Tacrolimus is a medicine that inhibits the activation of the serine-threonine phosphatase, calcineurin, in T lymphocytes. This suppresses T lymphocyte activation and the subsequent generation of cytotoxic lymphocytes, thereby down regulating processes leading to acute graft rejection.

Tacrolimus is the primary immunosuppression drug used in kidney and liver transplant patients. It is also a drug with a narrow therapeutic index. Such drugs are defined by a narrow distance between the dosage that induces a desired effect and that dosage which already has a toxic effect [1].

Following organ transplantation, patients require lifelong treatment with immunosuppressants. Many transplant patients are faced with complicated post-transplant medication regimens and significant financial burden.

The generic tacrolimus, tacforius, is made by Teva Pharmaceutical Industries and is a generic version of the brand-name tacrolimus, Advagraf, which is made by Astellas Pharma and has been approved in the European Union since 25 April 2007.

The CHMP approved tacforius prolonged-release capsules in dosages of 0.5, 1, 3 and 5 mg, saying that studies of the generic ‘demonstrated the satisfactory quality of Tacforius, and its bioequivalence to the reference product Advagraf’. 

Related articles
Switching stable kidney transplant patients to generic tacrolimus safe

Novartis introduces branded generic tacrolimus

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Follow-up study finds generic tacrolimus safe for kidney transplant patients [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 10]. Available from: www.gabionline.net/Generics/Research/Follow-up-study-finds-generic-tacrolimus-safe-for-kidney-transplant-patients

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2017 Pro Pharma Communications International. All Rights Reserved.