Introduction:

There are limited data on outcomes when switching between tacrolimus brands in prevalent transplant recipients. We have undertaken a monitored switch from Prograf to Adoport in prevalent patients.

Methods:

All stable, prevalent patients were given written and verbal information in advance of the switch to Adoport. Patients were advised to use their Prograf stock before starting Adoport. Biochemistry and trough tacrolimus level were scheduled 7-14 days after switching, otherwise testing was as per routine practice. Data were analysed from the closest timepoint pre/post the switch (PRE/POST) as well as all data in the 6-month window pre/post the switch date (6Mpre/6Mpost).

Results:

768 tacrolimus levels from 106 patients were analysed: mean (SD) age 53yrs (14), weight 81kg (18), 69mth (45) post-transplant, 92% Caucasian, 63% Male, 14% DM. There were no episodes of rejection related to the switch.

There was no significant change of tacrolimus levels in either the short or long-term analysis and the eGFR was stable. The tacrolimus dose changes [(6Mpre – increase 1, decrease 6), (6Mpost, increase 6, decrease 20)] are reflected in a small but significant fall in the mean dose. Only 4/106 required a reduction after the day 7-14 level. Intra-patient variation in levels was high but equivalent for Prograf and Adoport (mean Coefficient of Variation 19% v 21%, p=0.229).

Conclusions:

In routine clinical practice, tacrolimus levels are intrinsically variable on both brands. The switch resulted in a small rise in dose change frequency and a marginal (<0.2mg/day) reduction in dose, with stable levels. Despite patient and clinician anxiety about generic switch, it can be safely achieved with good communication and minimal additional monitoring.

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