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ACEP Now: Vol 38 – No 01 – January 2019

ILLUSTRATION: Chris Whissen & shutterstock.com

Idarucizumab (Praxbind) is the first and only specific reversal agent for a novel oral anticoagulant (NOAC) approved by the US Food and Drug Administration (FDA). The FDA granted accelerated approval to Praxbind in October 2015 and provided full approval April 17, 2018. Praxbind is a humanized monoclonal antibody fragment (Fab) indicated in patients treated with dabigatran etexilate (Pradaxa) when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in the case of life-threatening or uncontrolled bleeding.¹

Dosing

This medication is for intravenous use only. The recommended dose of Praxbind is 5 g, provided as two separate vials each containing 2.5 g/50 mL of idarucizumab.

Medication Safety

The Institute for Safe Medication Practices (ISMP) has alerted health care professionals about the risks of confusing idarucizumab with the antineoplastic drug idarubicin.²

Warnings and Precautions

Thromboembolic Risk: Reversing dabigatran therapy exposes patients to the thromboembolic risk of their underlying disease. Resume anticoagulant therapy as soon as medically appropriate.

Re-elevation of coagulation parameters: In patients with elevated coagulation parameters and reappearance of clinically relevant bleeding or those requiring a second emergency surgery/urgent procedure, an additional 5 g dose of Praxbind may be considered.

Risks of serious adverse reactions in patients with hereditary fructose intolerance due to sorbitol excipient: When prescribing Praxbind to patients with hereditary fructose intolerance, the combined daily metabolic load of sorbitol/fructose from all sources, including other drugs containing sorbitol, must be considered. The recommended dose of Praxbind contains 4 g of sorbitol, and the minimum amount of sorbitol that can trigger a serious reaction is not known.

Adverse Reactions: The most frequently reported adverse reactions (≥5 percent) in patients treated with Praxbind were hypokalemia, delirium, constipation, pyrexia, and pneumonia.

Price

The cost of Praxbind intravenous solution (2.5 g/50 mL) is approximately $3,662 for a supply of 100 mL.³ Discount cards are available.

Read the emergency medicine commentary on Praxbind then complete the CME activity.

Dr. Choy is director of pharmacy practice at the New York State Council of Health-system Pharmacists in Albany.

References

1. Drugs @ FDA, Praxbind Prescribing information. FDA website. Accessed Dec. 14, 2018.
2. Warning: don’t confuse idarucizumab with idarubicin. Institute for Safe Medication Practices website. Accessed Dec. 14, 2018.
3. Praxbind prices, coupons and patient assistance programs. Drugs.com website. Accessed Dec. 14, 2018.