Fondaparinux instructions for administration

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

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.

Instructions for Administration

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.

• Wipe the surface of the injection site with an alcohol swab.
• Twist the plunger cap and remove it.
• 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.
• Pinch a fold of skin at the injection site between your thumb and forefinger and hold it throughout the injection.
• 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.
• Insert the full length of the syringe needle perpendicularly into the skin fold held between the thumb and forefinger.
• 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.
• 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.
• 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.

Adapted from the FDA Package Insert.