ARIXTRA


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Indications & Efficacy
for ARIXTRA


Treatment of
deep vein thrombosis


Treatment of pulmonary embolism

Hip fracture surgery

Extended prophylaxis in
hip fracture surgery


Knee replacement surgery

Hip replacement surgery

Abdominal surgery in
patients who are at risk
for thromboembolic
complications


Important Safety Information

How ARIXTRA Works

Safety Data
From Clinical Trials


Dosing & Administration

Healthcare
Professional Materials


Materials for Your Patients

Support Hotline for ARIXTRA

Prescribing Information

Reduce the risk of VTE - Learn more!

Reduce the Risk of VTE: Indications & Efficacy

The Only Synthetic,
Selective Factor Xa Inhibitor

ARIXTRA Injection is indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism in:

ARIXTRA Cut Venous Thromboembolism (VTE)* by More Than Half
vs Enoxaparin Sodium

As proven in three out of four clinical studies, ARIXTRA significantly reduced the risk of VTE vs enoxaparin sodium in patients undergoing hip fracture surgery, knee replacement surgery, or hip replacement surgery, respectively.

Reduce the Risk of VTEwith ARIXTRA
   *VTE, the primary endpoint, was a composite of documented DVT and/or
documented symptomatic PE reported up to day 11
    Number of patients randomized.

Click on efficacy links at left for complete study information for ARIXTRA.

In two other clinical studies:

  • In a second hip replacement study, ARIXTRA was associated with a VTE rate of 6.1% compared with a VTE rate of 8.3% for enoxaparin sodium for a relative risk reduction of 26% (95% CI: -11%, 53%; P = NS).
  • In an abdominal surgery study, ARIXTRA was associated with a VTE rate of 4.6% compared with a VTE rate of 6.1% for dalteparin sodium (P = NS).

In the four orthopedic surgery studies, overall major bleeding rate across the pivotal perioperative clinical studies was 2.7% for ARIXTRA and 1.9% for enoxaparin sodium. However, in a separate analysis, major bleeding was reduced to 1.9% when the first injection of ARIXTRA was given 6 to 8 hours postsurgical closure.

In an abdominal surgery study, overall major bleeding was 3.4% for ARIXTRA and 2.4% for dalteparin sodium. A separate analysis of major bleeding was performed, according to the time of the first injection of ARIXTRA after surgical closure. In this analysis, the incidences of major bleeding were as follows: <6 hours was 3.4% (9/263) and 6 to 8 hours was 2.9% (32/1,112).

ARIXTRA for the treatment of DVT and PE

ARIXTRA Injection is also indicated for:

  • the treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium, and
  • the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital.

Efficacy for the treatment of DVT and PE

When epidural/spinal anesthesia or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low-molecular-weight heparins, heparinoids, or fondaparinux sodium are at risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis. The risk of these events may be higher with postoperative use of indwelling epidural catheters or concomitant use of drugs affecting hemostasis. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture. Patients should be frequently monitored for signs and symptoms of neurological impairment. (See BOXED WARNING for Spinal/Epidural Hematomas.)

Please see Important Safety Information and complete Prescribing Information, including BOXED WARNING regarding epidural and spinal hematomas.


Extending therapy with ARIXTRA reduced VTE to 1.4% and symptomatic VTE to 0.3% in hip fracture patients. Learn more.

 

Only ARIXTRA has FDA-approved indications for hip fracture and extended prophylaxis in hip fracture.
Learn more.

Home : Indications & Efficacy for ARIXTRA : Important Safety Information : How ARIXTRA Works
Safety Data From Clinical Trials : Dosing & Administration : Healthcare Professional Materials
Materials for Your Patients : Support Hotline for ARIXTRA : Site Map

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