Idarucizumab (Praxbind)

Approved to reverse the blood thinning effects of dabigatran (Pradaxa), in emergency or life-threatening situations when bleeding cannot be controlled.

Used when the reversal of the anticoagulated effects is needed such as for emergency surgery and urgent procedure or if there is life-threatening or uncontrolled bleeding.

Rapidly and completely reverses blood thinning effects of dabigatran in patients with uncontrolled bleeding or needed emegency procedures (RE-VERSE AD).

It is a humanized monoclonal antibody fragment (Fab) indicated in patients treated with dabigatran (Pradaxa) when reversal of the anticoagulant effects are needed for emergency surgery or urgent procedures, or in the event of life-threatening or uncontrolled bleeding.


Specifically binds to dabigatran molecules and neutralizes their anticoagulant effect without interfering with the coagulation cascade.

The drug is a monoclonal antibody fragment given intravenously. 


Renal or hepatic impairment does  not impact the reversal effect of idarucizumab, and dosage adjustment required


Immediately reduces the amount of dabigatran in a patient’s blood stream for at least 24 hours.

Fully reverses dabigatran anticoagulant effect within four hours in 89% of patients. 


Adverse Effects of 1-10% include: 


Hypokalemia (7%)


Delirium (7%)


Constipation (7%)


Pyrexia (6%)


Pneumonia (6%)


Headache (5%)


Use reversing the anticoagulant effect increases the risk of blood clots and strokes from underlying diseases, for which the anticoagulant is being administered.

Patient should resume anticoagulant therapy as soon as possible.


Caution with hereditary fructose intolerance; 


The recommended dose of idarucizumab contains 4 g sorbitol as an excipient.


In patients  with hereditary fructose intolerance,  the administration of sorbitol in these patients is known to cause serious adverse reactions, including fatal reactions including hypoglycemia, hypophosphatemia, metabolic acidosis, increase in uric acid, and acute liver failure with breakdown of excretory and synthetic function.


In a limited number of patients, between 12-24 hr after administrating idarucizumab 5 g, elevated coagulation parameters have been observed.


If reappearance of clinically relevant bleeding together with elevated coagulation parameters is observed the administration of an additional 5 g dose may be considered


No adequate  studies of idarucizumab in pregnant or lactating women exist.


Metabolic  pathways contribute to the metabolism of antibodies involving biodegradation of the antibody to smaller molecules which are reabsorbed and incorporated in the general protein synthesis


Half-life: initial clearance 47 minutes and 10.3 hr terminal clearance.


Excretion: 32.1% urine within 6 hr after administration.


Administration:


Infuse 5-g dose IV as 2 consecutive 2.5-g infusions or give as a bolus injections by injecting both 2.5-g vials consecutively one after another via syringe.


Restarting antithrombotic therapy in patients being treated with dabigatran should be considered as soon as medically appropriate.



Idarucizumab is a specific reversal agent for dabigatran, with no impact on the effect of other anticoagulant or antithrombotic therapy.


Dabigatran treatment can be initiated 24 hr after administration of idarucizumab.


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