Basiliximab: indicated for renal transplantation only; efficacy and safety not shown in heart transplantation

Basiliximab (Simulect) is indicated for preventing acute organ rejection only for allogeneic renal transplantation in patients receiving organ transplantation for the first time.

Article date: October 2014

A European regulatory review investigated the safety and efficacy of basiliximab for off-label use in heart transplantation. This review was triggered by three unexplained deaths in Sweden in patients who received basiliximab for heart transplantation. All three patients had signs and symptoms of thromboembolic events and potential cardiac disorders.

The review found no adequately powered randomised studies of basiliximab in heart transplantation. The clinical trials that have been done in heart transplantation did not prove basiliximab to be effective. Furthermore, serious cardiac side effects such as cardiac arrest, atrial flutter, and palpitations were observed more frequently with basiliximab than with other induction agents. Therefore a new warning has been included in the basiliximab product information regarding the lack of proven safety and efficacy in heart transplantation (see link below).

Call for reporting

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Further information

Letter sent to healthcare professionals in September 2014 (275Kb)

Basiliximab summary of product characteristics

Article citation: Drug Safety Update volume 8 issue 3, October 2014: S1

Published 11 December 2014