ARIXTRA for VTE prophylaxis after major orthopedic surgery

ARIXTRA significantly reduced the rate of venous thromboembolism (VTE) by 55% compared to enoxaparin [4]

A meta-analysis of 4 randomized, double-blind clinical trials involving patients undergoing elective hip replacement, total hip replacement, elective major knee, or hip fracture surgery was performed to compare the efficacy and safety of once-daily ARIXTRA 2.5 mg in the prevention of DVT or PE following major orthopedic surgery. The primary efficacy endpoint in these studies was the presence of VTE including DVT, PE, or both, up to Day 11 following surgery. These 4 studies were planned with the purpose of subsequently performing a meta-analysis of the data. [4]

ARIXTRA provided significant VTE risk reduction in all orthopedic surgery studies

ARIXTRA significantly reduced the risk of VTE vs enoxaparin in all orthopedic surgery studies with a risk reduction of:

• 56% in hip fracture (52/626 for ARIXTRA vs 119/624 for enoxaparin, P<0.001) [5]
• 55% in knee replacement(45/361 for ARIXTRA vs 101/363 for enoxaparin, P<0.001) [6]
• 56% in hip replacement (37/908 for ARIXTRA vs 85/919 for enoxaparin, P<0.0001) [7]
• In a fourth clinical study, ARIXTRA reduced VTE by 26% (48/787 for ARIXTRA vs 66/797 for enoxaparin, P=NS) following hip replacement surgery [8]

No difference in clinically relevant bleeding compared with enoxaparin. [5]

Clinically relevant bleeding was defined by the study authors to be fatal bleeding, bleeding in a critical organ, or bleeding leading to another operation.

• In a separate analysis, the incidence of major bleeding when ARIXTRA was dosed <4 hours after surgery was 4.8% (5/104) and 2.3% (28/1,196) when ARIXTRA was dosed 4-6 hours after surgery. However, when ARIXTRA was dosed 6-8 hours after surgery, the incidence of bleeding was 1.9% (38/1,965).

Select a link below to learn more about the studies in the meta-analysis:

Hip fracture surgery
Knee replacement surgery
Hip replacement surgery

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.