Outcome following switch between brand name and generic tacrolimus in paediatric population - 08/12/17
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Résumé |
Introduction |
For many medicines, a switch between formulations can be done with little monitoring. Tacrolimus provides an interesting challenge due to its narrow therapeutic window requiring careful medical supervision and therapeutic monitoring. Currently, there is limited evidence to show the effects of a switch between tacrolimus formulations in paediatric patients. We present the effects of our study switching our patients from brand to generic formulation.
Method |
Patients were given written and verbal advice to switch from Prograf® to the same dose of Adoport® two weeks before their next clinical review and bloods were tested. Then, we reviewed the data for tacrolimus and creatinine levels before and after the switch and assessed for any clinical variation.
Results |
Forty-one stable patients were switched from Prograf® to Adoport®. Four patients were lost to tertiary follow-up. Six patients had a rise in creatinine more than 15%: in 2 patients, the rise was associated with UTI, 2 patients were treated empirically with high dose steroids for concerns of rejection, 1 patient developed swelling of legs (cause unidentified, DVT ruled out with scan) managed with increase in maintenance dose steroids and the cause was unclear in the last patient. In remaining 31 patients, there was no significant change noted in the creatinine levels [t-test −2.38, P-value 0.01]. One patient developed hair loss and requested to go back onto Prograf®, but all others continued on Adoport® and patients with initial rise in creatinine stabilized to baseline.
Conclusion |
This study assessed the clinical outcomes for paediatric renal transplant/nephrotic patients switching from Prograf® to Adoport®. The majority of patients tolerated the switch well. There was significant cost saving associated for NHS England of approximately £36,000 (2015–2016). Our outcome data therefore support the switch from Prograf® to Adoport® and its continued use as a potentially safe and cost-saving measure.
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Vol 24 - N° 12
P. 1336-1337 - décembre 2017 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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