Parenteral Manual

Idarucizumab (STUDY DRUG)

Disclaimer: Official controlled document is the CHEO online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
PRAXBIND
Classification: 
antihemorrhagic agent
Original Date: 
March 2017
Indications: 
  • Antidote, specific for dabigatran.  Indicated for patient treated with dabigatran etexilate when rapid specific reversal of the anticoagulant effects of dabigatran is required for:
    -  emergency surgery/urgent procedures
    -  life-threatening or uncontrolled bleeding
Reconstitution and Stability: 
  • Available as 50 mg/mL solution - 50 mL vial
  • Store vials in refrigerator between 2˚- 8˚C.
  • Inspect visually for particulate matter and discolouration prior to administration. 
    Do not use if solution show haziness, particulate matter, discolouration, or leakage
  • If vials are taken out of the fridge and not used within 6 hours the vial may be re-refrigerated and used at a later date.  Product must remain in the vial with the septum intact.
Compatibility: 

-  Solutions Compatible: 0.9% NaCl

-  Y-site Compatible:  0.9% NaCl

-  Co-administration with any other IV medications or fluids is not permitted. 

-  A pre-existing intravenous line may be used for administration - must be flushed with sterile 0.9% NaCl prior to and at the end of infusion.  No other infusion should be administered in parallel via the same intravenous access.

Administration: 

(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)

SC NO
IM NO
IV Direct YES - preferred - use a 0.22 micron in-line filter
IV Intermittent Infusion YES - use a 0.22 micron in-line filter
IV Continuous Infusion NO

 

Dosage: 

(For neonatal dosages, refer to Neonatal IV Drug Manual.)

  • Total dose is based on patient's weight. Max dose: 5000 mg
  • Give as rapid infusions/injections, divided in two equal parts administered no more then 15 minutes apart
  • Treatment duration:  1 treatment
Weight (kg) from Weight (kg) to Rounded total dose, mg Rounded total dose, mL Application schedule (split dose application)
2.5 5 300 6 2 x 3 mL
6 10 600 12 2 x 6 mL
11 20 1250 25 2 x 12.5 mL
21

30

1850 37 2 x 18.5 mL
31 40 2500 50 2 x 25 mL
41 50 3100 62 2 x 31 mL
51 60 3750 75 2 x 37.5 mL
61 70 4350 87 2 x 43.5 mL
71 80 5000 100 2 x 50 mL
81 90 5000 100 2 x 50 mL
91

100

and greater

5000 100 2 x 50 mL
  • NO DOSE ADJUSTMENT IN RENAL FAILURE

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