Name of the Procedure:

Injection, Coagulation Factor Xa (Recombinant), Inactivated (Andexxa), 10 mg (C9041)

Summary

Andexxa is a medication administered via injection to reverse the effects of certain anticoagulant drugs, specifically Factor Xa inhibitors. These inhibitors are commonly used to prevent blood clots, but in certain emergency situations, such as uncontrolled bleeding, it becomes necessary to counteract their blood-thinning effects.

Purpose

Andexxa is used primarily to address uncontrolled or life-threatening bleeding in patients who are on anticoagulants like rivaroxaban or apixaban. The goal of administering Andexxa is to rapidly reverse the anticoagulant effects, thereby stopping or reducing the bleeding and stabilizing the patient.

Indications

• Major bleeding events, such as gastrointestinal bleeding or intracranial hemorrhage, in patients taking Factor Xa inhibitors.
• Emergency surgeries or urgent procedures where anticoagulation reversal is necessary.
• Patients with critically high levels of anticoagulation.

Preparation

• The patient may need to stop certain medications as directed by their healthcare provider.
• Blood tests to assess coagulation levels might be performed before administering Andexxa.
• Ensure the patient is hydrated and has an IV line in place for the injection.

Procedure Description

1. Preparation: The healthcare professional will confirm the need for Andexxa by evaluating the patient's medical condition and coagulation status.
2. Reconstitution: Andexxa comes as a powder and needs to be mixed with a specific diluent following the manufacturer’s instructions.
3. Administration: The medication is delivered via intravenous injection over a specified time period.
4. Monitoring: Continuous monitoring of vital signs and coagulation parameters is essential during and after administration.

Tools and Equipment:

• Vial of Andexxa powder and diluent.
• IV line and necessary syringes.
• Standard monitoring tools, such as blood pressure cuffs and heart rate monitors.

Anesthesia: Not applicable for this procedure.

Duration

The administration typically takes about 15 to 30 minutes, but the total duration may vary based on the patient's condition and response to the treatment.

Setting

Andexxa injection is usually performed in a hospital setting, such as the emergency room, intensive care unit (ICU), or a specialized procedure room.

Personnel

• Emergency medicine physicians or intensivists.
• Nurses specialized in emergency or critical care.
• Pharmacists for medication preparation and verification.

Risks and Complications

• Common: Infusion-related reactions like flushing, fever, or headache.
• Rare: Thromboembolic events, such as deep vein thrombosis or stroke, due to the reversal of anticoagulation.

Benefits

• Rapid reversal of anticoagulation, helping to control or stop bleeding.
• Stabilization of the patient's condition, allowing for necessary surgical interventions or other treatments. Benefits are typically seen immediately upon administration.

Recovery

• Close monitoring for several hours post-procedure to assess effectiveness and identify any adverse reactions.
• Follow-up blood tests to ensure that bleeding has stopped and anticoagulation levels are safe.
• Possible adjustment of anticoagulant therapy based on the patient’s clinical condition.

Alternatives

• Fresh frozen plasma (FFP) or prothrombin complex concentrates, though these are less specific and may be less effective for Factor Xa inhibitor reversal.
• Supportive measures like blood transfusions and surgical interventions to control bleeding.

Pros and Cons:

• Andexxa: Specific and rapid reversal but associated with a higher risk of thromboembolic events.
• FFP/Prothrombin Complex: More broadly available, but may be less effective and slower in action.

Patient Experience

During the procedure, the patient may feel the initial prick of the IV line. They might experience some discomfort or local side effects, such as mild pain at the injection site. As the medication takes effect, any bleeding-related symptoms should improve. Post-procedure, patients will be monitored extensively to ensure no complications arise and that the anticoagulation reversal is successful. Pain management and comfort measures will be provided as needed.