ARIXTRA PRESCRIBING INFORMATION PDF
GSK has halted all shipments of ARIXTRA Starter Kits containing the Triad For important product information, log onto Arixtra mg/ ml solution for injection, pre-filled syringe. 2. .. Detailed information on this medicinal product is available on the website of the European . Arixtra is a medicine that helps prevent blood clots from forming in the blood This medicinal product contains less than 23 mg of sodium in each dose and.
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Medically reviewed on Oct 23, Risk increased by use of indwelling epidural catheters or by concomitant arixtfa of drugs affecting hemostasis e. Risk also increased by prescrribing of traumatic or repeated epidural or spinal puncture, spinal deformity, or spinal surgery. Optimal timing between administration of fondaparinux and neuraxial procedures not known. Monitor frequently for manifestations of neurologic impairment and treat urgently if neurologic compromise noted.
Consider potential benefits versus risks of spinal or epidural anesthesia or spinal puncture in patients receiving or being considered for thromboprophylaxis with anticoagulants. Prevention of postoperative DVT and PE in patients undergoing hip-fracture, hip-replacement, or knee-replacement surgery. Used for extended prophylaxis i.
Several antithrombotic agents e. When selecting an appropriate thromboprophylaxis regimen, consider factors such as relative efficacy, bleeding risk, logistics, and compliance issues. If pharmacologic prophylaxis is indicated in patients undergoing general surgery, ACCP states that an LMWH or low-dose heparin is preferred; fondaparinux may be considered when both an LMWH and heparin are contraindicated or not available.
ACCP recommends fondaparinux as an option for thromboprophylaxis in acutely ill, hospitalized medical patients at increased risk of thrombosis.
In general, pharmacologic thromboprophylaxis is recommended only in such patients considered to be at high risk of venous thromboembolism. Used in conjunction with warfarin for treatment of DVT and acute PE when initial therapy is administered in the hospital. LMWHs or fondaparinux generally preferred over heparin for initial treatment of acute venous thromboembolism; however, heparin may be preferred in patients with renal impairment.
If PCI is performed while a patient is receiving fondaparinux, administer an additional anticoagulant with anti-factor IIa antithrombin activity because of the risk of catheter thrombosis. Initial parenteral anticoagulants with established efficacy in patients with NSTE ACS include enoxaparin, heparin, bivalirudin only in patients managed with an early invasive strategyand fondaparinux.
Used in patients undergoing PCI to prevent thrombus formation during the procedure; however, should not be used as the sole anticoagulant to support PCI.
Evaluate the possibility of an underlying bleeding disorder before initiation of treatment. Patients should be sitting or supine during administration. Administer by sub-Q injection into fatty tissue, alternating injection sites daily e. Insert the entire length of the needle into a skin fold created by the thumb and forefinger; hold the skin fold, and push the plunger of the syringe the full length of the syringe barrel.
Dosages for fondaparinux sodium and heparin, heparinoids, or LMWHs cannot be used interchangeably on a unit-for-unit or mg-for-mg basis 1 as they differ in the manufacturing process, anti-factor Xa and antithrombin activity, and dosage. The activity of fondaparinux sodium is measured based on plasma drug concentrations quantified by anti-factor Xa activity using fondaparinux as the calibrator. Dosage of fondaparinux sodium is expressed in terms of the salt. Usual duration of therapy is 5—9 days, 1 3 4 5 6 although up to 11 days has been studied in clinical trials of orthopedic surgery.
Extended thromboprophylaxis for up to 35 days is recommended in patients undergoing hip fracture surgery, 40 and suggested for patients undergoing other major orthopedic procedures. Usual duration of therapy is 5—9 days, although up to 10 days has been studied. Usual duration of therapy is 5—9 days, although up to 26 days of treatment has been used.
Initiate concurrent warfarin as soon as possible, 1 usually within 72 hours of fondaparinux injection; 1 20 ACCP recommends initiating warfarin simultaneously on the first day of fondaparinux treatment. Has been administered at an initial dose of 2. No dosage adjustment required in patients with mild to moderate arixtda impairment. No specific dosage recommendations; however, careful attention to dosage directions recommended.
Active major bleeding, bacterial endocarditis, or thrombocytopenia associated with a positive in vitro test for antiplatelet antibody HIT in the presence of the drug. History of serious hypersensitivity reaction e.
Epidural qrixtra spinal hematoma reported with concurrent use of anticoagulants e. Use with extreme caution in patients with an increased risk of hemorrhage e. Periodic routine blood counts, including platelet counts, and tests for occult blood in stool recommended.
Avoid concomitant use of drugs that increase risk of bleeding unless essential for management of underlying condition e. Do not administer earlier than 6—8 hours after surgery because of increased risk of major bleeding. Some packaging components e.
Distributed into milk in rats; not known whether distributed into human milk. Prescriging a single 7. Increased risk of hemorrhage; closely monitor for signs and symptoms of bleeding. Patients undergoing hip-fracture, hip- or knee-replacement surgery: Anemia, fever, nausea, edema, constipation, rash, vomiting, insomnia, increased wound drainage, hypokalemia, urinary tract infection, dizziness, purpura, infofmation, confusion, bullous eruption, urinary retention, hematoma, major bleeding, diarrhea, dyspepsia, postoperative hemorrhage, headache.
Patients undergoing abdominal surgery: Postoperative wound infection, postoperative hemorrhage, fever, surgical site reaction, anemia, hypertension, pneumonia, vomiting.
Constipation, headache, insomnia, fever, nausea, urinary tract infection, coughing. Discontinue oral anticoagulants prior to initiation of fondaparinux 1 If coadministration is essential, monitor patients closely 1 If coadministration is essential, monitor patients closely Discontinue platelet-aggregation inhibitors prior to initiation of fondaparinux 1 Anticoagulant effects may persist for 2—4 days following discontinuance of therapy in patients with normal renal function i.
In healthy adults, distributes mainly in blood and only to a minor extent in extravascular fluid. Eliminated unchanged in urine in individuals with normal renal function. Anticoagulation results from rapid inhibition of factor Xa by antithrombin Informatin bound to fondaparinux about fold greater than innate activity. Binds selectively to antithrombin III; unable to inactivate thrombin.
Platelet function or global clotting function tests e. Importance of advising patients who have had neuraxial anesthesia or spinal puncture to monitor for manifestations of spinal or epidural hematoma e. Importance of informing patients that concomitant use of aspirin or other NSAIAs can increase risk of bleeding, and to prescrobing use of these drugs whenever possible.
If fondaparinux therapy is to be continued after hospital discharge, importance iformation instructing patient on proper administration of the drug, including injection technique.
Importance of discontinuing prsscribing and immediately contacting a clinician if a serious allergic reaction e. Importance of patients informing clinicians including dentists that they are receiving fondaparinux therapy before scheduling any invasive procedures. Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.
Importance of informing patients of other important precautionary information. Excipients in commercially presscribing drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Arixtra fondaparinux sodium injection prescribing information.
Research Triangle Park, Ariixtra A synthetic pentasaccharide for the prevention of deep-vein thrombosis after total hip replacement.
N Engl J Med. Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after hip- fracture surgery. Fondaparinux compared with enoxaparin for the prevention of venous thromboembolism after elective major knee surgery. Postoperative fondaparinux versus preoperative enoxaparin for prevention of venous thromboembolism in elective agixtra surgery: A randomized double-blind comparison.
Postoperative enoxaparin for prevention of venous thromboembolism after elective hip-replacement surgery: A randomized double-blind trial. Am J Health-Syst Pharm. Synthetic pentasaccharides do not cause platelet activation by antiheparin-platelet factor 4 antibodies.
Clin Appl Thromb Hemost. Hull R, Pineo G. A synthetic pentasaccharide for the prescfibing of deep- vein thrombosis. Lovenox enoxaparin sodium injection prescribing information. Bridgewater, NJ; Jul. Bounameaux, H, Perneger T.
Arixtra Monograph for Professionals –
A new synthetic pentasaccharide for thrombosis prevention. Duration of prophylaxis against venous thromboembolism with fondaparinux after hip fracture surgery: Fondaparinux or enoxaparin for the initial treatment of symptomatic deep venous thrombosis: Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism.
Food and Drug Administration. Natural rubber-containing medical devices; user labeling.
Randomized clinical trial of postoperative fondaparinux versus perioperative dalteparin for prevention of venous thromboembolism in high-risk abdominal surgery. Amended economic impact pdescribing of final rule requiring use of labeling on natural rubber containing devices. Latex-containing devices; user labeling. Comparison of fondaparinux and enoxaparin in acute coronary syndromes.
Efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes undergoing percutaneous coronary arixtar J Am Coll Cardiol. The pharmacokinetics of fondaparinux sodium in healthy volunteers.