Prophylaxis of Deep Vein Thrombosis

ARIXTRA (fondaparinux sodium) ® 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;
• in patients undergoing hip replacement surgery;
• in patients undergoing knee replacement surgery;
• in patients undergoing abdominal surgery who are at risk for thromboembolic complications.

Treatment of Acute Deep Vein Thrombosis

ARIXTRA (fondaparinux sodium) is indicated for the treatment of acute deep vein thrombosis when administered in conjunction with warfarin sodium.

Treatment of Acute Pulmonary Embolism

ARIXTRA (fondaparinux sodium) is indicated for the treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium when initial therapy is administered in the hospital.

Do not mix other medications or solutions with ARIXTRA (fondaparinux sodium) . Administer ARIXTRA (fondaparinux sodium) only subcutaneously.

Deep Vein Thrombosis Prophylaxis Following Hip Fracture, Hip Replacement, and Knee Replacement Surgery

In patients undergoing hip fracture, hip replacement, or knee replacement surgery, the recommended dose of ARIXTRA (fondaparinux sodium) is 2.5 mg administered by subcutaneous injection once daily after hemostasis has been established. Administer the initial dose no earlier than 6 to 8 hours after surgery. Administration of ARIXTRA (fondaparinux sodium) earlier than 6 hours after surgery increases the risk of major bleeding. The usual duration of therapy is 5 to 9 days; up to 11 days of therapy was administered in clinical trials.

In patients undergoing hip fracture surgery, an extended prophylaxis course of up to 24 additional days is recommended. In patients undergoing hip fracture surgery, a total of 32 days (peri-operative and extended prophylaxis) was administered in clinical trials. [See WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, and Clinical Studies].

Deep Vein Thrombosis Prophylaxis Following Abdominal Surgery

In patients undergoing abdominal surgery, the recommended dose of ARIXTRA (fondaparinux sodium) is 2.5 mg administered by subcutaneous injection once daily after hemostasis has been established. Administer the initial dose no earlier than 6 to 8 hours after surgery. Administration of ARIXTRA (fondaparinux sodium) earlier than 6 hours after surgery increases the risk of major bleeding. The usual duration of administration is 5 to 9 days, and up to 10 days of ARIXTRA (fondaparinux sodium) was administered in clinical trials.

Deep Vein Thrombosis and Pulmonary Embolism Treatment

In patients with acute symptomatic DVT and in patients with acute symptomatic PE, the recommended dose of ARIXTRA (fondaparinux sodium) is 5 mg (body weight < 50 kg), 7.5 mg (body weight 50 to 100 kg), or 10 mg (body weight > 100 kg) by subcutaneous injection once daily (ARIXTRA (fondaparinux sodium) treatment regimen). Initiate concomitant treatment with warfarin sodium as soon as possible, usually within 72 hours. Continue treatment with ARIXTRA (fondaparinux sodium) for at least 5 days and until a therapeutic oral anticoagulant effect is established (INR 2 to 3). The usual duration of administration of ARIXTRA (fondaparinux sodium) is 5 to 9 days; up to 26 days of ARIXTRA (fondaparinux sodium) injection was administered in clinical trials. [See WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, and Clinical Studies].

Hepatic Impairment

No dose adjustment is recommended in patients with mild to moderate hepatic impairment, based upon single-dose pharmacokinetic data. Pharmacokinetic data are not available for patients with severe hepatic impairment. Patients with hepatic impairment may be particularly vulnerable to bleeding during ARIXTRA (fondaparinux sodium) therapy. Observe these patients closely for signs and symptoms of bleeding. [See CLINICAL PHARMACOLOGY.]

Instructions for Use

ARIXTRA (fondaparinux sodium) Injection is provided in a single-dose, prefilled syringe affixed with an automatic needle protection system. ARIXTRA (fondaparinux sodium) is administered by subcutaneous injection. It must not be administered by intramuscular injection. ARIXTRA (fondaparinux sodium) is intended for use under a physician's guidance. Patients may self-inject only if their physician determines that it is appropriate and the patients are trained in subcutaneous injection techniques.

Prior to administration, visually inspect ARIXTRA (fondaparinux sodium) to ensure the solution is clear and free of particulate matter.

To avoid the loss of drug when using the prefilled syringe, do not expel the air bubble from the syringe before the injection. Administration should be made in the fatty tissue, alternating injection sites (e.g., between the left and right anterolateral or the left and right posterolateral abdominal wall).

To administer ARIXTRA (fondaparinux sodium) :

1. Wipe the surface of the injection site with an alcohol swab.

2. Twist the plunger cap and remove it (Figure 1).

3. Hold the syringe with either hand and use your other hand to twist the rigid needle guard (covers the needle) counter-clockwise. Pull the rigid needle guard straight off the needle (Figure 2). Discard the needle guard.

4. Do not try to remove the air bubbles from the syringe before giving the injection.

5. Pinch a fold of skin at the injection site between your thumb and forefinger and hold it throughout the injection.

6. Hold the syringe with your thumb on the top pad of the plunger rod and your next 2 fingers on the finger grips on the syringe barrel. Pay attention to avoid sticking yourself with the exposed needle (Figure 3).

7. Insert the full length of the syringe needle perpendicularly into the skin fold held between the thumb and forefinger (Figure 4).

8. Push the plunger rod firmly with your thumb as far as it will go. This will ensure you have injected all the contents of the syringe (Figure 5).

9. When you have injected all the contents of the syringe, the plunger should be released. The plunger will then rise automatically while the needle withdraws from the skin and retracts into the security sleeve. Discard the syringe into the sharps container.

10. You will know that the syringe has worked when:

• The needle is pulled back into the security sleeve and the white safety indicator appears above the blue upper body.
• You may also hear or feel a soft click when the plunger rod is released fully.

Dosage Forms And Strengths

Single-dose, prefilled syringes containing either 2.5 mg , 5 mg , 7.5 mg , or 10 mg of fondaparinux.

Storage And Handling

ARIXTRA (fondaparinux sodium) Injection is available in the following strengths and package sizes:

2.5 mg ARIXTRA (fondaparinux sodium) in 0.5 mL single-dose prefilled syringe, affixed with a 27-gauge x ½-inch needle and an automatic needle protection system with blue plunger rod.

NDC 0007-3230-02 2 Single Unit Syringes
NDC 0007-3230-11 10 Single Unit Syringes

5 mg ARIXTRA (fondaparinux sodium) in 0.4 mL single-dose prefilled syringe, affixed with a 27-gauge x ½-inch needle and an automatic needle protection system with orange plunger rod.

NDC 0007-3232-02 2 Single Unit Syringes
NDC 0007-3232-11 10 Single Unit Syringes

7.5 mg ARIXTRA (fondaparinux sodium) in 0.6 mL single-dose prefilled syringe, affixed with a 27-gauge x ½-inch needle and an automatic needle protection system with magenta plunger rod.

NDC 0007-3234-02 2 Single Unit Syringes
NDC 0007-3234-11 10 Single Unit Syringes

10 mg ARIXTRA (fondaparinux sodium) in 0.8 mL single-dose prefilled syringe, affixed with a 27-gauge x ½-inch needle and an automatic needle protection system with violet plunger rod.

NDC 0007-3236-02 2 Single Unit Syringes
NDC 0007-3236-11 10 Single Unit Syringes

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F).

GlaxoSmithKline Research Triangle Park, NC 27709, Revised: March 2010

Last reviewed on RxList: 4/15/2010
This monograph has been modified to include the generic and brand name in many instances.