Monograph Details
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Hematology
> Thromboembolic disorders
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ARIXTRA |
| Manufacturer |
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GlaxoSmithKline Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Anticoagulant (Factor Xa inhibitor). |
| Generic Name |
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Fondaparinux sodium 2.5mg/0.5mL, 5mg/0.4mL. 7.5mg/0.6mL, 10mg/0.8mL; soln for SC inj; preservative free. |
| Indications |
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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 (initiate in hospital), or treatment of acute DVT. |
| Children |
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Not recommended. |
| Adults |
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Give by SC inj. Prophylaxis: Once hemostasis is achieved, give 1st dose 6–8 hours 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 72 hours. |
| Contraindications |
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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. |
| Precautions |
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Neuraxial anesthesia and post-op indwelling epidural catheter or spinal puncture (risk of epidural or spinal hematoma). Moderate renal impairment (CrCl 30–50mL/min). Monitor renal function; discontinue if severe renal impairment or labile renal function develops. Bleeding disorders. Recent GI ulcer, diabetic retinopathy, hemorrhage. Angiodysplastic or ulcerative GI disease. Hemorrhagic stroke. Uncontrolled hypertension. History of heparin-induced thrombocytopenia. Obtain CBCs, platelets, serum creatinine level, stool occult blood tests during therapy; discontinue if platelets <100,000 per mm3. Not interchangeable (unit-for-unit) with heparin, low molecular weight heparins, or heparinoids. Recent brain, spinal, or eye surgery. Latex allergy. Elderly. Pregnancy (Cat.B). Nursing mothers. |
| Interactions |
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Caution with drugs that affect hemostasis (eg, warfarin, ticlopidine, NSAIDs). |
| Adverse Reactions |
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Bleeding, thrombocytopenia, local reactions (hematoma, pain), elevated ALT/AST, anemia, fever, edema, rash, insomnia, GI upset, hypokalemia, hypotension, dizziness, purpura, confusion, headache. |
| How Supplied |
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Prefilled syringes—2, 10 |
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