Arixtra

Arixtra

fondaparinux sodium

Manufacturer:

Aspen

Distributor:

Zuellig
Concise Prescribing Info
Contents
Fondaparinux Na
Indications/Uses
Prevention of venous thromboembolic events (VTE) in patients undergoing major orthopedic surgery of the lower limbs eg, hip fracture including extended prophylaxis, knee & hip replacement surgery; abdominal surgery at risk of thromboembolic complications; medical patients at risk of thromboembolic complications due to restricted mobility during acute illness. Treatment of acute DVT & pulmonary embolism (PE), unstable angina or non-ST segment elevation MI (UA/NSTEMI) acute coronary syndrome for the prevention of death, MI & refractory ischemia; ST segment elevation MI (STEMI) acute coronary syndrome for the prevention of death & myocardial re-infarction in patients who are managed w/ thrombolytics or who initially are to receive no other form of reperfusion therapy.
Dosage/Direction for Use
Adult Prevention of VTE in orthopedic & abdominal surgery 2.5 mg SC once daily, starting not <6 hr post-op & after hemostasis is established for at least 5-9 days, up to an additional 24 days in hip fracture surgery. Patient at risk of thromboembolic complications 2.5 mg SC once daily for 6-14 days. Treatment of DVT & PE >100 kg 10 mg, 50-100 kg 7.5 mg, <50 kg 5 mg. Doses to be administered SC once daily for at least 5 days & until adequate oral anticoagulation is established (INR 2-3). Initiate concomitant treatment w/ vit K antagonists w/in 72 hr. Duration: 5-9 days. Treatment of UA/NSTEMI 2.5 mg SC once daily for up to 8 days or until hospital discharge. Treatment of STEMI 2.5 mg once daily, 1st dose to be given IV & subsequent doses given SC for up to 8 days or until hospital discharge.
Contraindications
Hypersensitivity, active clinically significant bleeding, acute bacterial endocarditis.
Special Precautions
Do not administer IM. Not to be given 24 hr prior to CABG surgery & may be restarted 48 hr post-op. STEMI patients undergoing primary PCI for reperfusion. Monotherapy in UA/NSTEMI & STEMI patients undergoing non-primary PCI. Increased risk of hemorrhage in congenital or acquired bleeding disorders, active ulcerative GI disease, recent intracranial hemorrhage, shortly after brain, spinal or ophth surgery. Low body wt <50 kg. Spinal/epidural anesth or spinal puncture. History of heparin-induced thrombocytopenia & latex allergy. Renal (CrCl <20 or 20-30 mL/min) or severe hepatic impairment. Close monitoring is recommended in patients concomitantly taking products enhancing the risk of hemorrhage. Pregnancy & lactation. Childn <17 yr. Elderly ≥75 yr.
Adverse Reactions
Anemia, bleeding, purpura; edema.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AX05 - fondaparinux ; Belongs to the class of other antithrombotic agents.
Presentation/Packing
Form
Arixtra soln for inj 2.5 mg/0.5 mL
Packing/Price
10 × 1's (P13,781.25/box);2 × 1's
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