Arixtra - fondaparinux sodium
What is Arixtra?
Arixtra comes as a solution for injection contained in a pre-filled syringe.
The active substance is fondaparinux sodium (1.5 mg, 2.5 mg, 5 mg, 7.5 mg or 10 mg per syringe).
What is Arixtra used for?
Arixtra (in the 1.5 mg and 2.5 mg strengths) is used for the prevention of venous thromboembolic episodes (VTE, or problems related to the formation of blood clots) in patients undergoing major orthopedic surgery of the lower limbs, for example hip replacement surgery and reduction of a hip or knee fracture. It can also be used in patients undergoing abdominal surgery, particularly for cancer, who, given their age or disease, are considered to be at high risk of VTE, or who are immobilized due to an acute disease.
At higher dosages (5 mg, 7.5 mg and 10 mg), Arixtra is used to treat venous thromboembolic episodes such as deep vein thrombosis (DVT, clot formation in the lower limbs) or pulmonary embolism (PE, clots in the lungs).
The 2.5 mg dose can also be used to treat patients with unstable angina (a type of chest pain that changes in severity) or myocardial infarction (heart attack):
- without "elevation of the ST roof" (an abnormal reading on the "electrocardiogram or ECG) in patients who do not have to undergo urgent angioplasty (within two hours): by angioplasty, or" percutaneous coronary intervention "(PCI), we mean a "operation to unblock the blood vessels of the heart;
- with "elevation of the ST roof" in patients given thrombolytic drugs ("clot busters") or are not undergoing any other treatment to restore blood flow to the heart.
The medicine can only be obtained with a prescription.
How is Arixtra used?
For the prevention of VTE, the recommended dose is 2.5 mg once daily by subcutaneous (under the skin) injection. For operated patients, the first dose should be given six hours after the end of surgery, after which treatment should be continued until the risk of VTE has been reduced or, usually, at least five to nine days after surgery. For patients with kidney problems, Arixtra may not be suitable, or the 1.5 mg dose may be used.
For the treatment of DVT or PE, the recommended dose is 7.5 mg once daily by subcutaneous (under the skin) injection, usually for seven days.
For patients with unstable angina or myocardial infarction, the recommended dose is 2.5 mg once daily by subcutaneous injection, but the first dose is given intravenously (into a vein), via an existing drip, or as a infusion (drip administration) in patients with ST roof elevation. Treatment should begin as soon as possible after diagnosis and continue for up to eight days or until the patient is discharged from the hospital. Arixtra is not recommended for patients who are about to undergo certain types of PCI.
For more information, see the summary of the product characteristics (also attached to the EPAR).
How does Arixtra work?
Blood clots can be a problem if they obstruct blood circulation in some way. Arixtra is an anticoagulant, which means it prevents blood clotting. The active substance contained in the medicine is fondaparinux sodium, which inhibits one of the substances (factors) involved in the clotting mechanism, factor Xa.Inhibition of this factor automatically blocks the production of thrombin (another clotting factor), which prevents the formation of clots. Used after surgery, Arixtra greatly reduces the risk of clots forming. By reducing the formation of clots. , Arixtra can also help maintain blood flow to the heart in patients suffering from angina or a heart attack.
How has Arixtra been studied?
The efficacy of Arixtra was studied for the prevention and treatment of VTE. In the prevention studies, Arixtra was compared with other anticoagulants: enoxaparin (cases of hip or knee surgery, over 8,000 patients) or dalteparin (abdominal surgery cases, 2,927 patients). It was also compared with placebo (a dummy treatment) in the preventive care of patients with acute illnesses (839 patients) and patients treated for an additional 24 days after surgery to reduce the hip fracture (656 patients). For the treatment of VTE, Arixtra was compared with enoxaparin (deep vein thrombosis, 2 192 patients) or with unfractionated heparin (pulmonary embolism, 2 184 patients). In all studies, the main measure of effectiveness was was the overall frequency of thrombotic events (i.e. the appearance of problems caused by blood clots).
Arixtra has also been studied in two main studies involving patients with unstable angina or myocardial infarction. The first study compared the effects of Arixtra with those of enoxaparin in more than 20,000 patients with unstable angina or myocardial infarction without ST segment elevation; the second compared Arixtra with standard therapy (unfractionated heparin in eligible patients, or placebo) in more than 12,000 patients with ST segment elevation myocardial infarction. The main measure of effectiveness was the proportion of patients who died or experienced an "ischemic event" (restriction of blood supply to an organ , including the heart).
What benefit has Arixtra shown during the studies?
The overall frequency of thrombotic events in Arixtra-treated patients was significantly lower than in patients treated with placebo or enoxaparin (after lower limb surgery) and similar compared to patients treated with enoxaparin (with deep vein thrombosis) as well as in patients treated with with dalteparin or unfractionated heparin.
Arixtra was as effective as enoxaparin in preventing death or an ischemic event in patients with unstable angina or myocardial infarction without ST segment elevation, in which approximately 5% of patients in each group had died or had contracted an ischemic event after nine days. In the ST-segment elevation myocardial infarction study, Arixtra, compared to standard therapy, reduced the risk of death or another heart attack by 14% after 30 days. These results, however, were not sufficient to show whether Arixtra was more effective than unfractionated heparin or not.
What is the risk associated with Arixtra?
As with other antithrombotic medicines, the most common side effect of Arixtra is bleeding. For the full list of side effects reported with Arixtra, see the package leaflet.
Arixtra should not be used in patients who may be hypersensitive (allergic) to fondaparinux sodium or any other substance, or who may have already existing bleeding, or acute bacterial endocarditis (a "heart infection), or severe problems. kidneys. For the full list of restrictions on use, see the Package Leaflet.
Why has Arixtra been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Arixtra's benefits are greater than its risks in both the prevention and treatment of VTE, unstable angina and myocardial infarction and therefore recommended that it be licensed. the placing on the market of Arixtra.
Other information about Arixtra:
On 21 March 2002, the European Commission issued a "Marketing Authorization" for Arixtra, valid throughout the European Union. The "Marketing Authorization" was renewed on 21 March 2007. The holder of this authorization is Glaxo Group Ltd.
For the complete version of Arixtra's EPAR click here.
Last update of this summary: 09-2007
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