Immunosuppressants and Antibiotics Bayesian dose adjustment

Pharmacokinetics Newsletter

LIMOGES, Thursday 20^th December 2018 

Web Portal  

Seasons Greetings

The TDM team

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Adaptation Bayésienne des ImmunoSuppresseurs, Antibiotiques et Anti-cancéreux

La NEWSLETTER Pharmacocinétique

LIMOGES, le jeudi 5 Octobre 2017 

Portail WEB

Le site ABIS fête sa 100.000^ème demande !

Chers utilisateurs du site ABIS, nous venons de valider la 100.000^ème demande d’adaptation d’immunosuppresseurs, depuis avril 2005. Prochain objectif la 200.000^ème !

Merci beaucoup pour votre confiance!

L’équipe STP

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Immunosuppressants and Antibiotics Bayesian dose adjustment

The Pharmacokinetics Newsletter

LIMOGES, Thursday 5^th October 2017 

WEB Portal

The ISBA website celebrates its 100,000^th request!

Dear ISBA users, we just validated the 100,000^th request for immunosuppressant dose individualization, since April 2005. On the road to the 200,000^th!

Thank you so much for your trust!

The TDM Team

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Immunosuppressants and Antibiotics Bayesian dose adjustment

The Pharmacokinetics Newsletter

LIMOGES, Friday 12^th May 2017 

WEB Portal

Hello !

We are pleased to announce the publication of a new article about population pharmacokinetic modeling and Bayesian estimation, which this time is about ENVARSUS^®  (Once-daily Tacrolimus) in renal and hepatic transplantation:

The ISBA platform is thriving and the number of registered transplantation centers is steadily increasing, while the platform’s activity has remained constant during the past year.

We are taking this opportunity to provide you with a quick overview of the website activity:

-       9836 immunosuppressant kinetics have been modeled so far this year, coming from 50 different hospital centers!

-       Among them, the three most active are:

Mycophenolic acid remains the most modeled immunosuppressant with about three quarters of the total number of requests:

The requests mainly come from metropolitan France and its overseas territories. About 10% of the requests are made by other countries, notably North Africa and the United States of America, or neighbouring countries such as Belgium and Switzerland!

The ergonomics of the web portal has been improved, and an ISBA mobile application will be launched in the near future. The interface will also be improved and a question-and-answer forum will be set up.

Thank you for your trust !

The TDM Team

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Immunosuppressants and Antibiotics Bayesian dose adjustment

The Pharmacokinetics Newsletter

LIMOGES, Tuesday 27^th December 2016 

WEB Portal

 ¤ The ISBA website has expanded this year :

-          Population pharmacokinetic models and Bayesian estimators have been developed for tacrolimus (Envarsus® formulation) in kidney and liver transplantation (optimal sampling times 0, 8 and 12h).

-          Population pharmacokinetic models and Bayesian estimators have been developed for tacrolimus (Advagraf® formulation) in liver transplantation (optimal sampling times 0, 2 and 6h).

¤ Among our New Year resolutions, we are planning to offer you :

-          A new and more ergonomic homepage, adapted for a variety of  screens (tablet, fixed navigator, …)

-          A question and answer forum for problems when entering data on ISBA ( coming summer 2017)

-          The development of PKJust (dose adjustment of antibiotics), taking into account biological and bacteriological information so as to personalize the therapeutic target.

Thank you for your trust !

The TDM Team

 Seasons Greetings to you all

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Immunosuppressants Bayesian Dose Adjustment

The I.S.B.A NEWSLETTER

Tuesday 28th June 2016

ISBA

New Bayesian estimators

We are pleased to inform you that new Bayesian estimators dedicated to the tacrolimus formulation Envarsus® in adult kidney and liver transplantation are now available on our ISBA website.

Envarsus® is a once-daily prolonged release formulation of tacrolimus. It is characterized by increased intestinal bioavailability owing to the Meltdose® technology. This leads to the administration of smaller doses (about 30% less) in comparison to other tacrolimus formulations. Since October 2014, Envarsus® has been approved in Europe for the prevention of rejection in kidney or liver transplantation or the treatment of rejection resistant to other immunosuppressants in adult transplant patients.

Veloxis and Chiesi provided us with the pharmacokinetic data of phase 2 clinical trials in renal and hepatic transplantation to allow us to develop population pharmacokinetic models and Bayesian estimators and we express our gratitude to them.

This tacrolimus formulation is characterized by a different pharmacokinetic profile as compared to Advagraf® with, in particular, lower maximal concentration (the figure below gives examples of modeled PK profiles in renal transplantation).

The slow and prolonged release of Envarsus® leads to a different limited sampling strategy for accurate Bayesian estimation of the AUC0-24h: 0, 8, 12h after dose intake for both types of transplantation.

Of note, it is the best limited sampling strategy leading to the lowest bias between predicted and observed AUC_0-24h. However, AUC_0-24h can be estimated from samples taken at (slightly) different times on condition that the exact times are known.

In conclusion, these new tools are available for adult renal and hepatic transplantation whatever the period post transplantation and the associated immunosupressants.

¤ Examples of PK profiles observed and modeled

Figure 1-Examples of PK profiles modeled using 3 samples (0, 8, 12h) (in black) and observed (in blue) in adult renal transplant patients in a validation dataset (data splitting).

Thank you for your trust!

The TDM Team

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