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The Annals of Pharmacotherapy: Vol. 37, No. 12, pp. 1793-1796. DOI 10.1345/aph.1D076
© 2003 Harvey Whitney Books Company.
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Tacrolimus and Lopinavir/Ritonavir Interaction in Liver Transplantation

Kristine S Schonder, PharmD

Assistant Professor of Pharmacy and Therapeutics, University of Pittsburgh School of Pharmacy; Clinical Pharmacist, University of Pittsburgh Medical Center, Pittsburgh, PA

Michael A Shullo, PharmD

Assistant Professor of Pharmacy and Therapeutics, University of Pittsburgh School of Pharmacy; Clinical Pharmacist, University of Pittsburgh Medical Center

Olanrewaju Okusanya, PharmD

Clinical Instructor of Pharmacy and Therapeutics, University of Pittsburgh School of Pharmacy; Pharmacy Practice Resident, University of Pittsburgh Medical Center

Reprints: Kristine S Schonder PharmD, University of Pittsburgh School of Pharmacy, Department of Pharmacy and Therapeutics, 302 Scaife Hall, 200 Lothrop St., Pittsburgh, PA 15213-2582, FAX 412/648-3098, schonderks{at}msx.upmc.edu

OBJECTIVE: To report an interaction between tacrolimus and the protease inhibitor combination lopinavir/ritonavir in a liver transplant patient.

CASE SUMMARY: A 48-year-old white male liver transplant recipient receiving tacrolimus 5 mg twice daily for immunosuppression started highly active antiretroviral therapy for his HIV-positive status. Three days after initiation of lopinavir/ritonavir, the tacrolimus concentration rose sharply to toxic levels. Subsequent tacrolimus doses were withheld until tacrolimus concentrations normalized over 15 days. The tacrolimus dose was reestablished at a much lower dose, 0.5 mg once weekly. An objective causality assessment revealed that the adverse event was highly probable.

DISCUSSION: Tacrolimus is metabolized in the liver via CYP3A4. Protease inhibitors are known to inhibit CYP3A4 and have been documented to increase tacrolimus concentrations, putting the patient at risk of developing nephrotoxic and/or neurotoxic symptoms. In this case, concomitant use of lopinavir/ritonavir caused tacrolimus concentrations to rise more dramatically than had been previously reported in the literature for other protease inhibitors.

CONCLUSIONS: Extreme caution must be used when administering tacrolimus concomitantly with lopinavir/ritonavir. Therapeutic concentrations of tacrolimus can be maintained with tacrolimus doses that are far below standard dosages.

Key Words: lopinavir/ritonavir, tacrolimus, toxicity

Published Online, October 10, 2003. www.theannals.com, DOI 10.1345/aph.1D076


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