1 Dosing Considerations Use in Patients with Renal Insufficiency The risk of hemorrhage increases with increasing renal insufficiency. Fondaparinux Sodium Injection should be used with caution in patients with moderate renal insufficiency (creatinine clearance 30–50 mL/min) (see ACTION AND CLINICAL PHARMACOLOGY, Renal Insufficiency).
In severe renal impairment, the use of Fondaparinux Sodium Injection should be avoided or, if the physician determines that the benefit outweighs the risk, Fondaparinux Sodium Injection should only be used with caution. Renal function should be assessed periodically in patients receiving the drug.
For prophylactic use following orthopedic surgery, Fondaparinux Sodium Injection should be discontinued immediately in patients who develop severe renal insufficiency or labile renal function while on therapy. e. at least 3-5 half-lives).
The anticoagulant effects of Fondaparinux Sodium Injection may persist even longer in patients with renal insufficiency. Use in Patients with Hepatic Insufficiency No dose adjustment is recommended in patients with mild to moderate hepatic impairment, based upon single-dose pharmacokinetic data.
Pharmacokinetic data are not available for patients with severe hepatic impairment. Patients with hepatic impairment may be particularly vulnerable to bleeding during Fondaparinux Sodium Injection therapy. Observe these patients closely for signs and symptoms of bleeding (see WARNINGS AND PRECAUTIONS).
Use in Pediatric Patients Health Canada has not authorized an indication for pediatric (<17 years of age) use. Use in Geriatric Patients Use with caution in elderly patients (see WARNINGS AND PRECAUTIONS, Geriatrics, and ADVERSE REACTIONS, Geriatrics).
Use in Patients with Low Body Weight For patients of body weight < 50 kg, Fondaparinux Sodium Injection should be used with caution (see WARNINGS AND PRECAUTIONS, Low Body Weight). 5 mg once daily administered post- operatively by subcutaneous injection.
After hemostasis has been established, the initial dose should be given no earlier than 6 hours after surgical closure. In clinical studies, 99% of the patients had received the initial dose of Fondaparinux Sodium Injection by 18 hours after surgical closure.
Administration before 6 hours after orthopedic surgery has been associated with an increased risk of major Page 5 of 65 bleeding. The timing of the first dose of Fondaparinux Sodium Injection following surgery requires strict adherence (see WARNING AND PRECAUTIONS, Hemorrhage, and Peri- Operative Considerations; ACTION AND CLINICAL PHARMACOLOGY).
The usual duration of prophylactic therapy with Fondaparinux Sodium Injection is 7 ± 2 days. Treatment should be continued for as long as the risk of VTE persists. In patients for whom extended prophylaxis is indicated, administration of Fondaparinux Sodium Injection in or out of the hospital up to an additional 24 days is recommended.
In clinical trials of extended prophylaxis, a total of 32 days (peri-operative and extended prophylaxis) has been tolerated. 5 mg once daily administered post- operatively by subcutaneous injection after hemostasis has been established.
The initial dose should be given 6 to 8 hours after surgery. Administration before 6 hours after abdominal surgery has been associated with an increased risk of major bleeding. The timing of the first dose of Fondaparinux Sodium Injection following surgery requires strict adherence (see WARNING AND PRECAUTIONS, Hemorrhage, and Peri-Operative Considerations; ACTION AND CLINICAL PHARMACOLOGY).
The usual duration of administration is 5 to 9 days, and up to 10 days of Fondaparinux Sodium Injection has been administered. 5 mg (body weight 50-100 kg) or 10 mg (body weight > 100 kg) by subcutaneous injection once daily. Concomitant oral anticoagulation treatment should be initiated as soon as possible, usually within 72 hours.
0). The average duration of administration is 7 days. In controlled clinical trials administration of fondaparinux sodium for up to 26 days to a small number of patients has been well tolerated. 5 mg once daily, administered by subcutaneous injection.
Treatment should be initiated as soon as possible following diagnosis and may be continued for up to 8 days or until hospital discharge. If a patient is to undergo percutaneous coronary intervention (PCI) while being treated with Fondaparinux Sodium Injection, an effective anti-thrombin regimen such as unfractionated heparin (UFH) should be administered as an adjunct to PCI, as per standard practice, taking into account the patient’s potential risk of bleeding, including the time since the last dose of Fondaparinux Sodium Injection (see WARNINGS AND PRECAUTIONS, Risk of catheter thrombosis during PCI, and Hemorrhage).
Page 6 of 65 The timing of the next dose of subcutaneous Fondaparinux Sodium Injection after sheath removal should be based on clinical judgment. In the UA/NSTEMI clinical trials treatment with Fondaparinux Sodium Injection was restarted no earlier than 2 hours after sheath removal.
In patients who are to undergo coronary artery bypass graft (CABG) surgery, Fondaparinux Sodium Injection where […]