Arixtra (Fondaparinux Sodium Subcutaneous) - Indications and Dosage

INDICATIONS AND USAGE

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

• 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.

ARIXTRA Injection is 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.

(See DOSAGE AND ADMINISTRATION section for appropriate dosage regimen.)

DOSAGE AND ADMINISTRATION

ARIXTRA Injection is administered by subcutaneous injection once daily.

Deep Vein Thrombosis Prophylaxis Following Hip Fracture, or Hip or Knee Replacement Surgeries

In patients undergoing hip fracture, hip replacement, or knee replacement surgery, the recommended dose of ARIXTRA is 2.5 mg administered by subcutaneous injection once daily. After hemostasis has been established, the initial dose should be given 6 to 8 hours after surgery. Administration before 6 hours after surgery has been associated with an increased risk of major bleeding. The usual duration of administration is 5 to 9 days, and up to 11 days administration has been tolerated. 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) has been tolerated. (See CLINICAL STUDIES, WARNINGS: Laboratory Testing and ADVERSE REACTIONS.)

Deep Vein Thrombosis Prophylaxis Following Abdominal Surgery

In patients undergoing abdominal surgery, the recommended dose of ARIXTRA is 2.5 mg administered by subcutaneous injection once daily after hemostasis has been established. The initial dose should be given 6 to 8 hours after surgery. Administration before 6 hours after surgery has been associated with an increased risk of major bleeding. The usual duration of administration is 5 to 9 days, and up to 10 days of ARIXTRA injection has been administered.

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 is 5 mg (body weight <50 kg), 7.5 mg (body weight 50-100 kg), or 10 mg (body weight >100 kg) by subcutaneous injection once daily (ARIXTRA treatment regimen). Treatment with ARIXTRA should be continued for at least 5 days and until a therapeutic oral anticoagulant effect is established (INR 2.0 to 3.0). Concomitant treatment with warfarin sodium should be initiated as soon as possible, usually within 72 hours. The usual duration of administration of ARIXTRA is 5 to 9 days; up to 26 days of ARIXTRA injection has been administered. (See CLINICAL STUDIES, WARNINGS: Laboratory Testing and ADVERSE REACTIONS.)

INSTRUCTIONS FOR USE

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

ARIXTRA Injection is provided in a single dose, prefilled syringe affixed with an automatic needle protection system. ARIXTRA is administered by subcutaneous injection. It must not be administered by intramuscular injections. ARIXTRA is intended for use under a physician’s guidance. Patients may self-inject only if their physician determines that it is appropriate and with medical follow-up as necessary. Proper training in subcutaneous injection technique should be provided.

To avoid the loss of drug when using the pre-filled 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:

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)
4. Pinch a fold of skin at the injection site between your thumb and forefinger and hold it throughout the injection.
5. 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).
6. Insert the full length of the syringe needle perpendicularly into the skin fold held between the thumb and forefinger (Figure 4).
7. 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).
8. 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 without replacing the rigid needle guard.
9. 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.

HOW SUPPLIED

ARIXTRA Injection is available in the following strengths and package sizes:

2.5 mg ARIXTRA in 0.5 mL single dose prefilled syringe, affixed with a 27-gauge x½-inch needle with a blue automatic needle protection system

NDC 0007-3230-02 2 Single Unit Syringes

NDC 0007-3230-1110 Single Unit Syringes

5 mg ARIXTRA in 0.4 mL single dose prefilled syringe, affixed with a 27-gauge x ½-inch needle with an orange automatic needle protection system

NDC 0007-3232-022 Single Unit Syringes

NDC 0007-3232-1110 Single Unit Syringes

7.5 mg ARIXTRA in 0.6 mL single dose prefilled syringe, affixed with a 27-gauge x ½-inch needle with a magenta automatic needle protection system

NDC 0007-3234-022 Single Unit Syringes

NDC 0007-3234-11 10 Single Unit Syringes

10 mg ARIXTRA in 0.8 mL single dose prefilled syringe, affixed with a 27-gauge x ½-inch needle with a violet automatic needle protectionsystem

NDC 0007-3236-02 2 Single Unit Syringes

NDC 0007-3236-1110 Single Unit Syringes

Store at 25°C (77°F); excursions permitted to 15−30°C (59−86°F) [See USP Controlled Room Temperature].

Keep out of the reach of children.

Distributed by GlaxoSmithKline

Research Triangle Park, NC 27709

ARIXTRA is a registered trademark of GlaxoSmithKline.

©2008, GlaxoSmithKline. All rights reserved.

April 2008ARX:1PI