ARIXTRA Rx

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ARIXTRA

Miscellaneous hematological agents
Only 4 drugs may be compared at once

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.

Select 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; monitor for signs/symptoms of neurological impairment. Hepatic or moderate renal impairment (CrCl 30–50mL/min). Monitor hepatic and renal function; discontinue if severe renal impairment develops. Bleeding disorders. Acute ulcerative or angiodysplastic GI disease. Hemorrhagic stroke. Uncontrolled hypertension. Diabetic retinopathy. Recent brain, spinal, or eye surgery. History of heparin-induced 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, low molecular weight heparins, or heparinoids. PE and DVT treatment: low body weight (<50kg). Latex allergy. Elderly. Pregnancy (Cat.B). Nursing mothers.

Interactions:

Caution with drugs that affect hemostasis (eg, warfarin, platelet inhibitors, NSAIDs).

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

ARIXTRA 10 syringes of 7.5mg/0.6ml cartons (Qty:1)

appx. price $1361.00