Why was Calibra™ developed?  
Calibra™ was developed in response to multiple requests from the WAPPS-Hemo user base who wanted to support personalisation of Emicizumab treatment for their patients.

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Who developed Calibra™?  
It was a collaboration between the WAPPS-Hemo research network and the core group of PopPK developers at McMaster University and the University of Waterloo.

 

Who can use Calibra™?  
Currently Calibra™ is only available to hemophilia treaters and physicians that are registered as WAPPS-Hemo users. It is a separate platform, but you use your WAPPS-Hemo credentials to access it.

 

Is Calibra™ privacy compliant?  
Calibra™ adheres to the same strict privacy regulations as WAPPS-Hemo.  More details are available in the Terms of Use and Privacy Policy statements.

 

What is myCalibra™? 
myCalibra™ is the companion patient app for Calibra™.  It is freely available on the Apple and Google applications stores and must be enabled by the treater or physician.  

 

How does myCalibra™ operate?  
After selecting one of the available treatment options in Calibra™, the physician/treater can activate the patient app, myCalibra™.  Once activated myCalibra™ advises the patient of the treatment plan and notifies them of their next scheduled infusion.  It also provides a convenient location to record infusions and bleeding episodes. 

 

Can the doctor or the patient see the data inputted in myCalibra™?  
myCalibra™ can generate an injection report similar to myWAPPS, and all the infusion and bleeding data are available to the doctor for review in the myWAPPS Dashboard.

 

Is the PK of Emicizumab very predictable i.e., does it maintain a narrow range while in the blood?
Although the PK is rather predictable, Emicizumab pharmacodynamics (i.e. its clotting effect) shows more variability.  Indeed, the clotting effect of Emicizumab for the same dose varies in different patients.

 

Does Calibra calculate exact theoretical dose?
Yes, and more than that Calibra™ will calculate the most efficient use of available vials.  It will suggest one or more vial combinations providing the closest amount of medication resulting in full vial(s) usage.  The physician can indicate which vial size(s) they want to use, or if using one or more sizes, and/or multiple vials. In MANUAL MODE, Calibra™ also allows “manual” input of the desired dose, or vial size and quantity.  In each case Calibra calculates the appropriate treatment interval based upon the theoretical dosage.

 

Are there practical concerns when dosing Emicizumab?
The practical implementation of the 1.5 mg/kg (or equivalent) regimen is not achievable in many patients using full vials.  Areas for concerns are (1) injecting only part of a vial content introduces the risk for errors in the administered amount, and (2) it implies wasting medication. Together, these two challenging realities are difficult to accept for patients and treaters in the haemophilia community.

 

How do we know how to calculate the efficiencies we are gaining using Calibra™?
Calibra will report how many injections per year can be eliminated by maximizing the use of full vial(s), and it will also report the estimated volume of drug savings over the same period

 

 

References

1)    Retout S, Schmitt C, Petry C, et al. Population Pharmacokinetic Analysis and Exploratory Exposure–Bleeding Rate Relationship of Emicizumab in Adult and Pediatric Persons with Hemophilia A. Clin Pharmacokinet 2020;59:1611–25. doi:10.1007/s40262-020-00904-z

2)    Yu JK, Iorio A, Chelle P, et al. Pharmacokinetic implications of dosing emicizumab based on vial size: A simulation study. Haemophilia 2021;27:358–65. doi:10.1111/hae.14292