Idarucizumab

Idarucizumab Brand Name– Praxbind

What is Idarucizumab

Idarucizumab is a humanized monoclonal antibody fragment indicated for dabigatran-treated patients when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery or urgent procedures or in life-threatening or uncontrolled bleeding.

It was initially granted accelerated approval based on data which showed a reduction of unbound dabigatran and normalization of coagulation parameters in healthy volunteers.

In the RE-VERSE AD study of patients who were receiving dabigatran and had uncontrolled bleeding or were to undergo an urgent procedure and had a prolonged diluted thrombin time or ecarin clotting time at baseline (n = 503), idarucizumab reversed anticoagulation rapidly and completely to a median maximum percentage of 100% within 4 hours in more than 98% of the patients.

A single idarucizumab dose was sufficient in 98% of patients, and reversal was maintained for 24 hours in most patients.

Idarucizumab is a reversal agent specific for dabigatran and has no impact on the effect of other anticoagulant or antithrombotic therapies.

Reversing the effect of dabigatran exposes patients to the thrombotic risk of their underlying disease; therefore, anticoagulant therapy should resume as soon as medically appropriate.

Indications

  • dabigatran reversal

For dabigatran reversal during emergency surgery, urgent procedures, or for life-threatening or uncontrolled bleeding

Side Effects

  1. antibody formation
  2. bronchospasm
  3. constipation
  4. delirium
  5. fever
  6. headache
  7. hyperventilation
  8. hypokalemia
  9. infection
  10. pruritus
  11. rash
  12. thrombosis

Monitoring Parameters

  • activated partial thromboplastin time (APTT)
  • clotting time
  • thrombin time

Contraindications

  • breast-feeding
  • hereditary fructose intolerance
  • pregnancy
  • thromboembolic disease

Interactions

There are no drug interactions associated with Idarucizumab products.

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