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ARIXTRA
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Drug Name:

ARIXTRA Rx

Generic Name and Formulations:
Fondaparinux sodium 2.5mg/0.5mL, 5mg/0.4mL. 7.5mg/0.6mL, 10mg/0.8mL; soln for SC inj; preservative free.

Company:
Mylan Inc.

Therapeutic Use:

Indications for ARIXTRA:

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.

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.

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.

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.

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.

Pharmacological Class:

Factor Xa inhibitor.

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.

How Supplied:

Prefilled syringes 2.5mg, 7.5mg, 10mg—2, 10; 5mg—10

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