The activity of fondaparinux sodium is measured based on plasma drug concentrations quantified by anti-factor Informatino activity using fondaparinux as the calibrator. Bounameaux, H, Perneger T. Postoperative fondaparinux versus preoperative enoxaparin for prevention of venous thromboembolism in elective hip-replacement surgery: Anticoagulation results from rapid inhibition of factor Xa by antithrombin III bound to fondaparinux about fold greater than innate activity. A synthetic pentasaccharide for the ariixtra of deep- vein thrombosis. Binds selectively to antithrombin III; unable to inactivate thrombin. Bridgewater, NJ; Jul.
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Postmarketing Experience The following adverse reactions have been identified during post-approval use of Arixtra. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In the postmarketing experience, epidural or spinal hematoma has been reported in association with the use of Arixtra by subcutaneous SC injection [see Warnings and Precautions 5.
Occurrences of thrombocytopenia with thrombosis that manifested similar to heparin-induced thrombocytopenia have been reported in the postmarketing experience and cases of elevated aPTT temporally associated with bleeding events have been reported following administration of Arixtra with or without concomitant administration of other anticoagulants [see Warnings and Precautions 5.
In addition, Arixtra 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 therapy with Arixtra unless these agents are essential. If co-administration is necessary, monitor patients closely for hemorrhage [see Warnings and Precautions 5.
Since fondaparinux sodium does not bind significantly to plasma proteins other than ATIII, no drug interactions by protein-binding displacement are expected. Fondaparinux sodium plasma concentrations obtained from four women treated with Arixtra during pregnancy and their newborn infants demonstrated low placental transfer of fondaparinux sodium see Data. There are risks to the mother associated with untreated venous thromboembolism in pregnancy and a risk of hemorrhage in the mother and fetus associated with use of anticoagulants see Clinical Considerations.
In animal reproduction studies, there was no evidence of adverse developmental outcomes when fondaparinux sodium was administered to pregnant rats and rabbits during organogenesis at doses 32 and 65 times, respectively, the recommended human dose based on body surface area.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U. Published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy.
Use of anticoagulants, including fondaparinux sodium, may increase the risk of bleeding in the fetus and neonate. Monitor neonates for bleeding [see Warnings and Precautions 5.
Labor or delivery All patients receiving anticoagulants, including pregnant women, are at risk for bleeding. Fondaparinux sodium use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas. Pregnant women receiving fondaparinux sodium should be carefully monitored for evidence of bleeding or unexpected changes in coagulation parameters.
Consideration for use of a shorter acting anticoagulant should be specifically addressed as delivery approaches [see Warnings and Precautions 5. Data Human Data In a study of five pregnant women treated with fondaparinux sodium during the third trimester of pregnancy at a dose of 2. Anti-factor Xa clotting times in these four cases were between The patient who did not have elevated anti-factor Xa activity had received only one dose of fondaparinux sodium 22 hours prior to delivery.
None of the infants experienced adverse effects. These studies have revealed no evidence of adverse developmental outcomes when fondaparinux sodium was administered to pregnant rats and rabbits during organogenesis.
Lactation Risk Summary There are no data on the presence of fondaparinux sodium in human milk, or the effects on milk production.
Pediatric Use Safety and effectiveness of Arixtra in pediatric patients have not been established. Geriatric Use In clinical trials the efficacy of Arixtra in the elderly 65 years or older was similar to that seen in patients younger than 65 years; however, serious adverse events increased with age. When using Arixtra in elderly patients, paying particular attention to dosing directions and concomitant medications especially anti-platelet medication [see Warnings and Precautions 5.
Fondaparinux sodium is substantially excreted by the kidney, and the risk of adverse reactions to Arixtra may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, assess renal function prior to Arixtra administration [see Contraindications 4 , Warnings and Precautions 5.
In the peri-operative hip fracture, hip replacement, or knee replacement surgery clinical trials with patients receiving Arixtra 2. The incidence of major bleeding in clinical trials of Arixtra by age is provided in Table 6. Table 6.
This medicine is authorised for use in the European Union. It explains how the Committee for Medicinal Products for Human Use CHMP assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Arixtra. Expand section Collapse section What is Arixtra? Arixtra is a solution for injection in a prefilled syringe. Arixtra contains the active substance fondaparinux sodium 1. What is Arixtra used for?