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Arixtra Generic Name & Formulations
Legal Class
Rx
General Description
Fondaparinux sodium 2.5mg/0.5mL, 5mg/0.4mL. 7.5mg/0.6mL, 10mg/0.8mL; soln for SC inj; preservative free.
Pharmacological Class
Factor Xa inhibitor.
How Supplied
Prefilled syringes 2.5mg, 7.5mg, 10mg—2, 10; 5mg—10
Manufacturer
Arixtra Indications
Indications
Prophylaxis of DVT in patients undergoing hip fracture surgery, or hip or knee replacement, or abdominal surgery with risk of thromboembolic complications. With warfarin: Treatment of acute pulmonary embolism (PE) (initiate in hospital), or treatment of acute DVT.
Arixtra Dosage and Administration
Adult
Give by SC inj. Prophylaxis: Once hemostasis is achieved, give 1st dose no earlier than 6–8hrs post-op. 2.5mg once daily for 5–9 days. Hip or knee replacement: max 11 days. Hip fracture: give for up to 24 more days (max 32 days). Abdominal: max 10 days. Treatment: (<50kg): 5mg; (50–100kg): 7.5mg; (>100kg): 10mg; for all: give once daily for at least 5 days and until INR= 2–3; usually 5–9 days; max 26 days; start warfarin usually within 72hrs.
Children
Not established.
Arixtra Contraindications
Contraindications
Severe renal impairment (CrCl <30mL/min). Active major bleeding. Bacterial endocarditis. Thrombocytopenia associated with (+) in vitro test for antiplatelet antibody in presence of fondaparinux. Also for prophylaxis: body weight <50kg.
Arixtra Boxed Warnings
Boxed Warning
Spinal/epidural hematomas.
Arixtra Warnings/Precautions
Warnings/Precautions
See full labeling. Increased risk of spinal/epidural hematoma in anticoagulated patients receiving neuraxial anesthesia or undergoing spinal puncture (esp. post-op indwelling epidural use); monitor for signs/symptoms of neurological impairment. Increased risk of hemorrhage in those with bleeding disorders, acute ulcerative or angiodysplastic GI disease, hemorrhagic stroke, uncontrolled hypertension, diabetic retinopathy, recent brain, spinal, or eye surgery. Increased risk of bleeding in renal impairment and in those with low body weight (<50kg). Assess hepatic and renal function periodically; discontinue if severe renal impairment develops. Monitor closely for thrombocytopenia. Obtain CBCs, platelets, serum creatinine level, stool occult blood tests during therapy; discontinue if platelets <100,000 per mm3 or major bleeding occurs. Not interchangeable (unit-for-unit) with heparin or low molecular weight heparins. Latex allergy. Elderly. Neonates. Pregnancy. Labor & delivery. Nursing mothers.
Arixtra Pharmacokinetics
See Literature
Arixtra Interactions
Interactions
Caution with drugs that affect hemostasis (eg, warfarin, platelet inhibitors, NSAIDs). Avoid drugs that increase risk of hemorrhage (eg, Vit. K antagonists); if co-admin necessary, monitor closely for bleeding.
Arixtra Adverse Reactions
Adverse Reactions
Bleeding, thrombocytopenia, local reactions (rash, pruritus, hematoma, pain), anemia, insomnia, increased wound drainage, hypokalemia, dizziness, hypotension, confusion, bullous eruption, post-op hemorrhage, purpura, elevated ALT/AST.
Arixtra Clinical Trials
See Literature
Arixtra Note
Not Applicable
Arixtra Patient Counseling
See Literature
