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Prescribing Information

Prescribing Information

 

Pharmacokinetic studies

 

Astcoff PK comparison study
(Tremblay et al. 2015) 1

  • Study of patients receiving Prograf for one week, then either one week of Envarsus® and one week of Advagraf, or vice versa
  • Envarsus® PK parameters differed significantly from Advagraf and Prograf, when normalised to Prograf AUC
  • Prograf to Envarsus® conversion required TDD adjustment of -30%; Advagraf to Envarsus® required TDD reduction of -36%
  • The SPC states that patients converting from Prograf or Advagraf to Envarsus® should be converted at 1:0.7mg:mg2
 

ASERTAA PK in black, stable kidney
patients (Trofe-Clark et al. 2015) 3

  • PK study of African-American patients converted from Prograf to Envarsus
  • Envarsus® PK parameters were less affected by CYP3A5 genotype than IR-tacrolimus
  • Envarsus® achieved similar exposure across all genotypes at a reduced dose vs.IR-tacrolimus
 
 

Abbreviations

 

ECG, European Consensus Guidelines; HCP, healthcare professional; RDS, respiratory distress syndrome; SmPC, Summary of Product Characteristics.  

 
 

References

  1. Karolinska Institutet Innovations AB. Available at https://ki.se/en/collaboration/industry-collaborations/20-years-of-innovation-karolinska-institutet/the-man-who-has-saved-the-lives-of-a-million-babies. Accessed September 2024.
  2. Curstedt T, Halliday HL, Speer CP. A Unique Story in Neonatal Research: The Development of a Porcine Surfactant. Neonatology 2015;107(4):321–329.