1. Idarucizumab (Praxbind®) for Dabigatran Reversal
Ruchi Jain, PharmD, BCPS
Clinical Pharmacy Specialist – Critical Care
HackensackUMC
NJSHP Medication Safety Symposium

2. Conflicts of Interest
Nothing to disclose

3. Objective Pharmacist Technicians
Explain the mechanism of action, dosing and logistical consideration for the use of idarucizumab for the reversal of dabigatran-related life-threatening bleeds
Technicians
Explain logistical/operational consideration for the use of idarucizumab

4. Patient Case Neurosurgery decided to administer idarucizumab
80 y/o male – presenting to the ED after slipping and falling on ice. Per wife, patient fell backwards hitting his left side and head
Hx of atrial fibrillation, diabetes, hypertension, coronary artery disease, hyperlipidemia, stroke, CAD
CT head: subdural hematoma
Medications prior to arrival
Dabigatran 150 mg bid
Aspirin 81 mg daily
Lisinopril 10 mg daily
Amlodipine 10 mg daily
Labs upon presentation:
Na: 139 mmol/L
K: 4.3 mmol/L
SCr: 2.5 mg/dL (baseline 1.2 mg/dL)
BUN: 57 mg/dL
Neurosurgery decided to administer idarucizumab
and possibly go to the OR for evacuation of hematoma

5. Idarucizumab (Praxbind®)
Therapeutic Class
Monoclonal Antibody; Antidote
FDA Indications and Uses
Reversal of the anticoagulant effects of dabigatran for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding
Praxbind®. [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2015.

6. Mechanism of Action
It is a humanized monoclonal antibody fragment (Fab) that binds specifically to dabigatran and its acylglucuronide metabolites with an affinity for dabigatran that is ~350 times greater than that of thrombin
Praxbind®. [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2015.

7. Dosage
The recommended dose of idarucizumab is 5 g, provided as two separate 50-mL vials, each containing 2.5 g given no more than 15 minutes apart
Praxbind®. [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2015.

8. Administration Option 1 Option 2
Hang vials and administer as 2 consecutive infusions
Inject both vials consecutively via syringe
Praxbind®. [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2015.

9. Take Away Messages
ISMP warning: Do not confuse Idarucizumab with IDArubicin
Tall Man lettering
idaruCIZUMAB and IDArubicin
Store separately, away from each other in the refrigerator
Barcoding
Have a system in place to ensure both vials are administered .

10. Pharmacist Question
Which of the following statement is FALSE regarding idarucizumab for the reversal of life-threatening bleeding?
It is NOT indicated for the reversal of Factor Xa inhibitors (i.e. apixaban, rivaroxaban)
It is a humanized monoclonal antibody fragment (Fab) that binds specifically to dabigatran with an affinity for dabigatran that is ~350 times greater than that of thrombin
The recommended dose of idarucizumab for reversal of dabigatran is 5 gm (2 vials)
The recommended dose of idarucizumab for reversal of dabigatran is 2.5 gm (1 vial)
None of the above

11. Technician Question
Which of the following statement is TRUE regarding idarucizumab for the reversal of life-threatening bleeding?
It is indicated for the reversal for dabigatran (Pradaxa)
It is stored in the freezer
It is stored in the refrigerator
Do not shake
A, C, and D
Answer is E

12. Questions?