Classes
DEA Class; Rx
Common Brand Names; Arixtra
- Anticoagulants, Hematologic;
- Factor Xa Inhibitors
Description
Pentasaccharide anticoagulant used SQ for the treatment of DVT and PE, and for DVT and PE prophylaxis in abdominal surgery, hip fracture surgery, and hip and knee replacement surgery. Inhibits factor Xa but not factor IIa (thrombin).
Indications
Indicated for the treatment of venous thromboembolism (VTE) including acute deep venous thrombosis (DVT) or pulmonary embolism (PE).
Contraindications
Severe renal impairment (CrCl <30 mL/min)
Body weight <50 kg (venous thromboembolism prophylaxis only)
Active major bleeding
Bacterial endocarditis
Thrombocytopenia with antiplatelet antibody in presence of fondaparinux
History of serious hypersensitivity reaction (eg, angioedema, anaphylactoid or anaphylactic reactions)
Adverse Effects
Anemia (1-20%)
Fever (4-14%)
Nausea (3-11%)
Rash (7.5%)
Dizziness (4%)
Confusion (3%)
Constipation (5-9%)
Diarrhea (2-3%)
Edema (9%)
Headache (2-5%)
Hypokalemia (1-4%)
Hypotension (4%)
Insomnia (4-5%)
Purpura (4%)
Thrombocytopenia (3%)
Urinary retention (3%)
Urinary tract infection (2-4%)
Vomiting (1-6%)
Thrombocytopenia with thrombosis that manifested similarly to HIT
Serious allergic reactions, including angioedema and anaphylactoid or anaphylactic reactions
Spinal or epidural hematomas
Hemorrhage
Increase in bleeding risk with renal impairment
Increase in bleeding risk with body weight <50 Kg
Increase in aminotransferase levels
Warnings
Use with caution in the elderly (prolonged half-life in patients >75 years of age), peptic ulcer disease, bleeding disorder, recent stroke, recent surgery (brain, spinal cord, or eye), concurrent use of platelet inhibitors or anticoagulants, moderate renal impairment (CrCl 30-50 mL/min); may cause prolonged anticoagulation in patients with CrCl 30 to 50 mL/min
Discontinue if platelets <100,000/μL
Not for IM administration
Therapy increases risk of hemorrhage in patients at risk for bleeding, including conditions such as congenital or acquired bleeding disorders, active ulcerative and angiodysplastic gastrointestinal disease, hemorrhagic stroke, uncontrolled arterial hypertension, diabetic retinopathy, or shortly after brain, spinal, or ophthalmological surgery; cases of elevated aPTT temporally associated with bleeding events have been reported following administration of drug (with or without concomitant administration of other anticoagulants); do not administer agents that enhance risk of hemorrhage unless essential for management of underlying condition, such as vitamin K antagonists for treatment of VTE; if co-administration is essential, closely monitor patients for signs and symptoms of bleeding
Do not use interchangeably with heparin or LMWHs
Thrombocytopenia with thrombosis reported with use; discontinue therapy if platelet count falls below 100,000/mm³
Pregnancy and Lactation
Available data from published literature and postmarketing reports have not reported clear association with adverse developmental outcomes
There are no data on presence in human milk, or effects on milk production; limited clinical data during lactation preclude a clear determination of risk of therapy to an infant during lactation
Maximum Dosage
2.5 mg/day subcutaneously for DVT prophylaxis (in clinical studies, doses greater than 3 mg/day were associated with a significant bleeding risk); up to 10 mg/day subcutaneously for the treatment of PE or DVT.
2.5 mg/day subcutaneously for DVT prophylaxis (in clinical studies, doses greater than 3 mg/day were associated with a significant bleeding risk); up to 10 mg/day subcutaneously for the treatment of PE or DVT.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Fondaparinux sodium
prefilled syringe
- 2.5mg/0.5mL
- 5mg/0.4mL
- 7.5mg/0.6mL
- 10mg/0.8mL
