Information and Steps for Administering ARIXTRA

How to Administer Subcutaneous ARIXTRA

ARIXTRA is administered by subcutaneous injection. It must not be administered by intramuscular injection.

Each syringe of ARIXTRA is affixed with an automatic needle-protection system. After injection, needle will automatically retract in to the built-in security sleeve, helping to eliminate the risk of needlestick injury.

Patients may self-inject as healthcare practitioner determines that it is appropriate. Proper training in subcutaneous injection administration should be provided.

Important points in the administration of ARIXTRA

• Inspect ARIXTRA visually for any particular matter prior to injection.
• To avoid loss of drug when using the prefilled syringe, do not expel the air bubble before the injection.
• Administration of ARIXTRA should be made in the fatty tissue.
• Administration sites of ARIXTRA should be alternating.

Steps for administering ARIXTRA

1. Wipe the surface of the injection site with an alcohol swab.
2. Twist the plunger cap and remove it.
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.
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.
6. Insert the full length of the syringe needle perpendicularly into the skin fold held between the thumb and forefinger.
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.
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

If you have additional questions regarding ARIXTRA, please call us at
1-866-ARIXTRA (1-866-274-9872).

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.