2008 Guidelines from the American College of Chest Physicians recommend ARIXTRA^® (fondaparinux sodium) Injection

ARIXTRA is contraindicated in patients with severe renal impairment (creatinine clearance <30 mL/min) and for prophylaxis in patients <50 kg.

*Abdominal Surgery Indication is included generally in section 2.1.2 and 2.1.3 in ACCP guidelines regarding general surgery on pages 395S-396S.

In addition to recommending ARIXTRA, ACCP Guidelines also include the following recommendations for the following surgeries and conditions:

• Elective total hip replacement: LMWH and vitamin K antagonist (VKA) are recommended with a grade of 1A
• Total knee replacement: LMWH and VKA are recommended with a grade of 1A
• Hip fracture surgery: LMWH, VKA, or LDUH are recommended with a grade of 1B
• Hip fracture surgery with extended prophylaxis: LMWH and VKA are recommended with a grade of 1C
• Confirmed DVT and PE: initial treatment with subcutaneous LMWH, intravenous UFH, and subcutaneous UFH are recommended with a grade of 1A
• Acute DVT and PE: VKA together with LMWH, UFH, or ARIXTRA are recommended with a grade of 1A

About ACCP Guidelines recommendations [21]:

• Grades of 1 or 2 respectively confer a strong or weaker recommendation
• Grades of A, B, or C respectively indicate high-quality evidence, moderate-quality evidence, or low-quality evidence

Click here, for more information on the 2008 ACCP Guidelines.

WARNING: SPINAL/EPIDURAL HEMATOMAS

Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH), heparinoids, or fondaparinux sodium and are receiving neuraxial anesthesia or undergoing spinal puncture.

These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

• use of indwelling epidural catheters
• concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants
• a history of traumatic or repeated epidural or spinal puncture
• a history of spinal deformity or spinal surgery

Monitor patients frequently for signs and symptoms of neurologic impairment. If neurologic compromise is noted, urgent treatment is necessary. Consider the benefit and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.

INDICATIONS AND USAGE
Prophylaxis of Deep Vein Thrombosis
ARIXTRA is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing:

• hip fracture surgery, including extended prophylaxis;
• hip replacement surgery;
• knee replacement surgery;
• abdominal surgery who are at risk for thromboembolic complications.

Treatment of Acute Deep Vein Thrombosis
ARIXTRA is indicated for the treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium.

Treatment of Acute Pulmonary Embolism
ARIXTRA is indicated for the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital.

CONTRAINDICATIONS
ARIXTRA is contraindicated in the following conditions:

• Severe renal impairment (creatinine clearance <30 mL/min) in prophylaxis or treatment of venous thromboembolism.
• Active major bleeding.
• Bacterial endocarditis.
• Thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of fondaparinux sodium.
• Body weight <50 kg (venous thromboembolism prophylaxis only).

WARNINGS AND PRECAUTIONS

• Use with caution in patients who have conditions or who are taking concomitant medications that increase risk of hemorrhage.
• Bleeding risk is increased in renal impairment and in patients with low body weight <50 kg.
• Thrombocytopenia can occur with administration of ARIXTRA.
• Periodic routine complete blood counts (including platelet counts), serum creatinine level, and stool occult blood tests are recommended.
• The packaging (needle guard) contains dry natural rubber and may cause allergic reactions in latex sensitive individuals.