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Retrospective Analysis of Oral Versus Intravenous Tacrolimus in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Patients undergoing allogeneic hematopoietic stem cell transplant (HSCT) require immunosuppression to prevent complications associated with graft versus host disease (GVHD). Tacrolimus is used as part of combination GVHD prophylaxis. Tacrolimus is available as an oral formulation but is often administered as a continuous IV infusion due to concerns of absorption and toxicity. We report our experience substituting oral tacrolimus for IV tacrolimus as a component of GVHD prophylaxis regimens in patients admitted for HSCT.
Methods
We conducted a retrospective chart review of 36 patients who underwent an allogeneic HSCT and received oral tacrolimus and 36 patients who received IV tacrolimus. The primary endpoint was percent of tacrolimus levels in therapeutic range. Other pertinent endpoints included the incidence of GVHD through day 100 post-transplant, increases in serum creatinine greater than 1 mg/dL from baseline, initiation or titration of scheduled anti-hypertensive agents, incidence of dialysis, cost, and hospital length of stay.
Results
Groups were similar at baseline in terms of age, gender, indication for transplantation, source of stem cells, parenteral nutrition, and length of stay for transplant admission. The percent of therapeutic tacrolimus levels was similar between groups (< 10% difference in percent of therapeutic levels, see Tacrolimus Monitoring Figures). The number of peripheral laboratory draws was reduced from 368 to 44 draws as the majority of levels obtained while on oral tacrolimus (n = 301 levels) were drawn from existing central lines. No difference was noted in safety endpoints or the occurrence of acute GVHD to day +100 post-transplant (See "Safety Endpoints Figure" ). Based on the average wholesale price of tacrolimus formulations, this change in practice resulted in a cost savings of up to $290000.
Conclusion
Our institution experience with oral tacrolimus for GVHD prophylaxis supports continuation of this practice as a viable alternative to IV tacrolimus and results in significant cost savings.
