P4 Outcome following switch between brand name and generic tacrolimus in paediatric population

Abstract

IntroductionGeneric preparations of drugs are often cheaper than brand names and offers significant cost benefits. For many medicines, a switch between preparations can be done with little or no monitoring. Tacrolimus prescription, however, provides an interesting challenge due to its narrow therapeutic window and requires careful medical supervision and therapeutic monitoring while switching. Adoport1 is a generic tacrolimus preparation introduced to the market after the exclusivity period for Prograf2 ended. At present there is limited evidence to show the effects of the switch between formulations in paediatric patients. In 2015, Nottingham Children’s Renal Unit undertook to switch all existing paediatric kidney transplant and nephrotic patients on Prograf to Adoport and we herewith present the effects on patients and their Tacrolimus levels.MethodPrescriptions for tacrolimus are dispensed and delivered by a homecare provider on a three monthly basis. Patients were given written and verbal advice to switch from Prograf to the same dose of Adoport two weeks before their next clinical appointment. After taking a stock of their existing Prograf supply, a prescription was given to ensure the patient did not run out of Prograf until their switch date and had enough Adoport until the following prescription was due. The Tacrolimus level was then reviewed by the patient’s doctor at their clinic appointment and dose adjustments were made if necessary as per standard of care. We reviewed data for Tacrolimus levels in the 3 months before and after the switch and assessed for any clinical variation in immunosuppression.Results36 patients were switched from Prograf to Adoport. One patient developed hair loss and requested to go back onto Prograf, all other patients tolerated the switch well. There was no significant change in the tacrolimus levels of the population following the switch (p=0.02). There was no significant change in creatinine of the population following the switch (p=0.02). One patient required a dose adjustment following the switch.ConclusionThis study assessed the clinical outcomes for paediatric patients switching from Prograf to Adoport. We noted stable Tacrolimus levels in most patients following the switch and similar therapeutic effectiveness. The majority of patients tolerated the switch well. This resulted in a cost saving for NHS England from which a gain share was negotiated to benefit Nottingham University Hospitals NHS Trust. Our outcome data therefore support the use of Adoport in place of Prograf as a potential cost-saving measure.ReferencesSummary of Product characteristics Astella Pharma Ltd. Prograf 0.5 mg , 1 mg , 5 mg Hard capsules 2 November 2015. www.medicines.org.uk [Accessed: 30 April 2016].Summary of Product characteristics Sandoz Ltd. Adoport 1 mg capsules 18 August 2015. www.medicines.org.uk [Accessed: 30 April 2016].

A comprehensive review of the effects of tacrolimus (FK-506) on dry eye disease (DED): Focus on inflammation and biochemical processes

“…Fujimycin is an early developmental name that was used for TAC when it was first discovered and researched by Fujisawa Pharmaceutical Company (now Astellas Pharma) in Japan in the 1980s [32,33]. The chemical formula for TAC is C 44 H 69 NO 12 and is sold under several brand names including Prograf, Advagraf, and Envarsus XR [34,35]. TAC is administrable through oral ingestion or intravenous infusion [36].…”