andexanet alfa

General

Pronunciation:
an-dex-a-net al-fa

Trade Name(s)

  • Andexxa

Ther. Class.

antidotes

Pharm. Class.

clotting factor replacements

Indications

To reverse the anticoagulant effect of rivaroxaban or apixaban in patients experiencing life-threatening or uncontrolled bleeding.

Action

Binds to and sequesters rivaroxaban or apixaban, thereby negating their anticoagulant effects. Also inhibits the activity of tissue factor pathway inhibitor, increasing tissue factor-initiated thrombin generation.

Therapeutic Effect(s):

Reversal of the anticoagulant effect of rivaroxaban or apixaban.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.

Distribution: Minimally distributed to tissues.

Metabolism and Excretion: Unknown.

Half-life: Low dose– 3.3 hr;  high dose– 2.7 hr.

TIME/ACTION PROFILE (reduction in anti-Factor Xa activity)

ROUTEONSETPEAKDURATION
IVrapidminutes2 hr†
† Following completion of bolus and continuous infusion.

Contraindication/Precautions

Contraindicated in:

  • None reported.

Use Cautiously in:

  • OB:   Safety not established in pregnancy;
  •  Lactation:  Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
  • Pedi:   Safety and effectiveness not established in children.

Adverse Reactions/Side Effects

CV: DEEP VENOUS THROMBOSIS, MI

Neuro: STROKE, transient ischemic attack

Resp: PULMONARY EMBOLISM

Metabolic: infusion reactions

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

None reported.

Route/Dosage

Low Dose (should be administered if last dose of rivaroxaban ≤10 mg, last dose of apixaban ≤5 mg, or time since patient's last dose (any dose) of rivaroxaban or apixaban ≥8 hr)

IV (Adults): 400 mg IV bolus, followed by 4 mg/min continuous infusion administered for up to 120 min (2 hr).

High Dose (should be administered if last dose of rivaroxaban >10 mg, apixaban >5 mg, or unknown dose AND dose given < 8 hr or at unknown time

IV (Adults): 800 mg IV bolus, followed by 8 mg/min continuous infusion administered for up to 120 min (2 hr).

Availability

Lyophilized powder for injection: 200 mg/vial

Assessment

  • Reversal of rivaroxaban or apixaban exposes patient to thrombotic risk of their underlying disease; may cause thromboembolism. Monitor for signs and symptoms of thromboembolism (pain, swelling, tenderness in extremities; headache; chest pain; blurred vision) and signs and symptoms that precede cardiac arrest (chest pain, dyspnea, nausea, vomiting, dizziness) and provide treatment as needed. Resume anticoagulant therapy as soon as medically appropriate.

Implementation

IV Administration

  • IV Push:  Reconstitute each vial with sterile water for injection slowly, directing solution to inside wall of vial to minimize foaming for a concentration of 10 mg/mL. Swirl gently until powder is completely dissolved; do not shake. Dissolution usually takes 3–5 min; discard vials with incomplete dissolution. Solution is clear; do not administer solutions that are discolored or contain particulate matter. Solution is stable for 8 hr at room temperature or 24 hr if refrigerated. Withdraw solution from each vial using a ≥60 mL syringe and a 20-gauge needle until required dosing volume in achieved. Transfer solution from syringe into an empty polyolefin or polyvinyl chloride IV bag with a volume of ≤250 mL. Discard syringe, needle, and unused portion of vials.
  • Rate: Infuse through a 0.2 or 0.22 micron in-line polyethersulfone or equivalent low protein-binding filter at a rate of 30 mg/min.
  • Continuous Infusion:  Follow the same procedure as IV bolus preparation.
  • Rate: Within 2 min following bolus dose, administer continuous IV infusion for up to 120 minutes.

Patient/Family Teaching

  • Explain purpose of andexanet alfa to patient.
  • Instruct patient to notify health care professional immediately if signs and symptoms of thromboembolism or cardiac arrest occur.
  • Advise female patients of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

Reversal of the anticoagulant effect of rivaroxaban or apixaban.

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