinux is administered intravenously and subsequent doses are administered by subcutaneous injection. Treatment should be initiated as soon as possible following diagnosis and continued for up to a maximum of 8 days or until hospital discharge. • Treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant DVT. • Treatment of adults with acute Deep Vein Thrombosis (DVT) and treatment of acute Pulmonary Embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.
Refer to product literature and local guidelines for dosing information
Drug and Therapeutics Decision Summary - 24/04/13
• Supported in line with application
Compiled from the original formulary application and the Drug and Therapeutics Committee minutes Harpreet Ghataure, Pre-Registration Pharmacist Dave Abbott, Medicines Information Pharmacist The Leeds Medicines Information Service [email protected]