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Active Pharma Ingredients / 25 Aug 2026

ANDEXANET ALFA

Generic Name: ANDEXANET ALFA

ABSTRACT -

Andexanet alfa is a recombinant modified human factor Xa decoy protein used to reverse anticoagulation from apixaban or rivaroxaban in adults with life-threatening or uncontrolled bleeding where approved. It binds factor Xa inhibitors with high affinity, reducing their anti-Xa activity while lacking normal factor Xa catalytic function.

DOSAGE - 

  • Dosage should be determined only by a qualified emergency, hematology, or critical-care professional.
  • Approved regimens use a low-dose or high-dose intravenous bolus followed by a two-hour infusion.
  • Dose selection depends on the specific factor Xa inhibitor, the last inhibitor dose, and the time since the last dose.
  • Restarting anticoagulation should be considered as soon as medically appropriate after bleeding control.

SIDE EFFECTS–

  • Possible side effects include:
  • Thromboembolic events
  • Infusion-related reactions
  • Fever
  • Flushing
  • Hypotension
  • Nausea
  • Headache
  • Rebound or recurrent anticoagulation effect
  • Possible cardiac, stroke, or venous thrombotic events

ALLRGIC REACTIONS–

  • Possible allergic reaction symptoms include:
  • Rash
  • Urticaria
  • Facial swelling
  • Bronchospasm
  • Anaphylaxis symptoms
  • Important: Patients who develop an allergic reaction to Andexanet Alfa should seek immediate medical attention and inform all future healthcare providers of the allergy.

DRUG INTERACTIONS–

  • Heparin responsiveness may be reduced after andexanet alfa; avoid use before planned heparinization when possible.
  • Concurrent anticoagulants, antiplatelets, or thrombolytics affect bleeding and thrombosis balance.
  • Procoagulant reversal agents may increase thrombotic risk.
  • Laboratory anti-Xa activity may not perfectly predict clinical hemostasis.
  • Patients should inform healthcare providers about all prescription medicines, over-the-counter medicines, herbal products, vaccines, and supplements they are using.

PREAUTIONS–

  • Use only for serious bleeding after confirmed or suspected apixaban/rivaroxaban exposure.
  • Monitor for thrombosis, recurrent bleeding, and hemodynamic instability.
  • Use caution in patients with recent thrombosis, stroke, myocardial infarction, or high thrombotic risk.
  • Plan post-reversal anticoagulation strategy once clinically safe.

WARNINGS –

  • Thrombotic events, ischemic events, cardiac arrest, and sudden death have been reported after reversal.
  • Emergency support and specialist assessment are required.
  • Not for routine reversal before procedures unless benefit clearly outweighs risk.
  • Keep out of reach of children.

Have any questions? or Need help Contact us – 022 6163 6163 | support@medicus.com

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