Praxbind (idarucizumab) The Pradaxa Reversal Agent: Cost, Side Effects, Dosing, And PI | Maysa Odeh, PharmD | RxEconsult

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Praxbind (idarucizumab) Cost, Side Effects, Dosing, And Prescribing Information For Pradaxa Reversal Category: Anticoagulation (clot prevention) by - October 20, 2015 | Views: 53542 | Likes: 0 | Comment: 0  

Interesting facts about Praxbind

  • The first approved to reversal agent for a new oral anticoagulant.
  • Praxbind will improve how patients taking Pradaxa are managed by anticoagulation clinics prior to surgical procedures and in the event of uncontrolled bleeding.
  • Praxbind does cause blood to coagulate.
  • Praxbind received accelerated approval based on limited clinical data and the reduction in unbound dabigatran and normalization of coagulation parameters in healthy volunteers. Continued approval for Praxbind may depend upon the result of an ongoing study.

What are side effects of Praxbind?

The most common side effects are:

  • a headache
  • low potassium
  • fever
  • confusion
  • constipation
  • pneumonia

Praxbind does not cause thromboembolic events (blood clots). In an analysis of the RE-VERSE AD trial, 5 of 123 patients reported thrombotic events. One of these patients experienced a thromboembolic event 2 days after treatment with Praxbind and 4 patients 7 days or more after treatment with Praxbind. None of these patients were receiving anticoagulants at the time  and the events were related to the each patient’s medical condition. [see Warnings and Precautions].

What is the dosage of Praxbind?

The dose of Praxbind is 5 g provided as 2 separate vials containing 2.5 g/50 mL each. It is given as two intravenous infusions no more than 15 minutes apart or by bolus injection by injecting both vials consecutively one after another via syringe. 

There is limited data to support the administration of an additional 5 g of Praxbind.

Renal impairment did not impact the reversal effect of Praxbind; no dosage adjustment required. Hepatic impairment has not been studied.

What are Praxbind drug interactions? 

There are no reported drug interactions. Praxbind should not be mixed with other medicinal products when administered.

What are warnings and precautions for Praxbind?

  • Reversing Pradaxa therapy may expose patients to the risk of clotting. To reduce this risk, anticoagulant therapy should be resumed as soon as possible.
  • If reappearance of bleeding occurs with elevated coagulation parameters after administration of Praxbind, an additional 5 g dose may be considered.
  • If an anaphylactic reaction or another serious allergic reaction occurs, Praxbind should be stopped immediately.

Pregnancy Warnings

Praxbind has not been studied in pregnant women. Therefore, its safety during pregnancy has not been established. It should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk, so caution should be exercised when Praxbind is administered to a nursing woman.

What is the cost of Praxbind?

The average wholesale price for a 5 g dose of Praxbind is $3500.

Also Read: Praxbind (Idarucizumab) Approval And Effect For Pradaxa (dabigatran) Reversal


Praxbind Prescribing Information (Package Insert)


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